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

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).

Trial Details

NCT ID
NCT07107529
Phase
PHASE2
Sponsor
European Myeloma Network B.V.
Status
RECRUITING
Cancer Type
Newly Diagnosed Multiple Myeloma
Interventions
  • Teclistamab
  • Talquetamab
  • Daratumumab
Locations (sample)
  • Ascoli Piceno, Italy|42.85351,13.57395
  • Bari, Italy|41.12066,16.86982
  • Bergamo, Italy|45.69601,9.66721
  • Bologna, Italy|44.49381,11.33875
  • Bolzano, Italy|46.49067,11.33982

Key Eligibility Criteria

  • Patient is ≥18 years of age and capable of giving informed consent and must sign an informed consent form (ICF), indicating that they understand th…
  • Newly diagnosed and treatment-naïve patients with a confirmed diagnosis of MM with measurable disease according to IMWG criteria
  • Measurable disease defined as M-protein in the serum (≥1 g/dL) or serum free light chain assay ≥10 mg/dL \[≥100 mg/L\] and abnormal serum immunoglo…
  • Frail according to the Simplified IMWG frailty index

For full eligibility, visit ClinicalTrials.gov.

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