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Teclistamab Plus Autologous Lymphocytes Infusion for the Treatment of Relapse/Refractory Multiple Myeloma (TALIM)
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
This is a prospective, multicenter, single arm, phase II trial designed to evaluate the efficacy and safety of the combination of Te and ALI. This combination will be tested in patients with RRMM who are at least in partial response (PR) according to the IMWG criteria after 5 cycles of treatment with Te single agent. Participants are planned to receive Te monotherapy during the first five cycles of treatment (1 cycle= 28 days) After cycle 5: Participants in PR or better will continue treatment with Te in combination with 4 Q12W ALI administration starting from cycle 6 (cycles +6, +9, +12, +15); Participants with \< PR after the first five cycles of Te monotherapy (Minimal Response, Stable Disease) will be allowed to continue treatment with Te monotherapy; After cycle 15: Patients with PR or better will continue Te monotherapy up to progressive disease, unacceptable toxicity, patients' refusal Patients with \< PR (Minimal Response, Stable Disease) will be allowed to continue treatment with Te monotherapy up to progressive disease, unacceptable toxicity, patients' refusal Patients with progressive disease (PD) will stop Te, go off treatment and will be treated according to investigator choice Final evaluation will be performed after the end of Te cycle 24.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Start Date
November 1, 2025
Primary Completion Date
November 1, 2029
Completion Date
November 1, 2029
Last Updated
April 3, 2025
52
ESTIMATED participants
Teclistamab
DRUG
Lead Sponsor
Gruppo Italiano Malattie EMatologiche dell'Adulto
NCT06827860
NCT06822972
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT05853965