Evaluating Mezigdomide with Carfilzomib and Dexamethasone for Multiple Myeloma
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
This study is testing if adding Mezigdomide to the standard treatment of Carfilzomib and Dexamethasone can help people with relapsed or refractory multiple myeloma feel better.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 525 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Bristol-Myers Squibb Industry-sponsored |
| Locations | 217 sites (Mobile, Alabama and 216 other locations) |
| Trial ID | NCT05552976 on ClinicalTrials.gov |
What this trial studies
This study aims to compare the effectiveness of Mezigdomide in combination with Carfilzomib and Dexamethasone against the standard treatment of Carfilzomib and Dexamethasone in patients with relapsed or refractory multiple myeloma. Participants must have measurable disease and a history of prior anti-myeloma therapy. The study is designed to assess the potential benefits of the new combination therapy in improving patient outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults with a documented diagnosis of multiple myeloma who have received at least one prior line of anti-myeloma therapy.
Not a fit: Patients who have not received prior treatment with lenalidomide or anti-CD38 monoclonal antibodies may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a more effective option for patients with relapsed or refractory multiple myeloma.
How similar studies have performed: Other studies have shown promise with similar combination therapies in treating multiple myeloma, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria - 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.
Where this trial is running
Mobile, Alabama and 216 other locations
- USA Mitchell Cancer Institute — Mobile, Alabama, United States (Recruiting)
- TOI Clinical Research — Cerritos, California, United States (Recruiting)
- Kaiser Permanente - Irvine — Irvine, California, United States (Recruiting)
- Los Angeles Hematology Oncology Medical Group — Los Angeles, California, United States (Recruiting)
- Sutter Santa Rosa — Santa Rosa, California, United States (Recruiting)
- Stockton Hematology Oncology Group — Stockton, California, United States (Recruiting)
- Local Institution - 0279 — Newark, Delaware, United States (Not_yet_recruiting)
- Florida Cancer Specialists - South — Fort Myers, Florida, United States (Recruiting)
- Florida Cancer Specialists - North — Saint Petersburg, Florida, United States (Recruiting)
- Florida Cancer Specialists - East — West Palm Beach, Florida, United States (Recruiting)
- Emory University School of Medicine- Grady Campus — Atlanta, Georgia, United States (Recruiting)
- Winship Cancer Institute, Emory University — Atlanta, Georgia, United States (Recruiting)
- Saint Alphonsus Regional Medical Center — Boise, Idaho, United States (Not_yet_recruiting)
- Anne Arundel Medical Center — Annapolis, Maryland, United States (Recruiting)
- Dana-Farber Cancer Institute — Boston, Massachusetts, United States (Recruiting)
- Minnesota Oncology Hematology, P.A. — Minneapolis, Minnesota, United States (Recruiting)
- Regional Cancer Care Associates — Little Silver, New Jersey, United States (Recruiting)
- Montefiore Medical Center — Bronx, New York, United States (Recruiting)
- University of North Carolina Medical Center — Chapel Hill, North Carolina, United States (Withdrawn)
- University Hospitals Cleveland Medical Center — Cleveland, Ohio, United States (Recruiting)
- Riverside Methodist Hospital — Columbus, Ohio, United States (Recruiting)
- Lifespan Cancer Institute — Providence, Rhode Island, United States (Recruiting)
- Charleston Oncology, P.A. — Charleston, South Carolina, United States (Withdrawn)
- Gibbs Cancer Center & Research Institute — Greer, South Carolina, United States (Recruiting)
- Tennessee Oncology Chattanooga — Chattanooga, Tennessee, United States (Recruiting)
- Tennessee Oncology — Nashville, Tennessee, United States (Recruiting)
- John Peter Smith Hospital — Fort Worth, Texas, United States (Recruiting)
- Kelsey-Seybold Clinic — Houston, Texas, United States (Recruiting)
- Houston Methodist Hospital — Houston, Texas, United States (Recruiting)
- Local Institution - 0195 — Temple, Texas, United States (Completed)
- Virginia Oncology Associates — Norfolk, Virginia, United States (Recruiting)
- Blue Ridge Cancer Care — Roanoke, Virginia, United States (Recruiting)
- Northwest Medical Specialties PLLC — Tacoma, Washington, United States (Recruiting)
- Northwest Cancer Specialists, P.C. — Vancouver, Washington, United States (Recruiting)
- WVU Cancer Institute — Morgantown, West Virginia, United States (Recruiting)
- Marshfield Medical Center - Marshfield — Marshfield, Wisconsin, United States (Recruiting)
- Instituto Alexander Fleming — Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina (Recruiting)
- Hospital Italiano de Buenos Aires — Abb, Ciudad Autónoma De Buenos Aires, Argentina (Recruiting)
- Fundacion Estudios Clinicos — Rosario, Santa Fe, Argentina (Recruiting)
- C.I.C.E. 9 de Julio — San Miguel de Tucumán, Tucumán, Argentina (Recruiting)
- Centro de Educación Médica e Investigaciones clínicas "Dr. Norberto Quirno" (CEMIC) — Buenos Aires, Argentina (Recruiting)
- Sanatorio Allende - Nueva Córdoba — Córdoba, Argentina (Recruiting)
- Royal Prince Alfred Hospital — Camperdown, New South Wales, Australia (Recruiting)
- Gosford Hospital — Gosford, New South Wales, Australia (Recruiting)
- Port Macquarie - Mid North Coast Cancer Institute — Port Macquarie, New South Wales, Australia (Recruiting)
- Royal North Shore Hospital — St Leonards, New South Wales, Australia (Recruiting)
- St Vincent's Hospital — Sydney, New South Wales, Australia (Recruiting)
- Royal Adelaide Hospital — Adelaide, South Australia, Australia (Recruiting)
- Local Institution - 0229 — Hobart, Tasmania, Australia (Withdrawn)
- Bendigo Health Care Group — Bendigo, Victoria, Australia (Recruiting)
+167 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.