Upfront Chimeric Antigen Receptor T-Cell to Upgrade Response in Multiple Myeloma (NCT05032820) | Clinical Trial Compass
CompletedPhase 2
Upfront Chimeric Antigen Receptor T-Cell to Upgrade Response in Multiple Myeloma
United States40 participantsStarted 2022-01-05
Plain-language summary
This study is designed as a Phase II, multicenter, single arm trial to assess anti-B Cell Maturation Antigen (BCMA) chimeric antigen receptor (CAR) T-cells (bb2121) to improve post autologous hematopoietic cell transplant (HCT) responses among patients with 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
. Age greater than or equal to 18.00 years
. Patients must meet the criteria for symptomatic MM requiring therapy (Appendix A) prior to initiating initial systemic anti-myeloma treatment.
. Patients must have received initial systemic anti- myeloma therapy consisting of induction therapy and consolidation with high-dose melphalan (\>140 mg/m\^2 ) followed by an auto HCT (minimum cell dose of 2x10\^6 CD34+ cells/kg (actual body weight) within 12 months from initiation of systemic anti-myeloma therapy.
. Patient must have additional stored stem cells greater than or equal to 2x10\^6 CD34+ cells per kg actual body weight.
. Patients must be less than or equal to 12 months after autologous HCT at the time of enrollment.
. Patients must have initiated maintenance therapy with lenalidomide-based regimen within 6 months after the auto HCT and have received at least 3 months of maintenance prior to enrollment.
. Patients must have tolerated a minimum dose of lenalidomide 5 mg/day for 21 days of a 28-day cycle for greater than 2 cycles without having to stop due to toxicities.
. Patients must have a VGPR or less (Section 3.1) in reference to time time of initiation of initial systemic anti-myeloma therapy at study enrollment.
Exclusion criteria
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 tested CAR-T cell therapy targeting BCMA as an upfront treatment for multiple myeloma — rather than waiting until relapse — so can you explain how that earlier timing might change what the results mean for my specific situation?
2Since this is a Phase 2 trial that has already completed, what efficacy data has come out of it, and does anything in those results suggest this approach could be relevant to my case?
3CAR-T cell therapy typically requires a conditioning chemotherapy regimen beforehand and a period of close monitoring afterward — is my current health status and support situation compatible with those demands?
4Given that this trial used BCMA-targeted CAR-T cells upfront, how does that compare to the standard treatment path I'd normally follow, and would starting with standard therapy first still leave this kind of option open later?
5Are there any serious side effects — like cytokine release syndrome or neurotoxicity — that were reported or are known to be associated with BCMA CAR-T therapy that I should weigh carefully before considering this approach?
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.