A Phase 3 Randomized Study Comparing Talquetamab in Combination With Pomalidomide (Tal-P), Talquetamab in Combination With Teclistamab (Tal-Tec), and Investigator's Choice of Either Elotuzumab, Pomalidomide, and Dexamethasone (EPd) or Pomalidomide, Bortezomib, and Dexamethasone (PVd) in Participants With Relapsed or Refractory Myeloma Who Have Received 1 to 4 Prior Lines of Therapy Including an Anti-CD38 Antibody and Lenalidomide
Janssen Research & Development, LLC
Summary
The purpose of this study is to compare the effectiveness of either talquetamab plus pomalidomide (Tal-P) or talquetamab plus teclistamab (Tal-Tec) with elotuzumab, pomalidomide, and dexamethasone (EPd) or pomalidomide, bortezomib, and dexamethasone (PVd).
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Documented multiple myeloma as defined by the criteria below: (a) multiple myeloma diagnosis according to the international myeloma working group (IMWG) diagnostic criteria (b) measurable disease at screening as assessed by central laboratory, defined by any of the following: (i) serum M-protein level greater than or equal to (\>=) 0.5 gram per deciliter (g/dL); or (ii) urine M-protein level \>= 200 milligram (mg) per 24 hours; or (iii) light chain multiple myeloma without measurable M-protein in the serum or the urine: serum immunoglobulin (Ig) free light chain (FLC) \>…
Interventions
- DrugTalquetamab
Talquetamab will be administered as a SC injection.
- DrugPomalidomide
Pomalidomide will be administered orally.
- DrugTeclistamab
Teclistamab will be administered as a SC injection.
- DrugElotuzumab
Elotuzumab will be administered intravenously.
- DrugDexamethasone
Dexamethasone will be administered either orally or intravenously.
- DrugBortezomib
Bortezomib will be administered as a SC injection.
Locations (242)
- UCSF FresnoClovis, California
- UCLASanta Monica, California
- Yale University School Of MedicineNew Haven, Connecticut
- Medical Oncology Hematology Consultants, PANewark, Delaware
- Memorial Healthcare SystemHollywood, Florida
- Moffitt Cancer CenterTampa, Florida