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)

JRCT ID: jRCT2071230097

Registered date:04/12/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Relapsed or Refractory Multiple Myeloma (RRMM)
• Date of first enrollment: 13/02/2024
• Target sample size: 48
• Countries of recruitment: Ireland,Japan,United States,Japan,Argentina,Japan,United Kingdom,,Japan,Israel,Japan,Italy,Japan,Australia,Japan,Austria,Japan,Canada,Japan,Republic of Korea,Japan,Greece,Japan,Spain,Japan,China,Japan,Czech Republic,Japan,Germany,Japan,Finland,Japan,France,Japan,Belgium,Japan,Poland,Japan,Portugal,Japan,Brazil,Japan,Romania,Japan
• Study type: Interventional

Intervention(s)

[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: Pomalidomide/Bortezomib/Dexamethasone
Specified dose on specified days

Outcome(s)

• Primary Outcome: Progression-Free Survival (PFS)

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Nishio Mitsufumi
• Secondary ID(s): NCT05519085