[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"multiple-myeloma-newly-diagnosed\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:multiple-myeloma-newly-diagnosed":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,7,0,[8,52,79,108,128,153,177],{"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":29,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":41,"startDateStruct":44,"completionDateStruct":46,"leadSponsor":48,"locationsCount":51},"100591004","phase-2-frontline-t-cell-engager-vs-autologous-stem-cell-transplant-asct-and-measurable-residual-disease-mrd-guided-sequential-intensification-therapy-in-multiple-myeloma-100591004",false,"NCT06974786","Frontline T-cell Engager vs Autologous Stem Cell Transplant (ASCT) and Measurable Residual Disease (MRD)-Guided Sequential Intensification thERapy in Multiple Myeloma","Frontline T-cell Engager vs Autologous Stem Cell Transplant and Measurable Residual Disease (MRD)-Guided Sequential Intensification thERapy in Multiple Myeloma (FASTER)","FASTER","Inclusion Criteria:\n\n1. Age \\>18 years with no upper age limit.\n2. Newly diagnosed multiple myeloma with indication for initiation of therapy diagnosed within last 12 months. Pretreatment parameters necessary for disease characterization and response assessment must be available.\n3. Eligible for ASCT according to institutional policy as evaluated by investigator.\n4. Eastern Cooperative Oncology Group (ECOG) performance status 0-1 (Appendix A).\n5. Prior induction therapy including one PI, lenalidomide, and an anti-CD38 mAb for 16-24 weeks, obtaining at least a partial response (PR).\n6. Measurable disease meeting at least 1 of the following criteria (at the time of diagnosis):\n\n   a. Serum monoclonal (M) protein ≥1.0 g\u002Fdl (≥0.5 g\u002Fdl if IgA, IgD, IgE or IgM MM).\n\n   b. ≥200 mg of M protein\u002F24h in the urine. c. Difference between affected and unaffected free light chain ≥10 mg\u002FdL with abnormal kappa to lambda ratio.\n7. Have trackable clonogenic sequence using ClonoSEQ® (Seattle, WA) identified from a high disease burden sample obtained as SoC and enabling MRD testing during screening phase.\n8. Have clinical laboratory values meeting the following criteria during the Screening Phase and also at start of administration of study treatment:\n\n   • Hemoglobin ≥8g\u002FdL without prior red blood cells (RBC) transfusion within 14 days before the laboratory test; recombinant human erythropoietin use is permitted\n\n   • Platelets ≥75,000\u002Fµl\n\n   • Absolute neutrophil count ≥1,000\u002Fµl (prior growth factor support is permitted but must be without support for 7 days for granulocyte colony stimulating factor (G-CSF) or granulocyte-macrophage colony stimulating Factor (GM-CSF) and for 14 days for pegylated G-CSF before screening lab test\n\n   • Aspartate aminotransferase and alanine aminotransferase ≤2.5 × upper limit of normal (ULN)\n   * Renal function: Creatinine clearance (CrCl) ≥40 mL\u002Fmin based on calculation using Cockcroft-Gault formula or measured by a 24-hour urine collection.\n   * Total bilirubin ≤2 × ULN, except in participants with congenital bilirubinemia, such as Gilbert syndrome (in which case direct bilirubin ≤3 × ULN is required)\n   * Serum calcium corrected for albumin ≤14 mg\u002FdL (≤3.5 mmol\u002FL) or free ionized calcium ≤6.5 mg\u002FdL (≤1.6 mmol\u002FL)\n9. Achievement of at least PR to induction therapy, without prior progression of disease.\n10. Prior completion of standard of care mobilization and collection of stem cells (minimum 2 × 106 CD34+ cells\u002Fkg) without use of chemotherapy mobilization, any time prior to or during screening phase.\n11. A woman of childbearing potential must have a negative highly sensitive serum pregnancy test at screening and again within 24 hours of the start of study treatment and must agree to further serum or urine pregnancy tests during the study.\n12. A woman must be:\n\n    a. Not of childbearing potential, or b. Of childbearing potential and practicing true abstinence; or i. Have a sole partner who is vasectomized; or ii. Practicing ≥1 highly-effective, user-independent method of contraception (Appendix B) NOTE: Participant must agree to continue the above throughout the study and for 4 months after the last dose of study treatment. If a woman becomes of childbearing potential after start of the study the woman must comply with point (b) as described above.\n13. A woman must agree not to donate eggs (ova, oocytes) or freeze for future use, for the purposes of assisted reproduction during the study and for 4 months after receiving the last dose of study treatment.\n14. A man must wear a condom (with or without spermicidal foam\u002Fgel\u002Ffilm\u002Fcream\u002Fsuppository) when engaging in any activity that allows for passage of ejaculate to another person during the study and for a minimum of 90 days after receiving the last dose of study treatment. If a female partner is of childbearing potential, she must also be practicing a highly effective method of contraception.\n\n    NOTE: If the male participant is vasectomized, he still must wear a condom (with or without spermicidal foam\u002Fgel\u002Ffilm\u002Fcream\u002Fsuppository), but his female partner is not required to use contraception.\n15. A male participant must agree not to donate sperm for the purpose of reproduction during the study and for a minimum of 90 days after receiving the last dose of study treatment.