A trial to determine the safety and effectiveness of CC-92480 in combination with bortezomib and dexamethasone as compared to pomalidomide in combination with bortezomib and dexamethasone in people who have Multiple Myeloma that is not responsive after treatment or has returned after a period of treatment.
Key facts
- Where
- Aachen, Bamberg, Bonn, Dresden, Duesseldorf, Hamburg, Hannover, Kiel, Marburg, Munich, Traunstein, Tuebingen, Weiden I.D.Opf. és Wuerzburg, NémetországSee the 15 sites
- Phase
- 3. fázis
Where in Németország
- Universitaetsklinikum Aachen AöRAachen, NémetországTaking people
- Sozialstiftung BambergBamberg, NémetországTaking people
- Universitaetsklinikum Bonn AöRBonn, NémetországTaking people
- Gemeinschaftspraxis Haematologie OnkologieDresden, NémetországTaking people
- Marien Hospital Duesseldorf GmbHDuesseldorf, NémetországTaking people
- Asklepios Kliniken Hamburg GmbHHamburg, NémetországTaking people
- University Medical Center Hamburg-EppendorfHamburg, NémetországTaking people
- Praxis Onkologie am Raschplatz HannoverHannover, NémetországTaking people
- Universitaetsklinikum Schleswig-Holstein AöRKiel, NémetországTaking people
- Philipps-Universitaet MarburgMarburg, NémetországTaking people
- Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)Munich, NémetországTaking people
- Kliniken Suedostbayern AGTraunstein, NémetországTaking people
- Universitaetsklinikum Tuebingen AöRTuebingen, NémetországTaking people
- MVZ Nordoberpfalz GmbHWeiden I.D.Opf., NémetországTaking people
- Haematologisch Onkologische SchwerpunktpraxisWuerzburg, NémetországTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Celgene Corp.
- Trial code
- EU 2023-509859-13-00
- Record updated
- 2026. szeptember 9.
- Original description
To compare the progression-free survival (PFS) of mezigdomide, bortezomib and dexamethasone (MeziVd) to that of pomalidomide, bortezomib and dexamethasone (PVd) in subjects with relapsed or refractory multiple myeloma (RRMM)Read full original descriptionShow less
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
To compare the progression-free survival (PFS) of mezigdomide, bortezomib and dexamethasone (MeziVd) to that of pomalidomide, bortezomib and dexamethasone (PVd) in subjects with relapsed or refractory multiple myeloma (RRMM)
Inclusion: Subject has documented diagnosis of MM and measurable disease, defined as: —M-protein ≥ 0.5 g/dL by serum protein electrophoresis (sPEP), or ≥ 200 mg/24-hour urine collection by urine protein electrophoresis (uPEP) or —For subjects 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; Subject has received 1 to 3 prior anti-myeloma lines of therapy; Subject must have received prior treatment with a lenalidomide containing regimen. For country-specific requirements, see APPENDIX I; Subject achieved a minimal response [MR] or better to at least 1 prior antimyeloma therapy; Subject must have documented disease progression during or after their last antimyeloma regimen; Subject has an Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1 or 2.
Exclusion: Subject has had prior treatment with mezigdomide or pomalidomide; Subject has had progression during treatment or within 60 days of the last dose of a proteasome inhibitor, except as noted below: a. 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.