[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"plasma-cell-leukemia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:plasma-cell-leukemia":31},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,20,0,[8,74,97,127,150,177,200,226,247,272,300,322,342,380,405,427,463,485,509,532],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":54,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":73},"100309946","phase-2-myeloablative-allo-hsct-with-related-or-unrelated-donor-for-heme-disorders-100309946",false,"NCT03314974","Myeloablative Allo HSCT With Related or Unrelated Donor for Heme Disorders","Myeloablative Allogeneic Hematopoietic Cell Transplantation Using a Related or Unrelated Donor for the Treatment of Hematological Diseases","-Inclusion Criteria:\n\n* Age: ≤ 60 years of age\n* Performance Status: Karnofsky ≥ 70%, Lansky play score ≥ 70\n* Consent: Voluntary written consent (adult or legally authorized representative; or parental\u002Fguardian)\n* Adequate Organ Function:\n\n  * Renal: Creatinine \\\u003C2x upper limit of normal. Patients above this limit must have creatinine clearance ≥ 40 ml\u002Fmin\u002F1.73m2 as determined by an age-appropriate method, such as cystatin C GFR.\n  * Hepatic: Bilirubin, AST, alkaline phosphatase \\\u003C4 times the upper limit of institutional normal\n  * Pulmonary: Diffusion capacity of oxygen, corrected for hemoglobin, \\> 50% of predicted. For pediatric patients not able to undergo PFTs or diffusion testing: O2 sat of \\>95% on room air\n  * Cardiac: Absence of decompensated congestive heart failure, or uncontrolled arrhythmia and left ventricular ejection fraction \\> 45%. For children not able to cooperate with MUGA or echocardiography, such should be clearly stated in the physician's documentation\n  * HIV Status: HIV infection with undetectable viral load. All HIV+ patients must be evaluated by Infectious Disease (ID) and a HIV management plan establish prior to transplantation\n\nOther Inclusion Criteria:\n\n* Women of child bearing potential and sexually active males with partners of child bearing potential must agree to use adequate birth control for the duration of treatment.\n* Donor Availability: Patients considered for transplantation must have a sufficient graft as based on current criteria of the University of Minnesota Blood and Marrow Transplantation Program\n* Eligible Diseases and Status: Patients are eligible unless their treatment is to be guided by a higher priority protocol.\n* Acute Leukemias: Must be in remission by morphology (≤5% blasts). Also a small percentage of blasts that is equivocal between marrow regeneration vs. early relapse are acceptable provided there are no associated cytogenetic markers consistent with relapse.\n* Acute Myeloid Leukemia (AML) and related precursor neoplasms: 2nd or greater complete remission (CR); first complete remission (CR1) in patients \\> 60 years old; CR1 in ≤ 60 years old that is NOT considered as favorable-risk.\n* Favorable risk AML is defined as having one of the following:\n\n  * t(8,21) without cKIT mutation\n  * inv(16) or t(16;16) without cKIT mutation\n  * Normal karyotype with mutated NPM1 and wild type FLT-ITD\n  * Normal karyotype with double mutated CEBPA\n  * Acute prolymphocytic leukemia (APL) in first molecular remission at the end of consolidation\n* Very high risk pediatric patients with AML: Patients \\\u003C21 years, however, are eligible with (M2 marrow) with \\\u003C 25% blasts in marrow after having failed one or more cycles of chemotherapy.\n* Acute lymphoblastic leukemia (ALL)\u002Flymphoma: second or greater CR; CR1 unable to tolerate consolidation chemotherapy due to chemotherapy-related toxicities; CR1 high-risk ALL.\n* High risk ALL is defined as having one of the following:\n\n  * Evidence of high risk cytogenetics, e.g. t(9;22), t(1;19), t(4;11), other MLL rearrangements, IKZF1\n  * 30 years of age or older at diagnosis\n  * White blood cell counts of greater than 30,000\u002FmcL (B-ALL) or greater than 100,000\u002FmcL (T-ALL) at diagnosis\n  * CNS leukemia involvement during the course of disease\n  * Slow cytologic response (\\>10% lymphoblasts in bone marrow on Day 14 of induction therapy)\n  * Evidence of persistent immonophenotypic or molecular minimal residual disease (MRD) at the end of induction and consolidation therapy\n* Very high risk pediatric patients with ALL: patients \\\u003C21 years are also considered high risk CR1 if they had M2 or M3 marrow at day 42 from the initiation of induction or M3 marrow at the end of induction. They are eligible once they achieve a complete remission.\n* Chronic Myelogenous Leukemia excluding refractory blast crisis: To be eligible in first chronic phase (CP1) patient must have failed or be intolerant to one or more tyrosine kinase inhibitors.\n* Plasma Cell Leukemia after initial therapy, in patients who have achieved at least a partial remission\n* Myeloproliferative Neoplasms\u002FMyelofibrosis, either primary as a result of polycythemia vera or essential thrombocythemia, with disease risk of intermediate or high-risk according to DIPSS criteria. Blasts must be \\\u003C10% by bone marrow aspirate morphology.\n* Myelodysplasia (MDS) IPSS INT-2 or High Risk (i.e. RAEB, RAEBt) or Refractory Anemia with severe pancytopenia, transfusion dependence, or high risk cytogenetics or molecular features. Blasts must be \\\u003C 10% by a representative bone marrow aspirate morphology.\n* Chronic Lymphocytic Leukemia\u002FSmall Lymphocytic Lymphoma (CLL\u002FSLL), Marginal Zone B-Cell Lymphoma or Follicular Lymphoma are eligible if there was disease progression\u002Frelapse within 12 of achieving a partial or complete remission. Patients who had remissions lasting \\> 12 months, are eligible after at least two prior therapies. Patients with bulky disease (nodal mass greater than 5 cm) should be considered for debulking chemotherapy before transplant.\n* Lymphoplasmacytic Lymphoma, Mantle-Cell Lymphoma, Prolymphocytic Leukemia are eligible after initial therapy in CR1+ or PR1+.\n* Diffuse large Cell NHL \\> CR\u002F\\> PR: Patients in CR\u002FPR with initial short remission (\\\u003C6 months) are eligible, or those who have failed\u002For are not eligible for autologous transplant.\n* Lymphoblastic Lymphoma, Burkitt's Lymphoma, and other high-grade NHL after initial therapy if stage III\u002FIV in CR1\u002FPR1 or after progression if stage I\u002FII \\\u003C 1 year.\n* Multiple Myeloma beyond PR2: Patients with chromosome 13 abnormalities, first response lasting less than 6 months, or β-2 microglobulin \\> 3 mg\u002FL, may be considered for this protocol after initial therapy.\n* Juvenile myelomonocytic leukemia\n* Biphenotypic\u002FUndifferentiated\u002FProlymphocytic Leukemias in first or subsequent CR.\n* MRD positive leukemia (AML, ALL or accelerated\u002Fblast phase CML). Selected patients in morphologic CR, but with positive immunophenotypic (flow cytometry) or molecular evidence of MRD may be eligible if recent chemotherapy has not resulted in MRD negative status.\n* Natural Killer Cell Malignancies\n* Acquired Bone Marrow Failure Syndromes except for Fanconi Anemia or Dyskeratosis Congenita\n* Other Leukemia Subtypes: A major effort in the field of hematology is to identify patients who are of high risk for treatment failure so that patients can be appropriately stratified to either more (or less) intensive therapy. This effort is continually ongoing and retrospective studies identify new disease features or characteristics that are associated with treatment outcomes. Therefore, if new features are identified after the writing of this protocol, patients can be enrolled with the approval of two members of the study committee.\n\nExclusion Criteria:\n\n* Chemotherapy refractory large cell and high grade NHL (i.e., progressive disease after \\> 2 salvage regimens)\n* CML in blast crisis\n* Large cell lymphoma, mantle cell lymphoma and Hodgkin disease that is progressing on salvage therapy.\n* Evidence of progressive disease by imaging modalities or biopsy - persistent PET activity, though possibly related to lymphoma, is not an exclusion criterion in the absence of CT changes indicating progression.\n* Active central nervous system malignancy\n* if ≤ 18 years old, prior myeloablative transplant within the last 6 months. If \\>18 years old prior myeloablative allotransplant or autologous transplant\n* Active HIV infection or known HIV positive serology\n* active uncontrolled infection\n* Pregnant or breastfeeding. The agents used in this study include Pregnancy Category D: known to cause harm to a fetus. Females of childbearing potential must have a negative pregnancy test prior to starting therapy.","ALL","60 Years",{"count":19,"type":20},300,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","This is a Phase II study of allogeneic hematopoietic stem cell transplant (HCT) using a myeloablative preparative regimen (of either total body irradiation (TBI); or, fludarabine\u002Fbusulfan for patients unable to receive further radiation). followed by a post-transplant graft-versus-host disease (GVHD) prophylaxis regimen of post-transplant cyclophosphamide (PTCy), tacrolimus (Tac), and mycophenolate mofetil (MMF).",[26,27,28,29,30,31,32,33,34,35,36,37,38,39,40,41,42,43,44,45,46,47,48,49,50,51,52,53],"Acute Leukemia","Acute Myeloid Leukemia","Acute Lymphoblastic Leukemia","Lymphoma","Chronic Myelogenous Leukemia","Plasma Cell Leukemia","Myeloproliferative Neoplasms","Myelofibrosis","Myelodysplasia","Refractory Anemia","High Risk Anemia","Chronic Lymphocytic Leukemia","Small Lymphocytic Lymphoma","Marginal Zone B-Cell Lymphoma","Follicular Lymphoma","Lymphoplasmacytic Lymphoma","Mantle-Cell Lymphoma","Prolymphocytic Leukemia","Diffuse Large Cell Non Hodgkins Lymphoma","Lymphoblastic Lymphoma","Burkitt Lymphoma","High Grade Non-Hodgkin's Lymphoma, Adult","Multiple Myeloma","Juvenile Myelomonocytic Leukemia","Biphenotypic\u002FUndifferentiated\u002FProlymphocytic Leukemias","MRD Positive Leukemia","Natural Killer Cell Malignancies","Acquired Bone Marrow Failure Syndromes",[55,16,56,57,58,59,60],"AML","MDS","NHL","CLL","CML","SLL","RECRUITING","2026-06-23",{"date":64,"type":65},"2026-06-25","ACTUAL",{"date":67,"type":65},"2018-03-30",{"date":69,"type":20},"2028-06-10",{"name":71,"class":72},"Masonic Cancer Center, University of Minnesota","OTHER",1,{"id":75,"slug":76,"hasResults":11,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":80,"eligibilityCriteria":81,"healthyVolunteers":11,"sex":16,"minAge":82,"maxAge":4,"enrollmentInfo":83,"targetDuration":4,"studyType":21,"phases":85,"briefSummary":86,"conditions":87,"keywords":4,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":73},"100470402","phase-2-impact-of-budesonide-on-incidence-of--gr2-diarrhea-in-multiple-myeloma-mm-patients-undergoing-autologous-stem-cell-transplant-100470402","NCT05405387","Impact of Budesonide on Incidence of ≥ Gr2 Diarrhea in Multiple Myeloma (MM) Patients Undergoing Autologous Stem Cell Transplant","A Randomized Phase 2 Trial Investigating the Impact of Budesonide Prophylaxis on Incidence of ≥ Grade 2 Diarrhea in Multiple Myeloma (MM) Patients Undergoing Autologous Stem Cell Transplant","IMPACT","Inclusion Criteria:\n\n* Subject aged ≥ 18 years.\n* History of histologically confirmed multiple myeloma and\u002For Plasma Cell Leukemia diagnosis undergoing ASCT who are determined to be fit by the investigator to undergo ASCT with melphalan 200 mg\u002Fm2 or melphalan 140 mg\u002Fm2 as conditioning.\n* Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines.\n* Adequate organ function as defined as:\n\n  --Hepatic:\n  * Total Bilirubin ≤ 2 x institutional upper limit of normal (ULN).\n  * AST(SGOT)\u002FALT(SGPT) ≤ 5 × institutional ULN\n* For female subjects who have not undergone surgical sterilization: Negative pregnancy test or evidence of post-menopausal status. The post-menopausal status will be defined as having been amenorrheic for 12 months without an alternative medical cause or having undergone surgical sterilization (bilateral oophorectomy or hysterectomy). The following age-specific requirements apply:\n\n  * Women \\\u003C 50 years of age:\n\n    * Amenorrheic for ≥ 12 months following cessation of exogenous hormonal treatments; and\n    * Luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution; or\n    * Underwent surgical sterilization (bilateral oophorectomy or hysterectomy).\n  * Women ≥ 50 years of age:\n\n    * Amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments; or\n    * Had radiation-induced menopause with last menses \\>1 year ago; or\n    * Had chemotherapy-induced menopause with last menses \\>1 year ago; or\n    * Underwent surgical sterilization (bilateral oophorectomy, bilateral salpingectomy, or hysterectomy).\n\nInclusion Criteria required for Patients Enrolling in Safety Run-In Cohort only:\n\n-Patient must have at least 2.5 x 106 CD34 cells in reserve for use if engraftment is delayed\n\nExclusion Criteria:\n\n* Ongoing or current use of oral budesonide at the time of enrollment.\n* Receiving other investigational agents, unless deemed acceptable after consultation with the PI\n* Subjects with moderate or severe pre-existing hepatic impairment as classified according to the Child-Pugh system.\n* Prior history or current diagnosis of inflammatory bowel disease, microscopic colitis at baseline.\n* Prior history of receiving an allogenic stem cell transplant\n* Medical, psychiatric, cognitive, or other conditions that may compromise the subject's ability to understand the subject information, give informed consent, comply with the study protocol or complete the study.\n* Known prior severe hypersensitivity to melphalan or budesonide or any component in their formulations or compounds of similar composition (NCI CTCAE v5.0 Grade ≥ 3).