\n16. Must be willing and able to adhere to the lifestyle restrictions specified in this protocol.\n17. Must sign an Informed Consent Form (ICF) (or their legally acceptable representative must sign) indicating that the participant understands the purpose of, and procedures required for, the study and is willing to participate in the study.\n18. All participants must agree to comply with and be enrolled in Revlimid Risk Evaluation and Mitigation Strategy (REMS) program.\n19. All participants must agree to comply with and be enrolled in elranatamab Risk Evaluation and Mitigation Strategy (REMS) program.\n20. All participants must meet institution-specific criteria for ASCT eligibility as assessed by the Investigator.\n\nExclusion Criteria:\n\n1. Diagnosis of primary light chain amyloidosis, POEMS, Waldenstrom's macroglobulinemia, plasma cell leukemia, or central nervous system (CNS) involvement by MM.\n2. Contraindications or life-threatening allergies, hypersensitivity, or intolerance to any study drug or its excipients (refer to the elranatamab Investigator's Brochure \\[IB\\] and appropriate package inserts).\n3. Prior or concurrent exposure to any of the following:\n\n   c. Any anti-BCMA therapy. d. 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\n   e. Investigational vaccine within 4 weeks. f. Live, attenuated vaccine within 4 weeks before randomization. g. Radiotherapy within 14 days. h. Gene-modified adoptive cell therapy (e.g., CAR modified T cells, NK cells). i. Cytotoxic therapy within 14 days.\n4. Minimum washout period for prior therapy:\n\n   1. PI therapy - 14 days.\n   2. IMiD agent therapy -14 days.\n   3. Anti CD38 monoclonal therapy - 14 days.\n   4. Corticosteroids - 7 days.\n5. Known active CNS involvement or exhibits clinical signs of meningeal involvement of MM. If either is suspected, negative whole brain magnetic resonance imaging and lumbar cytology are required.\n6. Myelodysplastic syndrome or active malignancies (i.e., progressing or requiring treatment change in the last 24 months) other than MM. The only allowed exceptions are:\n\n   a. Non-muscle invasive bladder cancer treated within the last 24 months that is considered completely cured.\n\n   b. Skin cancer (non-melanoma or melanoma) treated within the last 24 months that is considered completely cured.\n\n   c. Non-invasive cervical cancer treated within the last 24 months that is considered completely cured.\n\n   d. Localized prostate cancer (N0M0): i. With a Gleason score of ≤6, treated within the last 24 months, or untreated and under surveillance.\n\n1\\) With a Gleason score of 3+4 that has been treated \\>6 months prior to full study screening and considered to have a very low risk of recurrence, or e. History of localized prostate cancer and receiving androgen deprivation therapy and considered to have a very low risk of recurrence.\n\nf. Breast cancer: adequately treated lobular carcinoma in situ or ductal carcinoma in situ, or history of localized breast cancer and receiving antihormonal agents and considered to have a very low risk of recurrence (\\\u003C5% over 5 years).\n\ng. Other malignancy that is considered cured with minimal risk of recurrence. 7. Stroke or seizure within 6 months prior to signing ICF. 8. Chronic obstructive pulmonary disease (COPD) with a forced expiratory volume in 1 second (FEV1) \\\u003C50% of predicted normal. Note that FEV1 testing is required for participants suspected of having COPD and participants must be excluded if FEV1 is \\\u003C50% of predicted normal.\n\n9\\. Moderate or severe persistent asthma within the past 2 years or uncontrolled asthma of any classification. Note that participants who currently have controlled intermittent asthma or controlled mild persistent asthma are allowed to participate in the study.\n\n10\\. Prior allogeneic bone marrow, hematopoietic stem cell or solid organ transplant.\n\n11\\. Participant is pregnant, breast-feeding, or planning to become pregnant while enrolled in this study or within 6 months after the last dose of study treatment.\n\n12\\. Participant plans to father a child while enrolled in this study or within 90 days after the last dose of study treatment.\n\n13\\. Presence of the following cardiac conditions: h. New York Heart Association Class III or IV congestive heart failure i. Myocardial infarction or coronary artery bypass graft ≤6 months prior to randomization j. History of clinically significant ventricular arrhythmia or unexplained syncope, not believed to be vasovagal in nature or due to dehydration.\n\nk. History of severe non-ischemic cardiomyopathy. 14. Any of the following:\n\n1. History of Human Immunodeficiency Virus (HIV) infection or Acquired Immunodeficiency Syndrome (AIDS)-related illness.\n2. Active or recent infection (including SARS-COV-2). Participants with prior or recent infection must have infection resolved for \\>21 days and no use of systemic anti-infective therapy for \\>28 days.\n3. Hepatitis B infection (i.e., hepatitis B surface antigen \\[HBsAg\\] or hepatitis B virus \\[HBV\\]-DNA positive). In the event the infection status is unclear, quantitative viral levels are necessary to determine the infection status.