RecruitingInterventionalPhase 3

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

NCT ID: NCT05519085Sponsor: CelgeneLast updated: 2026-06-10

Summary

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.

Arms & interventions

Drugmezigdomide
Specified dose on specified days
DrugPomalidomide
Specified dose on specified days
DrugBortezomib
Specified dose on specified days
DrugDexamethasone
Specified dose on specified days

Outcome measures

Primary

Progression-free Survival (PFS)
Time frame: From date of randomization to date of disease progression or death due to any cause (Up to approximately 5 years)

Secondary

Recommended mezigdomide dose
Time frame: Up to 12 Months
Plasma concentrations of mezigdomide
Time frame: Up to 134 Days
Overall Survival (OS)
Time frame: From date of randomization to date of death due to any cause (Up to approximately 5 years)
Overall Response (OR)
Time frame: Up to approximately 5 years
Complete Response (CR) or better
Time frame: Up to approximately 5 Years
Very Good Partial Response (VGPR) or better
Time frame: Up to approximately 5 years
Time to Response (TTR)
Time frame: Up to approximately 5 years
Duration of Response (DOR)
Time frame: Up to approximately 5 years
Time to Progression (TTP)
Time frame: Up to approximately 5 years
Time to Next Treatment (TTNT)
Time frame: Up to approximately 5 years
Progression-free Survival 2 (PFS-2)
Time frame: Up to approximately 5 years
Minimal Residual Disease (MRD) negativity
Time frame: Up to approximately 5 years
Number of participants with Adverse Events (AEs)
Time frame: Up to approximately 5 years
Change from baseline in European Organization for Research and Treatment of Cancer - Quality of Life C30 questionnaire (EORTC QLQ-C30) scores
Time frame: Up to approximately 5 years
Change from baseline in European Organization for Research and Treatment of Cancer - Quality of Life Multiple Myeloma Module (EORTC QLQ-MY20) score
Time frame: Up to approximately 5 years

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No

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.

Study locations (56)

Local Institution - 0366

Los Alamitos, California, 90720

Active Not Recruiting

Local Institution - 0272

San Diego, California, 92123

Completed

Local Institution - 0273

West Hollywood, California, 90069

Completed

Local Institution - 0381

Aurora, Colorado, 80045

Not Yet Recruiting

Site 0381 · Contact

Local Institution - 0380

Farmington, Connecticut, 06030

Completed

Local Institution - 0208

New Haven, Connecticut, 06510

Withdrawn

Local Institution - 0303

Coral Springs, Florida, 33321

Active Not Recruiting

Local Institution - 0403

Fort Myers, Florida, 33901

Active Not Recruiting

Local Institution - 0401

St. Petersburg, Florida, 33701

Active Not Recruiting

Local Institution - 0402

West Palm Beach, Florida, 33401

Active Not Recruiting

Local Institution - 0211

Athens, Georgia, 30607

Active Not Recruiting

Local Institution - 0048

Marietta, Georgia, 30060

Withdrawn

Local Institution - 0330

Garden City, Kansas, 67846

Completed

Local Institution - 0080

Westwood, Kansas, 66205

Active Not Recruiting

Local Institution - 0358

Baton Rouge, Louisiana, 70808

Active Not Recruiting

Local Institution - 0255

New Orleans, Louisiana, 70112

Active Not Recruiting

Local Institution - 0385

Shreveport, Louisiana, 71103

Not Yet Recruiting

Site 0385 · Contact

Local Institution - 0357

Baltimore, Maryland, 21215

Completed

Local Institution - 0246

Boston, Massachusetts, 02215

Active Not Recruiting

Local Institution - 0271

Ann Arbor, Michigan, 48109

Active Not Recruiting

Local Institution - 0364

Detroit, Michigan, 48202

Active Not Recruiting

Local Institution - 0410

Minneapolis, Minnesota, 55404

Active Not Recruiting

Local Institution - 0088

Hattiesburg, Mississippi, 39401

Completed

Local Institution - 0242

Jackson, Mississippi, 39213

Withdrawn

Local Institution - 0288

East Brunswick, New Jersey, 08816

Active Not Recruiting

Local Institution - 0363

Ridgewood, New Jersey, 07450

Not Yet Recruiting

Site 0363 · Contact

Local Institution - 0302

Albuquerque, New Mexico, 87131

Active Not Recruiting

Local Institution - 0245

Buffalo, New York, 14215

Withdrawn

Local Institution - 0257

Lake Success, New York, 11042

Active Not Recruiting

Local Institution - 0373

New Hyde Park, New York, 11042

Completed

Local Institution - 0371

New York, New York, 10028

Completed

Local Institution - 0108

Rochester, New York, 14621

Active Not Recruiting

Local Institution - 0374

Shirley, New York, 11967

Active Not Recruiting

Local Institution - 0372

The Bronx, New York, 10469

Completed

Local Institution - 0274

Williamsville, New York, 14221

Withdrawn

Local Institution - 0260

Durham, North Carolina, 27710

Active Not Recruiting

Local Institution - 0400

Cincinnati, Ohio, 45242

Active Not Recruiting

Local Institution - 0377

Cleveland, Ohio, 44111

Active Not Recruiting

Local Institution - 0076

Cleveland, Ohio, 44195

Active Not Recruiting

Local Institution - 0376

Mayfield Heights, Ohio, 44124

Active Not Recruiting

Local Institution - 0359

Allentown, Pennsylvania, 18103

Completed

Local Institution - 0264

York, Pennsylvania, 17403

Completed

Local Institution - 0223

Germantown, Tennessee, 38138

Active Not Recruiting

Local Institution - 0378

Abilene, Texas, 79606

Active Not Recruiting

Local Institution - 0275

Houston, Texas, 77030

Active Not Recruiting

Local Institution - 0267

San Antonio, Texas, 78229

Active Not Recruiting

Local Institution - 0409

San Antonio, Texas, 78240

Active Not Recruiting

Local Institution - 0207

Salt Lake City, Utah, 84106

Active Not Recruiting

Local Institution - 0297

Fredericksburg, Virginia, 22408

Active Not Recruiting

Local Institution - 0408

Norfolk, Virginia, 23502

Active Not Recruiting

Local Institution - 0399

Roanoke, Virginia, 24014

Active Not Recruiting

Local Institution - 0268

Seattle, Washington, 98108

Active Not Recruiting

Local Institution - 0293

Seattle, Washington, 98109

Withdrawn

Local Institution - 0097

Spokane, Washington, 99208

Withdrawn

Local Institution - 0411

Vancouver, Washington, 98684

Active Not Recruiting

Local Institution - 0220

Madison, Wisconsin, 53792

Withdrawn