[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"multiple-myleoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:multiple-myleoma":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,52,75],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":32,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":41,"startDateStruct":44,"completionDateStruct":46,"leadSponsor":48,"locationsCount":51},"100488822","phase-3-a-study-to-evaluate-efficacy-safety-and-pk-of-xembifystandard-medical-treatment-smt-compared-to-placebosmt-to-prevent-infections-in-participants-with-hgg-and-recurrent-or-severe-infections-associated-with-b-cell-chronic-lymphocytic-leukemia-multiple-myeloma-and-non-hodgkin-lymphoma-100488822",false,"NCT05645107","A Study to Evaluate Efficacy, Safety, and PK of XEMBIFY®+Standard Medical Treatment (SMT) Compared to Placebo+SMT to Prevent Infections in Participants With HGG and Recurrent or Severe Infections Associated With B-cell Chronic Lymphocytic Leukemia, Multiple Myeloma, and Non-Hodgkin Lymphoma","A Randomized, Multi-Center, Parallel, Double-Blinded, Placebo-Controlled Clinical Trial to Evaluate Efficacy, Safety, and Pharmacokinetics of XEMBIFY® Plus Standard Medical Treatment Compared to Placebo Plus Standard Medical Treatment to Prevent Infections in Patients With Hypogammaglobulinemia and Recurrent or Severe Infections Associated With B-cell Chronic Lymphocytic Leukemia, Multiple Myeloma, and Non-Hodgkin Lymphoma","EXCELL","Inclusion Criteria:\n\n* Participants ≥18 years of age at screening visit\n* Participants with documented and confirmed diagnosis of any of the below diseases:\n\n  * B-cell CLL according to International Workshop on CLL (iwCLL) criteria and RAI staging of intermediate (1 and 2) or high (3 and 4)\n  * MM according to the International Myeloma Working Group criteria (IMWG), R-ISS stage II or, III; or\n  * Histologically confirmed diagnosis of B-Cell NHL, Stage III or above (IV, Progressive\u002Frefractory, or recurrent\u002Frelapsed stage) according to the Lugano Classification.\n* Participants with HGG with IgG levels less than 5 g\u002FL. (Note: For MM subjects, the IgG level is adjusted by subtracting the M-protein \\[Mspike\\] to reflect the true polyclonal IgG concentration.)\n* Participants with documented history of at least one severe bacterial infection (bacterial or viral) or recurrent bacterial\u002Fviral infections (that is., ≥ 3 infections) within 12 months before the screening visit. Severe bacterial\u002Fviral infections ≥ Grade 3 (as defined by Common Terminology Criteria for Adverse Events \\[CTCAE\\] Grades).\n\nExclusion Criteria:\n\n* Participants with documented history of hematopoietic stem cell transplant (allogenic transplant in the previous 24 months, and autologous transplant in the previous 3 months) before Screening visit.\n* Participants currently receiving immunoglobulin replacement therapy (IgRT) or have received IgG replacement treatment (i.e., prior immune globulin replacement therapy) within 6 months before the screening visit.\n* Participants with active infections at time of screening visit. Specific supportive anti-infective prophylactic defined in the CLL National Comprehensive Cancer Network (NCCN) or iwCLL guidelines and\u002For local\u002Finternational guidelines for the CLL, and defined in local\u002Finternational guidelines for MM and NHL are allowed, or recommended in the updated labelling of specific active target disease medicines used during the participation in the trial is also allowed.\n* Participants with active second malignancies.\n* Participants with known primary immunodeficiency (PI).\n* Participants with a life expectancy less than 1.5 years.\n* Participants with clinical evidence of any significant acute or chronic disease that, in the opinion of the investigator, may interfere with successful completion of the trial or place the subject at undue medical risk.\n* Participants have had a known serious adverse reaction (AR) to immunoglobulin or any anaphylactic reaction to blood or any blood-derived product.\n* Participants have a history of blistering skin disease, bleeding disorder, diffuse rash, recurrent skin infections, or other disorders where SC therapy would be contraindicated during the study based upon the Investigator's discretion.