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RECRUITING
NCT05695508
PHASE2

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

Sponsor: University of Heidelberg Medical Center

View on ClinicalTrials.gov

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

Interventions

DRUG

Teclistamab (Tec)

Subcutaneous administration of Teclistamab

DRUG

Daratumumab

Subcutaneous administration of Daratumumab

DRUG

Dexamethasone

administered i.v. or orally

DRUG

Lenalidomide

Administration oral

DRUG

Bortezomib

Subcutaneous administration

DRUG

Talquetamab

Subcutaneous administration of Daratumumab

DRUG

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