NCT06615479 · Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
A Study to Compare the Efficacy and Safety of BMS-986393 Versus Standard Regimens in Adult Participants With Relapsed or Refractory and Lenalidomide-exposed Multiple Myeloma (QUINTESSENTIAL-2)
What this study is about
The purpose of this study is to compare the effectiveness and safety of arlo-cel (BMS-986393) versus standard regimens in adult participants with Relapsed or Refractory and Lenalidomide-exposed Multiple Myeloma.
View original scientific description
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
DRUG
BMS-986393
Specified dose on specified days
DRUG
Cyclophosphamide
Specified dose on specified days
DRUG
Fludarabine
Specified dose on specified days
DRUG
Daratumumab
Specified dose on specified days
DRUG
Pomalidomide
Specified dose on specified days
DRUG
Dexamethasone
Specified dose on specified days
DRUG
Carfilzomib
Specified dose on specified days
Primary outcome measures
Progression Free Survival (PFS)
Time frame: Up to 5 years after the last participant is randomized
Minimal residual disease (MRD)-negativity in complete response (CR)
Time frame: Up to 1 year after the last participant is randomized
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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 progress
Where
- Birmingham, Alabama
- Los Angeles, California
- Orange, California
- Washington D.C., District of Columbia
- Jacksonville, Florida
- Miami, Florida
- Orlando, Florida
- Atlanta, Georgia
- Shreveport, Louisiana
- Boston, Massachusetts
- Minneapolis, Minnesota
- New York, New York
And 9 more locations — see the full list below.
Collaborators
Celgene Corporation
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 26, 2026 · Source of record for eligibility and locations