52
Participants
Start Date
November 1, 2025
Primary Completion Date
November 1, 2029
Study Completion Date
November 1, 2029
Teclistamab
"Participants are planned to receive Te monotherapy during the first 5 cycles of treatment (1 cycle= 28 days) Participants will receive Te sc monotherapy consisting of 2 step-up doses (0.06 and 0.3 mg/kg) followed by a weekly treatment dose of 1.5 mg/kg for the first 2 cycles From cycle 3 Day 1, participants will receive Te sc Q2W at the dose of 3 mg/kg- From cycle 7 Day 1, participants will receive Te sc Q4W at the dose of 3 mg/kg.~After cycle 5, participants in PR or better will continue treatment with Te in combination with 4 Ali infusions (cycles +6, +9, +12, +15). The four doses of ALI will be administered with increasing dosage during Te treatment as follows:~* before Te Cycle 6: ALI 10 x 10\^6/kg~* before Te Cycle 9: ALI 20 x 10\^6/kg~* before Te Cycle 12: ALI 30 x 10\^6/kg~* before Te Cycle 15: ALI 40 x 10\^6/kg~Teclistamab single agent will be continued until progression, unacceptable toxicity or patients refusal."
Gruppo Italiano Malattie EMatologiche dell'Adulto
OTHER