\n4. Active hepatitis C infection as measured by positive hepatitis C virus (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 HCVRNA positive) completed antiviral therapy and has undetectable HCV-RNA for at least 12 weeks following the completion of therapy, the participant is eligible for the study.\n\n   15\\. Major surgery within 14 days prior to the start of administration of study treatment, 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 or within 2 weeks after administration of the last dose of study treatment.\n\nNOTE: Participants with planned surgical procedures to be conducted under local anesthesia may participate. Kyphoplasty or vertebroplasty are not considered major surgery. If there is a question whether a procedure is considered a major surgery, the Investigator must consult with the appropriate Sponsor representative and resolve any issues before enrolling a participant in the study.\n\n16\\. Contraindication or intolerance to required supportive care medications in the absence of alternative options.\n\n17\\. Contraindication or intolerance to daratumumab or lenalidomide, or prior to toxicities to lenalidomide during induction requiring reduction of dose to \\\u003C10 mg\u002Fday.\n\n18\\. Significant neuropathy (Grades 3-4 or Grade 2 with pain). 19. History of Guillain-Barre Syndrome or variant. 20. Concurrent medical or psychiatric condition or disease that is likely to interfere with study procedures or results, or that in the opinion of the Investigator would constitute a hazard for participating in this study, such as:\n\n1. Uncontrolled diabetes.\n2. Acute diffuse infiltrative pulmonary disease.\n3. History of autoimmune disease with the exception of vitiligo, type I diabetes, and prior autoimmune thyroiditis that is currently euthyroid based on clinical symptoms and laboratory testing.\n4. Disabling psychiatric conditions (e.g., alcohol or drug abuse), severe dementia, or altered mental status.\n5. Any other issue that would impair the ability of the participant to receive or tolerate the planned treatment at the investigational site, to understand informed consent or any condition for which, in the opinion of the Investigator, participation would not be in the best interest of the participant (e.g., compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments.\n6. History of non-compliance with recommended medical treatments.","ALL","19 Years",{"count":20,"type":21},100,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This is an open-label, multi-site, Phase II randomized trial with response-adaptive design for newly diagnosed multiple myeloma (NDMM) participants who have had prior induction therapy. The primary objective of this study is to compare the rates of achieving undetectable measurable residual disease (MRD) in the bone marrow with elranatamab and daratumumab employed as post-induction consolidation and maintenance treatment (Arm A) versus autologous stem cell transplant (ASCT) followed by lenalidomide and daratumumab treatment (Arm B).",[27,28],"Multiple Myeloma, Newly Diagnosed","Multiple Myeloma (MM)",[30,31,32,33,34,35,36,37,38],"MM","Newly diagnosed multiple myeloma","NDMM","MRD","ASCT","T-cell engager","Elranatamab","Daratumumab","Lenalidomide","RECRUITING","2026-06-02",{"date":42,"type":43},"2026-06-04","ACTUAL",{"date":45,"type":43},"2025-08-08",{"date":47,"type":21},"2033-04",{"name":49,"class":50},"SCRI Development Innovations, LLC","OTHER",11,{"id":53,"slug":54,"hasResults":11,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":58,"eligibilityCriteria":59,"healthyVolunteers":11,"sex":17,"minAge":60,"maxAge":61,"enrollmentInfo":62,"targetDuration":4,"studyType":22,"phases":64,"briefSummary":66,"conditions":67,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":78},"100586640","phase-3-elranatamablenalidomide-consolidation-andor-elranatamab-maintenance-versus-standard-of-care-after-d-vrd-induction-in-transplant-eligible-ndmm-patients-100586640","NCT06918002","Elranatamab\u002FLenalidomide Consolidation and\u002For Elranatamab Maintenance Versus Standard of Care After D-VRd Induction in Transplant-eligible NDMM Patients","A Phase 3, Open-label, Controlled, Randomized Study of Newly Diagnosed Multiple Myeloma Treatment, Designed to Evaluate the Efficacy and Safety of the Elranatamab-lenalidomide Combination as a Replacement for Chemotherapy Followed by Autologous Stem Cell Transplant in the Consolidation Phase, and to Compare Elranatamab With Standard of Care in the Maintenance Phase","ElLen","Inclusion Criteria:\n\n1. Male or female subjects, aged over 18 but \\\u003C 70 years old\n2. Patients have provided voluntary written informed consent before performing any study-related procedure.\n3. Patients with newly diagnosed multiple myeloma (NDMM) eligible for high-dose chemotherapy (melphalan) and autologous stem cell transplantation (ASCT).\n4. Patients with documented symptomatic NDMM according to CRAB and\u002For SLIM criteria, with measurable disease as defined by:\n\n   * Presence of ≥10% monoclonal plasma cells in the bone marrow OR presence of a biopsy-proven plasmacytoma. In addition, the patient must have ≥1 of the following myeloma defining events:\n\n     \\- Hypercalcemia: serum calcium \\>0.25 mmol\u002FL (\\>1 mg\u002FdL) higher than upper limits of normal (ULN) or \\>2.75 mmol\u002FL (\\>11 mg\u002FdL).\n\n     \\- Renal insufficiency: creatinine clearance \\\u003C 40mL\u002Fmin\u002F1.73 m2 using CKD-EPI or serum creatinine \\>177 μmol\u002FL (\\>2 mg\u002FdL).