A Study to Evaluate the Safety of bb2121 in Subjects With High Risk, Newly Diagnosed Multiple Mye… (NCT04196491) | Clinical Trial Compass
CompletedPhase 1
A Study to Evaluate the Safety of bb2121 in Subjects With High Risk, Newly Diagnosed Multiple Myeloma (NDMM)
United States13 participantsStarted 2020-05-27
Plain-language summary
This is a multicenter, open-label, phase 1, single arm study intended to determine the optimal target dose and safety of bb2121 in subjects with HR (R-ISS Stage III per IMWG criteria) NDMM. Subjects should have received 3 Cycles of standard induction therapy prior to undergoing leukapheresis procedure to collect autologous mononuclear cells for manufacture of the drug product (bb2121). Following manufacture of the drug product, subjects will receive fourth cycle of induction therapy followed by lymphodepleting therapy with fludarabine and cyclophosphamide prior to bb2121 infusion. Maintenance therapy is recommended for all subjects who have received bb2121 infusion and should be initiated upon adequate bone marrow recovery or from 90-day post-bb2121 infusion, whichever is later.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Subject is newly diagnosed and has symptomatic Multiple Myeloma (MM) prior to initiating induction anti-myeloma therapy
✓. Subject is ≥ 18 years of age at the time of initial diagnosis of MM
✓. Subject has measurable disease at initial diagnosis by
✓. Subject has high-risk MM at the time of initial diagnosis of MM per R-ISS Stage III as defined by IMWG:
✓. Subject has Eastern Cooperative Oncology Group performance ≤ 1
✓. Subjects has received ≤ to 3 cycles of the following induction anti-myeloma therapy prior to enrollment:
Exclusion criteria
✕. Subject has non-secretory MM
✕. Subject received any treatments for MM other than up to 3 cycles of induction therapy per protocol
✕. Subject has any of the following laboratory abnormalities:
✕
What they're measuring
1
Dose-limiting toxicity (DLT) rates
Timeframe: Up to completion of DLT period after last subject bb2121 infused
2
Adverse Events (AEs)
Timeframe: Approximately 2 years after last subject bb2121 infused