ClinicalTrials.Veeva

Menu
The trial is taking place at:
H

Hospital Costa del Sol | Internal Medicine

Veeva-enabled site

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 logo

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
2021-001957-30 (EudraCT Number)
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 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

Trial contacts and locations

229

Loading...

Central trial contact

First line of the email MUST contain the NCT# and Site #.; BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems