drugset / Trial / NCT05695508
GMMG-HD10 / DSMM-XX / 64007957MMY2003, MajesTEC-5
Phase 2
Recruiting
160 enrolled
University of Heidelberg Medical Center
Deutsche Studiengruppe Multiples Myelom (DSMM) · collabJanssen Research & Development, LLC · collab
Non-randomizedParallel-groupOpen-labelTreatment
Summary
A Phase 2 Study to Evaluate Safety and Efficacy of Teclistamab-, Talquetamab-, and JNJ-79635322-based Combination Regimens in Participants with Newly Diagnosed Transplant Eligible Multiple Myeloma OBJECTIVES: To evaluate the safety and tolerability of teclistamab-, talquetamab-, and JNJ-79635322-based combination regimens over the entire treatment phase for each arm, in participants with ND-TEMM To evaluate the efficacy of teclistamab- and talquetamab-based combination regimens as induction and post-transplant maintenance treatments; JNJ-79635322-based combinations as induction and as replacement for HDT+ASCT following induction; and teclistamab in combination with talquetamab
Timeline
- Start
- 2022-12-01
- Primary completion
- 2028-09-15
- Completion
- 2029-09-15
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bortezomib | Small molecule | — | Subcutaneous |
| Subject | JNJ-79635322 | Unknown | — | Subcutaneous |
| Subject | Lenalidomide | Other / unclassified | — | Oral |
| Subject | Talquetamab | Monoclonal antibody | — | Subcutaneous |
| Subject | Teclistamab | Monoclonal antibody | — | Subcutaneous |
| Background | Daratumumab | Monoclonal antibody | — | Subcutaneous |
| Background | Dexamethasone | Small molecule | — | Intravenous |