\n* Subjects taking prohibited medications as described in Section 6.6.1. A washout period of prohibited medications for a period of at least five half-lives or 14 days (whichever is shorter) should occur before the start of treatment.","18 Years",{"count":84,"type":20},120,[23],"A randomized placebo controlled, phase 2 study of budesonide in subjects with multiple myeloma undergoing autologous stem cell transplant (ACST). The study includes a run-in period with 20 patients.",[48,31],"2026-06-04",{"date":90,"type":65},"2026-06-05",{"date":92,"type":65},"2023-05-03",{"date":94,"type":20},"2028-03",{"name":96,"class":72},"University of Utah",{"id":98,"slug":99,"hasResults":11,"nctId":100,"briefTitle":101,"officialTitle":101,"acronym":4,"eligibilityCriteria":102,"healthyVolunteers":11,"sex":16,"minAge":103,"maxAge":104,"enrollmentInfo":105,"targetDuration":4,"studyType":21,"phases":107,"briefSummary":109,"conditions":110,"keywords":4,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":119,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":73},"100446362","phase-1-phase-iii-study-of-car70--engineered-il15-transduced-cord-blood-derived-nk-cells-in-conjunction-with-lymphodepleting-chemotherapy-for-the-management-of-relapserefractory-hematological-malignances-100446362","NCT05092451","Phase I\u002FII Study of CAR.70- Engineered IL15-transduced Cord Blood-derived NK Cells in Conjunction With Lymphodepleting Chemotherapy for the Management of Relapse\u002FRefractory Hematological Malignances","Inclusion criteria:\n\n1. Patients with hematological malignances with an expression of CD70 in the pre-enrollment tumor sample ≥ 10% measured by immunohistochemistry or flow cytometry.\n2. Patients must meet diseases specific eligibility criteria (see below)\n3. Patients at least 1 week from last cytotoxic chemotherapy at the time of starting lymphodepleting chemotherapy, except for Hydroxyurea which is allowed for peripheral blood count control in AML, CML, and MDS patients until the day prior to administration of lymphodepleting chemotherapy. Patients may continue tyrosine kinase inhibitors or other targeted therapies until up to three days prior to administration of lymphodepleting chemotherapy.\n4. Localized radiotherapy to one or more disease sites is allowed prior the infusion provided that there are additional disease sites that are not irradiated to assess response\n5. Karnofsky Performance Scale \\> 50% for patients who are \\>16 years old or Lansky score ≥50% for patients who are ≤16 years of age.\n6. Adequate organ function:\n\n   1. Renal: Serum creatinine \\\u003C\u002F= 2x ULN or estimated Glomerular Filtration Rate \\>\u002F= 30 ml\u002Fmin\u002F1.73 m2\n   2. Hepatic: ALT\u002FAST \\\u003C\u002F= 3 x ULN or \\\u003C\u002F= 5 x ULN if documented liver metastases, Total bilirubin \\\u003C\u002F2xULN, except in subjects with Gilbert's Syndrome in whom total bilirubin must be \\\u003C\u002F= 3 x.ULN. No history of liver cirrhosis. No ascites.\n   3. Cardiac: Cardiac ejection fraction \\>\u002F= 40%, no clinically significant pericardial effusion as determined by an ECHO, and no uncontrolled arrhythmias or symptomatic cardiac disease.\n   4. Pulmonary: No clinically significant pleural effusion (per PI discretion), baseline oxygen saturation \\> 92% on room air and adequate pulmonary function with FEV1, FVC and DLCO (corrected for Hgb) \\>50%.\n7. Able to provide written informed consent.\n8. 12-80 years of age.\n9. Weight ≥40 kg\n10. All participants who are able to have children must practice effective birth control while on study and up to 3 months post completion of study therapy. Acceptable forms of birth control for female patients include: hormonal birth control, intrauterine device, diaphragm with spermicide, condom with spermicide, or abstinence, for the length of the study. If the participant is a female and becomes pregnant or suspects pregnancy, she must immediately notify her doctor. If the participant becomes pregnant during this study, she will be taken off this study. Men who are able to have children must use effective birth control while on the study. If the male participant fathers a child or suspects that he has fathered a child while on the study, he must immediately notify his doctor.\n11. Signed consent to long-term follow-up protocol PA17-0483 to fulfill the institutional responsibilities to various regulatory agencies.\n12. Are willing and able to provide informed consent, as appropriate (either directly or through a legally authorized representative \\[LAR\\])\n\nExclusion criteria:\n\n1. Positive beta HCG in female of child-bearing potential defined as not postmenopausal for 24 months or no previous surgical sterilization or lactating females.\n2. Presence of clinically significant Grade 3 or greater toxicity from the previous treatment, as determined by PI.\n3. Presence of uncontrolled fungal, bacterial, viral, or other infection not responding to appropriate therapy.\n4. HIV with detectable viral load\n5. Presence of active neurological disorder(s).\n6. Active autoimmune disease within 12 months of enrollment\n7. Amyloidosis or POEMS syndrome\n8. Active cerebral or meningeal involvement by the malignancy\n9. Active (defined as requiring therapy) acute or chronic GVHD\n10. Any other malignancy known to be active, except for treated cervical intra-epithelial neoplasia and non-melanoma skin cancer.\n11. Presence of any other serious medical condition that may endanger the patient at investigator discretion.\n12. Major surgery \\\u003C4 weeks prior to first dose of the preparatory chemotherapy\n13. Allogeneic SCT or DLI \\\u003C12 weeks prior to first dose of preparatory chemotherapy\n14. Concomitant use of other investigational agents.\n15. Concomitant use of other anti-cancer agents.\n16. Patients receiving systemic steroid therapy at time of NK cell infusion (physiological substitutive doses are allowed), or have received antithymocyte globulin or lymphocyte immune globulin within 14 days of enrollment or alemtuzumab within 28 days of enrollment.\n17. Patients receiving immunosuppressive therapy","12 Years","80 Years",{"count":106,"type":20},80,[108,23],"PHASE1","The goal of this clinical research study is to learn about the safety of giving immune cells called natural killer (NK) cells with chemotherapy to patients with leukemia, lymphoma, or multiple myeloma.\n\nImmune system cells (such as NK cells) are made by the body to attack foreign or cancerous cells. Researchers think that NK cells you receive from a donor may react against cancer cells in your body, which may help to control the disease.",[111,112,113,48,31,114,115,116,117,118],"B-Cell Lymphoma","Myelodysplastic Syndromes (MDS)","Acute Myeloid Leukemia (AML)","Hodgkin Lymphoma","T-cell Non-Hodgkin's Lymphoma\u002F T-cell Acute Lymphoblastic Leukmeia","Myelodysplastic Syndrome \u002F Chronic Myelomonocytic Leukemia","Blastic Transformation of Chronic Myeloid Leukemia","Germ Cell Tumors",{"date":120,"type":65},"2026-06-08",{"date":122,"type":65},"2022-11-01",{"date":124,"type":20},"2026-08-31",{"name":126,"class":72},"M.D. Anderson Cancer Center",{"id":128,"slug":129,"hasResults":11,"nctId":130,"briefTitle":131,"officialTitle":132,"acronym":4,"eligibilityCriteria":133,"healthyVolunteers":11,"sex":16,"minAge":82,"maxAge":104,"enrollmentInfo":134,"targetDuration":4,"studyType":21,"phases":136,"briefSummary":137,"conditions":138,"keywords":4,"overallStatus":139,"whyStopped":4,"lastUpdateSubmitDate":140,"lastUpdatePostDateStruct":141,"startDateStruct":143,"completionDateStruct":145,"leadSponsor":147,"locationsCount":4},"100637636","phase-2-testing-an-experimental-approach-to-treat-patients-with-plasma-cell-leukemia-the-quantum-trial-100637636","NCT07605416","Testing an Experimental Approach to Treat Patients With Plasma Cell Leukemia, The QUANTUM Trial","Quadruplet Induction Followed by Teclistamab Consolidation and Doublet Maintenance in Patients With Primary Plasma Cell Leukemia: The QUANTUM Trial","Inclusion Criteria:\n\n* Documented diagnosis of primary plasma cell leukemia according to IMWG criteria defined as 5% or greater circulating plasma cells at the time of initial diagnosis\n* Measurable disease at the time of initial diagnosis of at least one of the following as defined by IMWG criteria:\n\n  * Serum monoclonal protein ≥ 0.5 g\u002FdL or\n  * Urine monoclonal protein ≥ 200 mg\u002F24 hours (h) or\n  * Serum free light chain (FLC) assay: Serum free light chain ≥ 100 mg\u002FL and abnormal serum free light chain ratio\n* Age 18 - 80 years\n* Prior treatment:\n\n  * ≤ 1 cycle of induction treatment based on physician\u002Finvestigator discretion\n  * No history of severe allergic reaction (including erythema nodosum) to lenalidomide or other prior immunomodulatory imide drug (IMiD) therapy\n  * No history of clinically significant cardiopulmonary disease resulting from prior proteosome inhibitor therapy\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2\n* Not pregnant and not nursing, because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn, before study entry, the following criteria must be met\n\n  * Female of childbearing potential (FCBP) is a female who: 1) has achieved menarche (first menstrual cycle) at some point, 2) has not undergone a hysterectomy (the surgical removal of the uterus) or bilateral oophorectomy (the surgical removal of both ovaries), or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time during the preceding 24 consecutive months). \\* Female of childbearing potential (FCBP):\n\n    * Must use a contraceptive method that is highly effective (with a failure rate of \\\u003C 1% per year), preferably with low user dependency during the intervention and agrees to not donate eggs (ova, oocytes) for the purpose of reproduction during this period. The investigator should evaluate the effectiveness of the contraceptive method in relationship to the first dose of study intervention\n    * Given the risk of teratogenicity with immunomodulatory drugs (IMiD), females of child-bearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least 25 mIU\u002FmL within 10-14 days prior to, and again within 24 hours of starting lenalidomide, and must either commit to continued abstinence from heterosexual intercourse or being two acceptable methods of birth control, one highly effective method and one additional effective method at the same time, at least 28 days before she starts taking lenalidomide. Examples of highly effective methods are intrauterine device, hormonal contraceptives, tubal ligation, or partner's vasectomy. Examples of barrier method are male condom, diaphragm, or cervical cap. FCBP must also agree to ongoing pregnancy testing. Men must agree to use latex condom during sexual contract with a FCBP even if they have had a successful vasectomy. All patients must be counseled at a minimum frequency of 28 days about pregnancy precautions and risk of fetal exposure\n    * The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with a nearly undetected pregnancy\n  * Non-childbearing potential is defined as follows (by other than medical reasons):\n\n    * ≥ 45 years of age and has not had menses for \\> 1 year\n    * Patients who have been amenorrhoeic for \\\u003C 2 years without history of hysterectomy and oophorectomy must have a follicle stimulating hormone value in the postmenopausal range upon screening evaluation\n    * Post-hysterectomy, post-bilateral oophorectomy, or post-tubal ligation. Documented hysterectomy or oophorectomy must be confirmed with medical records of the actual procedure or confirmed by an ultrasound. Tubal ligation must be confirmed with medical records of the actual procedure\n* Male patients must agree to use an adequate method of contraception for the duration of the study and for 6 months afterwards.\n\n  * Male participants: Contraceptive use should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Male participants are eligible to participate if they agree to the following during the intervention period and for 6 months after the last dose of study treatment to allow for clearance of altered sperm:\n\n    * Refrain from donating sperm, PLUS, either:\n\n      * Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent, OR\n      * Must agree to use contraception\u002Fbarrier as detailed below:\n\n        * Agree to use a male condom, even if they have undergone successful vasectomy, and female partner to use an additional highly effective contraceptive method with a failure rate of \\\u003C 1% per year as when having sexual intercourse with a woman of childbearing potential (including pregnant females)\n* Patients may not have polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes (POEMS) syndrome, Waldenström's macroglobulinemia, or symptomatic amyloidosis. Amyloidosis found in skin or lymph nodes (\"non-vital organs\"), or incidental observation of amyloidosis on bone marrow biopsy, are permissible\n* Clinically significant adverse effects from any prior oncologic treatment (e.g., prior surgery, radiotherapy, or other antineoplastic therapy) must have resolved or have been determined to be clinically stable per the investigator\n* Patients with known HIV infection on effective anti-retroviral therapy with undetectable viral load within 6 months prior to registration are eligible for this trial\n* For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated\n* Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load\n* No patients known to have cardiac risk factors defined by any of the following criteria:\n\n  * Evidence of current clinically significant uncontrolled arrhythmias, including clinically significant electrocardiogram (ECG) abnormalities such as 2nd degree (Mobitz Type II) or 3rd degree atrioventricular (AV) block\n  * History of myocardial infarction, acute coronary syndromes (including unstable angina), coronary angioplasty, or stenting or bypass grafting within two (2) months of screening\n  * Class III or IV heart failure as defined by the New York Heart Association functional classification system\n  * Uncontrolled