Study of Teclistamab in Combination in Elderly Patients With Multiple Myeloma

Sponsor
University Hospital, Lille
Study ID
NCT05572229
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
65 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Teclistamab — DRUG
    Teclistamab will be administered via a subcutaneous injection (SC)
  • Daratumumab — DRUG
    Daratumumab will be administered via a subcutaneous injection (SC)
  • Lenalidomide — DRUG
    Lenalidomide will be administered orally

Study Details

The primary hypothesis of this study is that teclistamab SC in combination with daratumumab SC or lenalidomide will be safe and induce a high rate of VGPR or better in newly diagnosed multiple myeloma patients This is an open-label, multicenter, non-comparative, 2-cohort, 2-stage with interruption of enrollment for an efficacy and safety interim analysis, interventional Phase 2 study evaluating the efficacy and safety of a combination with Tec-Dara (Cohort A) or Tec-Len (Cohort B) in patients with newly diagnosed multiple myeloma who are not eligible for SCT.

Key Dates

Start date
Dec 21, 2023
Status verified
Sep 2025
Primary completion
Apr 30, 2026
Completion
Sep 30, 2030

Study Design

Enrollment
74 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Tec-Dara
    For patients assigned to cohort A (Tec-Dara) patients will receive Tec-Dara until documented PD or unacceptable toxicity
  • Experimental: Tec-Len
    For patients assigned to cohort B (Tec-Len) patients will receive Tec-Len until documented PD or unacceptable toxicity

Primary Outcome Measure

Rate of very good partial response (VGPR) or better according to the IMWG criteria in patients with newly diagnosed multiple myeloma after 4 cycles of treatment with Tec-Dara or Tec-Len [ Time Frame: At the end of 4 th cycle (each cycle is 28 days), an average 4 months ]

Central Contacts

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