[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"relapsed-or-refractory-multiple-myeloma-rrmm\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:relapsed-or-refractory-multiple-myeloma-rrmm":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,7,0,[8,48,70,98,121,136,164],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100563385","phase-3-a-study-to-compare-the-efficacy-and-safety-of-bms-986393-versus-standard-regimens-in-adult-participants-with-relapsed-or-refractory-and-lenalidomide-exposed-multiple-myeloma-quintessential-2-100563385",false,"NCT06615479","A Study to Compare the Efficacy and Safety of BMS-986393 Versus Standard Regimens in Adult Participants With Relapsed or Refractory and Lenalidomide-exposed Multiple Myeloma (QUINTESSENTIAL-2)","A Phase 3, Randomized, Open-Label, Multicenter Study to Compare the Efficacy and Safety of Arlocabtagene Autoleucel (BMS-986393), a GPRC5D-directed CAR-T Cell Therapy, Versus Standard Regimens in Adult Participants With Relapsed or Refractory and Lenalidomide-exposed Multiple Myeloma","Inclusion Criteria\n\n* Participants must have relapsed or refractory multiple myeloma (RRMM).\n* Participants must have received at least 1 but no greater than 3 prior multiple myeloma (MM) regimens which may include a proteasome inhibitor (PI), an immunomodulatory drug (IMiD), and an anti-CD38 monoclonal antibody and have prior exposure to lenalidomide.\n* Participants must have a documented diagnosis of MM as per International Myeloma Working Group Criteria.\n* Participants must have measurable disease during screening.\n* Participants must have adequate organ function.\n* Participants must have an Eastern Cooperative Oncology group performance status 0 or 1.\n\nExclusion Criteria\n\n* Participants must not have known active or history of central nervous system (CNS) involvement of Multiple Myeloma (MM).\n* Participants must not have solitary plasmacytomas or non-secretory myeloma without other evidence of measurable disease.\n* Participants must not need urgent treatment due to rapidly progressing MM.\n* Other protocol-defined Inclusion\u002FExclusion criteria apply.","ALL","18 Years",{"count":19,"type":20},440,"ESTIMATED","INTERVENTIONAL",[23],"PHASE3","The purpose of this study is to compare the efficacy and safety of arlo-cel (BMS-986393) versus standard regimens in adult participants with Relapsed or Refractory and Lenalidomide-exposed Multiple Myeloma.",[26],"Relapsed or Refractory Multiple Myeloma (RRMM)",[28,29,30,31,32,33,34],"Relapsed or Refractory Multiple Myeloma","Multiple Myeloma","BMS-986393","Chimeric Antigen Receptor T-cell (CAR T-cell)","CAR T-cell Therapy","Arlocabtagene Autoleucel","Arlo-cel","RECRUITING","2026-06-25",{"date":38,"type":39},"2026-06-26","ACTUAL",{"date":41,"type":39},"2025-03-12",{"date":43,"type":20},"2032-06-22",{"name":45,"class":46},"Juno Therapeutics, Inc., a Bristol-Myers Squibb Company","INDUSTRY",140,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":21,"phases":57,"briefSummary":58,"conditions":59,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":69},"100638687","phase-3-a-multicenter-randomized-open-label-parallel-group-controlled-superiority-phase-iii-clinical-study-comparing-the-efficacy-and-safety-of-f182112-versus-standard-of-care-in-patients-with-relapsed-or-refractory-multiple-myeloma-100638687","NCT07579234","A Multicenter, Randomized, Open-label, Parallel-group, Controlled, Superiority Phase III Clinical Study Comparing the Efficacy and Safety of F182112 Versus Standard of Care in Patients With Relapsed or Refractory Multiple Myeloma","Phase III Clinical Study of F182112 in Patients With Relapsed or Refractory Multiple Myeloma","Inclusion Criteria:\n\n1. Patients must meet all of the following inclusion criteria to be eligible for enrollment in this study:\n2. Provide informed consent and voluntarily sign the informed consent form; Be male or female, aged ≥18 years;\n3. Have relapsed or refractory multiple myeloma (RRMM) who have previously failed therapy with regimens containing at least one agent from each of the following three drug classes: proteasome inhibitors, immunomodulatory agents, and anti-CD38 monoclonal antibodies; i. Relapsed: Disease progression requiring salvage therapy after achieving a minimal response (MR) or better following prior anti-myeloma therapy; ii. Refractory: Lack of response (failure to achieve MR or better) during the last anti-myeloma therapy, or disease progression within 60 days after the last anti-myeloma therapy;\n4. Before randomization, the investigator must pre-select a standard of care (SOC) treatment regimen based on the patient's disease status;\n5. Have an ECOG performance status of 0-2;\n6. Have at least one measurable disease parameter:\n\n   * Serum M-protein ≥5 g\u002FL;\n   * Urine M-protein ≥200 mg\u002F24 h;\n   * Serum free light chain (FLC) assay: involved FLC level ≥100 mg\u002FL with an abnormal serum FLC ratio (\\\u003C0.26 or \\>1.65);\n7. Have organ function meeting the following requirements (no blood components or hematopoietic growth factors permitted within 7 days prior to first dose):\n\n   * Hematology: Absolute neutrophil count (ANC) ≥1.0×10⁹\u002FL, hemoglobin ≥70 g\u002FL, platelets ≥50×10⁹\u002FL;\n   * Liver function: Total bilirubin ≤1.5×ULN, ALT ≤2.5×ULN, AST ≤2.5×ULN;\n   * Renal function: Creatinine clearance ≥30 mL\u002Fmin;\n8. All prior treatment-related toxicities (as defined by NCI CTCAE v6.0) must be ≤Grade 1 at screening, except for alopecia, non-clinically significant and asymptomatic Grade 2 laboratory abnormalities, and those parameters specifically permitted in the inclusion criteria;\n9. Have an expected survival of ≥3 months.\n\nExclusion Criteria:\n\n1. Central nervous system involvement or clinical symptoms of meningeal involvement by multiple myeloma;\n2. Concomitant light chain amyloidosis, plasma cell leukemia, Waldenström macroglobulinemia, or POEMS syndrome;\n3. History of any other malignancy within 3 years prior to first dose, except for malignancies with very low recurrence risk after curative treatment (e.g., squamous cell carcinoma or basal cell carcinoma of the skin, in situ cervical or breast cancer), or those who have undergone curative surgical resection (or other treatment) with no current evidence of disease and unlikely to impact survival during the study period;\n4. Dysphagia or active gastrointestinal dysfunction that may impair drug absorption;\n5. Evidence of cardiovascular risk, including any of the following:\n\n   * QTc interval: ≥450 ms in males, ≥470 ms in females (QT interval must be corrected for heart rate using Friderici's formula);\n   * Left ventricular ejection fraction (LVEF) \\\u003C50%;\n   * Electrocardiographic abnormalities deemed by the investigator to pose unacceptable risk, including clinically significant untreated or uncontrolled