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

Newly Diagnosed Multiple Myeloma

PFS at 18 months, defined as the duration from the date of randomization to first documented PD, or death, whichever occurs first.

Secondary efficacy endpoints: ● PFS ● OS ● MRD negativity rate at 18 months and over time ● MRD-negative CR at 18 months and over time ● Sustained MRD-negative CR (≥12 months) ● Depth of response defined by the ORR and the rate of sCR, CR, VGPR and PR ● Time to partial response and time to best response ● EFS, with events defined as: PD, death, treatment discontinuation due to toxicity ● PFS2 from the date of randomization to 2nd PD or death, whichever comes first ● TNT, ● Depth of response defined by the ORR (sCR, CR, VGPR and PR) after re-treatment ● MRD-negativity rate after re-treatment, ● Incidence and severity of AEs during initial therapy, TFI and after restarting therapy ● Discontinuation rate due to treatment related toxicity during initial therapy and after restarting therapy, including overall discontinuation rate, discontinuation rate of daratumumab, teclistamab and talquetamab ● Causes of discontinuation of therapy during initial therapy and after restarting therapy ● Incidence, grade and cause of infections [...] (for more information, refer to the protocol)

Italy, Netherlands, Norway, Spain