Study for Frail Patients With Newly Diagnosed Multiple Myeloma Treated With Daratumumab With Teclistamab or Talquetamab.

Sponsor
European Myeloma Network B.V.
Study ID
NCT07107529
Phase
PHASE2
Status
Recruiting
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Conditions

  • Multiple Myeloma (MM)

Eligibility Criteria

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

Interventions

  • Teclistamab — DRUG
    Teclistamab will be administered via a subcutaneous injection (SC), fixed duration and will be retreated until disease progression or intolerable toxicity.
  • Talquetamab — DRUG
    Talquetamab will be administered via a subcutaneous injection (SC), fixed duration and will be retreated until disease progression or intolerable toxicity.
  • Daratumumab — DRUG
    Dartumumab will be administered via a subcutaneous injection (SC), fixed duration and will be retreated until disease progression or intolerable toxicity.

Study Details

This is a multicenter, open-label phase II study with 2 parallel cohorts for frail patients with newly diagnosed multiple myeloma treated with daratumumab in combination with teclistamab and talquetamab. The main purpose of this study is to determine the progression free survival at 18 months in patients treated with teclistamab and daratumumab (Cohort 1) or talquetamab and daratumumab (Cohort 2).

Key Dates

Start date
Dec 12, 2025
Status verified
Apr 2026
Primary completion
Apr 30, 2029
Completion
Feb 28, 2034

Study Design

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

Arms

  • Experimental: Cohort 1
    Tec-Dara
  • Experimental: Cohort 2
    Tal-Dara

Primary Outcome Measure

Progression Free Survival (PFS) per IMWG criteria [ Time Frame: 18 months ]

Central Contacts

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