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Phase 3 Study to Evaluate Mezigdomide, Bortezomib and Dexamethasone (MEZIVd) Versus Pomalidomide, Bortezomib and Dexamethasone (PVd) in Participants With Relapsed or Refractory Multiple Myeloma (RRMM) (SUCCESSOR-1)

A Phase 3, Two-Stage, Randomized, Multicenter, Open-Label Study Comparing Mezigdomide (CC-92480), Bortezomib and Dexamethasone (MEZIVd) Versus Pomalidomide, Bortezomib and Dexamethasone (PVd) in Subjects With Relapsed or Refractory Multiple Myeloma (RRMM): SUCCESSOR-1

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2071230097
Enrollment
48
Registered
2023-12-04
Start date
2024-02-13
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Relapsed or Refractory Multiple Myeloma (RRMM)

Interventions

[Japan safety lead-in cohort] Mezigdomide/Bortezomib/Dexamethasone Specified dose on specified days [Stage 2] Arm A: Mezigdomide/Bortezomib/Dexamethasone Specified dose on specified days Arm B: Pomal

Sponsors

Nishio Mitsufumi
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Participant has documented diagnosis of multiple myeloma and measurable disease, defined as any of the following: a. M-protein >= 0.5 grams per deciliter (g/dL) by serum protein electrophoresis (sPEP) or b. M-protein >=200 milligrams (mg) per 24-hour urine collection by urine protein electrophoresis (uPEP) c. 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 kappa/lambda FLC ratio. 2. Participants received 1 to 3 prior lines of antimyeloma therapy. 3. Subject must have received prior treatment with a lenalidomide-containing regimen. 4. Participants achieved minimal response [MR] or better to at least 1 prior antimyeloma therapy.

Exclusion criteria

Exclusion criteria: 1. Participant has had progression during treatment or within 60 days of the last dose of a proteasome inhibitor, except as noted below: a. Subjects who progressed while being treated with, or within 60 days of last dose of bortezomib maintenance given once every 2 weeks or less are not excluded. 2. For participants with prior treatment of a bortezomib containing regimen, the best response achieved was not a minimal response (MR) or better, or participant discontinued bortezomib due to toxicity. 3. Participant has had prior treatment with mezigdomide or pomalidomide.

Design outcomes

Primary

MeasureTime frame
Progression-Free Survival (PFS)

Secondary

MeasureTime frame
Overall Survival (OS),Overall Response (OR),Complete Response (CR) or better,Very Good Partial Response (VGPR) or better,Time to Response (TTR),Duration of Response (DOR),Time to Progression (TTP),Time to Next Treatment (TTNT),Progression-free Survival 2 (PFS-2),Minimal Residual Disease (MRD) negativity,Safety,Health Related Quality of Life (HRQoL) Evaluation

Countries

Argentina, Australia, Austria, Belgium, Brazil, Canada, China, Czech Republic, Finland, France, Germany, Greece, Ireland, Israel, Italy, Japan, Poland, Portugal, Republic of Korea, Romania, Spain, United Kingdom,, United States

Contacts

Public ContactMitsufumi Nishio

Bristol-Myers Squibb

MG-JP-RCO-JRCT@bms.com+81-120-093-507

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026