hypertension, defined as persistently elevated blood pressure (BP) meeting Common Terminology Criteria for Adverse Events (CTCAE) version (v) 6.0 for ≥ grade 3 despite medical intervention\n  * Patients with congenital long QT syndrome, Fridericia's formula-corrected QT interval (QTcF) interval QTcF \\> 480 msec (the QT interval values must be corrected for heart rate by Fridericia's formula \\[QTcF\\])\n  * Left ventricular ejection fraction \\\u003C 40%\n* No significant neuropathy ≥ grade 3 or grade 2 neuropathy with pain at baseline\n* No known allergies, hypersensitivity, or intolerance to daratumumab and hyaluronidase-fihj, carfilzomib, lenalidomide, or dexamethasone\n* No known medical condition causing an inability to swallow oral formulations of agents\n* No major surgery within \\\u003C 2 weeks prior to registration or who have not recovered from the side effects of surgery\n* Contraindication to any concomitant medication, including antivirals or anticoagulation\n* Absolute neutrophil count (ANC) ≥ 1,000\u002Fmm\\^3 (or ≥ 500\u002Fmm\\^3 if due to underlying disease)\n* Total bilirubin ≤ 2 x upper limit of normal (ULN)\n* Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \\[SGOT\\])\u002Falanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \\[SGPT\\]) ≤ 3 x upper limit of normal (ULN)\n* Calculated (calc.) creatinine clearance ≥ 30 mL\u002Fmin by Modification of Diet in Renal Disease (MDRD)",{"count":135,"type":20},74,[23],"This phase II trial compares standard consolidation with daratumumab, carfilzomib, lenalidomide, and dexamethasone to consolidation with teclistamab following standard induction therapy and autologous hematopoietic stem cell transplant for improving overall survival of patients with plasma cell leukemia. Consolidation therapy is treatment given after initial therapy to kill any cancer cells that may remain in the body. Daratumumab is in a class of medications called monoclonal antibodies. It binds to a protein called CD38, which is found on some types of immune cells and cancer cells, including myeloma cells. Daratumumab may block CD38 and help the immune system kill cancer cells. Carfilzomib inhibits protein complexes called proteasomes, which inhibits cancer cell growth and leads to cancer cell death. Lenalidomide may help kill cancer cells and prevents the growth of blood vessels that cancer cells need to survive. Dexamethasone is in a class of medications called corticosteroids. It is used to reduce inflammation and lower the body's immune response to help lessen the side effects of chemotherapy drugs. Teclistamab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Giving teclistamab as consolidation therapy after induction and autologous hematopoietic stem cell transplant may improve survival outcomes in patients with plasma cell leukemia, compared to standard consolidation with daratumumab, carfilzomib, lenalidomide, and dexamethasone.",[31],"NOT_YET_RECRUITING","2026-05-22",{"date":142,"type":65},"2026-05-26",{"date":144,"type":20},"2026-07-01",{"date":146,"type":20},"2032-11-06",{"name":148,"class":149},"National Cancer Institute (NCI)","NIH",{"id":151,"slug":152,"hasResults":11,"nctId":153,"briefTitle":154,"officialTitle":154,"acronym":4,"eligibilityCriteria":155,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":4,"targetDuration":4,"studyType":156,"phases":4,"briefSummary":157,"conditions":158,"keywords":163,"overallStatus":170,"whyStopped":4,"lastUpdateSubmitDate":171,"lastUpdatePostDateStruct":172,"startDateStruct":4,"completionDateStruct":4,"leadSponsor":174,"locationsCount":4},"100295215","expanded-access-to-venetoclax-100295215","NCT03123029","Expanded Access to Venetoclax","Exclusion Criteria:\n\n* There are other suitable treatment options.\n* The participant qualifies for ongoing clinical trials.","EXPANDED_ACCESS","This is an expanded access program (EAP) for eligible participants. This program is designed to provide access to Venetoclax prior to approval by the local regulatory agency. Availability will depend on territory eligibility. A medical doctor must decide whether the potential benefit outweighs the risk of receiving an investigational therapy based on the individual patient's medical history and program eligibility criteria.",[159,48,113,160,161,162,31],"Chronic Lymphocytic Leukemia (CLL)","Non-Hodgkin's Lymphoma","Acute Lymphoblastic Leukemia (ALL)","Amyloidosis",[164,165,166,167,168,169],"Expanded Access","Pre-approval Access","Compassionate Use","Special Access Program","Named Patient Basis","Special Access Scheme","AVAILABLE","2026-01-29",{"date":173,"type":65},"2026-01-30",{"name":175,"class":176},"AbbVie","INDUSTRY",{"id":178,"slug":179,"hasResults":11,"nctId":180,"briefTitle":181,"officialTitle":181,"acronym":182,"eligibilityCriteria":183,"healthyVolunteers":11,"sex":16,"minAge":184,"maxAge":4,"enrollmentInfo":185,"targetDuration":187,"studyType":188,"phases":4,"briefSummary":189,"conditions":190,"keywords":4,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":191,"lastUpdatePostDateStruct":192,"startDateStruct":194,"completionDateStruct":196,"leadSponsor":198,"locationsCount":73},"100482046","cancer-and-aging-resilience-evaluation-in-older-adults-with-hematologic-malignancies-the-care-heme-registry-100482046","NCT05556928","Cancer and Aging Resilience Evaluation in Older Adults With Hematologic Malignancies: The CARE-Heme Registry","CARE-Heme","Inclusion Criteria:\n\n* Patients are ≥50 years of age.\n* Patients have a biopsy proven diagnosis of Hematologic Malignancy (Multiple Myeloma, AL Amyloidosis, Waldenstrom's Macrogloblunemia, Hodgkin Lymphoma, Non-Hodgkin Lymphoma, Myelodysplastic syndromes, Myeloproliferative Neoplasm, Acute\u002FChronic Myeloid Leukemia, Acute\u002FChronic Lymphoid Leukemia).\n* Patients have appointments at UAB including if they are an inpatient or other clinic locations.\n\nExclusion Criteria:\n\n* Individuals who are \\\u003C50 years old.\n* Patients who do not read and\u002For speak English will not be eligible for this study as many of the questionnaires are not validated in other languages. No exclusions will be made based on gender, ethnicity or race.","50 Years",{"count":186,"type":20},5000,"12 Months","OBSERVATIONAL","The primary purpose of this protocol is to create a registry of older (≥50 years old) patients with Hematologic Malignancies. Our main objectives include: To understand the prevalence of frailty and geriatric impairments among patients aged ≥50y and above diagnosed with a hematologic malignancy at UAB and to gather information that would lend support for future research in this vulnerable population.",[48,162,31],"2025-12-05",{"date":193,"type":65},"2025-12-08",{"date":195,"type":65},"2020-07-21",{"date":197,"type":20},"2027-12-31",{"name":199,"class":72},"University of Alabama at Birmingham",{"id":201,"slug":202,"hasResults":11,"nctId":203,"briefTitle":204,"officialTitle":205,"acronym":206,"eligibilityCriteria":207,"healthyVolunteers":11,"sex":16,"minAge":82,"maxAge":4,"enrollmentInfo":208,"targetDuration":4,"studyType":188,"phases":4,"briefSummary":210,"conditions":211,"keywords":4,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":215,"lastUpdatePostDateStruct":216,"startDateStruct":218,"completionDateStruct":220,"leadSponsor":222,"locationsCount":225},"100534359","european-myeloma-network-emn-sample-project-100534359","NCT06237803","European Myeloma Network (EMN) Sample Project","EMN Prospective Sample Collection Project","EMN36","Inclusion Criteria:\n\n* Subjects with MGUS, smouldering Multiple Myeloma (SMM) , MM (Multiple Myeloma) (+\u002F- EMD), plasma cell leukemia (PCL) (+\u002F- EMD)\n* Subjects are ≥ 18 years old.\n* Subjects have provided written informed consent in accordance with federal, local, and institutional guidelines prior to initiation of any project-specific activities or procedures.\n\n  1. Subjects do not have kind of condition that, in the opinion of the Investigators, may compromise the ability of the subjects to give written informed consent and\n  2. subjects are, in the investigator's opinion, willing and able to comply with the protocol requirements.\n\nExclusion Criteria:\n\n* Previous treatment with anti-myeloma therapy (excluding one course of therapy in patients in which urgent therapy is deemed necessary according to physician's discretion, e.g. myeloma-related complications resistant to supportive care).\n* Subjects have had prior unforeseen (serious) adverse reactions to blood donation including, but not limited to fainting, angina, severe bruising, allergic reactions, or any other adverse events.\n* Any psychological, familial, sociological and geographical condition potentially hampering compliance with the protocol and follow-up schedule.",{"count":209,"type":20},6000,"This is an observational, non-interventional, multicenter study for the prospective collection, storage and analysis of patients' biological samples.\n\nThis study establishes a common international infrastructure useful to collect standard clinical variables at baseline and during treatment and to uniformly collect and store biological samples",[48,212,31,213,214],"Smoldering Multiple Myeloma","Extramedullary Myeloma","MGUS","2025-12-02",{"date":217,"type":65},"2025-12-03",{"date":219,"type":65},"2022-12-21",{"date":221,"type":20},"2037-12",{"name":223,"class":224},"European Myeloma Network B.V.","NETWORK",41,{"id":227,"slug":228,"hasResults":11,"nctId":229,"briefTitle":230,"officialTitle":231,"acronym":232,"eligibilityCriteria":233,"healthyVolunteers":11,"sex":16,"minAge":82,"maxAge":4,"enrollmentInfo":234,"targetDuration":4,"studyType":21,"phases":236,"briefSummary":237,"conditions":238,"keywords":4,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":239,"lastUpdatePostDateStruct":240,"startDateStruct":242,"completionDateStruct":244,"leadSponsor":246,"locationsCount":73},"100555817","phase-2-use-of-isatuximab-dexamethasone-and-lenalidomide-in-a-go-slow-fashion-for-ultra-frail-patients-with-multiple-myeloma-100555817","NCT06517017","Use of Isatuximab, Dexamethasone and Lenalidomide in a Go-Slow Fashion for Ultra-Frail Patients With Multiple Myeloma","Use of Isatuximab, Dexamethasone and Lenalidomide in a Go-Slow Fashion for Ultra-Frail Patients With Multiple Myeloma: A Phase 2 Multicenter Study","UltraFrailMM","Inclusion Criteria:\n\n* Male or female subject aged ≥ 18 years.\n* Histologically confirmed myeloma and\u002For Plasma Cell Leukemia who are newly diagnosed and having completed ≤ 1 prior cycle of myeloma treatment.\n* For female subjects of childbearing potential: Negative pregnancy test or evidence of post-menopausal status or evidence of permanent surgical sterilization (bilateral oophorectomy or hysterectomy). The post-menopausal status will be defined as having been amenorrheic for 24 months without an alternative medical cause.\n* Subjects must be willing to follow contraception requirements listed in the protocol, agree to participate in the Lenalidomide REMS program, and have signed the Patient-Physician Agreement Form.\n* Male subjects must agree to use a latex condom during intercourse for the duration of study therapy as described in the protocol, even if he has undergone a successful vasectomy.\n* Recovery to baseline or ≤ Grade 1 CTCAE v5 from toxicities related to any prior treatments, unless AE(s) are clinically nonsignificant and\u002For stable on supportive therapy per the treating investigator.\n* Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines.\n* IMWG defined frailty score ≥ 3. IMWG definition available here: http:\u002F\u002Fwww.myelomafrailtyscorecalculator.net\n\nExclusion Criteria:\n\n* Receiving other investigational agents.\n* Any condition that would, in the Investigator's judgment, compromise the subject's ability to understand the subject information, give informed consent, and\u002For contraindicate the subject's participation in the clinical study due to safety concerns or compliance with clinical study procedures (e.g., infection\u002Finflammation, intestinal obstruction, unable to swallow medication, \\[subjects may not receive the drug through a feeding tube\\], social\u002F psychological issues, etc.)\n* Known prior severe hypersensitivity (NCI CTCAE v5.0 Grade ≥ 3) to investigational product (IP) or any component in its formulations. This includes hypersensitivity or history of intolerance to steroids, mannitol, pregelatinized starch, sodium stearyl fumarate, histidine (as base and hydrochloride salt), arginine hydrochloride, poloxamer 188, sucrose or any of the other components of study intervention that are not amenable to premedication with steroids and H2 blockers or would prohibit further treatment with these agents.\n* Subjects currently taking prohibited medications as described in the protocol.",{"count":235,"type":20},40,[23],"Historically, the frailest patients with multiple myeloma are under-represented in clinical trials, and have very high rates of treatment discontinuation, and early treatment mortality. The investigators hypothesize that a go-slow gentle approach to starting treatment in such patients, starting with just Isatuximab and dexamethasone with a gentle introduction to lenalidomide third cycle onwards, may improve treatment adherence and quality of life. The goal of this clinical trial is to learn if a go-slow approach to treating MM in ultra-frail patients may improve the ability to adhere to treatment and improve quality of life.",[48,31],"2025-11-25",{"date":241,"type":65},"2025-11-28",{"date":243,"type":65},"2025-10-09",{"date":245,"type":20},"2027-11",{"name":96,"class":72},{"id":248,"slug":249,"hasResults":11,"nctId":250,"briefTitle":251,"officialTitle":251,"acronym":4,"eligibilityCriteria":252,"healthyVolunteers":11,"sex":16,"minAge":82,"maxAge":4,"enrollmentInfo":253,"targetDuration":255,"studyType":188,"phases":4,"briefSummary":256,"conditions":257,"keywords":4,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":263,"lastUpdatePostDateStruct":264,"startDateStruct":266,"completionDateStruct":268,"leadSponsor":270,"locationsCount":73},"100340846","registry-for-adults-with-plasma-cell-disorders-pcds-100340846","NCT03717844","Registry for Adults With Plasma Cell Disorders (PCD's)","Inclusion Criteria:\n\n* Patients have an outpatient appointment or are hospitalized inpatient at UNC Cancer Hospitals, or affiliated clinic settings or participating sites for the evaluation and management of a PCD.