NCT07107529

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

EFfIcacy and Tolerability of FIXed Duration Teclistamab and Talquetamab FOR FRAIL Patients With Newly Diagnosed Multiple Myeloma (2 Cohort Study) - the EMN 37 FITFIX FOR FRAIL Trial

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: European Myeloma Network B.V. · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

This study will consist of 4 phases: * Initial treatment phase where patients will receive fixed duration of Tec-Dara or Tal-Dara. * TFI. * Re-treatment phase, where patients with confirmed PD will continue treatment with Tec-Dara or Tal-Dara per their assignment in the initial treatment phase. * Post-treatment follow-up phase.

Conditions

• Multiple Myeloma (MM)

Interventions

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

Timeline

• Start date: 2025-12-12
• Primary completion: 2029-04-01
• Completion: 2034-02-01
• First posted: 2025-08-06
• Last updated: 2026-04-15

Locations

29 sites across 4 countries: Italy, Netherlands, Norway, Spain