arrhythmias, second-degree (Mobitz II) or third-degree atrioventricular (AV) block;\n   * History of myocardial infarction, acute coronary syndrome (including unstable angina), coronary angioplasty, stent placement, or bypass surgery within 6 months prior to screening;\n   * Heart failure classified as NYHA Class III or IV;\n   * Uncontrolled severe hypertension (systolic blood pressure ≥170 mmHg or diastolic blood pressure ≥110 mmHg);\n6. Active infection requiring antimicrobial, antiviral, or antifungal therapy (prophylactic therapy excluded):\n\n   * Oral antimicrobial therapy within 2 weeks prior to first dose;\n   * Intravenous antimicrobial therapy within 4 weeks prior to first dose;\n   * History of viral respiratory infection (e.g., COVID-19, influenza A or B) within 2 weeks prior to first dose;\n7. Serological findings:\n\n   * HBsAg positive and\u002For HbcAb positive with HBV-DNA positive or above upper limit of normal (ULN); HCV antibody positive with HCV-RNA positive or above ULN;\n   * Active autoimmune disease, including HIV infection. Patients with well-controlled type 1 diabetes, euthyroid autoimmune thyroiditis, or skin diseases not requiring systemic therapy (e.g., vitiligo, psoriasis) are permitted;\n   * Active syphilis infection;\n   * Active tuberculosis (evidenced by chest imaging or other relevant testing within 3 months prior to screening or during screening; tuberculosis screening will be conducted per center protocol);\n8. Received live or attenuated vaccine within 4 weeks prior to first dose;\n9. Underwent major surgery within 4 weeks prior to first dose, or anticipated to undergo major surgery during the study period;\n10. Received the following anti-myeloma therapies prior to first dose:\n\n    * Plasmapheresis within 28 days prior to first dose;\n    * Monoclonal antibody therapy within 21 days prior to first dose;\n    * Small molecule targeted therapy, cytotoxic chemotherapy, and\u002For proteasome inhibitor and\u002For other anti-tumor traditional Chinese medicine within 14 days or 5 half-lives (whichever is shorter) prior to first dose;\n    * Systemic corticosteroids (prednisone \\>10 mg\u002Fday or equivalent dose) within 7 days prior to first dose;\n    * Autologous stem cell transplantation within 3 months prior to first dose;\n    * CAR-T or CAR-NK cell therapy within 3 months prior to first dose;\n11. Previously received allogeneic stem cell transplantation;\n12. Previously received BCMA-targeted therapy;\n13. Plan to receive other anticancer therapy or investigational drugs during the study period;\n14. Any severe and\u002For unstable pre-existing medical condition, psychiatric disorder, or other disease (including laboratory abnormalities) that may affect participant safety, informed consent acquisition, or adherence to study procedures;\n15. Pregnant or lactating women; male participants (or their partners) or female participants who plan to become pregnant during the study or within 6 months after the last dose, and who are unwilling to use a medically accepted effective contraceptive method (e.g., intrauterine device or condom) during the study period;\n16. Any patient deemed unsuitable for participation by the investigator..\n\n    SAT-specific exclusion criteria:\n17. Inability to receive bortezomib as determined by the investigator;\n18. Contraindication to bortezomib or history of life-threatening allergic reaction or intolerance (defined as drug-related AE leading to discontinuation of treatment);\n19. Grade 1 peripheral neuropathy with pain or Grade ≥2 peripheral neuropathy;\n20. Received a strong CYP3A4 inducer within 5 half-lives prior to first dose;\n21. Previously received pomalidomide or have a contraindication to pomalidomide (e.g., history of arterial or deep vein thrombosis within the past 3 months \\[except intermuscular vein thrombosis\\], contraindication to or unwillingness to receive prophylactic antithrombotic therapy as required by protocol), or life-threatening allergic reaction or intolerance to pomalidomide;\n22. Previously received selinexor or have a contraindication to selinexor or life-threatening allergic reaction or intolerance to selinexor.",{"count":56,"type":20},261,[23],"A Multicenter, Randomized, Open-label, Parallel-group, Controlled, Superiority Phase III Clinical Study Comparing F182112 with Standard of Care in Patients with Relapsed or Refractory Multiple Myeloma",[26],"2026-05-06",{"date":62,"type":39},"2026-05-12",{"date":64,"type":39},"2026-01-25",{"date":66,"type":20},"2029-01-25",{"name":68,"class":46},"Shandong New Time Pharmaceutical Co., LTD",1,{"id":71,"slug":72,"hasResults":11,"nctId":73,"briefTitle":74,"officialTitle":74,"acronym":75,"eligibilityCriteria":76,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":77,"targetDuration":4,"studyType":21,"phases":79,"briefSummary":81,"conditions":82,"keywords":83,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":69},"100619728","phase-2-a-phase-2-single-arm-multicenter-study-testing-mezigdomide-carfilzomib-and-dexamethasone-480kd-in-participants-with-relapsed-or-refractory-multiple-myeloma-rrmm-100619728","NCT07348393","A Phase 2, Single Arm Multicenter, Study Testing Mezigdomide, Carfilzomib, and Dexamethasone (480Kd) in Participants With Relapsed or Refractory Multiple Myeloma (RRMM)","Mezi-KD","Inclusion Criteria:\n\n1. Signed Written Informed Consent\n2. Adult patients (≥18 years old)\n3. ECOG Performance Status score of 0, 1, or 2.\n4. Participant has documented diagnosis of multiple myeloma (MM) and measurable disease, defined as any of the following:\n\n   1. M-protein ≥ 0.5 g\u002FdL by serum protein electrophoresis (sPEP), or\n   2. M-protein ≥ 200 mg\u002F24-hour urine collection by urine protein electrophoresis (uPEP) or,\n   3. For participants without measurable disease in sPEP or uPEP: serum free light chain (sFLC) levels \\> 100 mg\u002FL (10 mg\u002FdL) involved light chain and an abnormal κ\u002Fλ FLC ratio.\n5. Participant has received one or two prior line of anti-myeloma therapy. Note: One line can contain several phases (eg, induction, \\[with or without\\] hematopoietic stem cell transplant, (with or without) consolidation, and\u002For \\[with or without\\] maintenance therapy).\n6. Participant must have received prior treatment with lenalidomide and an anti-CD38 monoclonal antibody.\n7. Participant achieved minimal response \\[MR\\] or better to at least 1 prior anti-myeloma therapy.\n8. Participant must have documented disease progression during or after their last antimyeloma regimen.\n9. Reproductive Status\n\n   • Females of childbearing potential (FCBP) must :\n   * Have 2 negative pregnancy tests as verified by the Investigator prior to starting study therapy and must agree to ongoing pregnancy testing during the course of the study, and after end of study therapy. This applies even if the participant practices true abstinence\\* from heterosexual contact.