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 range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial combines teclistamab with something called autologous lymphocyte infusion — can you explain what ALI actually involves, and whether the added procedure would make this significantly harder on my body compared to teclistamab alone?
2Since this is a Phase 2 trial, what do we already know about the safety profile of teclistamab from earlier studies, and what new risks might come from adding the lymphocyte infusion component?
3The trial is listed as 'not yet recruiting' — do you have a sense of when it might open, and is waiting for it a realistic option given where my myeloma stands right now?
4The primary goal of this trial is measuring how long responses last — does that suggest the researchers are already seeing responses and are now trying to make them more durable, and what would that mean for me?
5Given that I've already relapsed or my myeloma is refractory, are there standard treatments or other trials I should try first, or is this combination approach something you'd consider a strong option at this point in my care?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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