\n\n     \\- Anemia: hemoglobin \\>2 g\u002FdL below the lower limit of normal (LLN) or hemoglobin \\\u003C10 g\u002FdL.\n\n     \\- Bone lesions: ≥1 osteolytic lesion on skeletal radiography, CT or PET-CT.\n\n     \\- Clonal bone marrow plasma cell percentage ≥60%.\n\n     \\- Serum involved\u002Funinvolved free light chain ratio ≥100.\n     * More than 1 focal lesion (≥5 mm diameter) on MRI.\n   * Measurable disease as defined by serum M-component ≥5 g\u002FL, and\u002For urine M-component ≥200 mg\u002F24 h and\u002For serum FLC ≥100 mg\u002FL.\n5. Patient has an Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤2.\n6. Patients must have clinical laboratory values (within 15 days of initiating induction therapy) as follows:\n\n   • Hemoglobin ≥7.5 g\u002FdL (≥5 mmol\u002FL). Prior red blood cell (RBC) transfusion or the use of recombinant human erythropoietin is permitted.\n\n   • Absolute neutrophil count (ANC) ≥1.0 G\u002FL (granulocyte colony stimulating factor \\[G-CSF\\] use is permitted).\n\n   • Aspartate aminotransferase (AST) ≤3 x ULN.\n\n   • Alanine aminotransferase (ALT) ≤ 3 x ULN.\n\n   • Total bilirubin ≤3 x ULN (except in subjects with congenital bilirubinemia, such as Gilbert syndrome, that require a direct bilirubin ≤3 x ULN).\n\n   • Calculated creatinine clearance ≥40 mL\u002Fmin\u002F1.73 m².\n   * Albumin corrected serum calcium ≤14 mg\u002FdL (\\\u003C3.5 mmol\u002FL); or free-ionized calcium ≤6.5 mg\u002FdL (≤1.6 mmol\u002FL).\n   * Platelet count ≥50 Giga\u002FL for subjects who have \\\u003C50% of bone marrow nucleated cells as plasma cells. If not, platelet count \\>30 G\u002FL (platelets transfusions done during the 15 days before initiating induction therapy are not permitted).\n7. Women of childbearing potential must have a negative serum or urine pregnancy test during the screening period before randomization AND within 3 days before of initiating induction therapy.\n8. Patients must be willing and able to comply with scheduled appointments, treatment plan, laboratory tests, and other study procedures (such as blood transfusion if required, ASCT, IVIG prophylaxis, etc.).\n\nExclusion Criteria:\n\n1. Subjects previously treated with any systemic therapy for multiple myeloma. Patients are allowed corticosteroids before or during screening, as far as the total dose received is not \\>160 mg of dexamethasone (or equivalent) within 14 days before initiating induction therapy. Patients with concurrent radiotherapy within the 14 days before initiating induction therapy are not eligible (If possible, in these cases, enrolment should be deferred).\n2. Subject with ongoing Grade ≥ 3 peripheral sensory or motor neuropathy.\n3. Subject with history of GBS or GBS variants, or history of any Grade ≥3 peripheral motor polyneuropathy.\n4. Subject with a current diagnosis of primary amyloidosis, monoclonal gammopathy of undetermined significance, smoldering multiple myeloma, or solitary plasmacytoma.\n5. Subject has a diagnosis of Waldenström's macroglobulinemia, or other conditions in which IgM M-protein is present in the absence of a clonal plasma cell infiltration with lytic bone lesions.\n6. The subject has had plasmapheresis within 14 days of initiating induction therapy.\n7. Subject with clinical signs of meningeal involvement of multiple myeloma.\n8. The subject has plasma cell leukemia (by WHO criterion: ≥5% of plasma cells in the peripheral blood) or POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes).\n9. Subject has any concurrent medical or psychiatric condition or disease (e.g., active systemic infection, uncontrolled diabetes, acute diffuse infiltrative pulmonary disease) that is likely to interfere with the study procedures or results, or that in the opinion of the investigator, would constitute a hazard for participating in this study.\n10. Subject has clinically significant cardiac disease, including:\n\n    • Subject has had myocardial infarction within 1 year before initiating induction therapy, or currently has an unstable or uncontrolled disease\u002Fcondition related to or affecting cardiac function (e.g., unstable angina, congestive heart failure, New York Heart Association \\[NYHA\\] class III IV).\n    * Subject has uncontrolled cardiac arrhythmia (common terminology criteria for adverse events \\[CTCAE\\] version 4 grade ≥2) or clinically significant electrocardiography (ECG) abnormalities.\n    * Subject with a baseline QT interval as corrected by Fridericia's formula (QTcF) \\>470 msec (12-lead ECG).\n11. Subjects taking systemic treatment with strong inhibitors of CYP1A2 (fluvoxamine, enoxacin), strong inhibitors of CYP3A (clarithromycin, telithromycin, itraconazole, voriconazole, ketoconazole, nefazodone, posaconazole) or strong CYP3A inducers (rifampin, rifapentine, rifabutin, carbamazepine, phenytoin, phenobarbital), or use of Ginkgo biloba or St. John's wort (millepertuis) within the 14 days before initiating induction therapy.\n12. Known intolerance to steroids, mannitol, pregelatinized starch, sodium stearyl fumarate, histidine (as base and hydrochloride salt), arginine hydrochloride, poloxamer 188, sucrose or any of the other components of study intervention that are not amenable to premedication with steroids and H2 blockers or would prohibit further treatment with these agents.\n13. Known allergies to any of the study medications, their analogues, or excipients in the various formulations.