\n   * Either commit to true abstinence\\* from heterosexual contact (which must be reviewed on a monthly basis and source documented) or agree to use, and be able to comply with, 2 forms of contraception: one highly effective, and one additional effective (barrier) contraception without interruption, 28 days prior to starting study intervention, during treatment (including dose interruptions), and for at least 28 days after the last dose of CC-92480, or 6 months after the last dose carfilzomib, whichever is longest.\n\n   Refer to the Celgene CC-92480\u002FBMS-986348 Pregnancy Prevention Plan for additional guidance.\n\n   Note: A FCBP is a female who: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy, or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy or amenorrhea due to other medical reasons does not rule out childbearing potential) for at least 24 consecutive months (eg, has had menses at any time in the preceding 24 consecutive months).\n\n   • Male participants must :\n\n   \\- Practice true abstinence\\* (which must be reviewed on a monthly basis) or agree to use a condom during sexual contact with a pregnant female or a FCBP while participating in the study, during dose interruptions and for at least 90 days after the last dose of CC-92480 or carfilzomib, even if he has undergone a successful vasectomy.\n\n   Refer to the Celgene mezigdomide Pregnancy Prevention Plan for additional guidance.\n\n   \\* True abstinence is acceptable when this is in line with the preferred and usual lifestyle of the participant. Periodic abstinence (eg, calendar, ovulation, symptothermal, or post-ovulation methods) and withdrawal are not acceptable methods of contraception.\n   * Male participants must agree to refrain from donating sperm while on study intervention, during dose interruptions, and for at least 90 days following last dose of mezigdomide or carfilzomib.\n   * Females must agree to refrain from donating eggs while on study intervention and for at least 28 days after last dose of mezigdomide\n   * Participants must agree to refrain from donating blood while on study intervention, during dose interruptions, and for at least 28 days following the last dose of study intervention.\n   * All male and female participants must follow all requirements defined in the Pregnancy Prevention Plan in Appendix 11 for mezigdomide\n\n   Exclusion Criteria:\n   * Participant that received \\> 3 prior line of anti-myeloma therapy.\n   * Medical conditions\n\n     * Participant who has had prior treatment with mezigdomide or carfilzomib.\n     * Participant who has had any investigational agents within 28 days or 5 half-lives (whichever is shorter) of initiating study intervention (Participation in another interventional clinical trial concurrent with this study is not permitted, except for those who have completed treatment with the prior investigational agent(s) and are currently in long-term follow-up.)\n     * Participant has received any of the following:\n   * Plasmapheresis within the last 28 days of initiating study intervention.\n   * Major surgery (as defined by the Investigator) within 28 days of initiating study intervention.\n   * Radiation therapy, other than local palliative therapy, for myeloma-associated bone lesions within 14 days of initiating study intervention.\n   * Use of any systemic anti-myeloma drug therapy within 14 days of initiating study intervention.\n\n     * Participant has previously received allogeneic stem cell transplant at any time or received autologous stem cell transplant within 12 weeks of initiating study treatment.\n     * Participant has plasma cell leukemia, Waldenstrom macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes), or clinically significant light-chain amyloidosis.\n     * Participant with known central nervous system (CNS) involvement with myeloma.\n     * Participant has any significant medical condition, including active or uncontrolled infection, presence of laboratory abnormality, or psychiatric illness that places the participant at an unacceptable risk for treatment-related complications, if he\u002Fshe were to participate in the study.\n     * Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection within 14 days for mild or asymptomatic infections or 28 days for severe\u002Fcritical illness prior to initiating study intervention (Acute symptoms must have resolved and there are no sequelae that would place the participant at a higher risk of receiving study intervention, based on Investigator assessment in consultation with the Sponsor Medical Monitor)\n     * Participant has any condition that confounds the ability to interpret data from the study\n     * Participant has any of the following laboratory abnormalities:\n   * Absolute neutrophil count (ANC) \\\u003C 1,000\u002F¬µL. It is not permissible to administer GCSF to achieve minimum ANC levels within 7 days prior to screening complete blood count (CBC) (or within 14 days prior for pegfilgrastim).\n   * Platelet count: \\\u003C 75,000\u002F¬µL for participants in whom \\\u003C 50% of bone marrow nucleated cells are plasma cells; or a platelet count \\\u003C 50,000\u002F¬µL for participants in whom 'â• 50% of bone marrow nucleated cells are plasma cells. Platelet transfusions are not permitted within 7 days prior to screening complete blood count (CBC).\n   * Hemoglobin \\\u003C 8 g\u002FdL (\\\u003C 4.9 mmol\u002FL).\n   * Estimated glomerular filtration rate (eGFR) \\\u003C 30 mL\u002Fmin or requiring dialysis. eGFR will be calculated using the Modification of Diet in Renal Disease (MDRD) formula (see http:\u002F\u002Fmdrd.com).\n   * Corrected serum calcium \\> 13.5 mg\u002FdL (\\> 3.4 mmol\u002FL)\n   * Serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \\> 2.5xx upper limit of normal (ULN)\n   * Serum total bilirubin \\> 1.5 x ULN; \\> 3.0 mg\u002FdL is allowed for participants with documented Gilbert's syndrome.\n\n     * Participant with gastrointestinal disease or surgery (eg, gastric bypass surgery) that may significantly alter the absorption of Mezigdomide and\u002For other oral study intervention.\n     * Participant has prior history of malignancies, other than MM, unless the participant has been free of the disease for 'â• 5 years with the exception of the following noninvasive malignancies:\n   * Basal cell carcinoma of the skin\n   * Squamous cell carcinoma of the skin in situ (Stage 0)\n   * Carcinoma in situ of the cervix\n   * Carcinoma in situ of the breast\n   * Incidental histologic finding of prostate cancer (T1a or T1b using the TNM \\[tumor, nodes, metastasis\\] clinical staging system) or prostate cancer that is curative\n\n     * Participant has received immunosuppressive medication within the last 14 days of initiating study intervention. The following are exceptions to this criterion:\n   * Intranasal, inhaled, or topical corticosteroids or local corticosteroid injections (eg, intra-articular injection).