Teclistamab Plus Autologous Lymphocyte Infusion (ALI) for the Treatment of R/R Multiple Myeloma

PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

52

Participants

Timeline

Start Date

November 1, 2025

Primary Completion Date

November 1, 2029

Study Completion Date

November 1, 2029

Conditions
Multiple MyleomaMultiple Myeloma in RelapseMultiple Myeloma Refractory
Interventions
DRUG

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."

All Listed Sponsors
lead

Gruppo Italiano Malattie EMatologiche dell'Adulto

OTHER