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NCT07348393PHASE2NOT_YET_RECRUITING

A Phase 2, Single Arm Multicenter, Study Testing Mezigdomide, Carfilzomib, and Dexamethasone (480Kd) in Participants With Relapsed or Refractory Multiple Myeloma (RRMM)

Sponsor: Assistance Publique - Hôpitaux de Paris + Bristol-Myers Squibb

No open prediction endpoints

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Key Facts

Study type
INTERVENTIONAL
Conditions
Relapsed or Refractory Multiple Myeloma (RRMM)
Interventions
Administration of a combination of treatments
Enrollment
70 participants
Primary completion
Feb 2029
Study completion
Feb 2029
First posted
Jan 2026
Last updated
Jan 2026

Primary Endpoints (CT.gov)

Determine the progression-free survival (PFS) of mezigdomide, carfilzomib and dexamethasone (480Kd) in participants with relapsed or refractory multiple myeloma (RRMM)

Time frame: 2 years

Secondary Endpoints

Overall Survival (OS)

Best overall Response Rate (ORR)

Rate of very good partial response (VGPR) or better (VGPRR)

Eligibility Criteria

Inclusion Criteria: 1. Signed Written Informed Consent 2. Adult patients (≥18 years old) 3. ECOG Performance Status score of 0, 1, or 2. 4. Participant has documented diagnosis of multiple myeloma (MM) and measurable disease, defined as any of the following: 1. M-protein ≥ 0.5 g/dL by serum protein electrophoresis (sPEP), or 2. M-protein ≥ 200 mg/24-hour urine collection by urine protein electrophoresis (uPEP) or, 3. For participants without measurable disease in sPEP or uPEP: serum free light chain (sFLC) levels \> 100 mg/L (10 mg/dL) involved light chain and an abnormal κ/λ FLC ratio. 5. 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/or \[with or without\] maintenance therapy). 6. Participant must have received prior treatment with lenalidomide and an anti-CD38 monoclonal antibody. 7. Participant ach

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✦ Analyst Commentary

Expert commentary on why this trial matters and what to watch for.

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Source

Open on ClinicalTrials.gov