Bispecific T-cell Redirectors as Part of First Line Treatment in Transplant Eligible Multiple Myeloma Patients

Sponsor
North Estonia Medical Centre
Study ID
NCT06505369
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

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

Interventions

  • Daratumumab — DRUG
    Daratumumab will be administered by SC injection
  • Bortezomib — DRUG
    Bortezomib will be administered by SC injection
  • Lenalidomide — DRUG
    Lenalidomide will be administered by oral route
  • Dexamethasone — DRUG
    Dexamethasone will be administered by oral route
  • Talquetamab — DRUG
    Talquetamab will be administered by SC injection
  • Teclistamab — DRUG
    Teclistamab will be administered by SC injection

Study Details

This is Phase 2, open-label, multicentre, non-randomised study evaluating participants with newly diagnosed MM eligible for high-dose therapy. The goal of the study is to determine if consolidation with T-cell redirectors - Talquetamab and Teclistamab in sequence will improve the response depth: increase MRD negative CR rate.

Key Dates

Start date
Jun 19, 2024
Status verified
Jul 2024
Primary completion
Nov 30, 2026
Completion
Oct 31, 2028

Study Design

Enrollment
50 participants (estimated)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Induction with Dara -VRd + Consolidation with Talquetamab and Teclistamab as monotherapy in sequence
    Induction with Daratumumab-VRd; Consolidation part I with Talquetamab; Consolidation part II with Teclistamab.

Primary Outcome Measure

Evaluate efficacy in terms of Minimal Residual Disease (MRD) negative Complete Remission rate by next generation sequencing ( NGS) after completing consolidation with talquetamab and teclistamab. [ Time Frame: 18 months approximately ]

Central Contacts

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