\n* Patients have a documented diagnosis of PCD defined as the presence of a monoclonal protein and\u002For monoclonal plasma cell population. Examples of PCDs include but are not limited to monoclonal gammopathy of uncertain significance; smoldering myeloma; multiple (active) myeloma; plasma cell leukemia; Castleman's disease; amyloidosis; light and\u002For heavy chain deposition disease; Polyneuropathy, Organomegaly, Endocrinopathy,Monoclonal gammopathy and Skin changes (POEMS) syndrome; and cryoglobulinemia.\n* Age ≥18 years.\n* Must consent to participation in this study and agree to complete the assessment at baseline and follow-up time points.\n* Must be able to read and speak English.\n\nExclusion Criteria:\n\n* Physical or psychiatric\u002Fbehavioral illnesses or problems that the treating clinician feels would preclude successful participation in the study.\n* There are no imaging or lab studies required to determine eligibility.",{"count":254,"type":20},2000,"10 Years","The primary purpose of this protocol is to create a registry of patients with plasma cell disorders (PCDs), including for example the cancer multiple myeloma (MM), who complete the assessment, previously known as a \"geriatric assessment,\" as is outlined in this protocol. Secondary objectives include measuring the response rate to participation of patients in this study, assessing patient satisfaction with the questionnaire, and gathering information that would lend support for future research into these types of assessments in patients with PCDs. Additionally the study offers an optional blood draw to look at a genetic marker of aging called p16INK4a (IRB 15-1899, IRB 15-0244).",[48,162,258,259,260,261,262,212,31],"Cryoglobulinemia","Castleman's Disease","Light Chain Deposition Disease","Heavy Chain Deposition Disease","Polyneuropathy Organomegaly Endocrinopathy Monoclonal Gammopathy and Skin Changes","2025-11-19",{"date":265,"type":65},"2025-11-20",{"date":267,"type":65},"2018-02-09",{"date":269,"type":20},"2029-02",{"name":271,"class":72},"UNC Lineberger Comprehensive Cancer Center",{"id":273,"slug":274,"hasResults":11,"nctId":275,"briefTitle":276,"officialTitle":277,"acronym":4,"eligibilityCriteria":278,"healthyVolunteers":11,"sex":16,"minAge":82,"maxAge":279,"enrollmentInfo":280,"targetDuration":4,"studyType":21,"phases":282,"briefSummary":283,"conditions":284,"keywords":4,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":291,"lastUpdatePostDateStruct":292,"startDateStruct":294,"completionDateStruct":296,"leadSponsor":298,"locationsCount":73},"100601348","phase-1-autologous-transplantation-combined-with-bcma-car-t-in-the-treatment-of-uhr-mm-100601348","NCT07109323","Autologous Transplantation Combined With BCMA CAR-T in the Treatment of UHR-MM","Clinical Study on the Safety and Efficacy of Autologous Hematopoietic Stem Cell Transplantation Combined With BCMA-CAR-T in the Treatment of Ultra-high Risk Multiple Myeloma","Inclusion Criteria:\n\nSubjects must meet all of the following criteria to be enrolled:\n\nUltra high risk mm (UHR-MM), 18-70 years old, suitable for ASCT. And meet any of the following definitions of UHR-MM: 1) cytogenetic ultra-high risk, which meets any of the following conditions, including: del(17p)≥60%； Two or more cytogenetic features: TP53 mutation, del (17p) or p53 deletion, t (4; 14), t (14; 16), t (14; 20), 1q21 gain or amplification, 1p deletion, myc translocation (deletion or copy number abnormality: ≥ 20% is positive; translocation: ≥ 10% is positive); 2) Primary refractory (first-line induction therapy based on standard three drug combination: 2 courses \\\u003C Mr, 4 courses \\\u003C PR); 3) Early progression (the best first-line treatment response of the regimen based on the standard three drug combination is maintained for less than 6 months); 4) Plasma cell leukemia (meeting the diagnostic criteria of mm at the initial diagnosis, and the proportion of peripheral plasma cells ≥ 5%); 5) Non paraosseous extramedullary infiltration; 6) R2-iss-iv \u002Fmpss-iv.\n\n1. The subjects voluntarily participated in the study and signed the informed consent form (ICF) by themselves or their legal guardians;\n2. The subject must have proper organ function and meet all the following inspection results:\n\nSerum total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal (ULN); Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN; Creatinine clearance (CrCl) (Cockcroft Gault formula) ≥ 40ml\u002Fmin; Prothrombin time (PT) ≤ 1.5 × ULN, partial prothrombin time (APTT) \\\u003C 1.5 × ULN, international normalized ratio (INR) \\\u003C 1.5 × ULN; Hemoglobin (HB) ≥ 60g\u002FL; Absolute neutrophil count (ANC) ≥ 1.0 × 10\\^9\u002FL (no growth factors such as granulocyte colony-stimulating factor \\[G-CSF\\] received within 7 days before laboratory examination in screening period); Absolute lymphocyte count (ALC) ≥ 0.5 × 10\\^9\u002FL; Platelet (PLT) ≥ 50 × 10\\^9\u002FL (no platelet transfusion within 7 days before laboratory examination in screening period); Left ventricular ejection fraction (LVEF) ≥ 45%; Blood oxygen saturation (SpO2) ≥ 92%; (3) The ECoG score is 0-1. See Appendix V for ECOG score; (4) Estimated survival ≥ 3 months; (5) The pregnancy test of fertile female subjects should be negative and not within the lactation period; Both female and male subjects need to take effective contraceptive tools or drugs within 24 months after cell infusion.\n\n\\-\n\nExclusion Criteria:Subjects who have one or more of the following cannot be selected for this study:\n\n1. Have a history of allergy to any component in cell products;\n2. Serious heart disease, including but not limited to:\n\n   Myocardial infarction, cardiac angioplasty or stent implantation within 6 months before signing ICF Unstable angina Severe arrhythmia History of severe non ischemic cardiomyopathy Congestive heart failure (New York Heart Association \\[nyha\\] class III or IV), and the NYHA score is shown in Appendix II\n3. History of autologous \u002F allogeneic hematopoietic stem cell transplantation;\n4. Stroke or seizure within 6 months before signing ICF;\n5. Have autoimmune disease, immune deficiency or other diseases requiring immunosuppressant treatment;\n6. Within 3 years before signing the ICF, patients with malignant tumors other than multiple myeloma, except for fully treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, local prostate cancer after radical surgery, breast ductal carcinoma in situ after radical surgery, and carcinoma in situ in other parts one year after radical surgery, and there has been no treatment and no recurrence in the screening period Signs;\n7. The presence of uncontrolled active infection;\n8. Unstable systemic diseases judged by the investigator: including but not limited to serious liver, kidney or metabolic diseases requiring drug treatment;\n9. Any of the following conditions exist within 1 week before lymphocyte collection:\n\n   The detection value of hepatitis B virus (HBV) DNA in peripheral blood was higher than the lower limit of detection Hepatitis C virus (HCV) antibody positive and peripheral HCV-RNA positive Human immunodeficiency virus (HIV) antibody positive Syphilis antigen or antibody positive Cmv-dna positive\n10. More than 5mg\u002Fd prednisone (or equivalent amount of other corticosteroids) was applied within 1 week before lymphocyte collection Vegan);\n11. Have used any car-t cell products or other genetically modified T cell therapies;\n12. Received BCMA targeted therapy;\n13. Have a history of live vaccination within 4 weeks before signing ICF;\n14. Have a history of alcohol abuse, drug abuse or mental illness;\n15. Other researchers consider it inappropriate to participate in this study. -","70 Years",{"count":281,"type":20},50,[108,23],"To evaluate the safety and efficacy of autologous hematopoietic stem cell transplantation (ASCT) combined with BCMA-CART in the treatment of UHR-MM.",[285,286,287,288,31,289,290],"Ultra High Risk mm (uhr-mm), 18-70 Years Old, Suitable for ASCT. And Meet Any of the Following uhr-mm Definitions","Cytogenetics Ultra High Risk","Primary Refractory","Early Progression","Non Paraosseous Extramedullary Infiltration","R2-ISS-IV \u002FMPSS-IV","2025-07-31",{"date":293,"type":65},"2025-08-07",{"date":295,"type":65},"2025-03-03",{"date":297,"type":20},"2030-03-02",{"name":299,"class":72},"Institute of Hematology & Blood Diseases Hospital, China",{"id":301,"slug":302,"hasResults":11,"nctId":303,"briefTitle":304,"officialTitle":305,"acronym":4,"eligibilityCriteria":306,"healthyVolunteers":11,"sex":16,"minAge":82,"maxAge":4,"enrollmentInfo":307,"targetDuration":4,"studyType":21,"phases":309,"briefSummary":311,"conditions":312,"keywords":313,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":315,"lastUpdatePostDateStruct":316,"startDateStruct":318,"completionDateStruct":320,"leadSponsor":321,"locationsCount":73},"100592025","early-phase-1-a-study-of-ct0596-in-plasma-cell-leukemia-100592025","NCT06988059","A Study of CT0596 in Plasma Cell Leukemia","A Clinical Study to Explore the Safety, Efficacy, and Pharmacokinetics of CT0596 CAR-T Cell Injection in Patients With Plasma Cell Leukemia","Inclusion Criteria:\n\n1. Patients must voluntarily sign the informed consent form (ICF) and must be willing and be able to adhere to the trial visit schedule and other protocol requirements and agree to be in long term follow-up (LTFU) for up to 15 years as mandated by the regulatory guidelines.\n2. Age ≥ 18 years;\n3. PCL after inductive treatment or R\u002FR pPCL.\n4. Patients must have measurable disease。\n5. Expected survival \\> 12 weeks;\n6. Eastern Cooperative Oncology Group (ECOG) score 0- 1 ;\n7. Patients should have good organ function。\n8. Female patients of childbearing potential must have a negative pregnancy test at screening and prior to receiving lymphodepletion therapy and are willing to use a highly effective and reliable method of contraception for 1 year after receiving study treatment and are absolutely prohibited from donating eggs for 1 year after receiving study treatment infusion during the study ;Male patients are willing to use a highly effective and reliable method of contraception for 1 year after receiving study treatment if they are sexually active with a female of childbearing potential. Sperm donation is absolutely prohibited within 1 year following study treatment infusion for all male patients during the study.\n\nExclusion Criteria:\n\n1. Pregnant or lactating women;\n2. Patients seropositive for HIV, active hepatitis C virus (HCV), or active hepatitis B virus (HBV) infection. History of treated hepatitis B or C is permitted if the viral load is undetectable per qPCR and or nucleic acid testing;\n3. Patients with any uncontrolled active infection, including but not limited to patients with active tuberculosis (investigator 's judgment);\n4. Toxicities caused by previous treatment have not recovered to Common Terminology Criteria for Adverse Events (CTCAE) ≤ Grade 1, except alopecia and other events that are judged tolerable by the investigator;\n5. Patient has any significant condition(s), laboratory abnormality or psychiatric illness that would impair the ability of the patient to receive or tolerate the planned treatment or in the opinion of the investigator, participation would not be in the best interest of the patient (eg, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments\n6. Previous allogeneic stem cell transplantation; autologous stem cell transplantation within 12 weeks prior to signing informed consent;\n7. Have received treatment for the disease within 14 days or five half-lives before preconditioning\n8. Have received cell therapy within 28 days before informed consent.