[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"primary-plasma-cell-leukemia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:primary-plasma-cell-leukemia":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,49,75],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":30,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100526916","phase-2-study-to-evaluate-the-safety-and-efficacy-of-daratumumab-and-carfilzomib-based-inductionconsolidationmaintenance-therapy-in-transplant-eligible-ultra-high-risk-newly-diagnosed-multiple-myeloma-100526916",false,"NCT06140966","Study to Evaluate the Safety and Efficacy of Daratumumab and Carfilzomib-based Induction\u002FConsolidation\u002FMaintenance Therapy in Transplant-eligible, Ultra High-risk, Newly Diagnosed Multiple Myeloma","Clinical Study to Evaluate the Safety and Efficacy of Daratumumab and Carfilzomib-based Induction\u002FConsolidation\u002FMaintenance Therapy in Transplant-eligible, Ultra High-risk, Newly Diagnosed Multiple Myeloma","Inclusion Criteria:\n\n1. Patients must have newly diagnosed ultra high-risk disease, as defined by one of the following:1)\"Double hit\"Multiple Myeloma (≥2 adverse markers: t(4;14), t(14;16), t(14;20), 1q21+, del(17p),p53 mutation) ,2)Extramedullary Multiple Myeloma, 3) primary plasma cell leukemia.\n2. Patients must be either untreated or have not received systemic MM therapy. Prior bisphosphonates and localized radiation are allowed.\n3. Aged 18 years to 70 years.\n4. Fit for intensive chemotherapy and autologous stem cell transplant (at clinician's discretion).\n5. Eastern Cooperative Oncology Group (ECOG) score ≤2 before induction chemotherapy.\n\nExclusion Criteria:\n\n1. No evidence of high-risk disease.\n2. Primary diagnosis of Waldenstrom's disease\u002FPOEMS syndrome\u002Flight chain amyloidosis.\n3. Received therapy for multiple myeloma.\n4. Prior or concurrent invasive malignancies.\n5. Eastern Cooperative Oncology Group (ECOG) score \\>2 before induction chemotherapy.\n6. Clinically significant allergies or intolerance to daratumumab,carfilzomib,lenalidomide, dexamethasone, cisPlatin, epirubicin, cyclophosphamide,melphalan, and etoposide.\n7. Participants with contraindication to thromboprophylaxis.\n8. Any uncontrolled or severe cardiovascular or pulmonary disease.\n9. Platelet count \\\u003C 50,000\u002FμL, absolute neutrophil count \\\u003C1000\u002FμL, and haemoglobin \\\u003C60 g\u002FL before induction chemotherapy.\n10. Calculated creatinine clearance \\\u003C30 mL\u002Fmin, alanine transaminase (ALT) or aspertate aminotransferase (AST) \\>3 times upper limit of normal (ULN). Bilirubin \\>2 times ULN, except in participants with congenital bilirubinemia, such as Gilbert syndrome (direct bilirubin \\>2.0 times ULN).\n11. Known to be seropositive for history of HIV or known to have active hepatitis B or hepatitis C.\n12. Ejection fraction by echocardiogram (ECHO) ≥ 45%, pulmonary function studies \\\u003C50% of predicted on mechanical aspects (Forced Expiratory Volume 1 (FEV1), Forced Vital Capacity (FVC) and diffusion capacity (DLCO) \\\u003C 50% of predicted.\n13. Uncontrolled or severe cardiovascular or pulmonary disease, clinically significant cardiac disease, uncontrolled diabetes mellitus, or other serious medical or psychiatric illness that could potentially interfere with the completion of treatment according to this protocol.\n14. Known\u002Funderlying medical conditions that, in the investigator's opinion, would make the administration of the study drug hazardous.\n15. Participant is a woman who is pregnant, or breast feeding, or planning to become pregnant while enrolled in this trial or within at least 6 months after the last dose of trial treatment. Or, participant is a man who plans to father a child while taking part in this trial or within at least 6 months after the last dose of trial treatment.\n16. Received an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 4 weeks before treatment protocol registration or is currently enrolled in an interventional investigational study.\n17. Major surgery within 2 weeks before treatment protocol registration or has not fully recovered from surgery, or has surgery planned during the time the participant is expected to participate in the study. Kyphoplasty or vertebroplasty is not considered major surgery.