Full Title:

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

Myeloma stage or condition:

Relapsed or Refractory Multiple Myeloma

Study phase:

Phase 3

Summary/Purpose:

The purpose of this study is to compare the efficacy and safety of mezigdomide (CC-92480), bortezomib and dexamethasone (MeziVd) versus pomalidomide, bortezomib and dexamethasone (PVd) in participants with relapsed or refractory multiple myeloma (RRMM) who received between 1 to 3 prior lines of therapy and who have had prior lenalidomide exposure.

Detailed Description:

Not available

Treatments:

Drug : mezigdomide

Specified dose on specified days

Drug : Pomalidomide

Specified dose on specified days

Drug : Bortezomib

Specified dose on specified days

Drug : Dexamethasone

Specified dose on specified days

Study Arms:

Experimental : MeziVd (mezigdomide, bortezomib and dexamethasone)

Experimental : PVd (pomalidomide, bortezomib and dexamethasone)

Study Type:

Interventional

Study Design:

Allocation: Randomized

Intervention Model: Parallel

Primary Purpose: Treatment

Masking: None

Recruitment status:

Recruiting

Eligibility criteria:

eria - Participant has documented diagnosis of MM and measurable disease, defined as any of the following:. i) M-protein ≥ 0.5 grams per deciliter (g/dL) by serum protein electrophoresis (sPEP) or. ii) M-protein ≥ 200 milligrams (mg) per 24-hour urine collection by urine protein electrophoresis (uPEP). iii) 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. * Participants received 1 to 3 prior lines of antimyeloma therapy. * Participants achieved minimal response [MR] or better to at least 1 prior antimyeloma therapy. Exclusion Criteria * Participant has had progression during treatment or within 60 days of the last dose of a proteasome inhibitor, except as noted below:. i) 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. * 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. * Participant has had prior treatment with mezigdomide or pomalidomide. * Other protocol-defined Inclusion/Exclusion criteria apply.

Locations / Centres:

Centre Intégré de Santé et de Services Sociaux de la Montérégie-Centre, Greenfield Park, Quebec – Recruiting

Centre intégré universitaire de santé et de services sociaux du Nord-de-l'Île-de-Montréal (CIUSSS NÎM) - Hôpital du Sacré-Coeur, Montreal, Quebec – Recruiting

Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus, Quebec City, Quebec – Recruiting

Contacts:

Name: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
Phone: 855-907-3286
Email: [email protected]

Publications:

???

First posted:

Not available

Actual start date:

2022-09-20

Last updated:

2024-07-24

Estimated enrollment:

810

Estimated completion date:

2033-11-30

Estimated primary completion date:

2025-11-03

Condition:

Relapsed or Refractory Multiple Myeloma

Gender:

All

Ages:

18 Years-

Accepts healthy volunteers:

Not available

Listed location countries:

Not available

NCT number:

NCT05519085

Other study ID numbers:

CA057-001

Has Data monitoring committee:

Yes

U.S. FDA-regulated product:

Yes

IPD Sharing Statement :

???

Responsible party:

Sponsor

Study sponsor:

lead_sponsor
Celgene
Industry

Collaborators:

???

Investigators:

Bristol-Myers Squibb Bristol-Myers Squibb

Protocol Registration and Results System:

???

Verification date:

2024-07-01