\n9. Systemic glucocorticoids equivalent to \\> 15 mg\u002Fday prednisone within 7 days prior to informed consent, with the exception of topical glucocorticoids;\n10. Vaccination with live attenuated vaccines , inactivated vaccines or RNA vaccines within 4 weeks prior to informed consent;\n11. Major surgery within 2 weeks before informed consent or planned during the study period or within 4 weeks after giving study treatment (excluding local anesthesia such as cataract);\n12. Allergic or intolerant to lymphodepletion, tocilizumab, or allergic to components (DMSO) in CT0596 CART cell infusion preparation; or previous history of other serious allergies such as anaphylactic shock;\n13. Patients with secondary plasma cell leukemia, Waldenström macroglobulinemia, POEMS syndrome, or primary light chain amyloidosis at screening;\n14. Patients with any of the following cardiac conditions within 6 months prior to screening:\n15. Patients who require supplemental oxygen to maintain oxygen saturation \\> 92%; or Patients with known or suspected COPD who have Forced Expiratory Volume in 1 second (FEV1) \\\u003C 50% of predicted normal on spirometry;\n16. Patients with active autoimmune diseases, including but not limited to psoriasis, rheumatoid arthritis and other diseases requiring long-term immunosuppressive therapy;\n17. Patients with second primary malignancies in addition to MM are not eligible if the second primary malignancy has required treatment within the past 2 years or is not in complete remission. Exceptions include the following that have been successfully treated - nonmetastatic basal cell or squamous cell skin carcinoma, non-metastatic prostate cancer, carcinoma-in-situ of breast or cervix, non-muscle invasive bladder cancer\n18. Patients with symptomatic central nervous system (CNS) disease or suspected CNS metastases;\n19. The patient is unable or unwilling to comply with protocol, or there are other reasons for being unsuitable to participate in this clinical study evaluated by investigators.",{"count":308,"type":20},27,[310],"EARLY_PHASE1","This study is a single-arm, open-label, exploratory dose-escalation and dosefinding clinical trial to evaluate the safety, efficacy, cellular pharmacokinetics and pharmacodynamics of CT0596 cells in patients with PCL.",[31],[31,314],"CAR-T cells","2025-07-30",{"date":317,"type":65},"2025-08-01",{"date":319,"type":65},"2025-06-25",{"date":197,"type":20},{"name":299,"class":72},{"id":323,"slug":324,"hasResults":11,"nctId":325,"briefTitle":326,"officialTitle":327,"acronym":328,"eligibilityCriteria":329,"healthyVolunteers":11,"sex":16,"minAge":82,"maxAge":330,"enrollmentInfo":331,"targetDuration":4,"studyType":21,"phases":332,"briefSummary":333,"conditions":334,"keywords":4,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":315,"lastUpdatePostDateStruct":335,"startDateStruct":337,"completionDateStruct":339,"leadSponsor":341,"locationsCount":73},"100514504","phase-2-a-study-of-bortezomib-lenalidomide-and-dexamethasone-vrd-based-regimen-followed-by-bcma-car-t-therapy-in-transplant-ineligible-patients-with-primary-plasma-cell-leukemia-100514504","NCT05979363","A Study of Bortezomib, Lenalidomide and Dexamethasone (VRd)-Based Regimen Followed by BCMA CAR-T Therapy in Transplant-Ineligible Patients With Primary Plasma Cell Leukemia","Safety and Efficiency of VRd Combining BCMA CAR-T Regimen for Transplant-ineligible Patients With Primary Plasma Cell Leukemia: a Prospective, Single-arm, Single-center, Phase II Study.","CAREMM-002","Inclusion Criteria:\n\n1. Age ≥ 18 years and ≤ 75 years.\n2. Participants with documented primary plasma cell leukemia according to IMWG diagnostic criteria (circulating plasma cells ≥5%, determined by morphology on peripheral blood smear; or absolute value of peripheral blood tumorigenic plasma cells exceeds 2×10\\^9\u002FL).\n3. Measurable disease, at screening as defined by any of the following: Serum monoclonal paraprotein (M-protein) level ≥1.0 g\u002FdL or urine M-protein level ≥200 mg\u002F24 hours; or Light chain MM without measurable disease in serum or urine: serum Ig free-light chain (FLC) ≥10 mg\u002FdL and abnormal serum Ig kappa lambda FLC ratio.\n4. Not considered for high-dose chemotherapy with Autologous Stem Cell Transplant (ASCT) due to: Ineligible due to advanced age (≥65); or Ineligible evaluated by researchers; or Eastern Cooperative Oncology Group Performance Status grade of 3 or 4; or Repeated hematopoietic stem cell mobilization failure； or Deferral of high-dose chemotherapy with ASCT as initial treatment.\n5. Bone marrow sample is confirmed as BCMA-positive by flow cytometry or pathological examination.\n6. All screening blood biochemistry: tests should be performed according to the protocol and within 14 days before enrollment. Screening laboratory values must meet the following criteria: a.TBIL\\\u003C2 x upper limit of normal (ULN) (\\\u003C3 x ULN in patients with Gilbert's syndrome); b.AST and ALT \\\u003C3 x ULN.; c. Creatinine clearance ≥ 30mL\u002Fmin (calculated using Cockroft-Gault formula).\n7. Routine blood tests (performed within 7 days, no RBC transfusion, no G-CSF\u002FGM-CSF\u002Fplatelet agonists, no drug correction within 14 days before screening, no PLT transfusion within 7 days) : WBC ≥ 1.5 x 109\u002FL, ANC ≥ 1.0 x 109\u002FL, Hb ≥ 70 g\u002FL PLT ≥ 75 x 109\u002FL (if BMPC \\\u003C 50%) or PLT ≥ 50 x 109\u002FL (if BMPC ≥ 50%).\n8. Patients must be able to take prophylactic anticoagulant therapy as recommended by the study.\n9. The woman is not breastfeeding, is not pregnant and agrees not to be pregnant during the study period and for the following 12 months. Male patients agreed that their spouse would not become pregnant during the study period and for 12 months thereafter.\n\nExclusion Criteria:\n\n1. Documented active amyloidosis.\n2. Documented with central nervous system (CNS) invasion.\n3. Prior exposure to any BCMA-targeted therapy or CAR-T therapy.\n4. Patients with peripheral neuropathy greater than grade 2 or peripheral neuropathy greater than grade 2 with pain at baseline, regardless of whether they were currently receiving medical therapy.\n5. Known intolerance, hypersensitivity, or contraindication to glucocorticoids, bortezomib, lenalidomide, and BCMA-CART cellular products.\n6. Seropositive for human immunodeficiency virus (HIV)\n7. Hepatitis B infection\n8. Hepatitis C infection\n9. Life expectancy of \\\u003C6 months\n10. Women who are pregnant or breastfeeding\n11. Any active gastrointestinal dysfunction that affects the patient's ability to swallow tablets, or any active gastrointestinal dysfunction that may affect the absorption of the studied treatment medication\n12. Subjects had major surgery within 2 weeks before randomization (for example, general anesthesia), or is not fully recovered from the surgery, or surgery is arranged during study period.\n13. Received live attenuated vaccine within 4 weeks prior to study treatment.\n14. According to the researcher's judgment, any condition including but not limited to serious mental illness, medical illness, or other symptoms\u002Fconditions that may affect study treatment, compliance, or the capability of providing informed consent.\n15. Necessary medication or supportive therapy is contraindicated with study treatment.\n16. Any diseases or complications that may interfere with the study.\n17. Patients are not willing to or cannot comply with study scheme.","75 Years",{"count":5,"type":20},[23],"This is a single-arm, open-label study to evaluate the efficacy and safety of VRD-based regimen combined with BCMA CAR-T in transplant-ineligible patients with primary plasma cell leukemia",[31],{"date":336,"type":65},"2025-08-03",{"date":338,"type":65},"2023-08-14",{"date":340,"type":20},"2028-07-01",{"name":299,"class":72},{"id":343,"slug":344,"hasResults":11,"nctId":345,"briefTitle":346,"officialTitle":347,"acronym":4,"eligibilityCriteria":348,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":330,"enrollmentInfo":349,"targetDuration":4,"studyType":21,"phases":351,"briefSummary":352,"conditions":353,"keywords":365,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":372,"lastUpdatePostDateStruct":373,"startDateStruct":375,"completionDateStruct":377,"leadSponsor":379,"locationsCount":73},"100501157","phase-2-allo-hsct-using-ric-and-ptcy-for-hematological-diseases-100501157","NCT05805605","Allo HSCT Using RIC and PTCy for Hematological Diseases","Allogeneic Hematopoietic Stem Cell Transplantation Using Reduced Intensity Conditioning (RIC) With Post-Transplant Cytoxan (PTCy) for the Treatment of Hematological Diseases","Inclusion Criteria:\n\n* Age 0 to 75 years of age with Karnofsky score ≥ 70% (≥ 16 years) or Lansky score ≥ 50 (\\\u003C 16 years).\n* 5\u002F6 or 6\u002F6 related donor, OR a 7-8\u002F8 HLA-A, B, C, DRB1 allele match, OR a haplotype (at least 5\u002F10) matched related donor. Donors will be requested to provide PBSCs although bone marrow is acceptable according to donor preference.\n\nEligible Diseases Acute Leukemias: Must be in remission by morphology (≤5% blasts) AND without evidence of MRD by flow cytometry, FISH, or conventional cytogenetics. PCR based MRD detection is not an exclusion to proceed.\n\nAcute Myeloid Leukemia (AML) and related precursor neoplasms:\n\n2nd or greater complete remission (CR); first complete remission (CR1) in patients \\> 60 years old; CR1 in ≤ 60 years old that is NOT considered as favorable-risk.\n\nFavorable risk AML is defined as having one of the following:\n\n* t(8,21) without cKIT mutation\n* inv(16) or t(16;16) without cKIT mutation\n* Normal karyotype with mutated NPM1 and wild type FLT-ITD (unless persistently NPM1 positive by PCR following two cycles of chemotherapy)\n* Normal karyotype with double mutated CEBPA\n* Acute prolymphocytic leukemia (APL) in first molecular remission at the end of consolidation\n\nAcute lymphoblastic Leukemia (ALL) \u002Flymphoma:\n\nCR2 or greater, CR1 unable to tolerate consolidation chemotherapy due to chemotherapy-related toxicities; CR1 high-risk ALL.\n\nHigh risk ALL is defined as having one of the following:\n\n* Evidence of high risk cytogenetics, e.g. t(9;22), t(1;19), t(4;11), other MLL rearrangements, IKZF1\n* 30 years of age or older at diagnosis\n* White blood cell counts of greater than 30,000\u002FmcL (B-ALL) or greater than 100,000\u002FmcL (T-ALL) at diagnosis\n* CNS leukemia involvement during the course of disease\n* Slow cytologic response (\\>10% lymphoblasts in bone marrow on Day 14 of induction therapy)\n* Evidence of persistent immonophenotypic or molecular minimal residual disease (MRD) at the end of induction and consolidation therapy.\n\nVery high risk pediatric patients with ALL:\n\npatients \\\u003C21 years are also considered high risk CR1 if they had M2 or M3 marrow at day 42 from the initiation of induction or M3 marrow at the end of induction. They are eligible once they achieved a complete remission.\n\nBiphenotypic\u002FUndifferentiated\u002FProlymphocytic Leukemias in first or subsequent CR.\n\nChronic Myelogenous Leukemia in chronic or accelerated phase, or CML blast crisis in morphological remission (\\\u003C5% blasts) and with negative MRD by flow cytometry (a positive PCR for BCRABL is acceptable for BMT): Chronic phase patients must have failed at least two different TKIs, been intolerant to all available TKIs or have T315I mutation. Patients with CML blast crisis in CR are only eligible if there is an feasible TKI maintenance plan following BMT.\n\nPlasma Cell Leukemia after initial therapy, who achieved at least a partial remission; or relapsed and achieved subsequent remission (CR\u002FPR) Myelodysplastic Syndrome: IPSS INT-2 or High Risk; R-IPSS High or Very High; WHO classification: RAEB-1, RAEB-2; Severe Cytopenias: ANC \\\u003C 0.8, Anemia or thrombocytopenia requiring transfusion; Poor or very poor risk cytogenetics based on IPSS or R-IPSS definitions; therapy-related MDS. Blasts must be \\\u003C 5% by bone marrow aspirate morphology. If ≥5% blasts, patient requires chemotherapy for cytoreduction to \\\u003C5% blasts prior to transplantation Leukemia or MDS in aplasia. These patients may be taken to transplant if after induction therapy they remain with aplastic bone marrow and no morphological or flow-cytometry evidence of disease ≥ 28 days post-therapy. These high risk patients will be analyzed separately.\n\nBurkitt's Lymphoma in CR2 or subsequent CR. Relapsed T-Cell Lymphoma that is chemotherapy sensitive in CR\u002FPR that has failed or ineligible for an autologous transplantNatural Killer Cell Malignancies. Relapsed Chronic Lymphocytic Leukemia\u002FSmall Lymphocytic Lymphoma (CLL\u002FSLL), Marginal Zone B-Cell Lymphoma or Follicular Lymphoma which have progressed within 12 months of achieving a partial or complete remission. Patients who had remissions lasting \\> 12 months, are eligible after at least two prior therapies. Patients with bulky disease should be considered for de-bulking chemotherapy before transplant. Patients with refractory disease may be eligible, unless bulky disease and an estimated tumor doubling time of less than one month.\n\nLymphoplasmacytic Lymphoma, Mantle-Cell Lymphomais eligible after initial therapy if chemotherapy sensitive.\n\nLarge Cell and other high risk NHL \\> CR2\u002F\\> PR2: Patients in CR2\u002FPR2 with initial short remission (\\\u003C6 months) are eligible.\n\nRelapsed Multiple Myeloma: that is chemotherapy sensitive and has failed or ineligible for an autologous transplant.\n\nMyeloproliferative Neoplasms\u002FMyelofibrosis - with transfusion dependence or expected survival under 5 years by DIPSS, DIPSS-plus, or MPSS70 calculator.\n\nAcquired Bone Marrow Failure Syndromes except for Fanconi anemia Other Leukemia Subtypes: A major effort in the field of hematology is to identify patients who are of high risk for treatment failure so that patients can be appropriately stratified to either more (or less) intensive therapy. This effort is continually ongoing and retrospective studies identify new disease features or characteristics that are associated with treatment outcomes. Therefore, if new features are identified after the writing of this protocol, patients can be enrolled with the approval of two members of the study committee.\n\nAdditional Criteria for Bulky Disease (lymphomas) if stable disease is best response, the largest residual nodal mass must \\\u003C 5 cm (approximately) If response to previous therapy, the largest residual mass must represent a 50% reduction and be \\\u003C 7.5 cm (approximately)\n\nOrgan Function Criteria\n\nAdequate organ function is defined as:\n\nLiver: Transaminases ≤ 5 x upper limit of normal (ULN) and total bilirubin ≤ 2.5 mg\u002FdL except for patients with Gilbert's syndrome or hemolysis.\n\nRenal: A normal creatinine (adults) or creatinine clearance ≥ 40 mL\u002Fmin (pediatrics). Adults with a creatinine \\> 1.2 mg\u002Fdl or a history of renal dysfunction must have estimated GFR ≥ 40 ml\u002Fmin\u002F1.73m2.\n\nCardiac: Absence of decompensated congestive heart failure, or uncontrolled arrhythmia and left ventricular ejection fraction \\> 40%. For children that are not able to cooperate with MUGA and echocardiography, such should be clearly stated in the physician's note.\n\nPulmonary: DLCO, FEV1, FVC ≥ 40% predicted, and absence of O2 requirements. For children that are not able to cooperate with PFTs, a pulse oximetry with exercise should be attempted. If neither test can be obtained it should be clearly stated in the physician's note.