Relapsed or Refractory Multiple Myeloma (RRMM)
Conditions
Keywords
Relapsed or Refractory Multiple Myeloma, Multiple Myeloma, BMS-986393, Chimeric Antigen Receptor T-cell (CAR T-cell), CAR T-cell Therapy, Arlocabtagene Autoleucel, Arlo-cel
Brief summary
The purpose of this study is to compare the efficacy and safety of arlo-cel (BMS-986393) versus standard regimens in adult participants with Relapsed or Refractory and Lenalidomide-exposed Multiple Myeloma.
Interventions
DRUGBMS-986393
Specified dose on specified days
DRUGCyclophosphamide
Specified dose on specified days
DRUGFludarabine
Specified dose on specified days
DRUGDaratumumab
Specified dose on specified days
DRUGPomalidomide
Specified dose on specified days
DRUGDexamethasone
Specified dose on specified days
DRUGCarfilzomib
Specified dose on specified days
Sponsors
Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
Celgene Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 have prior exposure to lenalidomide. * 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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression Free Survival (PFS) | Up to 5 years after the last participant is randomized |
| Minimal residual disease (MRD)-negativity in complete response (CR) | Up to 1 year after the last participant is randomized |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival (OS) | Up to 5 years after the last participant is randomized | — |
| Overall response rate (ORR) | Up to 5 years after the last participant is randomized | — |
| Minimal residual disease (MRD)-negative status | Up to 5 years after the last participant is randomized | — |
| Complete response rate (CRR) | Up to 5 years after the last participant is randomized | — |
| Time to response (TTR) | Up to 5 years after the last participant is randomized | — |
| Duration of response (DOR) | Up to 5 years after the last participant is randomized | — |
| Maximum observed concentration (Cmax) of transgene level | Up to 5 years after the last participant is randomized | — |
| Time of maximum observed plasma concentration (Tmax) of transgene level | Up to 5 years after the last participant is randomized | — |
| Area under the concentration-time curve (AUC) of transgene level | Up to 5 years after the last participant is randomized | — |
| Changes from baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire- Core 30 items (QLQ-C30) primary domains | Up to 5 years after the last participant is randomized | EORTC QLQ-C30 primary domains: fatigue, pain, physical functioning, role functioning, cognitive functioning, and global health status/quality of life (QoL). |
| Changes from baseline in EORTC Quality of Life Multiple Myeloma Module- 20 items (QLQ-MY20) primary domains | Up to 5 years after the last participant is randomized | EORTC QLQ-MY20 primary domains: disease symptoms and side effects of treatment |
| Time to meaningful improvement in EORTC QLQ-C30 global health status/QoL. | Up to 5 years after the last participant is randomized | — |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Canada, Czechia, Denmark, Finland, France, Germany, Greece, Hungary, Israel, Italy, Japan, Netherlands, Norway, Poland, Portugal, Romania, Saudi Arabia, Singapore, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey (Türkiye), United Kingdom, United States
Contacts
CONTACTBMS Clinical Trials Contact Center www.BMSClinicalTrials.com
CONTACTFirst line of the email MUST contain NCT # and Site #.
STUDY_DIRECTORBristol-Myers Squibb
Bristol-Myers Squibb
Outcome results
None listed