Minimal Residual Disease-based Strategy With T-Cell Redirector After Treatment With Daratumumab, Bortezomib, Lenalidomide, and Dexamethasone (D-VRd) in Newly Diagnosed Multiple Myeloma

Sponsor
Nantes University Hospital
Study ID
NCT06353022
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Teclistamab — DRUG
    Maintenance therapy wtih teclistamab (administered via SC injections) for finite duration. Teclistamab will be used in 28 day cycles following initial step up doses
  • Talquetamab — DRUG
    Maintenance therapy with talquetamab (administered via SC injections) for finite duration. Talquetamab will be used in 28 day cycles following initial step up doses
  • Lenalidomide — DRUG
    Induction therapy with lenalidomide: Lenalidomide 25 mg/day oral from Day 1 to Day 21. Maintenance therapy lenalidomide (administered orally) for finite duration.
  • Bortezomib — DRUG
    Induction therapy with Borthezomib Cycle 1 to 6: Bortezomib 1.3 mg/m² SC twice a week on Days 1, 4, 8 and 11
  • Daratumumab — DRUG
    Induction therapy with Daratumumab Cycle 1 to 6 Daratumumab 1800 mg SC on Days 1, 8, 15, 22 of Cycle 1 and Cycle 2 and on Days 1 and 15 of Cycle 3
  • Dexamethasone — DRUG
    Induction therapy with Dexamethasone: cycle 1 to 3 Dexamethasone 40 mg/day oral or IV on Days 1, 8, 15, 22 Cycle 4 to 6 --\> Dexamethasone 40 mg/day oral or IV on Days 1, 8, 15, 22

Study Details

This is a Phase 2 study, open-label, 2-cohort, multicenter, national, interventional in patients with newly diagnosed multiple myeloma. The study will investigate teclistamab (Tec) in combination with lenalidomide (Len) (Tec-Len; Cohort A) or in combination with talquetamab (Tal) (Tec-Tal; Cohort B), allocated based on minimal residual disease (MRD) status (MRD \[-\] \[standard-risk\] vs MRD \[+\] \[high-risk\] respectively). The patient population will consist of adults men and women at least 18 years to younger than 66 years of age, who meet eligibility criteria.

Key Dates

Start date
Jun 26, 2024
Status verified
Mar 2026
Primary completion
Apr 26, 2028
Completion
Jun 26, 2030

Study Design

Enrollment
103 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Teclistamab and Lenalidomide
    Patients treated with Teclistamab and Lenalidomide for finite duration.
  • Experimental: Talquetamab andTeclistamab
    Patients treated with Teclistamab and Talquetamab for finite duration

Primary Outcome Measure

Rate of sustained MRD negativity (NGS, 10^-5) [ Time Frame: 38 months ]

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