\n14. Subjects who have had major surgery within 2 weeks before study inclusion (signing of the informed consent) OR will not have fully recovered from surgery before initiating induction therapy OR have surgery planned during their study participation. Kyphoplasty and vertebroplasty are not considered as major surgery.\n15. Subjects with any prior or concurrent malignancy (other than multiple myeloma) within 5 years of study inclusion study, except for adequately treated basal cell or squamous cell carcinoma of the skin, in situ carcinoma of the cervix, or localized prostate adenocarcinoma diagnosed ≥3 years ago and without evidence of biological failure, or other cancers for which the subject has undergone potentially curative therapy and has without evidence of relapse\u002Frecurrence for ≥5 years.\n16. Pregnant or breast-feeding women.\n\nWomen that refuse to abstain from heterosexual intercourse or refuse to use adequate contraceptives during heterosexual intercourse starting at least 4 weeks before initiating induction therapy and continually until at least 4 weeks after discontinuing lenalidomide,90 days after discontinuing daratumumab and 6 months after discontinuing elranatamab.\n\n18\\. Men with partners of childbearing potential, even men with a successful vasectomy, that refuse to use a condom during intercourse, from initiating induction therapy to ≥4 weeks ys after discontinuing lenalidomide,. Furthermore, men must agree to not donate sperm during this period.\n\n19\\. Known positive for HIV or active hepatitis A, B or C: Uncontrolled or active HBV infection: Patients with positive HBsAg and\u002For HBV DNA\n\nOf note:\n\nPatients can be eligible if anti-HBc IgG positive (with or without positive anti-HBs) but HBsAg and HBV DNA are negative.\n\no If anti-HBV therapy in relation to prior infection was started before initiation of IMP, the anti-HBV therapy and monitoring should continue throughout the study treatment period.\n\nPatients with negative HBsAg and positive HBV DNA observed during screening period will be evaluated by a specialist for start of anti-viral treatment: study treatment could be proposed if HBV DNA becomes negative, and all the other study criteria are still met.\n\n• Active HCV infection: positive HCV RNA and negative anti-HCV.\n\nOf note:\n\nPatients with antiviral therapy for HCV started before initiation of IMP and positive HCV antibodies are eligible. The antiviral therapy for HCV should continue throughout the treatment period until seroconversion.\n\nPatients with positive anti-HCV and undetectable HCV RNA without antiviral therapy for HCV are eligible.\n\n20\\. Patient with an active systemic infection or severe infections requiring parenteral administration of antibiotics.\n\n21\\. Patients with a gastrointestinal disease\u002Fdisorder that may significantly impact the absorption of oral treatments.\n\n22\\. Patients unable or unwilling to undergo antithrombic prophylaxis.\n\n23\\. A person under guardianship, trusteeship, or deprived of freedom by a judicial or administrative decision.","18 Years","69 Years",{"count":63,"type":21},824,[65],"PHASE3","This study is designed as a multicenter, randomized, parallel groups, open-label, phase 3 study in subjects with untreated newly diagnoses Multiple Myeloma eligible for ASCT.\n\n824 patients will be enrolled in this study from approximately 70 study sites.\n\nThe 2 parts in the Treatment Phase are described below.\n\nPart 1: Induction\u002FASCT\u002FConsolidation Phase (1:1 Randomization)\n\nAfter the screening period, patients will be randomly allocated (1:1) to either:\n\n* Arm A (standard of care arm): standard induction therapy with 4 cycles of D-VRd, followed by HDCT (Melphalan) + ASCT, D-VRd consolidation therapy\n* Arm B (experimental arm): standard induction therapy with 4 cycles of D-VRd, followed by elranatamab and lenalidomide consolidation therapy.\n\nPart 2: Maintenance Phase (1:1 Re-randomization) Patients will be re-randomized (1:1) and will enter the Maintenance Phase upon completion of consolidation therapy.\n\n• Arm C (standard of care arm): daratumumab + lenalidomide approx 2 years. Subjects with a negative MRD (for at least 12 months) after 24 cycles of daratumumab-lenalidomide will discontinue daratumumab and continue with lenalidomide monotherapy until disease progression, or study cut-off date (whichever occurs first).\n\nSubjects who did not achieve MRD negativity for at least 12 months after 24 cycles of daratumumab-lenalidomide will continue to receive daratumumab-lenalidomide until:\n\n* MRD negativity for at least 12 months is reached. Subjects will then continue with lenalidomide monotherapy until disease progression, or study cut-off date (whichever occurs first).\n* Disease progression\n* Or study cut-off date (whichever occurs first).\n\n  * Arm D (experimental arm): elranatamab. Approx 2 years. Subjects with a negative MRD (for at least 12 months) after receiving M22 administration of elranatamab will discontinue study treatment with elranatamab.