Comparing two treatment combinations for relapsed or refractory multiple myeloma
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
PHASE3 · Celgene · NCT05519085
This study is testing whether a new combination of mezigdomide, bortezomib, and dexamethasone works better than another combination for people with relapsed or refractory multiple myeloma who have already tried some treatments.
Quick facts
| Phase | PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 810 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Celgene (industry) |
| Locations | 266 sites (Los Alamitos, California and 265 other locations) |
| Trial ID | NCT05519085 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness and safety of mezigdomide combined with bortezomib and dexamethasone (MeziVd) against a different combination of pomalidomide, bortezomib, and dexamethasone (PVd) in patients with relapsed or refractory multiple myeloma. Participants must have received 1 to 3 prior lines of therapy and have had previous exposure to lenalidomide. The study aims to determine which treatment combination provides better outcomes for patients with measurable disease.
Who should consider this trial
Good fit: Ideal candidates are adults with a documented diagnosis of multiple myeloma who have measurable disease and have received 1 to 3 prior lines of therapy.
Not a fit: Patients who have progressed during treatment with a proteasome inhibitor within the last 60 days may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more effective treatment options for patients with relapsed or refractory multiple myeloma.
How similar studies have performed: Other studies have shown promising results with similar treatment combinations in multiple myeloma, indicating potential for success.
Eligibility criteria
Show full inclusion / 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.
Where this trial is running
Los Alamitos, California and 265 other locations
- Local Institution - 0366 — Los Alamitos, California, United States (ACTIVE_NOT_RECRUITING)
- Local Institution - 0272 — San Diego, California, United States (COMPLETED)
- Local Institution - 0273 — West Hollywood, California, United States (COMPLETED)
- Local Institution - 0381 — Aurora, Colorado, United States (NOT_YET_RECRUITING)
- Local Institution - 0380 — Farmington, Connecticut, United States (ACTIVE_NOT_RECRUITING)
- Local Institution - 0208 — New Haven, Connecticut, United States (WITHDRAWN)
- Local Institution - 0303 — Coral Springs, Florida, United States (ACTIVE_NOT_RECRUITING)
- Local Institution - 0403 — Fort Myers, Florida, United States (ACTIVE_NOT_RECRUITING)
- Local Institution - 0401 — St. Petersburg, Florida, United States (ACTIVE_NOT_RECRUITING)
- Local Institution - 0402 — West Palm Beach, Florida, United States (ACTIVE_NOT_RECRUITING)
- Local Institution - 0211 — Athens, Georgia, United States (ACTIVE_NOT_RECRUITING)
- Local Institution - 0048 — Marietta, Georgia, United States (WITHDRAWN)
- Local Institution - 0330 — Garden City, Kansas, United States (COMPLETED)
- Local Institution - 0080 — Westwood, Kansas, United States (ACTIVE_NOT_RECRUITING)
- Local Institution - 0358 — Baton Rouge, Louisiana, United States (ACTIVE_NOT_RECRUITING)
- Local Institution - 0255 — New Orleans, Louisiana, United States (ACTIVE_NOT_RECRUITING)
- Local Institution - 0385 — Shreveport, Louisiana, United States (NOT_YET_RECRUITING)
- Local Institution - 0357 — Baltimore, Maryland, United States (ACTIVE_NOT_RECRUITING)
- Local Institution - 0246 — Boston, Massachusetts, United States (ACTIVE_NOT_RECRUITING)
- Local Institution - 0271 — Ann Arbor, Michigan, United States (ACTIVE_NOT_RECRUITING)
- Local Institution - 0364 — Detroit, Michigan, United States (ACTIVE_NOT_RECRUITING)
- Local Institution - 0410 — Minneapolis, Minnesota, United States (ACTIVE_NOT_RECRUITING)
- Local Institution - 0088 — Hattiesburg, Mississippi, United States (ACTIVE_NOT_RECRUITING)
- Local Institution - 0242 — Jackson, Mississippi, United States (WITHDRAWN)
- Local Institution - 0288 — East Brunswick, New Jersey, United States (ACTIVE_NOT_RECRUITING)
- Local Institution - 0363 — Ridgewood, New Jersey, United States (NOT_YET_RECRUITING)
- Local Institution - 0302 — Albuquerque, New Mexico, United States (ACTIVE_NOT_RECRUITING)
- Local Institution - 0245 — Buffalo, New York, United States (WITHDRAWN)
- Local Institution - 0257 — Lake Success, New York, United States (ACTIVE_NOT_RECRUITING)
- Local Institution - 0373 — New Hyde Park, New York, United States (COMPLETED)
- Local Institution - 0371 — New York, New York, United States (COMPLETED)
- Local Institution - 0108 — Rochester, New York, United States (ACTIVE_NOT_RECRUITING)
- Local Institution - 0374 — Shirley, New York, United States (ACTIVE_NOT_RECRUITING)
- Local Institution - 0372 — The Bronx, New York, United States (COMPLETED)
- Local Institution - 0274 — Williamsville, New York, United States (WITHDRAWN)
- Local Institution - 0260 — Durham, North Carolina, United States (ACTIVE_NOT_RECRUITING)
- Local Institution - 0400 — Cincinnati, Ohio, United States (ACTIVE_NOT_RECRUITING)
- Local Institution - 0377 — Cleveland, Ohio, United States (ACTIVE_NOT_RECRUITING)
- Local Institution - 0076 — Cleveland, Ohio, United States (ACTIVE_NOT_RECRUITING)
- Local Institution - 0376 — Mayfield Heights, Ohio, United States (ACTIVE_NOT_RECRUITING)
- Local Institution - 0359 — Allentown, Pennsylvania, United States (COMPLETED)
- Local Institution - 0264 — York, Pennsylvania, United States (COMPLETED)
- Local Institution - 0223 — Germantown, Tennessee, United States (ACTIVE_NOT_RECRUITING)
- Local Institution - 0378 — Abilene, Texas, United States (ACTIVE_NOT_RECRUITING)
- Local Institution - 0275 — Houston, Texas, United States (ACTIVE_NOT_RECRUITING)
- Local Institution - 0267 — San Antonio, Texas, United States (ACTIVE_NOT_RECRUITING)
- Local Institution - 0409 — San Antonio, Texas, United States (ACTIVE_NOT_RECRUITING)
- Local Institution - 0207 — Salt Lake City, Utah, United States (ACTIVE_NOT_RECRUITING)
- Local Institution - 0297 — Fredericksburg, Virginia, United States (ACTIVE_NOT_RECRUITING)
- Local Institution - 0408 — Norfolk, Virginia, United States (ACTIVE_NOT_RECRUITING)
+216 more sites — see ClinicalTrials.gov for the full list.
Study contacts
- Study coordinator: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
- Email: Clinical.Trials@bms.com
- Phone: 855-907-3286
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Relapsed or Refractory Multiple Myeloma, Multiple myeloma, RRMM, MeziVd, PVd, CC92480, pomalidomide, bortezomib