臨床研究等提出・公開システム

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

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) (CA057-001)

Nishio Mitsufumi

Bristol-Myers Squibb

1-2-1 Otemachi, Chiyoda-ku, Tokyo

mg-jp-clinical_trial@bms.com

Nishio Mitsufumi

Bristol-Myers Squibb

1-2-1 Otemachi, Chiyoda-ku, Tokyo

+81-120-093-507

MG-JP-RCO-JRCT@bms.com

Recruiting

Jan. 04, 2024

Interventional

randomized controlled trial

open(masking not used)

active control

parallel assignment

treatment purpose

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.

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.

Both

Relapsed or Refractory Multiple Myeloma (RRMM)

[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

Progression-Free Survival (PFS)

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

+81-95-847-1511

Nov. 16, 2023

Yes

Bristol Myers Squibb will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myers Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosurecommitment.html

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