\n18. Known or suspected of not being able to comply with the study protocol.","ALL","18 Years","70 Years",{"count":20,"type":21},54,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This study will assess whether the combination of daratumumab and carfilzomib-based Induction\u002FConsolidation\u002FMaintenance Therapy with ASCT improves the outcome of patients with ultra high-risk, newly diagnosed multiple myeloma",[27,28,29],"Multiple Myeloma","Primary Plasma Cell Leukemia","Extramedullary Multiple Myeloma",[31,32,27,33,28,29,34,35],"Daratumumab","Carfilzomib","Ultra High-risk","Autologous stem cell transplant","Double hit","RECRUITING","2025-04-12",{"date":39,"type":40},"2025-04-16","ACTUAL",{"date":42,"type":40},"2023-10-20",{"date":44,"type":21},"2027-10-20",{"name":46,"class":47},"Union Hospital, Tongji Medical College, Huazhong University of Science and Technology","OTHER",1,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":57,"enrollmentInfo":58,"targetDuration":4,"studyType":22,"phases":60,"briefSummary":61,"conditions":62,"keywords":63,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":74},"100565005","phase-2-an-investigator-initiated-phase-ii-multicenter-open-label-single-arm-prospective-clinical-trial-to-evaluate-the-efficacy-and-safety-of-alternating-bortezomib-based-regimens-in-combination-with-daratumumab-followed-by-maintenance-with-daratumumab-in-the-frontline-setting-of-primary-plasma-cell-l-100565005","NCT06636552","An Investigator-Initiated, Phase II, Multicenter, Open-Label, Single-Arm, Prospective Clinical Trial to Evaluate the Efficacy and Safety of Alternating Bortezomib-Based Regimens in Combination With DaratUMumab Followed by Maintenance With Daratumumab in the Frontline Setting of Primary Plasma CEll L","An Investigator-Initiated, Phase II, Multicenter, Open-Label, Single-Arm, Prospective Clinical Trial to Evaluate the Efficacy and Safety of Alternating Bortezomib-Based Regimens in Combination With DaratUMumab Followed by Maintenance With Daratumumab in the Frontline Setting of Primary Plasma CEll LEukemIA: A Trial of the Greek Myeloma Study Group The \" EUMELEIA \" Study","EUMELEIA","Inclusion\n\n1. Age between 18 and 80 years (inclusive) at the time of signing the informed consent.\n2. Patients newly diagnosed with documented pPCL as defined by the current IMWG criteria for PCL and MM:\n\n   * Documented presence of ≥5% PBPCs and\u002For absolute number ≥0.5 × 103\u002FμL, assessed either morphologically in the peripheral blood (PB) smear or by flow cytometry, and confirmation of plasma cell clonality by flow cytometry\n   * Clonal BMPCs ≥10% or biopsy-proven bony or extramedullary plasmacytoma\n   * At least one of the following myeloma defining events:\n   * Evidence of end organ damage that can be attributed to the underlying plasma cell proliferative disorder, specifically (one or more of the following):\n   * Hypercalcemia: serum calcium \\>0.25 mmol\u002FL (\\>1 mg\u002FdL) higher than the upper limit of normal (ULN) or \\>2.75 mmol\u002FL (\\>11 mg\u002FdL)\n   * Renal insufficiency: Creatinine clearance (CrCl) \\\u003C40 mL\u002Fmin (measured or estimated by validated equations) or serum creatinine \\>177 μmol\u002FL (\\>2 mg\u002FdL)\n   * Anemia: hemoglobin value of \\>20 g\u002FL below the lower limit of normal (LLN), or a hemoglobin value \\\u003C100 g\u002FL\n   * Bone lesions: One or more osteolytic lesions on skeletal radiography, computed tomography (CT), or positron emission tomography (PET)-CT.\n   * Any one or more of the following biomarkers of malignancy:\n   * Clonal bone marrow plasma cell percentage ≥60%\n   * Involved:Uninvolved serum free light chain (sFLC) ratio ≥100 \\>1 focal lesions on MRI studies (each focal lesion must be 5 mm or more in size).\n3. Measurable disease by protein electrophoresis as defined by any of the following:\n\n   * Serum M-protein level:\n   * For IgG MM: ≥1.0 g\u002FdL or urine M-protein level ≥200 mg\u002F24 hours\n   * For IgA, IgE and IgM MM: ≥0.5 g\u002FdL or urine M-protein level ≥200 mg\u002F24 hours\n   * For IgD MM: ≥0.05 g\u002FdL or urine M-protein level ≥200 mg\u002F24 hours\n   * Light chain MM without measurable disease in the serum or the urine: sFLC ≥10 mg\u002FdL (involved light chain) and abnormal sFLC κ\u002Fλ ratio.