A Study to Compare the Efficacy and Safety of BMS-986393 Versus Standard Regimens in Adult Participants With Relapsed or Refractory and Lenalidomide-refractory Multiple Myeloma (QUINTESSENTIAL-2)
Sponsor: Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
ClinicalTrials ID:NCT06615479
This clinical trial evaluates the efficacy and safety of BMS-986393 compared to standard regimens in adults with relapsed or refractory, lenalidomide-refractory multiple myeloma. Participants receive specified doses of BMS-986393 or standard drugs like Cyclophosphamide, Fludarabine, Daratumumab, Pomalidomide, Dexamethasone, and Carfilzomib. Eligibility criteria focus on adults with specific myeloma conditions.
Patient Parameters
| Parameter | Options |
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Program Overview
The purpose of this study is to compare the efficacy and safety of BMS-986393 versus standard regimens in adult participants with Relapsed or Refractory and Lanalidomide-refractory Multiple Myeloma.
Eligibility Criteria
Inclusion Criteria
- Participants must have relapsed or refractory multiple myeloma (RRMM).
- Participants must have received at least 1 but no greater than 3 prior multiple myeloma (MM) regimens which may include a proteasome inhibitor (PI), an immunomodulatory drug (IMiD), and an anti-CD38 monoclonal antibody, and be refractory to lenalidomide (LEN) (progression on or within 60 days of completing LEN therapy).
- Participants must have a documented diagnosis of MM as per International Myeloma Working Group Criteria.
- Participants must have measurable disease during screening.
- Participants must have adequate organ function.
- Participants must have an Eastern Cooperative Oncology group performance status 0 or 1.
Exclusion Criteria
- Participants must not have known active or history of central nervous system (CNS) involvement of Multiple Myeloma (MM).
- Participants must not have solitary plasmacytomas or non-secretory myeloma without other evidence of measurable disease.
- Participants must not need urgent treatment due to rapidly progressing MM.
- Other protocol-defined Inclusion/Exclusion criteria apply.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Local Institution - 0071 | 35205 | Birmingham | Alabama |
| UCLA Hematology/Oncology - Santa Monica | 90404 | Los Angeles | California |
| Local Institution - 0130 | 33136 | Miami | Florida |
| Winship Cancer Institute, Emory University | 30322 | Atlanta | Georgia |
| Local Institution - 0133 | 21218 | Baltimore | Maryland |
| Local Institution - 0131 | 27710 | Durham | North Carolina |
| Local Institution - 0193 | 44195 | Cleveland | Ohio |
| Local Institution - 0097 | 19111 | Philadelphia | Pennsylvania |
| Local Institution - 0044 | 84112 | Salt Lake City | Utah |
| Local Institution - 0068 | 53792 | Madison | Wisconsin |
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