A Phase 3 interventional study of BMS-986393 and Cyclophosphamide in Relapsed or Refractory Multiple Myeloma (RRMM), sponsored by Juno Therapeutics, Inc., a Bristol-Myers Squibb Company. Recruiting at 141 sites in 31 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-29.
Sponsored by Juno Therapeutics, Inc., a Bristol-Myers Squibb Company (part of Bristol-Myers Squibb) · Phase 3, Interventional, and Treatment
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.
3,760 studies on the registry are indexed under Multiple Myeloma; 769 are open to participants now.
This study's planned enrollment of 440 is above the median of 41 across 3,005 interventional studies indexed under Multiple Myeloma.
Browse Multiple Myeloma studies →Juno Therapeutics, Inc., a Bristol-Myers Squibb Company is the lead sponsor of 17 studies on the registry; 12 are open to participants now.
First submitted after Juno Therapeutics, Inc. became part of Bristol-Myers Squibb.
Compared within Multiple Myeloma, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Recurrence. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: BMS-986393 · Drug: Cyclophosphamide · Drug: Fludarabine · Drug: Daratumumab · Drug: Pomalidomide · Drug: Dexamethasone · Drug: Carfilzomib
Drug: Daratumumab · Drug: Pomalidomide · Drug: Dexamethasone · Drug: Carfilzomib
Specified dose on specified days
Also known as: Arlo-cel
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
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
Overall survival (OS)
Time frame: Up to 5 years after the last participant is randomized
Overall response rate (ORR)
Time frame: Up to 5 years after the last participant is randomized
Minimal residual disease (MRD)-negative status
Time frame: Up to 5 years after the last participant is randomized
Complete response rate (CRR)
Time frame: Up to 5 years after the last participant is randomized
Time to response (TTR)
Time frame: Up to 5 years after the last participant is randomized
Duration of response (DOR)
Time frame: Up to 5 years after the last participant is randomized
Maximum observed concentration (Cmax) of transgene level
Time frame: Up to 5 years after the last participant is randomized
Time of maximum observed plasma concentration (Tmax) of transgene level
Time frame: Up to 5 years after the last participant is randomized
Area under the concentration-time curve (AUC) of transgene level
Time frame: 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
EORTC QLQ-C30 primary domains: fatigue, pain, physical functioning, role functioning, cognitive functioning, and global health status/quality of life (QoL).
Time frame: Up to 5 years after the last participant is randomized
Changes from baseline in EORTC Quality of Life Multiple Myeloma Module- 20 items (QLQ-MY20) primary domains
EORTC QLQ-MY20 primary domains: disease symptoms and side effects of treatment
Time frame: Up to 5 years after the last participant is randomized
Time to meaningful improvement in EORTC QLQ-C30 global health status/QoL.
Time frame: Up to 5 years after the last participant is randomized
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Showing the first 100 of 141 sites across 31 countries. Choose a country and city above to see the rest.
Plan to share: Yes — BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Supporting information: Study protocol, Statistical analysis plan, Clinical study report
Time frame: See Plan Description
Access criteria: See Plan Description
Data sharing details ↗ · www.bms.com
Started Mar 2025 (actual). Primary completion is estimated for Dec 2027, 33 months after the start.
Of 107 industry-sponsored phase 3 interventional studies under Multiple Myeloma, half reached primary completion within 45 months of starting (the median), counting those still running; a quarter within 31 and three quarters within 66. This study's planned 33 months is below that.
Counting every sponsor, half of 178 studies reached it within 56 months; a quarter within 35 and three quarters within 95.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
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Studies of the drug tested here: Arlocabtagene autoleucel
Juno Therapeutics, Inc., a Bristol-Myers Squibb Company →