\n4. Patients for whom high-dose therapy, with or without stem cell transplantation, is part of the intended treatment plan.\n5. Patient not currently or previously treated with any systemic therapy or stem cell transplant for any plasma cell dyscrasia, apart from a short course of corticosteroid therapy (equivalent of dexamethasone 40 mg\u002Fday for up to 4 days).\n6. Adequate bone marrow function as determined by the following:\n\n   * Hemoglobin ≥7.0 g\u002FdL \\[≥4.34 mmol\u002FL; prior red blood cell transfusion or recombinant human erythropoietin use is permitted\\]\n   * Absolute neutrophil count ≥1.0 x 109\u002FL \\[granulocyte-colony stimulating factor use is permitted\\]\n   * Platelet count ≥50 x 109\u002FL if disease involvement in bone marrow is \\>50%; otherwise ≥75% x 109\u002FL.\n7. Adequate liver function as determined by the following:\n\n   * Serum Aspartate Transaminase ≤2.5 x ULN\n   * Serum Alanine Aminotransferase ≤2.5 x ULN\n   * Total bilirubin ≤1.5 x ULN (for subjects with congenital bilirubinemia, such as Gilbert syndrome, direct bilirubin ≤1.5 x ULN is required).\n8. Adequate renal function as determined by estimated CrCl ≥20 mL\u002Fmin.\n9. Eastern Cooperative Oncology Group (ECOG) Performance status 0-3.\n10. If females of childbearing potential (FCBP), the following apply:\n\n    * Willingness to use an acceptable form of birth control during the clinical trial. FCBPs must commit to either abstain continuously from heterosexual sexual intercourse or to use 2 methods of reliable birth control simultaneously during the treatment period, and for 3 months after the last dose of any component of the treatment regimen.\n    * They must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for a period of 3 months after receiving the last dose of any component of the study treatment.\n    * They must have 2 negative serum or urine pregnancy tests; one at Screening and in particular within 10-14 days prior to C1D1, and the second within 24 hours prior to C1D1.\n11. If male subjects of reproductive potential who are sexually active with FCBPs the following apply.\n\n    * Must always use a latex or synthetic condom during the study and for 3 months after discontinuing study treatment (even if they have undergone a successful vasectomy).\n    * They must not donate sperm during the study or for 3 months after the last dose of study treatment.\n12. Patients who are able to comprehend and willing to follow the requirements of the study.\n13. Patients (or patients' legally acceptable representative as applicable) who are able to understand and willing to provide voluntary written informed consent before any clinical trial-related procedure is performed.\n\nExclusion\n\n1. Patients with secondary PCL.\n2. Prior or concurrent invasive malignancy (other than PCL) within 5 years of date of study treatment initiation except for the following:\n\n   * Malignancy treated with curative intent and with no known active disease present for ≥3 years before study treatment initiation.\n   * Adequately treated non-melanoma skin cancer, carcinoma in situ of the cervix or breast, incidental histologic finding of prostate cancer (T1a or T1b) or other non-invasive lesion that, as per Investigator's judgement, is considered cured with minimal risk of recurrence over the next 3 years.\n3. Radiation therapy within 14 days before study treatment initiation.\n4. Plasmapheresis within 28 days before study treatment initiation.\n5. Exhibiting clinical signs of meningeal or central nervous system involvement by PCL.\n6. Patients with peripheral neuropathy or neuropathic pain Grade 2 or higher, as defined by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.\n7. Concurrent systemic amyloidosis, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and\u002For skin changes), active systemic infection, uncontrolled diabetes, acute diffuse infiltrative pulmonary disease, and any other medical condition\u002Fdisease that is likely to interfere with the study procedures or results, or that in the opinion of the Investigator, places the subject at unacceptable risk if he\u002Fshe were to participate in the study or confounds the ability to interpret data from the study.\n8. Known chronic obstructive pulmonary disease with a forced expiratory volume in 1 second \\[FEV1\\] \\\u003C50% of predicted normal.