\n   * Systemic corticosteroids at doses that do not exceed 10 mg\u002Fday of prednisone or the equivalent (see Table 7.7.2-1).\n   * Steroids as premedication for hypersensitivity reactions (eg, computed tomography \\[CT\\] scan premedication).\n\n     \\- Administration of strong CYP3A modulators; administration of proton-pump inhibitors (eg, omeprazole, esomeprazole, lansoprazole, pantoprazole, rabeprazole) within 2 weeks of starting study intervention.\n\n     \\- Participant has impaired cardiac function or clinically significant cardiac disease, including any of the following:\n   * Myocardial infarction within 1 year before inclusion, or an unstable or uncontrolled disease\u002Fcondition related to or affecting cardiac function (eg, unstable angina, congestive heart failure New York Heart Association Class III-IV) or pericardial disease.\n   * Uncontrolled cardiac arrhythmia or clinically significant electrocardiogram (ECG) abnormalities, including prolongation of QT interval on Screening ECG as defined by a QTc interval \\> 470 msec using Fridericia's QT correction formula\n   * Left ventricular ejection fraction \\\u003C 40% as assessed by transthoracic echocardiogram (TTE) or multigated acquisition scan (MUGA)\n\n     \\- Participant has uncontrolled hypertension or uncontrolled diabetes within 14 days prior to enrollment.\n\n     \\- Participant who has had a live vaccine within 3 months of start of study therapy.\n     * Participant is unable or unwilling to undergo protocol required thromboembolism or antiviral prophylaxis\n     * Participant is positive for human immunodeficiency virus (HIV), chronic or active hepatitis B, active hepatitis A, or active hepatitis C:\n   * Known positive HIV status.\n   * Seropositive for hepatitis B (defined by a positive test for hepatitis B surface antigen \\[HBsAg\\]). Participants with resolved infection (ie, participants 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) deoxyribonucleic acid (DNA) levels. Those who are PCR positive will be excluded. EXCEPTION: 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 PCR.\n   * Known to be seropositive for hepatitis C virus (HCV); anti-HCV antibody positive or HCV- ribonucleic acid (RNA) quantitation positive, except in the setting of a sustained virologic response (SVR), defined as viremia at least 12 weeks after completion of antiviral therapy.\n   * Reproductive Status\n\n     \\- Participant is a female who is pregnant or breastfeeding, or who intends to become pregnant during participation in the study.\n   * Contraindication to investigational medicinal products (mezigdomide, carfilzomib and dexamethasone)\n   * Participation in another interventional study or being in the exclusion period at the end of a previous study.\n   * Prior\u002FConcomitant Therapy\n\n     \\- Inability to comply with restrictions and prohibited treatments as listed in Section 7.7: Concomitant Therapy.\n   * Physical and Laboratory Test Findings - Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG, or clinical laboratory determinations beyond what is consistent with the target population\n   * Allergies and Adverse Drug Reaction\n\n     * Participant has a history of anaphylaxis or hypersensitivity to thalidomide, lenalidomide (including 'â• Grade 3 rash during prior thalidomide or lenalidomide therapy), carfilzomib or dexamethasone or the excipients contained in the formulations, or participant has any contraindications per local prescribing information.\n   * Other Exclusion Criteria - Prisoners or participants who are involuntarily incarcerated. (Note: Under certain specific circumstances and only in countries where local regulations permit, a person who has been imprisoned may be included or permitted to continue as a participant. Strict conditions apply, and BMS approval is required.) - Participants must agree to refrain from donating blood while on study intervention, during dose interruptions, and for at least 28 days following the last dose of study intervention.\n\n   Eligibility criteria for this study have been carefully considered to ensure the safety of the study participants and that the results of the study can be used. It is imperative that participants fully meet all eligibility criteria.",{"count":78,"type":20},70,[80],"PHASE2","Despite advances in multiple myeloma (MM) therapy, patients continue to suffer from frequent relapses and treatment-resistant disease. Therefore, additional novel, safe, and effective therapies are needed to drive deeper and more prolonged responses for patients with RRMM.\n\nMezigdomide (also known as CC-92480 or BMS-986348) is a novel, highly potent cereblon (CRBN)-E3 ligase modulating drug (CELMoD) and represents a new generation of CRBN-modulating (CM) agents optimized to induce rapid and robust degradation of the transcription factors Aiolos and Ikaros, which are important regulators for lymphocyte development and differentiation. CC-92480 was discovered via characterization of structure-activity relationships and exhibits enhanced autonomous cell killing activity in MM cells compared to lenalidomide and pomalidomide due to its increased efficiency at inducing Aiolos and Ikaros degradation. The increased potency of Mezigdomide (also overcomes lenalidomide and pomalidomide resistance in preclinical models inducing potent antiproliferative activity and apoptosis in MM cells with acquired resistance to lenalidomide or pomalidomide.\n\nCarfilzomib is a selective PI that irreversibly binds the proteasome, eliciting antimyeloma activity through unfolded protein stress response and other mechanisms. Carfilzomib is indicated for the treatment of RRMM in combination with dexamethasone (Kd), lenalidomide plus dexamethasone (KRd), and with anti-CD38 monoclonal antibodies daratumumab and isatuximab plus dexamethasone (DKd and IsaKd). However, as lenalidomide has become the foundation for a wide range of regimens used in newly diagnosed multiple myeloma (NDMM) and early in the therapeutic course of MM, KRd is not always a relevant therapeutic option in RRMM. In addition, given the increasing use of anti-CD38 mAb therapy in NDMM and early lines of therapy, DKd and IsaKd will also become less attractive therapeutic options in RRMM. This study will explore mezigdomide with carfilzomib and dexamethasone (480Kd) in a patient population where KRd and DKd\u002FIsaKd are not appropriate treatment options due to prior treatment with lenalidomide and anti-CD38 mAb therapy.