\n\nIf recent confirmed mold infection (e.g. aspergillus) must have minimum of 30 days of therapy and responsive disease and be cleared by Infectious Disease HIV infection with undetectable viral load. All HIV+ patients must be evaluated by Infectious Disease (ID) and a HIV management plan establish prior to transplantation Sexually active females of child bearing potential and sexually active males with partners of child bearing potential must agree to use adequate birth control during study treatment Voluntary written consent (adult or parent\u002Fguardian with presentation of the minor information sheet, if appropriate)\n\nRelated donors will be evaluated and collected according to UMN BMT program standard processes. Unrelated donors will be identified and collected through the National Marrow and Donor Program (NMDP) per usual steps.\n\nExclusion Criteria:\n\n* Pregnant or breast feeding. The agents used in this study include Pregnancy Category D: known to cause harm to a fetus. Females of childbearing potential must have a negative pregnancy test prior to starting therapy.\n* Untreated active infection\n* Active central nervous system malignancy\n* CML in blast crisis\n* Intermediate or high grade NHL, mantle cell NHL, and Hodgkin disease that is progressive on salvage therapy. Stable disease is acceptable to move forward provided it is non-bulky.\n* Less than 3 months since prior myeloablative transplant\n* Evidence of progressive disease by imaging modalities or biopsy - persistent PET activity, though possibly related to lymphoma, is not an exclusion criterion in the absence of CT changes indicating progression.",{"count":350,"type":20},56,[23],"This is a Phase II study following subjects proceeding with our Institutional non-myeloablative cyclophosphamide\u002F fludarabine\u002Ftotal body irradiation (TBI) preparative regimen followed by a related, unrelated, or partially matched family donor stem cell infusion using post-transplant cyclophosphamide (PTCy), sirolimus and MMF GVHD prophylaxis.",[354,355,356,357,43,30,31,358,359,360,46,361,362,38,363,40,364,33],"Acute Myelogenous Leukemia","Acute Lymphocytic Leukemia","Biphenotypic Acute Leukemia","Undifferentiated Leukemia","Myelodysplastic Syndromes","Leukemia, Myeloid","Myelodysplastic Syndrome With Excess Blasts-1","Relapsed T-Cell Lymphoma","Relapsed Chronic Lymphocytic Leukemia","Marginal Zone Lymphoma","Myeloproliferative Neoplasm",[56,58,60,55,59,366,367,368,369,370,371,16],"PFS","TRM","GVHD","MMF","TBI","PTCy","2025-06-27",{"date":374,"type":65},"2025-07-01",{"date":376,"type":65},"2023-05-01",{"date":378,"type":20},"2028-10-22",{"name":71,"class":72},{"id":381,"slug":382,"hasResults":11,"nctId":383,"briefTitle":384,"officialTitle":385,"acronym":4,"eligibilityCriteria":386,"healthyVolunteers":11,"sex":16,"minAge":82,"maxAge":330,"enrollmentInfo":387,"targetDuration":4,"studyType":21,"phases":389,"briefSummary":390,"conditions":391,"keywords":393,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":396,"lastUpdatePostDateStruct":397,"startDateStruct":399,"completionDateStruct":401,"leadSponsor":403,"locationsCount":73},"100456141","phase-1-a-study-of-car-gprc5d-in-patients-with-relapsedrefractory-multiple-myeloma-or-plasma-cell-leukemia-100456141","NCT05219721","A Study of CAR-GPRC5D in Patients With Relapsed\u002FRefractory Multiple Myeloma or Plasma Cell Leukemia","An Exploratory Study of Fully Human Anti-GPRC5D Chimeric Antigen Receptor T Cells (CAR-GPRC5D) in Patients With Relapsed\u002FRefractory Multiple Myeloma or Plasma Cell Leukemia","Inclusion Criteria:\n\n* Subjects must satisfy all the following criteria to be enrolled in the study:\n\n  1. age 18 to 75 years old, male or female.\n  2. Subjects have had at least 3 prior lines of therapy including chemotherapy based on proteasome inhibitors (PIs) and immunomodulatory agents (IMiDs).\n\n     According to the International Myeloma Working Group (IMWG) consensus (2016) standard on multiple myeloma, the disease has recurred, progressed or is refractory, or according to the IMWG consensus (2013) standard on plasma cell leukemia (Appendix 4), the disease appears relapse, progress or refractory;\n  3. Evidence of cell membrane GPRC5D expression, as determined by a validated immunohistochemistry (IHC) or flow cytometry of tumor tissue (e.g., bone marrow biopsies, or plasmacytoma).\n  4. The subjects should have measurable disease based on at least one of the following parameters:\n\n     The proportion of primitive immature or monoclonal plasma cells detected by bone marrow cytology, bone marrow biopsy, or flow cytometry is ≥ 10%.\n\n     Serum M-protein ≥ 0.5 g\u002FdL. Urine M-protein ≥ 200 mg\u002F24 hrs. For those whose Serum or Urine M-protein does not meet the measurable criteria but the light chain type, serum free light chain (sFLC) : involved sFLC level ≥ 10mg\u002FdL (100 mg\u002FL) provided serum FLC ratio is abnormal.\n\n     In subjects with extramedullary myeloma, if there are no other evaluable lesions, require extramedullary lesions with a maximum diameter of ≥2cm\n  5. ECOG performance score 0-2.\n  6. Estimated life expectancy ≥ 12 weeks.\n  7. Subjects should have adequate organ function:\n\n     * Hematology: Absolute neutrophil count (ANC) ≥1×10\\^9 \u002FL (prior use of growth factor support is permitted, but subjects must not have received supportive treatment within 7 days prior to laboratory examination); absolute lymphocyte count (ALC) ≥0.3×10\\^9 \u002FL; platelets ≥40×10\\^9 \u002FL (subjects must not have received blood transfusion support within 7 days prior to laboratory examination); hemoglobin ≥60 g\u002FL (subjects must not have received transfusion of red blood cells \\[RBC\\] within 7 days prior to laboratory examination; the use of recombinant human erythropoietin is permitted).\n     * Liver function: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5×upper limit of normal (ULN); total serum bilirubin ≤ 1.5×ULN.\n     * Renal function: Creatinine clearance rate (CrCl) calculated according to Cockcroft-Gault formula ≥ 40 ml\u002Fmin.\n     * Coagulation function: Fibrinogen ≥ 1.0 g\u002FL; activated partial thromboplastin time (APTT) ≤ 1.5×ULN, prothrombin time (PT) ≤1.5×ULN.\n     * SpO2 \\> 91%.\n     * Left ventricular ejection fraction (LVEF) ≥ 50%.\n  8. The subject and his\u002Fher spouse agree to use an effective contraceptive tool or medication (excluding safety period contraception) for one year from the date of the subject's informed consent to the date of CAR T cell infusion.\n  9. Subject must sign the informed consent form approved by ethics board in person before starting any screening procedure.\n\n     Exclusion Criteria:\n* The presence of any of the following will exclude a subject from enrollment:\n\n  1. Subjects who are known to have GVHD or need long-term immunosuppressive therapy.\n  2. Subjects have received any anti-cancer treatment as follows:\n\n     monoclonal antibody for treating multiple myeloma within 21 days before leukapheresis, or cytotoxic therapy or proteasome inhibitors within 14 days before leukapheresis, or immunomodulatory agents within 7 days before leukapheresis. or anti-tumor treatments other than those listed above within 30 days before leukapheresis.\n  3. Subjects who were receiving a used therapeutic dose of corticosteroid treatment (defined as prednisone or equivalent \\> 20mg) within 7 days prior to screening, except for physiological alternatives, inhalation, or topical use.\n  4. Subjects with hypertension that cannot be controlled by medication.\n  5. Subjects with serious heart disease: including but not limited to unstable angina, myocardial infarction (within 6 months prior to screening), congestive heart failure (NYHA classification ≥III), and severe arrhythmias.\n  6. Subjects with systemic diseases that the investigator determined to be unstable include, but are not limited to, severe liver and kidney or metabolic diseases requiring medical treatment.\n  7. Subjects with second malignancies in addition to MM within the past 5 years before the screening, exceptions to this criterion: successfully treated cervical carcinoma in situ and non-metastatic basal or squamous cell skin carcinoma, local prostate cancer after radical surgery, and ductal carcinoma in situ of the breast after radical surgery.\n  8. Subjects with a history of organ transplantation.\n  9. Subjects have received major surgery within 2 weeks prior to leukapheresis or plan to receive surgery during the study or within 2 weeks after the study treatment (excluding local anesthesia).\n  10. Subjects participated in another interventional clinical study 1 months before signing the informed consent (ICF);\n  11. Subjects with any uncontrolled active infection needed to receive systemic therapy within 7 days before leukapheresis collection (excluding # CTCAE grade 2 urogenital infection and upper respiratory infection).\n  12. Positive for any of the following tests:\n\n      * Hepatitis B virus (HBV) surface antigen (HBsAg) or hepatitis B core antibody-positive and detectable HBV DNA in peripheral blood\n      * Hepatitis C virus (HCV) antibody and hepatitis C virus RNA in peripheral blood\n      * Human immunodeficiency virus (HIV) antibody\n      * Cytomegalovirus (CMV) DNA\n      * Treponema Pallidum antibody\n  13. Pregnant or lactating women.\n  14. Subjects with mental illness or consciousness disorder or disease of the central nervous system\n  15. Other conditions that researchers consider inappropriate for inclusion.",{"count":388,"type":20},18,[108],"This study is a single-center, open-label, dose-exploration study to observe the safety and efficacy of different doses of CAR-GPRC5D in patients with R\u002FR MM or plasma cell leukemia.",[392,31],"Relapsed\u002FRefractory Multiple Myeloma",[394,395],"CAR-T","GPRC5D","2025-06-06",{"date":398,"type":65},"2025-06-11",{"date":400,"type":65},"2022-03-17",{"date":402,"type":20},"2025-10-01",{"name":404,"class":72},"Chunrui Li",{"id":406,"slug":407,"hasResults":11,"nctId":408,"briefTitle":384,"officialTitle":385,"acronym":4,"eligibilityCriteria":409,"healthyVolunteers":11,"sex":16,"minAge":82,"maxAge":330,"enrollmentInfo":410,"targetDuration":4,"studyType":21,"phases":412,"briefSummary":413,"conditions":414,"keywords":415,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":418,"lastUpdatePostDateStruct":419,"startDateStruct":421,"completionDateStruct":423,"leadSponsor":425,"locationsCount":73},"100497634","phase-1-a-study-of-car-gprc5d-in-patients-with-relapsedrefractory-multiple-myeloma-or-plasma-cell-leukemia-100497634","NCT05759793","Inclusion Criteria:\n\nSubjects must satisfy all the following criteria to be enrolled in the study:\n\n1. age 18 to 75 years old, male or female.\n2. Subjects have had at least 3 prior lines of therapy including chemotherapy based on proteasome inhibitors (PIs) and immunomodulatory agents (IMiDs).\n\n   According to the International Myeloma Working Group (IMWG) consensus (2016) standard on multiple myeloma, the disease has recurred, progressed or is refractory, or according to the IMWG consensus (2013) standard on plasma cell leukemia (Appendix 4), the disease appears relapse, progress or refractory;\n3. Evidence of cell membrane GPRC5D expression, as determined by a validated immunohistochemistry (IHC) or flow cytometry of tumor tissue (e.g., bone marrow biopsies, or plasmacytoma).\n4. The subjects should have measurable disease based on at least one of the following parameters:\n\n   1. The proportion of primitive immature or monoclonal plasma cells detected by bone marrow cytology, bone marrow biopsy, or flow cytometry is ≥ 10%.\n   2. Serum M-protein ≥ 10 g\u002FL for IgG type, serum M-protein ≥ 5 g\u002FL for other types, such as IgA, IgD, IgM, IgE.\n   3. Urine M-protein ≥ 200 mg\u002F24 hrs.\n   4. For those whose Serum or Urine M-protein does not meet the measurable criteria but the light chain type, serum free light chain (sFLC) : involved sFLC level ≥ 10mg\u002FdL (100 mg\u002FL) provided serum FLC ratio is abnormal.\n   5. In subjects with extramedullary myeloma, if there are no other evaluable lesions, require extramedullary lesions with a maximum diameter of ≥2cm\n5. ECOG performance score 0-2.\n6. Estimated life expectancy ≥ 12 weeks.\n7. Subjects should have adequate organ function:\n\n   1. Hematology: Absolute neutrophil count (ANC) ≥1×10\\^9 \u002FL (prior use of growth factor support is permitted, but subjects must not have received supportive treatment within 7 days prior to laboratory examination); absolute lymphocyte count (ALC) ≥0.3×10\\^9 \u002FL; platelets ≥40×10\\^9 \u002FL (subjects must not have received blood transfusion support within 7 days prior to laboratory examination); hemoglobin ≥60 g\u002FL (subjects must not have received transfusion of red blood cells \\[RBC\\] within 7 days prior to laboratory examination; the use of recombinant human erythropoietin is permitted).\n   2. Liver function: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5×upper limit of normal (ULN); total serum bilirubin ≤ 1.5×ULN.\n   3. Renal function: Creatinine clearance rate (CrCl) calculated according to Cockcroft-Gault formula ≥ 40 ml\u002Fmin.\n   4. Coagulation function: Fibrinogen ≥ 1.0 g\u002FL; activated partial thromboplastin time (APTT) ≤ 1.5×ULN, prothrombin time (PT) ≤1.5×ULN.\n   5. SpO2 \\> 91%.\n   6. Left ventricular ejection fraction (LVEF) ≥ 50%.\n8. The subject and his\u002Fher spouse agree to use an effective contraceptive tool or medication (excluding safety period contraception) for one year from the date of the subject's informed consent to the date of CAR T cell infusion.\n9. Subject must sign the informed consent form approved by ethics board in person before starting any screening procedure.\n\nExclusion Criteria:\n\nThe presence of any of the following will exclude a subject from enrollment:\n\n1. Subjects who are known to have GVHD or need long-term immunosuppressive therapy.