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GMMG-HD11/DSMM XXI/64007957MMY3010

NCT07671287 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 399

Last updated 2026-06-26

No results posted yet for this study

Summary

This is an open-label, randomized interventional multicenter Phase 3 clinical trial to investigate the efficacy and safety of Tec-DRd induction therapy and fixed-duration Tec-D maintenance post ASCT in adult participants with TE NDMM, compared with the SoC PERSEUS regimen.

A total of 399 participants with TE NDMM aged ≥18 and ≤70 years and an Eastern CooperativeOncology Group (ECOG) status 0-2 will be included.

The primary objective of the clinical trial:

To determine the efficacy of Tec-DRd compared to DVRd after 6 cycles of induction/consolidation therapy and HD melphalan and ASCT, before start of maintenance therapy in participants with TE NDMM.

Endpoint: Cumulative MRD negativity by NGS at a sensitivity level of 10-6 before start of maintenance therapy.

Conditions

Interventions

DRUG

Teclistamab

TEC SC

DRUG

Daratumumab

subcutaneous

DRUG

Lenalidomide

oral administration

DRUG

Bortezomib (B)

subcutaneous

DRUG

dexamethsone

iv; po

Sponsors & Collaborators

  • University of Heidelberg Medical Center

    lead OTHER

Principal Investigators

  • Marc S Raab, Prof. Dr. med · University Hospital Heidelberg

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2026-06-30
Primary Completion
2031-02-14
Completion
2033-01-30

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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 NCT07671287 on ClinicalTrials.gov