A 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)

Celgene

Status and phase: Enrolling; Phase 3

Conditions: Relapsed or Refractory Multiple Myeloma

Treatments: Drug: Pomalidomide; Drug: mezigdomide; Drug: Dexamethasone; Drug: Bortezomib

Study type: Interventional

Funder types: Industry

Identifiers

NCT05519085

2023-509859-13 (Other Identifier)

CA057-001

Details and patient eligibility

About

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.

Enrollment: 810 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion 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 frequently) are not excluded.

ii) Participants who progressed while being treated with ixazomib monotherapy maintenance ≥ 6 months prior to the time of starting study treatment 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

810 participants in 2 patient groups

MeziVd (mezigdomide, bortezomib and dexamethasone)

Experimental group

Treatment:

Drug: Bortezomib

Drug: Dexamethasone

Drug: mezigdomide

PVd (pomalidomide, bortezomib and dexamethasone)

Experimental group

Treatment:

Drug: Bortezomib

Drug: Dexamethasone

Drug: Pomalidomide