\n9. Known moderate or severe persistent asthma within the past 2 years, or the patient currently has uncontrolled asthma of any classification.\n10. Any of the following:\n\n    * Known seropositivity for human immunodeficiency virus\n    * Seropositivity for hepatitis B virus defined by a positive test for hepatitis B surface antigen.\n    * Known seropositivity for hepatitis C virus defined by anti-HCV antibody positive or HCV-RNA quantitation positive.\n11. Clinically significant cardiac disease including:\n\n    * Myocardial infarction within 6 months before study treatment initiation\n    * Unstable or uncontrolled disease\u002Fcondition related to or affecting cardiac function (e.g., unstable angina, congestive heart failure, New York Heart Association Class III-IV)\n    * Pericardial disease\n    * Cardiac amyloidosis\n    * Uncontrolled cardiac arrhythmia (NCI CTCAE v5 Grade 2 or higher) or clinically significant electrocardiogram (ECG) abnormalities\n    * Screening 12-lead ECG showing a baseline QT interval \\>470 msec (except for subjects with pacemaker)\n    * Screening transthoracic echocardiogram showing left ventricular ejection fraction (LVEF) \\\u003C40% (screening TTE is required only for subjects aged ≥ 65 years).\n12. Receipt of a strong CYP3A4 inducer within 5 half-lives prior to study treatment initiation.\n13. Known allergies, hypersensitivity, or intolerance to boron or mannitol, corticosteroids, monoclonal antibodies or human proteins, or their excipients, or known sensitivity to mammalian-derived products.\n14. Gastrointestinal disease that may significantly affect the absorption of oral drugs as per Investigator's discretion.\n15. Vaccination with live attenuated vaccines within 4 weeks of study treatment initiation.\n16. Major surgery within 2 weeks before study treatment initiation or will not have fully recovered from surgery, or has surgery planned during the time the subject is expected to start the study treatment.\n17. Concurrent use of other anti-cancer agents\u002Ftreatments.\n18. Subject is known or suspected of not being able to comply with the study protocol (e.g., because of alcoholism, drug dependency, or psychological disorder). Subject has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the subject (e.g., compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments.\n19. Females who are pregnant, breast feeding, or planning to become pregnant while enrolled in this study or within 3 months following the last dose of any component of the study treatment.\n20. Males who plan to father a child while enrolled in this study or within 3 months following the last dose of any component of the study treatment.\n21. Patients who currently receive treatment with any investigational drug\u002Fvaccine\u002Fdevice\u002Fintervention or who have received any investigational product within 30 days or 5 half-lives of the investigational agent (whichever is longer) before the screening.\n22. Contraindications to the use of any components of the study treatment (daratumumab, bortezomib, dexamethasone, cyclophosphamide, doxorubicin) per local prescribing information.","80 Years",{"count":59,"type":21},43,[24],"The primary objective of this study is to evaluate the efficacy of the alternating D-PAD\u002FD-CVD induction regimen followed by D-CVD consolidation regimen and maintenance with daratumumab monotherapy, in terms of PFS, in the first-line setting of pPCL.",[28],[64],"primary plasma cell leukemia","2024-10-09",{"date":67,"type":40},"2024-10-10",{"date":69,"type":40},"2021-11-19",{"date":71,"type":21},"2029-01-05",{"name":73,"class":47},"Hellenic Society of Hematology",7,{"id":76,"slug":77,"hasResults":11,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":4,"eligibilityCriteria":81,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":82,"targetDuration":4,"studyType":22,"phases":84,"briefSummary":86,"conditions":87,"keywords":88,"overallStatus":96,"whyStopped":4,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":4},"100541718","phase-1-anti-gprc5d-car-t-cells-ct071-in-participants-with-rrmm-or-rrppcl-100541718","NCT06333509","Anti-GPRC5D CAR-T Cells (CT071) in Participants With RRMM or RRpPCL","A Phase 1\u002F2 Open Label Study to Evaluate the Safety and Efficacy of CT071, an Autologous Anti-GPRC5D CAR T, in Relapsed\u002FRefractory Multiple Myeloma (RRMM) or Relapsed\u002FRefractory Primary Plasma Cell Leukemia (RRpPCL)","Inclusion Criteria:\n\n* Voluntarily signed consent;\n* Age of ≥ 18;\n* Willing and able to adhere to trial visit schedule and other protocol requirements\n* Received sufficient prior lines of therapy;\n* RRMM participants must have received treatment with at least one proteasome inhibitor, one IMiD and CD38 anti body, must be refractory to the last line of therapy, must have achieved a response (PR or better) to a least 1 prior treatment line;\n* RRpPCL participants must have received at least one prior line of therapy.