Taking people in NetherlandsPhase 3
Tests arlo-cel against standard treatments in relapsed multiple myeloma
Compares arlo-cel, a cell therapy, with standard treatments in adults with myeloma.
Key facts
- Who runs it
- Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
- Where
- Amsterdam, Maastricht, Nijmegen, and Utrecht, NetherlandsSee the 4 sitesAlso in 30 other countries, 136 sites
- Trial code
- NCT06615479
- EU 2024-515279-37-00
- U1111-1308-9347
- Registry title
- 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)
- Status
- Recruiting
- Phase
- Phase 3
- People taking part
- 440 people, planned
- Started
- 12 Mar 2025
- Expected to end
- 22 Jun 2032
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- BMS-986393
- Cyclophosphamide
- Fludarabine
- Daratumumab
- Pomalidomide
- Dexamethasone
- Carfilzomib
- Record updated
- 29 October 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with multiple myeloma that has come back or stopped responding to treatment, who have already taken lenalidomide.
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- Relapsed or refractory multiple myeloma, with measurable disease and a documented diagnosis; performance status 0 or 1; adequate organ function
- Earlier treatment
- At least 1 but no more than 3 earlier myeloma treatment regimens, which may include a proteasome inhibitor, an immunomodulatory drug and an anti-CD38 antibody; must have had lenalidomide before
Main reasons for not taking part
- Known active or past myeloma in the central nervous system
- Solitary plasmacytoma or non-secretory myeloma without other measurable disease
- Need for urgent treatment because the myeloma is progressing rapidly
The registry criteria, word for word
Show all 10 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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/Exclusion criteria apply
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Which of these best describes your myeloma treatment so far?
- Have you ever taken lenalidomide (also called Revlimid), a tablet medicine for myeloma?
- Has a doctor told you that your myeloma can be measured in your blood or urine tests?
- Which describes how well you can look after yourself?
- Has a doctor told you that you have myeloma in the brain or in the fluid and membranes around the brain and spinal cord, now or in the past?
Where in Netherlands
Also in 30 other countries, 136 sites
- Amsterdam UMC StichtingAmsterdam, NetherlandsTaking people
- Academisch Ziekenhuis MaastrichtMaastricht, NetherlandsTaking people
- Radboud universitair medisch centrum StichtingNijmegen, NetherlandsTaking people
- Universitair Medisch Centrum UtrechtUtrecht, NetherlandsTaking people
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- Arm ATreatment being tested
Treatment: BMS-986393, Cyclophosphamide, Fludarabine, Daratumumab, Pomalidomide, Dexamethasone, and Carfilzomib
- Arm BExisting treatment, for comparison
Treatment: Daratumumab, Pomalidomide, Dexamethasone, and Carfilzomib
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
- Official title
- A Phase 3, Randomized, Open-Label, Multicenter Study to Compare the Efficacy and Safety of Arlocabtagene Autoleucel (BMS-986393), a GPRC5D-directed CAR-T Cell Therapy, Versus Standard Regimens in Adult Participants With Relapsed or Refractory and Lenalidomide-exposed Multiple Myeloma
- Plain-language title
- Tests arlo-cel against standard treatments in relapsed multiple myelomaGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT06615479, who can take part
- Record updated
- 29 October 2026