\n* Participants have known Selective Immunoglobulin A (IgA) Deficiency (with or without antibodies to IgA) (Note: exclusion is for the specific diagnostic entity. It does not exclude other forms of humoral primary immunodeficiency which have decreased IgA in addition to decreased IgG requiring IgG replacement).\n* Participants with severe known kidney disease \\[as defined by estimated glomerular filtration rate \\[eGFR\\] less than (\\<) 30 milliliter (mL)\u002Fmin\u002F1.73 square meter (m2)\\] as determined by the Principal Investigator.\n* Participants that have liver enzyme levels (alanine aminotransferase \\[ALT\\], aspartate aminotransferase \\[AST\\], gammaglutamyl transferase \\[GGT\\], or lactate dehydrogenase \\[LDH\\]) greater than 3 times the upper limit of normal (ULN) at the Screening Visit as defined by the testing laboratory.\n* Participants have a history (either 1 episode within the year prior to the Screening Visit or 2 previous episodes over a lifetime) of or current diagnosis of thromboembolism (example, myocardial infarction, cerebrovascular accident, or transient ischemic attack) or deep venous thrombosis.\n* Participants currently have a known hyperviscosity syndrome or hypercoagulable states.\n* Participants have a known previous infection or clinical signs and symptoms consistent with current hepatitis B virus or hepatitis C virus infection.\n* Participants with non-controlled arterial hypertension (systolic blood pressure \\[SBP\\] greater than 140 millimeters of mercury (mmHg) and\u002For diastolic blood pressure \\[DBP\\] greater than 90 mmHg), and\u002For a heart rate (HR) greater than100 bpm.\n* Participants with known substance or prescription drug abuse within 12 months before the Screening Visit.\n* Participants have participated in another clinical trial within 30 days prior to screening (observational studies without investigative treatments \\[non-interventional\\] are permitted).","ALL","18 Years",{"count":20,"type":21},386,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","The primary purpose of the study is to evaluate whether biweekly administered XEMBIFY® plus Standard Medical Treatment (SMT) over a one-year period will reduce the rate of major bacterial infections per participant per year in B-cell CLL, MM, and NHL participants with hypogammaglobulinemia (HGG) in comparison to the Placebo plus SMT group.",[27,28,29,30,31],"Hypogammaglobulinemia","Bacterial Infections","B-cell Chronic Lymphocytic Leukemia","Multiple Myleoma","Non-Hodgkin Lymphoma",[33,34,35,36,37,38],"XEMBIFY","CLL","SMT","Hypogammaglobulinemia (HGG)","MM","NHL","RECRUITING","2026-04-08",{"date":42,"type":43},"2026-04-13","ACTUAL",{"date":45,"type":43},"2022-12-26",{"date":47,"type":21},"2026-06",{"name":49,"class":50},"Grifols Therapeutics LLC","INDUSTRY",62,{"id":53,"slug":54,"hasResults":11,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":4,"eligibilityCriteria":58,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":59,"targetDuration":4,"studyType":22,"phases":61,"briefSummary":63,"conditions":64,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":74},"100589258","phase-2-gr1803-injection-in-patients-with-rrmm-100589258","NCT06952075","GR1803 Injection in Patients With RRMM","Single-Arm, Open, Multi-Center Phase II Clinical Trial of the Efficacy, Safety, Pharmacokinetics, and Immunogenicity of GR1803 Injection in Patients With Relapsed\u002FRefractory Multiple Myeloma Complicated by Extramedullary Plasmacytoma","Inclusion Criteria:\n\n* 1、ECOG score 0-2 2、≥18 years of age 3、Multiple myeloma must be Complicated by Extramedullary Plasmacytoma.\n\nExclusion Criteria:\n\n* 1、Prior treatment with any BCMA-targeted therapy 2、Known active CNS involvement or exhibits clinical signs of meningeal involvement of multiple myeloma 3、Known allergies, hypersensitivity, or intolerance to the study drug (teclistamab) or its excipients 4、Plasma cell leukemia , Waldenström's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes), or primary amyloid light-chain amyloidosis.",{"count":60,"type":21},30,[62],"PHASE2","All subjects will receive GR1803 injection until intolerable toxicity or investigator-assessed disease progression occurs (except in cases of disease progression due to discontinuation of the drug as a result of an adverse event) or until the subject has been administered the drug for 2 years or until the subject withdraws consent