\n* Participants must have documented diagnosis of RRMM or RRpPCL.\n* The participants should have measurable disease.\n* Estimated life expectancy \\> 12 weeks;\n* ECOG performance score 0-1;\n* Participants should have bone marrow reserve, renal and hepatic functions;\n* Sufficient venous access for apheresis collection, and no other contraindications to apheresis;\n* Must be able to stop any anticancer therapy for planned apheresis collection\n* Women of childbearing age must undergo a serum pregnancy test with negative results before screening, and are willing to use effective and reliable method of contraception for at least 12 months after T cell infusion;\n* Men must be willing to use effective and reliable method of contraception for at least 12 months after T cell infusion.\n\nExclusion Criteria:\n\n* Any significant condition(s), laboratory abnormality or psychiatric illness that would impair the ability of the participant to receive or tolerate the planned treatment or in the opinion of the investigator, participation would not be in the best interest of the participant (eg, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments.\n* Pregnant or lactating women;\n* HIV, active hepatitis C virus (HCV), or active hepatitis B virus (HBV) infection;\n* Any uncontrolled active infection;\n* AEs from previous treatment that have not recovered;\n* Participants who have had anti-GPRC5D targeted agents;\n* Participants who have received autologous stem cell transplantation 12 weeks before apheresis;\n* Participants who have received allogenic stem cell transplantation within 6 months of apheresis;\n* Participants who have graft versus host disease (GvHD);\n* Participants who have received steroids within 14 days of apheresis or lymphodepletion;\n* Participants who have plasma cell leukemia secondary to multiple myeloma, Waldenström macroglobulinemia, POEMS (polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes) syndrome or clinically significant symptomatic immunoglobulin light chain (AL) amyloidosis with evidence of end-organ damage;\n* Participants who have been administered live attenuated vaccine 4 weeks before apheresis or lymphodepletion;\n* Participants who are allergic to fludarabine, cyclophosphamide, tocilizumab, dimethyl sulfoxide (DMSO) or CT071;\n* Participants who have clinical significant cardiac conditions that researchers believe that participating in this clinical trial may endanger the health of the patients;\n* Participants who require supplemental oxygen;\n* Participants who have clinically significant pulmonary conditions;\n* Participants who are known to have active autoimmune diseases including but not limited to psoriasis, rheumatoid arthritis and other needs of long-term immunosuppressive therapy;\n* Participants with malignancies in addition to MM\u002FpPCL;\n* Participants who have central nervous system (CNS) metastases or CNS involvement;\n* Participants with a history of stroke or seizures within 6 months prior to apheresis;\n* Participants who have undergone major surgery 14 days prior to apheresis or within 28 days of CT071 administration.",{"count":83,"type":21},166,[85,24],"PHASE1","A Phase 1\u002F2 Open label, multicenter, clinical trial of autologous CAR T-cell therapy targeting GPRC5D, in participants with relapsed\u002Frefractory multiple myeloma or relapsed\u002Frefractory primary plasma cell leukemia.",[27,28],[89,27,90,91,92,93,94,95],"CAR-T","Primary plasma cell myeloma","CT071","GPRC5D","anti-GPRC5D","genetically modified T-cells","hematologic cancer","NOT_YET_RECRUITING","2024-03-25",{"date":99,"type":40},"2024-03-27",{"date":101,"type":21},"2024-04-15",{"date":103,"type":21},"2027-12-31",{"name":105,"class":106},"CARsgen Therapeutics Co., Ltd.","INDUSTRY"]