Teclistamab Plus Autologous Lymphocyte Infusion (ALI) for the Treatment of R/R Multiple Myeloma (NCT06880601) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Teclistamab Plus Autologous Lymphocyte Infusion (ALI) for the Treatment of R/R Multiple Myeloma
52 participantsStarted 2025-11-01
Plain-language summary
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
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* • Patient has a confirmed diagnosis of MM according to the WHO 2022 classification (18)
* Patient age is ≥ 18 years of age
* Patient has a Relapsed or refractory disease as defined below:
* 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 1 or 2 lines of treatment (induction plus autologous stem cell transplant plus consolidation and maintenance has to be considered one single line)
* Previous triple exposure that included an IMID, a PI, and an anti-CD38 antibody (patients with no response or relapse after front line therapy with Dara-VTD or Dara-VRD are eligible)
* Progressive active symptomatic disease
* Patient has measurable disease as defined by any of the following:
* Serum M-protein level ≥0.5 g/dL; or
* Urine M-protein level ≥200 mg/24 hours; or
* Serum immunoglobulin free light chain ≥10 mg/dL and abnormal serum immunoglobulin kappa lambda free light chain ratio.
* Patient has an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2
* Able to adhere to the study visit schedule and all the other protocol procedures a…
What they're measuring
1
Duration of response
Timeframe: 24 months from the beginning of Te monotherapy
Trial details
NCT IDNCT06880601
SponsorGruppo Italiano Malattie EMatologiche dell'Adulto