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

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

Primary Purpose: Treatment

Masking: None

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:

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

Publications:

???

First posted:

Not available

Actual start date:

2023-01-10

Last updated:

2024-07-24

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-

Accepts healthy volunteers:

Not available

Listed location countries:

Not available

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:

2024-07-01