\n\nMezigdomide has shown marked synergy in combination with PIs in lenalidomide resistant mouse xenograft models with combination treatment resulting in near complete tumor regressions. The combination of mezigdomide with carfilzomib has also shown synergistic anti-proliferative activity in MM cell lines resistant to lenalidomide and deeper tumor cell killing than combinations of other\n\nCELMoD agents with carfilzomib. These preclinical data demonstrate the potent synergy of mezigdomide with PIs, including carfilzomib, and the ability of mezigdomide to overcome IMiD drug resistance.\n\nThe pleiotropic anti-myeloma effects of mezigdomide include its potent tumoricidal activity in IMiD (lenalidomide and pomalidomide)-resistant cell lines, synergistic anti-tumor effects when combined with proteasome inhibitors and dexamethasone, and the promising clinical activity seen in the Phase 1\u002F2 CC-92480-MM-002 study, all make 480Kd a highly attractive regimen to be further investigated for the treatment of RRMM patients.\n\nThis study is a single arm multicenter, Phase 2 study investigating the efficacy and safety of 480Kd in participants with RRMM who received at least 1 prior line of therapy, including lenalidomide and an anti-CD38 mAb, however are carfilzomib naïve.",[26],[26,84,85,86],"Mezigdomide","Carfilzomib","Dexamethasone","NOT_YET_RECRUITING","2026-01-12",{"date":90,"type":39},"2026-01-16",{"date":92,"type":20},"2026-02",{"date":94,"type":20},"2029-02",{"name":96,"class":97},"Assistance Publique - Hôpitaux de Paris","OTHER",{"id":99,"slug":100,"hasResults":11,"nctId":101,"briefTitle":102,"officialTitle":103,"acronym":4,"eligibilityCriteria":104,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":105,"enrollmentInfo":106,"targetDuration":4,"studyType":21,"phases":108,"briefSummary":110,"conditions":111,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":113,"startDateStruct":115,"completionDateStruct":117,"leadSponsor":119,"locationsCount":69},"100593216","phase-1-dual-target-bcma-cd19-car-t-cell-therapy-for-rrmm-with-extramedullary-infiltration-100593216","NCT07003555","Dual-target BCMA-CD19 CAR-T Cell Therapy for RR\u002FMM With Extramedullary Infiltration","Practical Clinical Study of Dual-targeting BCMA-CD19 CAR-T Cell Therapy for Extramedullary Infiltration in Refractory\u002FRelapsed Multiple Myeloma","Inclusion Criteria:\n\n1. Voluntarily participate in the trial and have good compliance.\n2. Aged between 18 and 75 years old, regardless of gender.\n3. Diagnosed with relapsed or refractory multiple myeloma according to the criteria of the International Myeloma Working Group (IMWG)2, and have measurable extramedullary lesions due to multiple myeloma.\n4. Positive for BCMA in flow cytometry of bone marrow or cerebrospinal fluid tumor cells or immunohistochemistry of tumor tissue.\n5. Organ functions: ① Cardiac function: Left ventricular ejection fraction \\> 50% (by echocardiogram) in the past 2 weeks. ② Liver function: Alanine aminotransferase and aspartate aminotransferase \\\u003C 3 times the upper limit of normal (ULN). ③ Renal function: Creatinine clearance rate ≥ 40 mL\u002Fmin (by Cockcroft and Gault formula). ④ Coagulation function: PT and APPT \\\u003C 1.5 times the ULN. ⑤ Arterial oxygen saturation (SpO₂) \\> 95%. ⑥ Pulmonary function: FEV₁% predicted value ≥ 50%.\n6. Female patients of childbearing age must have a negative serum pregnancy test at screening and before receiving cyclophosphamide and fludarabine or melphalan treatment; male patients should be willing to use effective contraceptive methods for 1 year after receiving the study treatment.\n7. ECOG score ≤ 2.\n8. Expected survival time \\> 3 months.\n\nExclusion Criteria:\n\n1. Pregnant or lactating women.\n2. Active infections that have not been effectively controlled.\n3. Active autoimmune diseases that have not been effectively controlled.\n4. Adverse reactions caused by previous treatments have not recovered to CTCAE grade ≤ 1.\n5. For allogeneic transplant patients, active graft - versus - host disease (GVHD) that has not been effectively controlled.\n6. Presence of any of the following: HBV - DNA copy number above the lower limit of detection; positive hepatitis C antibody (HCV - Ab) with HCV - RNA copy number above the lower limit of measurability; positive anti - Treponema pallidum antibody (TP - Ab); positive human immunodeficiency virus (HIV) antibody test.\n7. Allergic or intolerant to fludarabine or cyclophosphamide.\n8. Suffering from known symptomatic non - plasma cell infiltrative central nervous system diseases.\n9. Uncontrollable cardiovascular and cerebrovascular diseases within 6 months, such as: a. New York Heart Association (NYHA) class III or IV congestive heart failure. b. Myocardial infarction occurred or coronary artery bypass grafting (CABG) was received ≤ 6 months before enrollment. c. Clinically significant ventricular arrhythmia or a history of unexplained syncope (excluding cases caused by vasovagal or dehydration). d. A history of severe non - ischemic cardiomyopathy.\n10. A history of other untreated malignancies within the past 5 years or having other untreated malignancies concurrently.\n11. The investigator assesses that the subject cannot or is unwilling to comply with the requirements of the study protocol.\n12. Previous use of a CAR - T vector with the same structure.","75 Years",{"count":107,"type":20},18,[109],"PHASE1","This is a multicenter, open-label, non-randomized, single-arm clinical trial. Patients with relapsed\u002Frefractory multiple myeloma accompanied by extramedullary infiltration will receive BCMA - CD19 CAR-T cell therapy.\n\nThe primary objective is to prospectively evaluate the safety of dual-targeting BCMA and CD19 CAR - T cell therapy for extramedullary infiltration in relapsed\u002Frefractory multiple myeloma. The primary endpoints are to assess the type and incidence of dose-limiting toxicity (DLT) within one month after the infusion of BCMA-CD19 CAR-T cells in patients, as well as the incidence and severity of adverse events within one month after the infusion. It is expected that no more than 18 participants will be recruited.",[26],"2025-11-21",{"date":114,"type":39},"2025-11-26",{"date":116,"type":39},"2025-05-25",{"date":118,"type":20},"2027-06-25",{"name":120,"class":97},"Beijing GoBroad Hospital",{"id":122,"slug":123,"hasResults":11,"nctId":124,"briefTitle":125,"officialTitle":126,"acronym":4,"eligibilityCriteria":127,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":105,"enrollmentInfo":128,"targetDuration":4,"studyType":21,"phases":129,"briefSummary":130,"conditions":131,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":132,"startDateStruct":133,"completionDateStruct":134,"leadSponsor":135,"locationsCount":69},"100593217","phase-1-dual-target-bcma-gprc5d-car-t-cell-therapy-for-rrmm-with-extramedullary-infiltration-100593217","NCT07003568","Dual-target BCMA-GPRC5D CAR-T Cell Therapy for RR\u002FMM With Extramedullary Infiltration","Practical Clinical Study of Dual-targeting BCMA-GPRC5D CAR-T Cell Therapy for Extramedullary Infiltration in Refractory\u002FRelapsed Multiple Myeloma","Inclusion Criteria:\n\n1. Voluntarily participate in the trial and have good compliance.