Full Title:

A Phase 3, Two-stage, Randomized, Multicenter, Open-label Study Comparing Mezigdomide (CC-92480/BMS-986348), Carfilzomib, and Dexamethasone (MeziKD) Versus Carfilzomib and Dexamethasone (Kd) in Participants With Relapsed or Refractory Multiple Myeloma (RRMM): SUCCESSOR-2

Myeloma stage or condition:

Relapsed or Refractory Multiple Myeloma

Study phase:

Phase 3

Summary/Purpose:

The purpose of the study is to compare Mezigdomide (CC-92480/BMS-986348) with carfilzomib and dexamethasone (MeziKD) against carfilzomib and dexamethasone (Kd) in the treatment of RRMM: SUCCESSOR-2.

Detailed Description:

Not available

Treatments:

Drug : Mezigdomide

Specified dose on specified days

Drug : Carfilzomib

Specified dose on specified days

Drug : Dexamethasone

Specified dose on specified days

Study Arms:

Experimental : MeziKd (Mezigdomide + Carfilzomib + Dexamethasone)

Active Comparator : Kd (Carfilzomib + Dexamethasone)

Study Type:

Interventional

Study Design:

Allocation: Randomized

Intervention Model: Parallel Assignment

Intervention Model Description: This is a two-stage inferentially seamless design.

Primary Purpose: Treatment

Masking: None (Open Label)

Masking Description: This is an open-label study; however, any review of aggregate study data by the Sponsor will be performed in a blinded manner.

Recruitment status:

Recruiting

Eligibility criteria:

sion Criteria

Participant has documented diagnosis of multiple myeloma and measurable disease, defined as any of the following:. i) Myeloma-protein (M-protein) ≥ 0.5 grams/deciliter (g/dL) by serum protein electrophoresis (sPEP), or. ii) M-protein ≥ 200 milligrams (mg)/24-hour urine collection by urine protein electrophoresis (uPEP) or,. iii) For participants without measurable disease in sPEP or uPEP: serum free light chain levels > 100 mg/liter (L) (10 mg/dL) involved light chain and an abnormal κ/λ free light chain ratio.

Participant has received at least one prior line of anti-myeloma therapy. Note: One line can contain several phases (e.g., induction, [with or without] hematopoietic stem cell transplant, (with or without) consolidation, and/or [with or without] maintenance therapy).

Participant must have received prior treatment with lenalidomide and at least 2 cycles of an anti-CD38 monoclonal antibody (mAb) (participants who were intolerant of an anti-CD38 mAb and received < 2 cycles are still eligible).

Participant achieved minimal response or better to at least 1 prior anti-myeloma therapy.

Participant must have documented disease progression during or after their last antimyeloma regimen. Exclusion Criteria

Participant who has had prior treatment with mezigdomide or carfilzomib.

Participant has previously received allogeneic stem cell transplant at any time or received autologous stem cell transplant within 12 weeks of initiating study treatment.

Other protocol-defined Inclusion/Exclusion criteria apply.

Locations / Centres:

QEII Health Sciences Centre - Victoria General Site, Halifax, Nova Scotia – Recruiting

Victoria Hospital & Children's Hospital - London Health Sciences Centre, London, Ontario – Recruiting

Princess Margaret Cancer Centre, Toronto, Ontario – Recruiting

Local Institution - 0186, Montreal, Quebec – Withdrawn

Contacts:

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

Publications:

???

First posted:

2022-09-23

Actual start date:

January 10, 2023

Last updated:

2024-05-01

Estimated enrollment:

525

Estimated completion date:

2029-07-25

Estimated primary completion date:

2026-02-04

Condition:

Relapsed or Refractory Multiple Myeloma

Gender:

All

Ages:

18 Years-N/A

Accepts healthy volunteers:

No

Listed location countries:

Argentina

Australia

Austria

Brazil

Bulgaria

Canada

China

Colombia

Denmark

Germany

Greece

Hong Kong

Hungary

India

Israel

Italy

Japan

Korea, Republic of

Netherlands

Norway

Puerto Rico

Romania

Singapore

Spain

Taiwan

United Kingdom

United States

NCT number:

NCT05552976

Other study ID numbers:

CA057-008

Has Data monitoring committee:

Yes

U.S. FDA-regulated product:

Yes

IPD Sharing Statement :

???

Responsible party:

Sponsor

Study sponsor:

lead_sponsor
Bristol-Myers Squibb
Industry

Collaborators:

???

Investigators:

Bristol-Myers Squibb Bristol-Myers Squibb

Protocol Registration and Results System:

???

Verification date:

2024-05-01