\n2. Subjects have received any anti-cancer treatment as follows:\n\n   monoclonal antibody for treating multiple myeloma within 21 days before leukapheresis, or cytotoxic therapy or proteasome inhibitors within 14 days before leukapheresis, or immunomodulatory agents within 7 days before leukapheresis. or anti-tumor treatments other than those listed above within 30 days before leukapheresis.\n3. Subjects who were receiving a used therapeutic dose of corticosteroid treatment (defined as prednisone or equivalent \\> 20mg) within 7 days prior to screening, except for physiological alternatives, inhalation, or topical use.\n4. Subjects with hypertension that cannot be controlled by medication.\n5. Subjects with serious heart disease: including but not limited to unstable angina, myocardial infarction (within 6 months prior to screening), congestive heart failure (NYHA classification ≥III), and severe arrhythmias.\n6. Subjects with systemic diseases that the investigator determined to be unstable include, but are not limited to, severe liver and kidney or metabolic diseases requiring medical treatment.\n7. Subjects with second malignancies in addition to MM within the past 5 years before the screening, exceptions to this criterion: successfully treated cervical carcinoma in situ and non-metastatic basal or squamous cell skin carcinoma, local prostate cancer after radical surgery, and ductal carcinoma in situ of the breast after radical surgery.\n8. Subjects with a history of organ transplantation.\n9. Subjects have received major surgery within 2 weeks prior to leukapheresis or plan to receive surgery during the study or within 2 weeks after the study treatment (excluding local anesthesia).\n10. Subjects participated in another interventional clinical study 1 months before signing the informed consent (ICF);\n11. Subjects with any uncontrolled active infection needed to receive systemic therapy within 7 days before leukapheresis collection (excluding # CTCAE grade 2 urogenital infection and upper respiratory infection).\n12. Positive for any of the following tests:\n\n    Hepatitis B virus (HBV) surface antigen (HBsAg) or hepatitis B core antibody-positive and detectable HBV DNA in peripheral blood; Hepatitis C virus (HCV) antibody and hepatitis C virus RNA in peripheral blood; Human immunodeficiency virus (HIV) antibody; Cytomegalovirus (CMV) DNA; Treponema Pallidum antibody\n13. Pregnant or lactating women.\n14. Subjects with mental illness or consciousness disorder or disease of the central nervous system\n15. Other conditions that researchers consider inappropriate for inclusion.",{"count":411,"type":20},12,[108],"This study is a single-center, open-label, dose-escalation study to observe the safety and efficacy of different doses of CAR-GPRC5D in patients with R\u002FR MM or Plasma Cell Leukemia.",[392,31],[395,416,417],"RRMM","PCL","2025-05-15",{"date":420,"type":65},"2025-05-20",{"date":422,"type":65},"2023-03-30",{"date":424,"type":20},"2026-10-01",{"name":426,"class":176},"Nanjing IASO Biotechnology Co., Ltd.",{"id":428,"slug":429,"hasResults":11,"nctId":430,"briefTitle":431,"officialTitle":432,"acronym":433,"eligibilityCriteria":434,"healthyVolunteers":11,"sex":16,"minAge":82,"maxAge":4,"enrollmentInfo":435,"targetDuration":4,"studyType":188,"phases":4,"briefSummary":437,"conditions":438,"keywords":441,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":454,"lastUpdatePostDateStruct":455,"startDateStruct":456,"completionDateStruct":458,"leadSponsor":460,"locationsCount":462},"100581808","the-norwegian-immunotherapy-in-multiple-myeloma-study-100581808","NCT06855121","The Norwegian Immunotherapy in Multiple Myeloma Study","The Norwegian Immunotherapy in Multiple Myeloma Study - A Population-based Longitudinal Observational Multicenter Study on Effectiveness and Complications of Immunotherapy in Multiple Myeloma in the Norwegian Myeloma Cohort","NIMMS","Inclusion criteria\n\n* Participants age ≥ 18 years\n* Prior diagnosis of one of the following\n\n  * Multiple myeloma as defined according to IMWG criteria\n  * Primary plasma cell leukemia as defined according to IMWG consensus definition\n  * AL-amyloidosis as defined according to IMWG criteria\n* Planned treatment with one of the following outside clinical trials (list to be amended based on approvals within the EU):\n\n  * Teclistamab (Tecvayli)\n  * Elranatamab (Elrexfio)\n  * Talquetamab (Talvey)\n  * Idecabtagene vicleucel (ide-cel\u002FAbecma)\n  * Ciltacabtagene autoleucel (cilta-cel\u002FCarvykti)\n\nExclusion Criteria:\n\n* None",{"count":436,"type":20},400,"The goal of this observational study is to study the effectiveness and complications of novel immunotherapies used in the treatment of multiple myeloma in routine care in Norway. The aim is to close knowledge gaps, generate evidence for future clinical trials and contribute to future consensus on how to monitor for adverse events, and what mitigation strategies should be implemented, so that we can increase patient survival and quality-of-life.",[439,31,440],"Myeloma Multiple","AL Amyloidosis",[442,443,444,445,446,447,448,449,450,451,452,453],"bispesific antibodies","teclistamab","elranatamab","talquetamab","cilta-cel","ide-cel","ciltacabtagene autoleucel","idecabtagene vicleucel","CRS","ICAN","infections","supportive care","2025-02-26",{"date":295,"type":65},{"date":457,"type":65},"2025-01-15",{"date":459,"type":20},"2037-12-01",{"name":461,"class":72},"St. Olavs Hospital",23,{"id":464,"slug":465,"hasResults":11,"nctId":466,"briefTitle":467,"officialTitle":468,"acronym":4,"eligibilityCriteria":469,"healthyVolunteers":11,"sex":16,"minAge":82,"maxAge":330,"enrollmentInfo":470,"targetDuration":4,"studyType":21,"phases":471,"briefSummary":472,"conditions":473,"keywords":474,"overallStatus":139,"whyStopped":4,"lastUpdateSubmitDate":476,"lastUpdatePostDateStruct":477,"startDateStruct":479,"completionDateStruct":481,"leadSponsor":483,"locationsCount":4},"100566464","phase-1-an-exploratory-study-of-rd140-injection-in-patients-with-relapsedrefractory-multiple-myeloma-or-plasma-cell-leukemia-100566464","NCT06655519","An Exploratory Study of RD140 Injection in Patients With Relapsed\u002FRefractory Multiple Myeloma or Plasma Cell Leukemia","An Exploratory Study of Fully Human Anti-B-Cell Maturation Antigen (BCMA)\u002FG Protein-coupled Receptor, Class C Group 5 Member (GPRC5D) Chimeric Antigen Receptor T Cells (RD140) in Patients With Relapsed\u002FRefractory Multiple Myeloma or Plasma Cell Leukemia","Inclusion Criteria:\n\n1. Age 18 to 75 years old, male or female;\n2. Diagnosed as Multiple Myeloma (MM) according to the international standard for multiple myeloma (IMWG), or diagnosed as primary plasma cell leukemia;\n3. Subjects have had at least 3 prior lines of therapy including at least one proteasome inhibitor (PI), one immunomodulatory agent (IMiD), and one anti-CD38 monoclonal antibody, or subjects who were refractory to the above treatments.\n4. Disease progression must be documented during or within 12 months following the most recent anti-tumor treatment (the progression for subjects whose last line treatment was CAR-T therapy was not limited to 12 months post-treatment);\n5. Presence of measurable lesion at screening as determined by any of the following criteria for subjects with MM:\n\n   * Serum M protein level: IgG type M protein ≥ 10 g\u002FL, or IgA, IgD, IgE, IgM type M protein ≥ 5 g\u002FL;\n   * Urine M protein level ≥ 200 mg\u002F24h;\n   * Light chain multiple myeloma without measurable M protein in serum or urine: Involved serum free light chain (sFLC) ≥ 100 mg\u002FL and abnormal serum κ\u002Fλ free light chain ratio；\n   * Serum M- protein, urine M- protein, or involved sFLC not meeting above criteria but bone marrow plasma cell percentage ≥30%;\n6. Subjects with primary plasma cell leukemia: peripheral blood plasma cell percentage≥5%at screening;\n7. ECOG score of 0 or 1;\n8. Estimated life expectancy ≥12 weeks;\n9. Subjects must have adequate organ function and meet all of the following laboratory test results prior to enrollment:\n\n   1. Blood routine: absolute neutrophil count (ANC) ≥ 1×10\\^9\u002FL (support with growth factor is allowed, but must not have received support treatment within 7 days before the laboratory test); Absolutely lymphocyte count (ALC) ≥0.3×10\\^9\u002FL; Platelets ≥50×10\\^9\u002FL (must not have received platelet transfusion support within 7 days before the laboratory test); Hemoglobin ≥60 g\u002FL(must not have received red blood cell \\[RBC\\] transfusion within 7 days before the laboratory test);\n   2. Liver function: alanine aminotransferase (ALT) and aspartate aminotransferase (AST)≤2.5× Upper limit of normal value (ULN); Serum total bilirubin ≤1.5 ×ULN;\n   3. Renal function: creatinine clearance (CrCl) calculated by Cockcroft-Gault formula ≥ 40 ml\u002Fmin;\n   4. Coagulation function: fibrinogen ≥ 1.0g \u002FL; Activated partial thromboplastin time (aPTT) ≤1.5× ULN, Pro thrombin time (PT) ≤1.5× ULN;\n   5. Blood oxygen saturation(SaO2) \\>91%;\n   6. Left ventricular ejection fraction (LVEF) ≥ 50%;\n10. Subjects agree to take effective measures or drug contraceptive measures (excluding safe period contraception) after signing the ICF and within one year after CAR-T cell infusion;\n11. Subjects must sign an informed consent approved by the Ethics Committee before starting any screening procedures.\n\nExclusion Criteria:\n\n1. Subjects who are known to have Graft-Versus-host disease (GVHD) or need long-term immunosuppressive therapy;\n2. Subjects have received an autologous hematopoietic stem cell transplantation (auto-HSCT) within 12 weeks before leukapheresis or have a previous history of two times of auto-HSCT or previous history of an allogeneic hematopoietic stem cell transplantation (allo-HSCT);\n3. Received targeted plasma cell therapy within 3 months before leukapheresis, or previous cell therapy products can still be detected in peripheral blood.\n4. Subjects have received any anti-tumor treatment as follows, prior to leukapheresis:\n\n   * Monoclonal antibody for multiple myeloma or plasma cell leukemia within 21 days, or;\n   * Cytotoxic chemotherapy or proteasome inhibitors within 14 days, or;\n   * Immunomodulators within 7 days, or;\n   * Received other anti-cancer therapy within 14 days or at least 5 half-lives\n5. Subjects require long-term use of glucocorticoids (defined as prednisone or equivalent \\> 20 mg\u002Fday) at a therapeutic dose during the study, physiologic replacement, topical, and inhaled steroids are permitted, nevertheless.\n6. Subjects with hypertension that cannot be controlled by medication;\n7. Sever cardiac disease including but not limited to unstable angina pectoris, myocardial infarction (within 6 months prior to screening), cardiac failure congestive (New York Heart Association \\[NYHA\\] class ≥ III), severe arrhythmia;\n8. Unstable systemic disease as judged by the investigator: including but not limited to severe liver, renal, or metabolic disease requiring drug therapy ;\n9. Subjects has prior history of malignancies, other than MM and plasma cell leukemia within 5 years before screening, with the exception of radical carcinoma in situ of the cervix, basal cell carcinoma or squamous cell carcinoma of skin, localized cancer of prostate after radical prostatectomy, ductal carcinoma in situ of breast after radical mastectomy, or papillary thyroid carcinoma after radical thyroidectomy;\n10. Subjects with a history of organ transplantation;\n11. Subjects with suspected or known central nervous system (CNS) involvement with myeloma;\n12. Subjects with history of major surgery within 2 weeks prior to leukapheresis or planned to have surgery within 2 weeks after study treatment (except for subjects who were planned to have local anesthesia);\n13. Treated with other investigational products within 1 month prior to leukapheresis;\n14. Subjects have uncontrolled systemic fungal, bacterial, viral or other infection (defined as exhibiting ongoing signs\u002Fsymptoms related to the infection and without improvement, despite appropriate antimicrobial treatment) or requiring IV antimicrobials for management;\n15. Positive hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) with detectable hepatitis B virus (HBV) DNA in peripheral blood; positive hepatitis C virus (HCV) antibody with positive HCV RNA in peripheral blood; positive human immunodeficiency virus (HIV) antibody; positive cytomegalovirus (CMV) DNA; Syphilis toluidine red unheated serum test (TRUST) and treponemal particle agglutination test (TPPA) were positive;\n16. Pregnant or breastfeeding women;\n17. Subjects have psychiatric disorders, conscious disorders, or central nervous system diseases;\n18. Any condition for which, at the discretion of investigators, participation would not be in the best interest of the subject.",{"count":411,"type":20},[108],"This is a single-center, open clinical study, divided into two phases of dose escalation and dose expansion, to observe the safety and efficacy of RD140 injection at different doses in patients with relapsed\u002Frefractory multiple myeloma or plasmacytic leukemia.",[392,31],[48,31,475],"RD140","2024-10-22",{"date":478,"type":65},"2024-10-23",{"date":480,"type":20},"2024-10-25",{"date":482,"type":20},"2041-07-05",{"name":484,"class":72},"Peking University People's Hospital",{"id":486,"slug":487,"hasResults":11,"nctId":488,"briefTitle":489,"officialTitle":490,"acronym":4,"eligibilityCriteria":491,"healthyVolunteers":11,"sex":16,"minAge":82,"maxAge":4,"enrollmentInfo":492,"targetDuration":4,"studyType":21,"phases":493,"briefSummary":494,"conditions":495,"keywords":496,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":500,"lastUpdatePostDateStruct":501,"startDateStruct":503,"completionDateStruct":505,"leadSponsor":507,"locationsCount":73},"100519557","early-phase-1-to-evaluate-the-safety-and-efficacy-of-human-bcma-targeted-car-nk-cells-injection-for-subjects-with-rr-mm-or-pcl-100519557","NCT06045091","To Evaluate the Safety and Efficacy of Human BCMA Targeted CAR-NK Cells Injection for Subjects With R\u002FR MM or PCL","A Early Phase 1 Clinical Trial to Evaluate the Safety and Efficacy of Human BCMA Targeted CAR-NK Cells Injection for Subjects With Relapsed\u002FRefractory Multiple Myeloma or Plasma Cell Leukemia","Inclusion Criteria:Subjects must meet all of the following criteria to be enrolled:\n\n* Subjects volunteer to participate in clinical trials, understand and sign the informed consent document, be willing to complete all the trial procedures;\n* 18 years and older, Male and female;\n* Expected survival \\> 12 weeks;\n* Documented evidence of multiple myeloma at diagnosis as defined by IMWG updated criteria (2014), or plasma cell leukemia at diagnosis as defined by Diagnosis and therapeutic criteria of hematologic disease (4th edition);\n* One of the following indicators is satisfied:\n\n  1. Serum M protein: IgG M protein ≥5 g\u002FL; or IgA M protein ≥5 g\u002FL; or IgD M protein and IgD \\>ULN;\n  2. Urine M protein ≥200 mg\u002F24h;\n  3. Affected serum free light chain ≥100 mg\u002FL and Serum free light chain ratio is abnormal;\n  4. Clonal bone marrow plasma cells ≥10 % for non-secretory myeloma;\n* Patients with relapsed\u002Frefractory multiple myeloma or plasma cell leukemia, satisfying:\n\n  1. Patients have received at least 3 prior MM or PCL treatment regimens containing at least one proteasome inhibitor and one immunomodulatory;\n  2. Progress is documented within 60 days of the most recent anti-tumor treatment, or efficacy assessment does not reach minimal response(MR) or above;\n* Liver, kidney and cardiopulmonary functions meet the following requirements:\n\n  1. Creatinine clearance rate (estimated by CockcroftGault formula) ≥30mL\u002Fmin;\n  2. Left ventricular ejection fraction \\> 50%;\n  3. Baseline peripheral oxygen saturation \\> 95%;\n  4. Total bilirubin≤ 2×ULN; Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5×ULN;\n* Blood routine examination satisfying hemoglobin≥60 g\u002FL, neutrophils≥ 1.0×10\\^9\u002FL, and platelets≥30×10\\^9\u002FL, can complete this trial according to the judgement of investigators.