\n2. Aged between 18 and 75 years old, regardless of gender.\n3. Diagnosed with relapsed or refractory multiple myeloma according to the criteria of the International Myeloma Working Group (IMWG)2, and have measurable extramedullary lesions due to multiple myeloma.\n4. Positive for BCMA and GPRC5D in flow cytometry of bone marrow or cerebrospinal fluid tumor cells or immunohistochemistry of tumor tissue.\n5. Organ functions: ① Cardiac function: Left ventricular ejection fraction \\> 50% (by echocardiogram) in the past 2 weeks. ② Liver function: Alanine aminotransferase and aspartate aminotransferase \\\u003C 3 times the upper limit of normal (ULN). ③ Renal function: Creatinine clearance rate ≥ 40 mL\u002Fmin (by Cockcroft and Gault formula). ④ Coagulation function: PT and APPT \\\u003C 1.5 times the ULN. ⑤ Arterial oxygen saturation (SpO₂) \\> 95%. ⑥ Pulmonary function: FEV₁% predicted value ≥ 50%.\n6. Female patients of childbearing age must have a negative serum pregnancy test at screening and before receiving cyclophosphamide and fludarabine or melphalan treatment; male patients should be willing to use effective contraceptive methods for 1 year after receiving the study treatment.\n7. ECOG score ≤ 2.\n8. Expected survival time \\> 3 months.\n\nExclusion Criteria:\n\n1. Pregnant or lactating women.\n2. Active infections that have not been effectively controlled.\n3. Active autoimmune diseases that have not been effectively controlled.\n4. Adverse reactions caused by previous treatments have not recovered to CTCAE grade ≤ 1.\n5. For allogeneic transplant patients, active graft - versus - host disease (GVHD) that has not been effectively controlled.\n6. Presence of any of the following: HBV - DNA copy number above the lower limit of detection; positive hepatitis C antibody (HCV - Ab) with HCV - RNA copy number above the lower limit of measurability; positive anti - Treponema pallidum antibody (TP - Ab); positive human immunodeficiency virus (HIV) antibody test.\n7. Allergic or intolerant to fludarabine or cyclophosphamide.\n8. Suffering from known symptomatic non - plasma cell infiltrative central nervous system diseases.\n9. Uncontrollable cardiovascular and cerebrovascular diseases within 6 months, such as: a. New York Heart Association (NYHA) class III or IV congestive heart failure. b. Myocardial infarction occurred or coronary artery bypass grafting (CABG) was received ≤ 6 months before enrollment. c. Clinically significant ventricular arrhythmia or a history of unexplained syncope (excluding cases caused by vasovagal or dehydration). d. A history of severe non - ischemic cardiomyopathy.\n10. A history of other untreated malignancies within the past 5 years or having other untreated malignancies concurrently.\n11. The investigator assesses that the subject cannot or is unwilling to comply with the requirements of the study protocol.\n12. Previous use of a CAR - T vector with the same structure.",{"count":107,"type":20},[109],"This is a multicenter, open-label, non-randomized, single-arm clinical trial. Patients with relapsed\u002Frefractory multiple myeloma accompanied by extramedullary infiltration will receive BCMA - GPRC5D CAR-T cell therapy.\n\nThe primary objective is to prospectively evaluate the safety of dual-targeting BCMA and GPRC5D CAR - T cell therapy for extramedullary infiltration in relapsed\u002Frefractory multiple myeloma. The primary endpoints are to assess the type and incidence of dose-limiting toxicity (DLT) within one month after the reinfusion of BCMA-GPRC5D CAR-T cells in patients, as well as the incidence and severity of adverse events within one month after the reinfusion. It is expected that no more than 18 participants will be recruited.",[26],{"date":114,"type":39},{"date":116,"type":39},{"date":118,"type":20},{"name":120,"class":97},{"id":137,"slug":138,"hasResults":11,"nctId":139,"briefTitle":140,"officialTitle":141,"acronym":142,"eligibilityCriteria":143,"healthyVolunteers":11,"sex":16,"minAge":144,"maxAge":4,"enrollmentInfo":145,"targetDuration":4,"studyType":21,"phases":146,"briefSummary":148,"conditions":149,"keywords":151,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":154,"lastUpdatePostDateStruct":155,"startDateStruct":157,"completionDateStruct":159,"leadSponsor":161,"locationsCount":69},"100589996","intravenous-autologous-cd19-car-t-cells-for-r-r-mm-b-all-and-b-cell-lymphoma-100589996","NCT06961669","Intravenous Autologous CD19 CAR-T Cells for R\u002F R MM, B-ALL, and B-Cell Lymphoma","An Early Exploratory Clinical Study of Enhanced Autologous CAR-T Cell Injection (ECAR01) Targeting CD19 and BCMA in Patients With Relapsed or Refractory Multiple Myeloma, Acute B-Cell Leukemia, and B-Cell Lymphoma","ECAR01","Inclusion Criteria:\n\n1. The patient or his\u002Fher guardian is fully informed and agrees to participate in this clinical study and signs the informed consent form;\n2. At the time of signing the informed consent form, be over 3 years of age, regardless of gender;\n3. Patients with a confirmed diagnosis of acute B-cell leukemia\u002FB-cell lymphoma\u002Fmultiple myeloma who meet one of the following criteria:\n\n   1. B diffuse large B-cell lymphoma (DLBCL), germinal center, or activated B-cell type; Primary cutaneous DLBCL; Primary mediastinal (thymic) large B-cell lymphoma; ALK anaplastic large B-cell lymphoma; High-grade B-cell lymphoma with MYC and BCL2 and\u002For BCL6 rearrangement (i.e., \"double or triple hit\"); High-grade B-cell lymphoma; T-cell-rich B-cell lymphoma; transformed follicular lymphoma; or any aggressive B-cell lymphoma caused by indolent lymphoma; follicular lymphoma; mantle cell lymphoma; Patients with large cell transformation (Richter's Transformation) with CLL who have not achieved remission or have progressed after achieving remission after at least 1 prior line of therapy.\n   2. Patients diagnosed with acute B-cell leukemia: Patients who have achieved relapse after achieving remission after prior chemotherapy; or patients who have failed to achieve remission (\\\u003C5% bone marrow blasts or persistent extramedullary or central nervous system disease) after 2 prior cycles of induction chemotherapy, or who still maintain MRD.\n   3. Multiple Myeloma: Patients with confirmed diagnosis of multiple myeloma and patients with relapsed or refractory multiple myeloma according to IMWG 2016 diagnostic criteria.