Evaluating a new treatment for relapsed and refractory multiple myeloma
A Phase 1, Multicenter, Open-label Study to Evaluate the Safety and Preliminary Efficacy of Arlocabtagene Autoleucel (BMS-986393) in Novel Combinations in Participants With Relapsed and/or Refractory Multiple Myeloma and Determine the Recommended Dose for Each Add-on Investigational Component
This study is testing a new treatment combination for people with relapsed or hard-to-treat multiple myeloma to see if it is safe and effective.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 147 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Juno Therapeutics, Inc., a Bristol-Myers Squibb Company Industry-sponsored |
| Drugs / interventions | alnuctamab, elranatamab |
| Locations | 19 sites (Birmingham, Alabama and 18 other locations) |
| Trial ID | NCT06121843 on ClinicalTrials.gov |
What this trial studies
This study aims to determine the safety and tolerable dosage of BMS-986393 when used in combination with other treatments such as alnuctamab, mezigdomide, and iberdomide in patients suffering from relapsed and/or refractory multiple myeloma. Participants will be closely monitored to assess the effectiveness of these combinations and to ensure patient safety throughout the trial. The study is designed for individuals who have previously undergone multiple treatment regimens for their condition.
Who should consider this trial
Good fit: Ideal candidates are individuals with a history of relapsed and/or refractory multiple myeloma who have received at least one prior treatment regimen.
Not a fit: Patients with active central nervous system involvement of multiple myeloma or those with conditions that could interfere with data interpretation may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new effective treatment option for patients with difficult-to-treat multiple myeloma.
How similar studies have performed: Other studies have shown promise with similar treatment combinations in multiple myeloma, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * History of relapsed and/or refractory multiple myeloma (RRMM) treated with at least 3 (Part 1) or at least 1 but not greater than 3 prior anti-myeloma treatment regimens (Part 2). * Measurable multiple myeloma (MM) as per International Myeloma Working Group (IMWG). * Eastern Cooperative Oncology Group performance status of 0-1. Exclusion Criteria: * Prior treatment with alnuctamab (Arm A), mezigdomide (Arm B), iberdomide (Arm C), elranatamab (Arm D) or BCMA-targeting therapy (Part 2 Arms A and D). * Prior treatment with GPRC5D-targeting therapies. * Other protocol-defined inclusion/exclusion criteria apply.
Where this trial is running
Birmingham, Alabama and 18 other locations
- University of Alabama at Birmingham — Birmingham, Alabama, United States (Recruiting)
- Mayo Clinic in Arizona - Phoenix — Phoenix, Arizona, United States (Recruiting)
- City of Hope Comprehensive Cancer Center — Duarte, California, United States (Recruiting)
- Mayo Clinic in Florida — Jacksonville, Florida, United States (Recruiting)
- Northside Hospital — Atlanta, Georgia, United States (Recruiting)
- Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States (Recruiting)
- Dana-Farber Cancer Institute — Boston, Massachusetts, United States (Recruiting)
- Mayo Clinic in Rochester, Minnesota — Rochester, Minnesota, United States (Recruiting)
- University Of Nebraska Medical Center — Omaha, Nebraska, United States (Recruiting)
- John Theurer Cancer Center at Hackensack University Medical Center — Hackensack, New Jersey, United States (Recruiting)
- Roswell Park Cancer Institute — Buffalo, New York, United States (Recruiting)
- Laura and Isaac Perlmutter Cancer Center — New York, New York, United States (Recruiting)
- Local Institution - 0009 — New York, New York, United States (Completed)
- Memorial Sloan Kettering Cancer Center — New York, New York, United States (Recruiting)
- Local Institution - 0023 — Pittsburgh, Pennsylvania, United States (Withdrawn)
- Tennessee Oncology — Nashville, Tennessee, United States (Recruiting)
- University of Texas MD Anderson Cancer Center — Houston, Texas, United States (Recruiting)
- Arthur J.E. Child Comprehensive Cancer Centre — Calgary, Alberta, Canada (Recruiting)
- Princess Margaret Cancer Centre — Toronto, Ontario, Canada (Recruiting)
Study contacts
- Study coordinator: BMS Study Connect Contact Center www.BMSStudyConnect.com
- Email: Clinical.Trials@bms.com
- Phone: 855-907-3286
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.