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 Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

Recruitment status:

Recruiting

Eligibility criteria:

sion Criteria

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 Study Connect Contact Center www.BMSStudyConnect.com
Phone: 855-907-3286
Email: [email protected]

Publications:

???

First posted:

2022-08-29

Actual start date:

September 20, 2022

Last updated:

2024-05-16

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-N/A

Accepts healthy volunteers:

No

Listed location countries:

Argentina

Australia

Austria

Belgium

Brazil

Canada

Chile

China

Czechia

Finland

France

Germany

Greece

India

Ireland

Israel

Italy

Japan

Korea, Republic of

New Zealand

Poland

Portugal

Puerto Rico

Romania

Spain

Turkey

United Kingdom

United States

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:

2024-05-01