Multiple Myeloma
Conditions
Keywords
Relapsed or Refractory Multiple Myeloma, Multiple Myeloma, BMS-986393, CAR T Cell Therapy, RRMM, Arlocabtagene Autoleucel
Brief summary
The purpose of this study is to evaluate the effectiveness and safety of Arlocabtagene Autoleucel (BMS-986393) in participants with relapsed or refractory multiple myeloma.
Interventions
BIOLOGICALArlocabtagene Autoleucel
Specified dose on specified days
Sponsors
Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Documented diagnosis of multiple myeloma (MM) as per International Myeloma Working Group (IMWG) criteria. * Received at least 4 classes of MM treatment \[including immunomodulatory drug (IMiD), proteasome inhibitor (PI), anti CD38 mAb, anti-BCMA therapy, and at least 3 prior lines of therapy (LOT). * Documented disease progression during or after their last anti-myeloma regimen as per IMWG 2016 criteria. * Participants must have measurable disease during screening. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Exclusion criteria
* Active or history of central nervous system involvement with MM. * Active systemic fungal, bacterial, viral, or other infection despite appropriate anti-infective treatment at the time of leukapheresis. Participants with severe infection, severe sepsis or bacteremia in the last 28 days prior to leukapheresis are excluded. * Received any prior therapy directed at G protein-coupled receptor class C, group 5, member D (GPRC5D) or has received other prior treatment for MM without the required washout prior to leukapheresis. * Other protocol-defined Inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cohort 1: Best overall response (BOR) of partial response (PR) or better | Up to approximately 5 years | The number and percent of participants achieving BOR of partial response (PR) or better in quadruple class exposed participants received at least 4 prior lines of therapy (LOT) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| BOR of partial response (PR) or better | Up to approximately 5 years | The number and percent of participants achieving BOR of PR in quadruple class exposed participants received at least 3 prior LOT |
| Best overall response (BOR) of complete response (CR) including stringent complete response (sCR) | Up to approximately 5 years | The number and percent of participants achieving complete response (CR) \[including stringent complete response sCR\] in participants having received at least 3 prior lines of therapy (LOT) |
| Minimal residual disease (MRD) negative status | Up to approximately 5 years | — |
| Time from BMS-986393 infusion to first documentation of response of partial response (PR) or better according to the International Myeloma Working Group (IMWG) Response Criteria assessed by an independent review committee (IRC) | Up to approximately 5 years | — |
| Duration of response (DOR) assessed by an IRC | Up to approximately 5 years | Median DOR for responders only as estimated using Kaplan-Meier method and frequencies of participants who progressed, died, and were censored |
| Progression-free survival (PFS) | Up to approximately 5 years | — |
| Overall survival (OS) | Up to approximately 5 years | — |
| Overall response rate (ORR) assessed by an Investigator | Up to approximately 5 years | — |
| Complete response rate (CRR) assessed by an Investigator | Up to approximately 5 years | — |
| Time to response (TTR) assessed by an Investigator | Up to approximately 5 years | — |
| Duration of response (DOR) assessed by an Investigator | Up to approximately 5 years | — |
| Progression-free survival (PFS) with BOR according to the IMWG Response Criteria assessed by Investigator | Up to approximately 5 years | — |
| Maximum observed plasma concentration (Cmax) | Up to approximately 5 years | — |
| Area under the concentration-time curve (AUC) | Up to approximately 5 years | — |
| Time of maximum observed plasma concentration (Tmax) | Up to approximately 5 years | — |
| Mean changes from baseline in European Organization for Research and Treatment of Cancer - Quality of Life C30 (EORTC QLQ-C30) selected subscales | Up to approximately 5 years | — |
| Incidence of healthcare resource utilization (HCRU) events during treatment and during post-treatment follow-up | Up to approximately 5 years | — |
Countries
Australia, Canada, Japan, 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