The goal of this clinical trial is to evaluate the efficacy of Teclistamab (Te) and autologous lymphocyte infusions (ALI) in relapse refractory multiple myeloma. The main question it aims to answer is: which is the Duration of response (DoR) with Teclistmab and ALI?
Participants will receive Te for 5 cycles. Participants in PR or better after the first five cycles of Te monotherapy will continue treatment with Te in combination with ALI administration starting from cycle 6
• Patient has a confirmed diagnosis of MM according to the WHO 2022 classification (18)
Patient age is ≥ 18 years of age
Relapsed disease is defined as an initial response to previous treatment, followed by confirmed progressive disease by the International Myeloma Working Group (IMWG) (15) criteria >60 days after cessation of treatment
Refractory disease is defined as failure to achieve a response or confirmed progressive disease by IMWG criteria (15) during previous treatment or ≤60 days after cessation of treatment.
• Previous treatment with > 2 lines of therapy
Patient has active central nervous system involvement with MM
Received any prior BCMA-directed therapy
Targeted therapy, epigenetic therapy, or treatment with an investigational drug or an invasive investigational medical device within 21 days or ≥5 half-lives, whichever is less
Single group
Teclistamab
DrugParticipants 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.
Duration of response
Duration of response is the time interval between the date of confirmed response at cycle 5 and the date of documented disease progression or death from any cause, whichever occurs first. Patients who have not progressed or died at the time of analysis will be censored at the date of their last disease evaluation.
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