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GMMG-HD10 / DSMM-XX / 64007957MMY2003, MajesTEC-5
Sponsor: University of Heidelberg Medical Center
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
Official title: 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
Key Details
Gender
All
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
160
Start Date
2022-12-01
Completion Date
2029-09-15
Last Updated
2025-12-24
Healthy Volunteers
No
Conditions
Interventions
Teclistamab (Tec)
Subcutaneous administration of Teclistamab
Daratumumab
Subcutaneous administration of Daratumumab
Dexamethasone
administered i.v. or orally
Lenalidomide
Administration oral
Bortezomib
Subcutaneous administration
Talquetamab
Subcutaneous administration of Daratumumab
JNJ-79635322
Subcutaneous administration
Locations (11)
Charité University Medicin Berlin
Berlin, Germany
Clinic Chemnitz gGmbH
Chemnitz, Germany
University Clinic Technical University Dresden
Dresden, Germany
University Clinic Düsseldorf
Düsseldorf, Germany
University Clinic Freiburg
Freiburg im Breisgau, Germany
Hamburg University Clinic Eppendorf
Hamburg, Germany
Asklepios Clinic Hamburg Altona
Hamburg, Germany
University Hospital Heidelberg
Heidelberg, Germany
University Clinic Schleswig-Holstein Campus Kiel
Kiel, Germany
Technical University Munich
Munich, Germany
University Würzburg
Würzburg, Germany