\n4. For patients with B-cell lymphoma, according to the recommendations for initial evaluation, staging, and response evaluation of Hodgkin and non-Hodgkin lymphoma (2014 edition), at least one measurable lesion in the baseline period, i.e., lymph node lesions with a length diameter of \\> 15 mm, or an extranodal lesion with a length diameter of \\> 10 mm according to PETCT or CT imaging;\n5. For patients with B-ALL, the proportion of bone marrow primitive and naïve lymphocytes in the screening period ≥5%;\n6. CD19 expression of tumor cells confirmed by flow cytometry or immunohistochemistry: the proportion of CD19 cells detected by peripheral blood flow cytometry in patients with B-ALL was ≥30%, and the proportion of CD19 cells in patients with B-cell lymphoma was positive by immunohistochemistry;\n7. Adequate function of vital organs: liver function satisfies ALT≤3×ULN, AST≤3×ULN; serum creatinine≤140μmol\u002FL; Total bilirubin ≤ 2× ULN, and total bilirubin ≤ 3.0× ULN for patients with Gilbert syndrome; Haemodynamically stable and left ventricular ejection fraction (LVEF) ≥45% as determined by echocardiography or multichannel radionuclide angiography (MUGA); No active pulmonary infection, transcutaneous arterial oxygen saturation ≥92% in non-oxygen-based state;\n8. ECOG score: 0\\~2 points;\n9. As judged by the investigator, the patient has an expected survival of more than 3 months;\n10. Subjects of childbearing potential agree to use a reliable and effective method of contraception (excluding contraception during the safe period) for 2 years from the time of signing the informed consent form until receiving ECAR01 cell infusion.\n\nExclusion Criteria:\n\n1. Episodes of central nervous system disease or presence of pathological changes within 6 months prior to screening, including but not limited to: stroke, stroke, aneurysm, epilepsy, convulsions, aphasia, severe head injury, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or mental disorder;\n2. patients with B-ALL with confirmed diagnosis of isolated extramedullary recurrence;\n3. presence of malignancies other than acute B-cell leukemia\u002FB-cell lymphoma;\n4. Received the following anti-tumor therapies before cell collection: chemotherapy, targeted therapy, and other drug therapy within 14 days or at least 5 half-lives; Radiotherapy within 14 days;\n5. Vaccination, B-cell targeted therapy within 4 weeks prior to screening;\n6. Patient has systemic autoimmune disease or immunodeficiency;\n7. Grade 2\\~4 acute graft-versus-host disease (GVHD) or moderate to severe chronic GVHD within 4 weeks prior to screening;\n8. Patients with relatively serious heart disease, such as angina, myocardial infarction, heart failure and arrhythmia;\n9. History of severe allergy to drugs used in clinical studies or raw and excipient materials of experimental drugs, such as cyclophosphamide, fludarabine, DMSO, etc.;\n10. Patient has active hepatitis B, or positive HCV antibody, or HIV antibody, or syphilis;\n11. Presence of active infection requiring intravenous antibiotics or hospitalization;\n12. Pregnant or lactating women;\n13. Other investigators believe that the subject is not suitable to participate in this clinical study because it will affect the safety and efficacy judgment of the subject, or for other reasons;","3 Years",{"count":107,"type":20},[147],"NA","This is an open label, single-site, dose-escalation study in up to 18 participants with Relapsed or Refractory Multiple Myeloma, Acute B-Cell Leukemia, and B-Cell Lymphoma. This study aims to evaluate the safety and efficacy of the treatment with Anti-BCMA and CD19 CART",[150,26],"Lymphoblastic Leukemia",[152,28,153],"B-cell lymphoma","Acute B-Cell Leukemia","2025-05-23",{"date":156,"type":39},"2025-05-29",{"date":158,"type":39},"2025-04-16",{"date":160,"type":20},"2028-08-31",{"name":162,"class":163},"Anhui Provincial Hospital","OTHER_GOV",{"id":165,"slug":166,"hasResults":11,"nctId":167,"briefTitle":168,"officialTitle":169,"acronym":4,"eligibilityCriteria":170,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":105,"enrollmentInfo":171,"targetDuration":4,"studyType":21,"phases":173,"briefSummary":174,"conditions":175,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":176,"lastUpdatePostDateStruct":177,"startDateStruct":179,"completionDateStruct":181,"leadSponsor":183,"locationsCount":69},"100553341","phase-1-purinostat-mesylate-combined-with-pomalidomide-capsules-and-low-dose-dexamethasone-in-patients-with-relapsed-or-refractory-multiple-myeloma-100553341","NCT06484829","Purinostat Mesylate Combined With Pomalidomide Capsules and Low-dose Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma","An Open-Label, Parallel-Controlled, Multi-Center Phase Ib\u002FIIa Clinical Study to Evaluate the Efficacy and Safety of Purinostat Mesylate for Injection Combined With Pomalidomide Capsules and Low-Dose Dexamethasone in Patients With Relapsed and Refractory Multiple Myeloma","Inclusion Criteria:\n\n1. Diagnosed with multiple myeloma (MM) by reference to the diagnostic criteria of the Chinese Guidelines for the Diagnosis and Treatment of Multiple Myeloma (Revised 2022);\n2. Those who have received at least one line of prior systemic antimyeloma therapy (which must include lenalidomide and proteasome inhibitors; see Appendix 4 for counts of myeloma treatment lines) and meet the definition of relapse or refractory; Definition of relapse: disease progression that occurs at least 60 days from the last treatment after the efficacy of a prior treatment regimen was evaluated at MR or better (except for those who relapsed more than 1 year after treatment); Definition of refractory: progression during prior therapy or progression within 60 days of the last treatment; or failure to achieve MR or better after at least 2 prior courses of therapy; or treatment intolerance.\n3. Age 18-75 years, male or female, if of childbearing potential subjects should be on effective contraception and must agree to comply with all contraceptive requirements:\n\n1\\) Females of childbearing potential must agree to and comply with the contraceptive measures specified in the protocol: beginning 4 weeks prior to treatment with this product, two reliable methods of contraception are required concurrently for the duration of the treatment, during the dose suspension, and for 4 weeks after termination of the treatment (one highly effective method of contraception-tubal ligation, intrauterine device, hormonal (contraceptive pills, injections, patches, vaginal rings, or implants), or partner's vasectomy, and another effective contraceptive method - male rubber or synthetic condom, diaphragm or cervical cap). Effective contraception is needed even with a history of infertility unless due to hysterectomy; 2) Men of childbearing potential must use a rubber or synthetic condom at all times during sexual contact with women of childbearing potential beginning 4 weeks prior to treatment with this product, during the treatment period, during the dose suspension period, and for 4 weeks after termination of treatment, even if they have had a successful vasectomy; 4. Subjects with multiple myeloma