\n\nSubjects who did not achieve MRD negativity for at least 12 months after M22 elranatamab administration will continue to receive elranatamab, every 24 weeks, until MRD negativity for at least 12 months is reached, disease progression, or study cut-off date (whichever occurs first).",[27],"2026-05-28",{"date":70,"type":43},"2026-06-01",{"date":72,"type":43},"2025-07-09",{"date":74,"type":21},"2036-05",{"name":76,"class":77},"Intergroupe Francophone du Myelome","NETWORK",64,{"id":80,"slug":81,"hasResults":11,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":85,"eligibilityCriteria":86,"healthyVolunteers":11,"sex":17,"minAge":60,"maxAge":87,"enrollmentInfo":88,"targetDuration":4,"studyType":22,"phases":90,"briefSummary":91,"conditions":92,"keywords":93,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":107},"100601147","phase-2-asct-combined-with-bcma-car-t-and-gprc5dcd3-bites-maintenance-for-transplant-eligible-ultra-high-risk-multiple-myeloma-100601147","NCT07106710","ASCT Combined With BCMA CAR-T and GPRC5D\u002FCD3 BiTEs Maintenance for Transplant-Eligible Ultra-High-Risk Multiple Myeloma","A Prospective, Single-Arm, Phase II Study of Autologous Stem Cell Transplantation Combined With BCMA CAR-T Therapy Followed by GPRC5D\u002FCD3 Bispecific Antibody Maintenance in Transplant-Eligible Patients With Ultra-High-Risk Multiple Myeloma","CAREMM-005","Inclusion Criteria:\n\n1. Age ≥ 18 years and ≤ 70 years.\n2. Participants with documented newly-diagnosed multiple myeloma according to IMWG diagnostic criteria.\n3. Measurable disease at screening, defined as: Serum M-protein level ≥1.0 g\u002FdL or urine M-protein level ≥200 mg\u002F24 hours; or Light chain MM without measurable disease in serum or urine: serum Ig free-light chain (FLC) ≥10 mg\u002FdL and abnormal serum Ig kappa lambda FLC ratio.\n4. Patients deemed eligible for high-dose chemotherapy with ASCT.\n5. Presence of at least one of the following ultra-high-risk features: a. Double-hit multiple myeloma, defined as the presence of at least two of the following high-risk cytogenetic abnormalities: t(4;14), t(14;16), deletion 1p, gain 1q, MYC rearrangement, deletion 17p, or TP53 mutation; b. Presence of extramedullary soft tissue plasmacytomas; c. Circulating plasma cells ≥2% in peripheral blood.\n6. Tumor cells were BCMA and GPRC5D positive.\n7. Serum total bilirubin \\\u003C2 x upper limit of normal (ULN), serum AST and ALT \\\u003C3 x ULN, creatinine clearance ≥ 30mL\u002Fmin (Cockroft-Gault formula).\n8. Informed Consent\u002FAssent: All subjects have the ability to understand and the willingness to sign a written informed consent.\n\nExclusion Criteria:\n\n1. Active amyloidosis.\n2. Central nervous system involvement.\n3. Prior BCMA-targeted therapy or CAR-T therapy.\n4. Active hepatitis B or hepatitis C virus infection.\n5. Known HIV infection.\n6. Life expectancy \\\u003C6 months.\n7. Woman who are pregnant or breastfeeding.\n8. Evidence of uncontrolled dysfunction of heart, lung, brain, and other important organs.\n9. Any other conditions that are not eligible for the trial in the judgement of the principal investigator.","70 Years",{"count":89,"type":21},30,[24],"This is a prospective, single-arm, phase II study to evaluate the efficacy and safety of autologous stem cell transplantation combined with BCMA CAR-T therapy followed by GPRC5D\u002FCD3 bispecific antibody maintenance in transplant-eligible patients with ultra-high-risk multiple myeloma.",[27],[94,95,96,97,34],"Multiple myeloma","Ultra-high-risk","CAR-T","BiTEs","2025-07-30",{"date":100,"type":43},"2025-08-06",{"date":102,"type":21},"2025-08-10",{"date":104,"type":21},"2028-08-01",{"name":106,"class":50},"Institute of Hematology & Blood Diseases Hospital, China",1,{"id":109,"slug":110,"hasResults":11,"nctId":111,"briefTitle":112,"officialTitle":113,"acronym":114,"eligibilityCriteria":115,"healthyVolunteers":11,"sex":17,"minAge":60,"maxAge":116,"enrollmentInfo":117,"targetDuration":4,"studyType":22,"phases":119,"briefSummary":120,"conditions":121,"keywords":122,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":123,"startDateStruct":124,"completionDateStruct":125,"leadSponsor":127,"locationsCount":107},"100601149","phase-2-mrd-adaptive-guided-immunotherapy-with-car-t-for-transplant-ineligible-patients-with-multiple-myeloma-100601149","NCT07106736","MRD-Adaptive Guided Immunotherapy With CAR-T for Transplant-Ineligible Patients With Multiple Myeloma","A Prospective, Open-Label, Single-Center Clinical Study of a Fully Immunotherapy-Based Strategy Driven by MRD-Guided Dynamic Risk Stratification in Transplant-Ineligible Newly Diagnosed Multiple Myeloma","MAGIC-TIEMM","Inclusion Criteria:\n\n1. Age ≥ 18 years and ≤ 75 years.\n2. Participants with documented newly-diagnosed multiple myeloma according to IMWG diagnostic criteria.\n3. Measurable disease at screening, defined as: Serum M-protein level ≥1.0 g\u002FdL or urine M-protein level ≥200 mg\u002F24 hours; or Light chain MM without measurable disease in serum or urine: serum Ig free-light chain (FLC) ≥10 mg\u002FdL and abnormal serum Ig kappa lambda FLC ratio.\n4. Patients deemed ineligible for high-dose chemotherapy with ASCT due to any of the following: Age ≥65 years; Investigator assessment of ineligibility; ECOG performance status 3-4; Repeated failure of hematopoietic stem cell mobilization; Patient's decision to defer ASCT.\n5. Tumor cells were BCMA and GPRC5D positive.\n6. Serum total bilirubin \\\u003C2 x upper limit of normal (ULN), serum AST and ALT \\\u003C3 x ULN, creatinine clearance ≥ 30mL\u002Fmin (Cockroft-Gault formula).\n7. Informed Consent\u002FAssent: All subjects have the ability to understand and the willingness to sign a written informed consent.\n\nExclusion Criteria:\n\n1. Active amyloidosis.