A Study of Ciltacabtagene Autoleucel and Talquetamab for the Treatment of Participants With High-… (NCT06550895) | Clinical Trial Compass
Active — Not RecruitingPhase 2
A Study of Ciltacabtagene Autoleucel and Talquetamab for the Treatment of Participants With High-Risk Multiple Myeloma
United States, Australia11 participantsStarted 2024-09-16
Plain-language summary
The purpose of this study is to define the safety of Ciltacabtagene Autoleucel (Cilta-cel) and Talquetamab in participants with high-risk multiple myeloma (MM).
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:
* Documented diagnosis of MM according to the IMWG diagnostic criteria and is defined as a measurable disease at screening
* Cohort 1: Received at least 3 prior lines of antimyeloma therapy and have undergone greater than or equal to (\>=) 1 complete cycle of the therapy
* Cohort 1: Documented evidence of progression of disease (PD) or failure to achieve a response to the last line of therapy
* Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
* Participant of childbearing potential (POCBP) must have a negative pregnancy test using a highly sensitive β-human chorionic gonadotropin (hCG) serum pregnancy test at screening
Exclusion Criteria:
* Cohort 1: Prior treatment with chimeric antigen receptor T cell (CAR-T) therapy directed at any target or any prior B cell maturation antigen (BCMA)-directed therapy/prior G protein-coupled receptor family C Group 5 member D (GPRC5D)-directed therapy
* Cohort 1: Received either of the following: An allogenic stem cell transplant within 6 months before apheresis/first dose of study drug and no immunosuppressive medications administered before the start of study treatment. And secondly, received an autologous stem cell transplant less than (\<)12 weeks before apheresis/first dose of study treatment
* Receive live, attenuated vaccine within 4 weeks of enrollment
* Toxicity from previous anticancer therapy not resolved to baseline levels or to Grade 1 or less except for alopecia or peripheral …
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 two immunotherapies — ciltacabtagene autoleucel, which is a CAR-T cell therapy, and talquetamab, a bispecific antibody — and its primary focus is tracking adverse events by severity; what serious side effects have been seen so far, and how does that safety profile compare to either treatment given alone?
2Since the trial is in Phase 2 and the main thing being measured is how often and how severely participants experience adverse events, does that mean there's still a lot we don't know about long-term safety for this combination, and how should that uncertainty factor into my decision?
3The study is listed as 'active but not recruiting,' meaning no new patients are being enrolled — does that close off this specific trial for me entirely, or are there related studies or expanded access programs using these same treatments that might still be worth exploring?
4My myeloma has been classified as high-risk — could you explain what criteria this trial uses to define 'high-risk,' whether my case fits that profile, and whether that changes how I should weigh this combination approach against standard treatment options available to me right now?
5CAR-T therapy like ciltacabtagene autoleucel typically requires a significant process including cell collection, a waiting period, and hospitalization — even though I can't enroll in this specific trial, is this kind of treatment approach something my care team could pursue through other channels, and am I in a position medically and logistically to handle that process?
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
Number of Participants With Adverse Events (AE) by Severity According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0