drugset / Trial / NCT05695508

GMMG-HD10 / DSMM-XX / 64007957MMY2003, MajesTEC-5

NCT05695508

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

EvaluationDrugModalityDoseRoute
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

Indications