\n\nExclusion Criteria:Any one of the following conditions cannot be selected as a subject：\n\n* Accompanied by other uncontrolled malignancies;\n* Subjects with positive Hepatitis B surface antigen(HBsAg) or Hepatitis B core antibody (HBcAb) and hepatitis B virus (HBV) DNA titers higher than the lower limit of the normal range of the investigative site; Hepatitis C virus (HCV) antibody positive and peripheral blood HCV RNA positive; Human Immunodeficiency Viral (HIV) antibody positive; syphilis primary screening antibody positive;\n* Any instability of systemic disease, including but not limited to unstable angina, cerebrovascular accident, or transient cerebral ischemic (within 6 months prior to screening), myocardial infarction (within 6 months prior to screening), congestive heart failure (New York heart association (NYHA) classification ≥ III), need drug therapy of severe arrhythmia, liver, kidney, or metabolic disease;\n* Subjects who are considered unsuitable to participate in this trial by the investigator.\n* Pregnant or lactating woman, and female subject who plans to have a pregnancy within 1 year after cell transfusion, or male subject whose partner plans to have a pregnancy within 1 year after cell transfusion;\n* Received CAR-NK treatment or other gene therapies before enrollment;\n* Subjects who have a disease that affects the signing of written informed consent or who are unable to comply with research procedures; or who are unwilling or unable to comply with research requirements;\n* Subjects who have had severe immediate hypersensitivity reactions to any drugs used in this research;\n* Active or uncontrollable infection requiring systemic therapy within 14 days prior to enrollment;\n* In the past two years, the terminal organ was damaged due to autoimmune diseases (such as Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus), or the systemic use of immunosuppressive or other systemic disease control drugs was required;\n* Patients with symptoms of central nervous system.",{"count":388,"type":20},[310],"This study is a single-arm, open-label, dose-escalation trial to explore the safety, tolerability and pharmacokinetic\u002Fpharmacodynamics characteristics of human BCMA targeted CAR-NK Cells injection, and to preliminarily observe the efficacy of the trial drug in patients with relapsed\u002Frefractory multiple myeloma or plasma cell leukemia.",[48,31],[497,498,48,31,499],"BCMA","CAR-NK","Relapsed \u002FRefractory","2023-09-13",{"date":502,"type":65},"2023-09-21",{"date":504,"type":65},"2023-07-04",{"date":506,"type":20},"2027-09-30",{"name":508,"class":176},"Hrain Biotechnology Co., Ltd.",{"id":510,"slug":511,"hasResults":11,"nctId":512,"briefTitle":513,"officialTitle":514,"acronym":4,"eligibilityCriteria":515,"healthyVolunteers":516,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":517,"targetDuration":4,"studyType":188,"phases":4,"briefSummary":518,"conditions":519,"keywords":4,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":523,"lastUpdatePostDateStruct":524,"startDateStruct":526,"completionDateStruct":528,"leadSponsor":530,"locationsCount":73},"100461081","a-cohort-study-of-plasma-cell-disorders-pcds-in-pkufh-100461081","NCT05283993","A Cohort Study of Plasma Cell Disorders (PCDs) in PKUFH","A Prospective Cohort Study of Patients With Plasma Cell Disorders (PCDs) in PKUFH","Inclusion Criteria:\n\n1. Patients included are those with confirmed diagnosis of PCDs and hospitalized into Peking University First Hospital (PKUFH)\n2. Patients of plasma cell disorders (PCDs) are recruited. PCDs include monoclonal gammopathy of uncertain significance; smoldering myeloma; multiple myeloma; plasma cell leukemia; amyloidosis; light chain deposition disease; heavy chain deposition disease; Castleman's disease (CD); Polyneuropathy, Organomegaly, Endocrinopathy, Monoclonal gammopathy and Skin changes syndrome; cryoglobulinemia; Monoclonal Gammopathy of Renal Significance (MGRS); Monoclonal gammopathy of neurological significance (MGNS).\n3. Patients are included into this cohort after signing the ICFs.\n\nExclusion Criteria:\n\nSignificant comorbidity may be life-threatening.",true,{"count":254,"type":20},"The primary aim is to establish a prospective cohort of patients with plasma cell disorders (PCDs). All of the hospitalized PCD patients who are willing to sign the informed consent form (ICF) will be included in this study. Clinical characteristics, treatment options and responses will be collected. Peripheral blood, bone marrow aspirate and urine samples before and after the treatment will banked for future research. Our team will focus on the clinical and pathological features of PCDs, the correlation between the minimal residual disease (MRD) status and prognosis, and the role of Tumor Microenvironment (TME) in the pathogenesis and progress of PCDs.",[48,162,258,259,260,261,262,212,31,520,521,522],"Monoclonal Gammopathy of Undetermined Significance (MGUS)","Monoclonal Gammopathy of Renal Significance (MGRS)","Monoclonal Gammopathy of Neurological Significance (MGNS)","2022-04-21",{"date":525,"type":65},"2022-04-25",{"date":527,"type":65},"2021-07-01",{"date":529,"type":20},"2030-12-31",{"name":531,"class":72},"Peking University First Hospital",{"id":533,"slug":534,"hasResults":11,"nctId":535,"briefTitle":536,"officialTitle":537,"acronym":538,"eligibilityCriteria":539,"healthyVolunteers":11,"sex":16,"minAge":82,"maxAge":540,"enrollmentInfo":541,"targetDuration":4,"studyType":21,"phases":543,"briefSummary":544,"conditions":545,"keywords":4,"overallStatus":139,"whyStopped":4,"lastUpdateSubmitDate":546,"lastUpdatePostDateStruct":547,"startDateStruct":549,"completionDateStruct":551,"leadSponsor":553,"locationsCount":4},"100443444","phase-2-primary-plasma-cell-leukemia-a-prospective-phase-2-study-incorporating-daratumumab-to-chemotherapy-and-stem-cell-transplantation-100443444","NCT05054478","Primary Plasma Cell Leukemia: a Prospective Phase 2 Study Incorporating Daratumumab to Chemotherapy and Stem Cell Transplantation","Primary Plasma Cell Leukemia: a Prospective Phase 2 Study Incorporating Daratumumab to Chemotherapy and Stem Cell Transplantation : PCL-2 Study","PCL-2","Inclusion Criteria:\n\n1. Male or female patients 18 to 69 years old.\n2. Patient with primary plasma cell leukemia disease as defined by the International Myeloma Working Group -IMWG (Annexe I)\n3. Voluntary written consent must be given before performance of any study related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care\n4. Eastern Cooperative Oncology Group (ECOG) performance status and\u002For other performance status 0, 1, or 2.\n5. Eligible for high dose Melphalan therapy with ASCT\n6. Total bilirubin \\\u003C= 2 X the upper limit of the normal range (ULN).\n7. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \\\u003C= 3 ULN.\n8. Calculated creatinine clearance \\>= 20 mL\u002Fmin\n9. Female patients who:\n\n   * Have been postmenopausal for at least 2 years before the screening visit, OR\n   * are surgically sterile, OR If they are of childbearing potential, agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent form through 90 days after the last dose of study drug, OR\n   * Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence \\[e.g., calendar, ovulation, symptothermal and post-ovulation methods\\] and withdrawal are not acceptable methods of contraception.)\n10. Male patients, even if surgically sterilized (i.e., status post-vasectomy), must agree to one of the following:\n\n    * Agree to practice effective barrier contraception during the entire study treatment period and through 90 days after the last dose of study drug, OR\n    * Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence \\[e.g., calendar, ovulation, symptothermal and post-ovulation methods\\] and withdrawal are not acceptable methods of contraception.)\n11. Patients agree\n\n    * not to share study medication with any other person and to return all unused study drugs to the investigator.\n    * to abstain from donating blood while taking the study drug therapy and for one week following discontinuation of the study drug therapy.\n12. Must be able to adhere to the study visit schedule and other protocol requirements\n13. Affiliated with an appropriate social security system\n\nExclusion Criteria:\n\n1. Male or female patients \\\u003C18 or \\> 69 years old\n2. Prior history of malignancies, unless free of the disease for ≥ 5 years.\n3. Prior history of symptomatic myeloma; did not received any previous chemotherapy for myeloma except corticotherapy (dexamethasone 40 mg\u002Fd for 4 days max).\n4. Any other uncontrolled medical condition or comorbidity that might interfere with subject's participation.\n5. Pregnant or breast feeding females\n6. Known positive for HIV\n7. Known seropositive for hepatitis C (except in the setting of a sustained virologic response \\[SVR\\], defined as a viremia at least 12 weeks after completion of antiviral therapy)\n8. Seropositive for hepatitis B (defined by a positive test for hepatitis B surface antigen \\[HBsAg\\]). Subjects with resolved infection (ie, subjects who are HBsAg negative but positive for antibodies to hepatitis B core antigen \\[anti-HBc\\] and\u002For antibodies to hepatitis B surface antigen \\[anti-HBs\\]) must be screened using real-time polymerase chain reaction (PCR) measurement of hepatitis B virus (HBV) DNA levels. Those who are PCR positive will be excluded. EXCEPTION: Subjects with serologic findings suggestive of HBV vaccination (anti- HBs positivity as the only serologic marker) AND a known history of prior HBV vaccination, do not need to be tested for HBV DNA by PCR.\n9. Patient with severe renal failure that require dialysis and clearance creatinine \\\u003C 20 ml\u002Fmin\n10. Prior local irradiation within two weeks before first dose. However, an exception (that is patients allowed to remain in the treatment phase of the study) is made for radiation therapy to a pathological fracture site to enhance bone healing or to treat post-fracture pain that is refractory to narcotic analgesics because pathologic bone fractures do not by themselves fulfil a criterion for disease progression.)\n11. Evidence of central nervous system (CNS) involvement\n12. Unable to take corticosteroid therapy, daratumumab, bortezomib and or lenalidomide at study entry.\n13. Ongoing active infection, especially ongoing pneumonitis\n14. Ongoing Cardiac dysfunction: specify e.g. uncontrolled hypertension, MI within 6 months, unstable Angina pectoris, Cardiac arrhythmia Grade 2 or higher, NYHA class III\u002FIV\n15. Patients with a left ventricular ejection fraction under to 40 % (LVEF \\\u003C40%).\n16. Use of any other experimental drug or therapy within 15 days of screening.\n17. Any \\>grade 2 toxicity unresolved\n18. Inability or unwillingness to comply with birth control requirements\n19. Unable to take antithrombotic medicines at study entry\n20. Major surgery within 14 days before enrolment\n21. Any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to this protocol.\n22. Known allergy to any of the study medications, their analogues, or excipients in the various formulations of any agent.\n23. Known GI disease or GI procedure that could interfere with the oral absorption or tolerance of daratumumab and lenalidomide including difficulty swallowing","69 Years",{"count":542,"type":20},29,[23],"Single-Arm phase 2 trial evaluating efficacy of incorporating Daratumumab to treatment of newly diagnosed primary plasma cell leukemia. Treatment will be based on Dara-VRd induction followed by first ASCT, Dara-VRd for first consolidation, second ASCT, Dara-VRd for 1 year as second consolidation and Lenalidomide for 1 year.",[31],"2021-09-22",{"date":548,"type":65},"2021-09-23",{"date":550,"type":20},"2021-10",{"date":552,"type":20},"2028-02",{"name":554,"class":72},"Assistance Publique - Hôpitaux de Paris"]