or until the investigator determines that the subject needs to be discontinued.",[30],"2025-04-23",{"date":67,"type":43},"2025-04-30",{"date":69,"type":43},"2025-04-24",{"date":71,"type":21},"2027-12-01",{"name":73,"class":50},"Genrix (Shanghai) Biopharmaceutical Co., Ltd.",1,{"id":76,"slug":77,"hasResults":11,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":81,"eligibilityCriteria":82,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":83,"targetDuration":4,"studyType":22,"phases":85,"briefSummary":86,"conditions":87,"keywords":90,"overallStatus":96,"whyStopped":4,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":4},"100583766","phase-2-teclistamab-plus-autologous-lymphocyte-infusion-ali-for-the-treatment-of-rr-multiple-myeloma-100583766","NCT06880601","Teclistamab Plus Autologous Lymphocyte Infusion (ALI) for the Treatment of R\u002FR Multiple Myeloma","Teclistamab Plus Autologous Lymphocytes Infusion for the Treatment of Relapse\u002FRefractory Multiple Myeloma (TALIM)","TALIM","Inclusion Criteria:\n\n* • Patient has a confirmed diagnosis of MM according to the WHO 2022 classification (18)\n\n  * Patient age is ≥ 18 years of age\n  * Patient has a Relapsed or refractory disease as defined below:\n\n    * Relapsed disease is defined as an initial response to previous treatment, followed by confirmed progressive disease by the International Myeloma Working Group (IMWG) (15) criteria \\>60 days after cessation of treatment\n    * Refractory disease is defined as failure to achieve a response or confirmed progressive disease by IMWG criteria (15) during previous treatment or ≤60 days after cessation of treatment.\n  * Previous treatment with 1 or 2 lines of treatment (induction plus autologous stem cell transplant plus consolidation and maintenance has to be considered one single line)\n  * Previous triple exposure that included an IMID, a PI, and an anti-CD38 antibody (patients with no response or relapse after front line therapy with Dara-VTD or Dara-VRD are eligible)\n  * Progressive active symptomatic disease\n  * Patient has measurable disease as defined by any of the following:\n\n    * Serum M-protein level ≥0.5 g\u002FdL; or\n    * Urine M-protein level ≥200 mg\u002F24 hours; or\n    * Serum immunoglobulin free light chain ≥10 mg\u002FdL and abnormal serum immunoglobulin kappa lambda free light chain ratio.\n  * Patient has an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2\n  * Able to adhere to the study visit schedule and all the other protocol procedures and requirements;\n  * Patient has the following laboratory parameters:\n\n    * Total lymphocytes count ≥ 0.3 x 109\u002FL\n    * Platelet count \\> 50 x 109\u002FL unless due to bone marrow involvement by MM\n    * Conjugated bilirubin up to 2 x ULN unless due to liver involvement by MM\n    * Alkaline phosphatase and transaminases up to 2 x ULN unless due to liver involvement by MM\n    * Creatinine clearance ≥ 30 ml\u002Fmin\n  * A female participant of childbearing potential must have a negative highly sensitive serum pregnancy test within 2-7 days prior to C1D1\n  * Life expectancy ≥ 2 months\n  * Successful collection of at least 100 x 106\u002Fkg autologous lymphocytes before starting treatment with Te.\n  * Patient understands and voluntarily signs an informed consent form\n\nExclusion Criteria:\n\n* • Previous treatment with \\> 2 lines of therapy\n\n  * Patient has active central nervous system involvement with MM\n  * Received any prior BCMA-directed therapy\n  * Received the following prior antimyeloma therapy, within the specified time frame prior to enrollment:\n\n    * Targeted therapy, epigenetic therapy, or treatment with an investigational drug or an invasive investigational medical device within 21 days or ≥5 half-lives, whichever is less\n    * Investigational vaccine within 4 weeks\n    * Monoclonal antibody therapy within 21 days\n    * Cytotoxic therapy within 21 days\n    * PI therapy within 14 days\n    * IMiD agent therapy within 14 days\n    * Radiotherapy within 14 days or focal radiation within 7 days\n  * Gene-modified adoptive cell therapy (eg, chimeric antigen receptor modified T cells, NK cells) within 3 months\n  * Stem cell transplant:\n\n    * previous allogeneic stem cell transplant\n    * autologous stem cell transplant performed within 12 weeks\n  * Patients with plasma cell