GMMG-HD11/DSMM XXI/64007957MMY3010

Sponsor
University of Heidelberg Medical Center
Study ID
NCT07671287
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Teclistamab — DRUG
    TEC SC
  • Daratumumab — DRUG
    subcutaneous
  • Lenalidomide — DRUG
    oral administration
  • Bortezomib (B) — DRUG
    subcutaneous
  • dexamethsone — DRUG
    iv; po

Study Details

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.

Key Dates

First listed
Jun 26, 2026
Start date
Jun 30, 2026
Status verified
Jun 2026
Primary completion
Feb 14, 2031
Completion
Jan 30, 2033

Study Design

Enrollment
399 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Arm A DVRd induction (+ HDT ASCT), DVRd consolidation therapy followed by DR maintenance
    SoC treatment based on the PERSEUS regimen - control): DVRd induction therapy, HD melphalan + ASCT, DVRd consolidation therapy, followed by DR maintenance therapy. After the maintenance therapy, the participant will be treated according to SoC.
  • Experimental: Arm B - Tec-DRd induction ( incl. HDT ASCT) followed by DR maintenance therapy.
    Tec-DRd induction therapy, HD melphalan + ASCT, followed by DR maintenance therapy. Treatment stopped thereafter.
  • Experimental: Arm C - Tec-DRd induction (incl. HDT ASCT), followed by Tec-D then DR maintenance therapy
    Tec-DRd induction therapy, HD melphalan + ASCT, followed by Tec-D then DR maintenance therapy. Treatment stopped thereafter.

Primary Outcome Measure

To determine the efficacy (MRD negativity at a level of 10-6) of Tec-DRd compared to DVRd after induction/consolidation therapy and HD melphalan and ASCT, before start of maintenance therapy in participants with TE NDMM [ Time Frame: after 6 cycles (each cycle is 28 days) of induction/consolidation therapy and HD melphalan and ASCT (which occurs appr. 1 year after start of treatment), before start of maintenance therapy. ]

Central Contacts

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