A Study Comparing Talquetamab Plus Pomalidomide, Talquetamab Plus Teclistamab, and Elotuzumab, Pomalidomide, and Dexamethasone or Pomalidomide, Bortezomib, and Dexamethasone in Participants With Relapsed or Refractory Myeloma Who Have Received an Anti-CD38 Antibody and Lenalidomide
Part of paid clinical trials in Clovis, California.
- Sponsor
- Janssen Research & Development, LLC
- Study ID
- NCT06208150
- Phase
- PHASE3
- Status
- Recruiting
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Talquetamab — DRUGTalquetamab will be administered as a SC injection.
- Pomalidomide — DRUGPomalidomide will be administered orally.
- Teclistamab — DRUGTeclistamab will be administered as a SC injection.
- Elotuzumab — DRUGElotuzumab will be administered intravenously.
- Dexamethasone — DRUGDexamethasone will be administered either orally or intravenously.
- Bortezomib — DRUGBortezomib will be administered as a SC injection.
Study Details
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).
Key Dates
- Start date
- Jan 22, 2024
- Status verified
- Jun 2026
- Primary completion
- Apr 1, 2026
- Completion
- Dec 31, 2028
Study Design
- Enrollment
- 795 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Arm A: Talquetamab + Pomalidomide (Tal-P)Participants will receive talquetamab as subcutaneous (SC) injections; pomalidomide will be self-administered as a single dose orally; dexamethasone may be given orally or intravenously as a pretreatment medication and study drug.
- Experimental: Arm B: Talquetamab + Teclistamab (Tal-Tec)Participants will receive teclistamab in combination with talquetamab both as SC injection; dexamethasone may be given orally or intravenously as a pretreatment medication and study drug.
- Active Comparator: Arm C: Elotuzumab+ Pomalidomide+Dexamethasone (EPd) or Pomalidomide+Bortezomib+Dexamethasone (PVd)Participants will either receive elotuzumab intravenous (IV) injection in combination with pomalidomide and dexamethasone orally; or pomalidamide orally in combination with bortezomib SC injection and dexamethasone orally as per investigator choice. Dexamethasone will be administered as a pretreatment medication.
Primary Outcome Measure
Progression Free Survival (PFS) [ Time Frame: Up to 3 years 5 months ]
Central Contacts
- Study Contact844-434-4210
Locations (49)
Related coverage on Hipa.ai
- Talquetamab Phase 3 Trial for Multiple Myeloma Reaches Primary CompletionTalquetamab · Apr 23, 2026 · ClinicalTrials.gov
- Talquetamab Phase 3 Trial for Relapsed/Refractory Myeloma Reaches Primary…Talquetamab · Apr 1, 2026 · ClinicalTrials.gov
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