leukemia (presence of 5% or more plasma cells in conventional peripheral blood smear white blood cell differential count)\n  * Contraindications or life-threatening allergies, hypersensitivity, or intolerance to any study drug or its excipients\n  * Any ongoing myelodysplastic syndrome or B-cell malignancy (other than MM)\n  * Any history of malignancy, other than MM, which is considered at high risk of recurrence requiring systemic therapy\n  * Any active malignancy (ie, progressing or requiring treatment change in the last 24 months) other than MM. The only allowed exceptions are malignancies treated within the last 24 months that are considered cured:\n\n    * Non-muscle invasive bladder cancer (solitary Ta-PUNLMP or low grade, \\\u003C3 cm, no CIS)\n    * Non-melanoma skin cancers treated with curative therapy or localized melanoma treated with curative surgical resection alone\n    * Non-invasive cervical cancer\n    * Breast cancer: adequately treated lobular carcinoma in situ or ductal carcinoma in situ, or history of localized breast cancer (anti-hormonal therapy is permitted)\n    * Localized prostate cancer (M0, N0) with a Gleason Score ≤7a, treated locally only (RP\u002FRT\u002Ffocal treatment)\n    * Other malignancy that is considered cured with minimal risk of recurrence in consultation with the treating physician\n  * Clinically relevant and active liver or renal insufficiency; significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, rheumatologic, hematologic, psychiatric, or metabolic disturbances\n  * Patient has any other concurrent severe and\u002For uncontrolled medical condition(s) (e.g., uncontrolled diabetes mellitus, uncontrolled hypertension, active\u002Fsymptomatic coronary artery disease, chronic obstructive pulmonary disease (COPD), active hemorrhage, psychiatric illness, active or uncontrolled infection that in the investigator opinion places the patient at unacceptable risk and would prevent the subject from signing the informed consent form\n  * Participant had major surgery or had significant traumatic injury within 2 weeks prior to enrollment, or will not have fully recovered from surgery, or has major surgery planned during the time the participant is expected to be treated in the study.\n  * Acute active infection requiring treatment (systemic antibiotics, antivirals, or antifungals) within 14 days prior to enrollment\n  * Patient has a known history of HIV seropositivity\n  * Seropositive for hepatitis B: defined by a positive test for HbsAg. Participants with resolved infection (ie, participants who are HbsAg negative with antibodies to total anti-HBc with or without the presence of anti-HBs) must be screened using RT-PCR measurement of HBV DNA levels. Participants with a known history of HBV infection must be screened using RT-PCR measurement of HBV DNA levels irrespective of serological results. Those who are RT-PCR positive will be excluded. Participants 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 RT-PCR (see Appendix 12).\n  * Active hepatitis C infection as measured by positive HCV-RNA testing. Participants with a history of HCV antibody positivity must undergo HCV-RNA testing. If a participant with history of chronic hepatitis C infection (defined as both HCV antibody and HCV-RNA positive) completed antiviral therapy and has undetectable HCV-RNA 12 weeks following the completion of therapy, the participant is eligible for the study.",{"count":84,"type":21},52,[62],"The goal of this clinical trial is to evaluate the efficacy of Teclistamab (Te) and autologous lymphocyte infusions (ALI) in relapse refractory multiple myeloma. The main question it aims to answer is: which is the Duration of response (DoR) with Teclistmab and ALI?\n\nParticipants will receive Te for 5 cycles. Participants in PR or better after the first five cycles of Te monotherapy will continue treatment with Te in combination with ALI administration starting from cycle 6",[30,88,89],"Multiple Myeloma in Relapse","Multiple Myeloma Refractory",[91,92,93,94,95],"Multiple Myeloma","Relapse","Refractoriness","Teclistamab","Autologous lymphocyte infusion","NOT_YET_RECRUITING","2025-03-31",{"date":99,"type":43},"2025-04-03",{"date":101,"type":21},"2025-11-01",{"date":103,"type":21},"2029-11-01",{"name":105,"class":106},"Gruppo Italiano Malattie EMatologiche dell'Adulto","OTHER"]