RecruitingPhase 2NCT05695508

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

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

Sponsor

University of Heidelberg Medical Center

Enrollment

160 participants

Start Date

Dec 1, 2022

Study Type

INTERVENTIONAL

Conditions

Multiple Myeloma

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

Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study (MajesTEC-5) tests a new combination of drugs including teclistamab — a bispecific antibody that targets myeloma cells — in patients with newly diagnosed multiple myeloma (a type of blood cancer affecting plasma cells). It compares different treatment combinations to find the best approach. **You may be eligible if...** - You are between 18 and 70 years old - You have been newly diagnosed with multiple myeloma - You have measurable disease in blood or urine markers, or abnormal free light chains - You are in reasonable health (ECOG performance status 0–2) **You may NOT be eligible if...** - You have previously received treatment for multiple myeloma - You have serious heart, liver, or kidney conditions - You have had a prior stem cell transplant (in certain study arms) - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTeclistamab (Tec)

Subcutaneous administration of Teclistamab

DRUGDaratumumab

Subcutaneous administration of Daratumumab

DRUGDexamethasone

administered i.v. or orally

DRUGLenalidomide

Administration oral

DRUGBortezomib

Subcutaneous administration

DRUGTalquetamab

Subcutaneous administration of Daratumumab

DRUGJNJ-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

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NCT05695508

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