\n2. Central nervous system involvement.\n3. Prior BCMA-targeted therapy or CAR-T therapy.\n4. Active hepatitis B or hepatitis C virus infection.\n5. Known HIV infection.\n6. Life expectancy \\\u003C6 months.\n7. Woman who are pregnant or breastfeeding.\n8. Evidence of uncontrolled dysfunction of heart, lung, brain, and other important organs.\n9. Any other conditions that are not eligible for the trial in the judgement of the principal investigator.","75 Years",{"count":118,"type":21},60,[24],"This is a prospective, single-center, clinical study to evaluate the efficacy and safety of a fully immunotherapy-based strategy guided by MRD-driven dynamic risk stratification in transplant-ineligible patients with newly diagnosed multiple myeloma.",[27],[94,33,96,97],{"date":100,"type":43},{"date":102,"type":21},{"date":126,"type":21},"2029-08-01",{"name":106,"class":50},{"id":129,"slug":130,"hasResults":11,"nctId":131,"briefTitle":132,"officialTitle":133,"acronym":134,"eligibilityCriteria":135,"healthyVolunteers":11,"sex":17,"minAge":60,"maxAge":87,"enrollmentInfo":136,"targetDuration":4,"studyType":22,"phases":137,"briefSummary":138,"conditions":139,"keywords":140,"overallStatus":143,"whyStopped":4,"lastUpdateSubmitDate":144,"lastUpdatePostDateStruct":145,"startDateStruct":147,"completionDateStruct":149,"leadSponsor":151,"locationsCount":107},"100590165","phase-2-comparing-asct-followed-by-anti-bcma-car-t-vs-asct-alone-in-ndmm-patients-eligible-for-asct-100590165","NCT06963866","Comparing ASCT Followed by Anti-BCMA CAR-T vs. ASCT Alone in NDMM Patients Eligible for ASCT","A Multicenter, Open-Label, Randomized, Controlled Study of Autologous Stem Cell Transplantation Followed by Anti-BCMA CAR-T Therapy Versus ASCT Alone in Transplant-Eligible Patients With Newly Diagnosed Multiple Myeloma","ASCTvsCAR-T","Inclusion Criteria:\n\n1. Age between 18 and 70 years (inclusive);\n2. Estimated life expectancy of more than 12 weeks;\n3. Diagnosis of multiple myeloma confirmed by physical examination, pathological evaluation, laboratory tests, and imaging studies;\n4. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels less than 3 times the upper limit of normal (ULN);\n5. Karnofsky Performance Status (KPS) score \\> 50%.\n6. Eligible for ASCT.\n\nExclusion Criteria:\n\n1. Pregnant or lactating women, or women planning to become pregnant within the next six months;\n2. Transduction efficiency of targeted lymphocytes \\\u003C10%, or expansion fold \\\u003C5× under CD3\u002FCD28 co-stimulation, as determined by feasibility screening;\n3. History of severe allergies or hypersensitivity, especially to interleukin-2 (IL-2);\n4. Significant dysfunction of vital organs including the heart, lungs, or brain;\n5. Any other condition that, in the investigator's judgment, makes the patient unsuitable for participation in this study.",{"count":118,"type":21},[24],"This is a prospective study comparing autologous hematopoietic stem cell transplantation followed by anti-BCMA CAR-T to autologous hematopoietic stem cell transplantation alone in the treatment of newly diagnosed multiple myeloma patients.",[27],[141,142,34,96],"Multiple Myeloma","Eligible for ASCT","NOT_YET_RECRUITING","2025-04-30",{"date":146,"type":43},"2025-05-09",{"date":148,"type":21},"2025-05-01",{"date":150,"type":21},"2028-04-30",{"name":152,"class":50},"Xuzhou Medical University",{"id":154,"slug":155,"hasResults":11,"nctId":156,"briefTitle":157,"officialTitle":158,"acronym":4,"eligibilityCriteria":159,"healthyVolunteers":11,"sex":17,"minAge":60,"maxAge":4,"enrollmentInfo":160,"targetDuration":4,"studyType":22,"phases":162,"briefSummary":163,"conditions":164,"keywords":165,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":168,"lastUpdatePostDateStruct":169,"startDateStruct":171,"completionDateStruct":173,"leadSponsor":175,"locationsCount":107},"100574368","phase-2-low-dose-teclistamab-in-newly-diagnosed-multiple-myeloma-patients-100574368","NCT06758375","Low Dose Teclistamab in Newly Diagnosed Multiple Myeloma Patients","Low-dose Teclistamab As Consolidation in the First-line Treatment of Patients with Newly Diagnosed Multiple Myeloma.","Inclusion Criteria:\n\n* ≥18 years of age.\n* Newly diagnosed multiple myeloma.\n* Eastern Cooperative Oncology Group (ECOG) Performance Status Score of 0 or 1.\n* Women of childbearing potential must have a negative serum pregnancy test prior to starting treatment and agree to use a highly effective method of contraception, such as a hormonal method that inhibits ovulation, an intrauterine device, or a vasectomy partner.\n* Males: agree to use a highly effective contraceptive method, such as a male condom or vasectomy.\n\nExclusion Criteria:\n\n* History of previous treatment for MM.\n* Active central nervous system (CNS) involvement or clinical signs of meningeal involvement of multiple myeloma.\n* Plasma cell leukemia, Waldenström's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein and skin changes) or AL amyloidosis.\n* Severe active infection secondary to viruses, bacteria or fungi.\n* Pulmonary disease requiring supplemental oxygen.\n* History of allogeneic or autologous hematopoietic cell transplantation.\n* Vaccination with live attenuated virus in the 4 weeks prior to teclistamab administration.\n* Major surgery during the 2 weeks prior to the first dose or absence of complete recovery from surgery.\n* Presence of other concomitant malignancy.