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

NCT05695508 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2025-12-24

No results posted yet for this study

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

Conditions

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

Sponsors & Collaborators

  • Janssen Research & Development, LLC

    collaborator INDUSTRY

  • Deutsche Studiengruppe Multiples Myelom (DSMM)

    collaborator UNKNOWN

  • University of Heidelberg Medical Center

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-01
Primary Completion
2028-09-15
Completion
2029-09-15

Countries

  • Germany

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05695508 on ClinicalTrials.gov