who have measurable M protein, i.e., at least one of the following 3 measurements:\n\n1. Serum M protein ≥ 0.5 g\u002FdL (5 g\u002FL);\n2. Urine M protein ≥ 200 mg\u002F24h;\n3. Serum free light chain assay: in the case of an abnormal serum free light chain ratio (less than 0.26 or greater than 1.65), an affected free light chain level ≥10mg\u002FdL (100mg\u002FL); 5. Hematologic fulfillment of the following conditions:\n\n1\\) ANC ≥ 1.0 x 109\u002FL (without granulocyte colony-stimulating factor within 7 days), with no specific requirement for neutrophil count when ≥ 50% of the bone marrow is plasma cells; 2) PLT ≥75 × 109\u002FL (no platelet transfusion or use of thrombopoietin within 7 days), and platelets ≥50 × 109\u002FL were eligible for enrollment when ≥50% of plasma cells were present in the bone marrow; 3) Hemoglobin ≥ 80 g\u002FL (no red blood cell suspension infusion or use of erythropoietin within 7 days); 6. Liver and kidney function tests fulfill the following conditions:\n\n1. TBIL ≤ 1.5 x ULN;\n2. ALT and AST are ≤ 2.5 x ULN;\n3. Glomerular filtration rate (GFR) ≥ 30mL\u002Fmin\u002F1.73m2 (Cockcroft-Gault formula) without the effects of dialysis therapy; 7. Ability to receive and have access to antithrombotic medications such as low molecular heparin sodium, heparin, warfarin or aspirin; 8. An ECOG (Appendix 2) score of 0-2 and an expected survival of ≥12 weeks; 9. Subjects voluntarily enrolled in the study and signed an informed consent form.\n\nExclusion Criteria:\n\n1. Those with prior antitumor therapy with histone deacetylase (HDAC) inhibitors (except cedarbenazine), antibody-coupled degradation agents (DAC), HSP90 inhibitors, or valproic acid; or those who, in the judgment of the investigator, are intolerant to treatment with the same type of drug as HDAC inhibitors, pomalidomide, thalidomide, lenalidomide, or the like (e.g., grade ≥3 rash during prior use, severe refractory myelosuppression, etc.);\n2. Those with disease progression following prior treatment with standard dose pomalidomide;\n3. Allergic reactions to the components of the test drug involved in this trial;\n4. A diagnosis of non-secretory MM (defined as a subject who is completely non-secretory or who has a small amount of free light chain but the affected light chain is less than 100 mg\u002FL), or MM in combination with amyloidosis, or plasma cell leukemia, either primary or during the course of therapy\n5. Those with active new thrombosis or who are unable to receive antithrombotic therapy;\n6. Other malignant tumors within 5 years prior to screening, with the exception of cured carcinoma in situ (e.g., cervix, breast, bladder, etc.), basal cell carcinoma of the skin, squamous epithelial cell carcinoma of the skin, or early-stage prostate carcinoma (with clinical staging of Tla or T1b);\n7. Those who have a combination of central nervous system disorders and require treatment for such disorders\n8. Peripheral neuropathy ≥ grade 3; and\n9. Co-morbidities requiring long-term treatment with immunosuppressive drugs or steroids; 10. active infectious diseases;\n10. Those with comorbid active infectious diseases, including the following:\n\n1\\) Hepatitis B Surface Antigen (HbsAg) or Hepatitis B Core Antibody (HbcAb) positive with HBV-DNA quantification higher than the upper limit of normal value 2) Positive Hepatitis C Virus Antibody (HCV-Ab) with HCV RNA quantification above the upper limit of normal; 3) Human immunodeficiency virus antibody (HIV-Ab) or anti-syphilis spirochete antibody (TP-Ab) positive; 11. Subjects with any of the following:\n\n1. Cardiac insufficiency ≥ grade 3 by NYHA classification (Appendix 1) criteria;\n2. Myocardial infarction within 6 months;\n3. Poorly controlled angina, including variant angina, within 6 months;\n4. Clinically significant arrhythmia;\n5. ECG QTcF \\>450 ms (men) and QTcF \\>470 ms (women) (Fridericia formula);\n6. Echocardiographic indication of left ventricular ejection fraction \\\u003C50%; 12. A combination of severe infectious disease requiring systemic intravenous antibiotic therapy 2 weeks prior to the first dose; 13. Those who have received an allogeneic hematopoietic stem cell transplant within 12 months, or those who have active graft-versus-host disease (GVHD) or GVHD requiring immunosuppressive therapy more than 12 months after the allogeneic hematopoietic stem cell transplant; 14. Who have participated in another clinical trial within 4 weeks prior to the first dose; 15. Those who have received other antitumor therapy (including herbal antitumor therapy, except for ≤20 mg\u002Fday of prednisone and its equivalent dose of steroid hormones) within 2 weeks prior to the first administration of the drug; 16. Those who have not recovered to Grade 1 or below from toxic reactions to prior antitumor therapy (except alopecia, malaise and those limited by entry criteria #6); 17. Those who have received major surgical treatment within 4 weeks prior to the first dose and have not fully recovered; 18. Women who are pregnant or breastfeeding; 19. Persons who, in the opinion of the investigator, have other factors that make them unsuitable for participation in the trial (e.g., uncontrolled active hypertension, uncontrolled active diabetes mellitus, poor adherence, substance abuse, etc.).",{"count":172,"type":20},144,[109,80],"Primary Purpose Phase Ib. To determine the Maximum Tolerated Dose (MTD) and establish the Recommended Phase IIa Dose (RP2D) of Purinostat Mesylate for Injection combined with fixed-dose Pomalidomide Capsules and Dexamethasone in patients with relapsed or refractory multiple myeloma.\n\nPhase IIa. To further evaluate the safety and tolerability of Purinostat Mesylate for Injection at the RP2D combined with fixed-dose Pomalidomide Capsules and Dexamethasone in patients with relapsed and refractory multiple myeloma (RRMM).\n\nSecondary Objectives Phase Ib\n\n1. To evaluate the safety and tolerability of Purinostat Mesylate for Injection combined with fixed-dose Pomalidomide Capsules and Dexamethasone in the treatment of relapsed or refractory multiple myeloma.\n2. To assess the pharmacokinetic (PK) parameters of the combination therapy in patients with relapsed or refractory multiple myeloma.\n3. To observe the preliminary efficacy of the combination therapy in patients with relapsed or refractory multiple myeloma.\n\nPhase IIa\n\n1. To evaluate the preliminary efficacy of the combination therapy in patients with relapsed and refractory multiple myeloma (RRMM).\n2. To characterize the population pharmacokinetic (PPK) profile of the combination therapy in patients with relapsed or refractory multiple myeloma (RRMM).",[26],"2025-03-27",{"date":178,"type":39},"2025-04-02",{"date":180,"type":39},"2024-03-25",{"date":182,"type":20},"2026-04-01",{"name":184,"class":46},"Chengdu Zenitar Biomedical Technology Co., Ltd"]