\n* Hepatitis B and C virus infection or human immunodeficiency virus (HIV) infection.\n* Cerebrovascular events or seizures in the last 6 months.\n* Congestive heart failure class III-IV according to NYHA (New York Heart Association Stage).\n* Acute myocardial infarction or history of coronary revascularization surgery in the last 6 months.\n* Women of childbearing age: active pregnancy prior to the first administration of treatment.",{"count":161,"type":21},10,[24],"This single-arm, open-label study aims to determine the efficacy and safety of low-dose, limited-duration teclistamab as a consolidation scheme in newly diagnosed multiple myeloma (NDMM) patients.",[27],[94,166,31,167],"Teclistamab","Low-dose teclistamab","2025-03-19",{"date":170,"type":43},"2025-03-20",{"date":172,"type":43},"2025-03-03",{"date":174,"type":21},"2026-12-01",{"name":176,"class":50},"Hospital Universitario Dr. Jose E. Gonzalez",{"id":178,"slug":179,"hasResults":11,"nctId":180,"briefTitle":181,"officialTitle":182,"acronym":4,"eligibilityCriteria":183,"healthyVolunteers":11,"sex":17,"minAge":60,"maxAge":4,"enrollmentInfo":184,"targetDuration":4,"studyType":22,"phases":186,"briefSummary":187,"conditions":188,"keywords":189,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":191,"lastUpdatePostDateStruct":192,"startDateStruct":194,"completionDateStruct":196,"leadSponsor":198,"locationsCount":200},"100583673","phase-2-kpd-consolidation-after-asct-in-ndmm-patients-100583673","NCT06879379","KPD Consolidation After ASCT in NDMM Patients","A Randomized, Multicenter Study Comparing Post-Transplant KPD Regimen Consolidation With No Consolidation in Newly Diagnosed Multiple Myeloma (NDMM) Transplant-eligible Patients","Inclusion Criteria:\n\n* Age ≥18 years.\n* Newly diagnosed MM eligible for transplantation.\n* Received upfront triplet or quadraplet induction regimen.\n* Received upfront ASCT after induction.\n* ECOG score \\\u003C 2.\n* Adequate Organ Function Reserve:\n\n  1. Alanine aminotransferase (ALT) \u002F Aspartate aminotransferase (AST) ≤ 2.5 × UNL (upper limit of normal);\n  2. Serum total bilirubin ≤ 1.5 × UNL. If the patient has congenitally high bilirubin, direct bilirubin must be ≤ 1.5 × UNL;\n  3. Left ventricular ejection fraction (LVEF) ≥ 50% as diagnosed by echocardiography, with no clinically significant electrocardiogram (ECG) abnormalities;\n  4. Basal oxygen saturation \\> 95% in room air;\n* Women of childbearing age agree to use effective contraceptive measures during the period of using the study drug and within 3 months after the last administration of the study drug; and to use highly effective contraceptive measures for at least 1 year thereafter. Male participants with fertile partners must agree to use effective barrier contraception during the period of using the study drug and within 3 months after the last administration of the study drug;\n* The participant is willing and able to comply with the study procedures and voluntarily signs the written informed consent form.\n\nExclusion Criteria:\n\n* Patients with primary plasma cell leukemia or POEMs syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes);\n* Patients diagnosed with primary amyloidosis, Waldenström's macroglobulinemia, monoclonal gammopathy of undetermined significance, or smoldering multiple myeloma;\n* Patients with severe mental disorders, altered mental status, or a history of central nervous system (CNS) diseases such as epileptic seizures, cerebral vascular ischemia\u002F hemorrhage, dementia, cerebellar diseases, or any autoimmune diseases involving the CNS;\n* Patients with a history of the following genetic diseases: Fanconi anemia, Shwachman-Diamond syndrome, Costello syndrome, or any other known bone marrow failure syndrome;\n* Patients who underwent a diagnosis or treatment for another malignancy within 1 year prior to randomization, or had a previous diagnosis of another malignancy with evidence of residual disease (excluding patients with any type of non-melanoma skin cancer or completely resected carcinoma in situ);\n* Patients with active infectious diseases, known human immunodeficiency virus (HIV) positivity, or active hepatitis B or C infection;\n* Patients known to be allergic to any of the study drugs, their analogs, or any excipients of the study drugs in various formulations;\n* Patients with concurrent or suspected central nervous system infiltration;\n* Patients with drug use, medical, psychological, or social conditions that may interfere with the participant's ability to participate in the study or the assessment of study outcomes;\n* Pregnant or lactating women;\n* Any other conditions deemed by the investigator as unsuitable for enrollment.",{"count":185,"type":21},202,[24,65],"This study aims to evaluate the efficacy and safety of post-transplant consolidation therapy with the KPD regimen (carfilzomib, pomalidomide, and dexamethasone) versus no consolidation, followed by maintenance therapy, in patients with transplant-eligible newly diagnosed multiple myeloma (TE-NDMM). The primary goal is to compare minimal residual disease (MRD) negativity rates and overall treatment outcomes between the two groups.",[27],[190],"consolidation","2025-03-14",{"date":193,"type":43},"2025-03-17",{"date":195,"type":21},"2025-03",{"date":197,"type":21},"2029-03",{"name":199,"class":50},"Peking University People's Hospital",3]