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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)

StatusRecruiting
PhasePhase 3
Started2025-03-12
View on ClinicalTrials.gov ↗

Amendment history

2026-08-17
Study Status, Contacts/Locations v27
Study sites141 entries, revised
LocalGeorgetown InstitutionUniversity - 0223 Fox Chase CancerMedical Center Local Institution - 02320097 LocalAHN InstitutionWest Penn Hospital Hamilton Health Sciences-Juravinski 0192Cancer Centre
2026-07-22
Study Status, Contacts/Locations v26
Study sites140→141
2026-06-25
Study Status, Contacts/Locations v25
Study sites140 entries, revised
LocalInstituto InstitutionD'Or -de 0103Pesquisa e Ensino (IDOR) LocalSociedade InstitutionBeneficente -Israelita 0031Brasileira Hospital Albert Einstein LocalTaipei InstitutionVeterans -General 0200Hospital
2026-06-02
Study Status, Contacts/Locations v24
Study sites138→140
2026-05-12
Study Status, Contacts/Locations v23
Study sites138 entries, revised
LocalUniversity Institutionof California, Irvine (UCI) Health - 0050UC Irvine Medical Center LocalWeill InstitutionCornell -Medical 0229College LocalP.O. Institution"S. -Maria 0106della Misericordia" Azienda Sanitaria Universitaria Friuli Centrale
Show 22 earlier versions
2026-04-13
Study Status, Contacts/Locations v22
Study sites138 entries, revised
LocalUniversity Institutionof -Miami 0130Hospital and Clinics, Sylvester Cancer Center LocalLevine InstitutionCancer -Institute Levine 0067Cancer Institute LocalMedical InstitutionCollege -of 0216 Local Institution - 0195Wisconsin
2026-03-16
Study Status, Contacts/Locations v21
Study sites137→138
2026-02-06
Study Status, Contacts/Locations, IPDSharing v20
Study sites135→137
2026-01-13
Study Status, Contacts/Locations v19
Study sites134→135
2025-12-16
Study Status, Contacts/Locations v18
Study sites130→134
2025-12-01
Study Status, Contacts/Locations v17
Study sites126→130
2025-11-11
Study Status, Contacts/Locations v16
Study sites125→126
2025-10-17
Study Status, Contacts/Locations v15
Study sites125 entries, revised
LocalUniversity Institutionof -Alabama 0071at Birmingham LocalPrincess InstitutionAlexandra -Hospital Fondazione 0140IRCCS Istituto Nazionale dei Tumori LocalWojewodzkie InstitutionWielospecjalistyczne -Centrum 0107 LocalOnkologii Institutioni -Traumatologii 0183im. M. Kopernika w Lodzi
2025-09-16
Study Status, Contacts/Locations v14
Study sites124→125
2025-08-19
Study Status, Contacts/Locations v13
Study sites126→124
2025-07-29
Study Status, Contacts/Locations v12
Study sites126 entries, revised
LocalFiona InstitutionStanley Hospital QEII Health Sciences Centre - 0141Victoria General Site LocalHenri InstitutionMondor -Hospital Kanazawa 0004University Hospital LocalMaastricht InstitutionUMC+ Addenbrooke's - 0079 Local Institution - 0104 Local Institution - 0163 Local Institution - 0182Hospital
2025-07-15
Study Identification, Study Status, Study Description, Conditions, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations v11
Eligibility criteria-62 characters
[...] modulatory drug (IMiD), and an anti-CD38 monoclonal antibody, and behave refractoryprior exposure to lenalidomide (LEN) (progression on or within 60 days of completing LEN therapy). Participants must have a documented diagnosis of MM as per [...]
Secondary endpoints15 to 12 entries
The proportion of participants with adverse events (AEs) The proportion of participants with adverse events of special interest (AESI) The proportion of participants with serious adverse events (SAEs)
Study sites126 entries, revised
LocalRigshospitalet Medizinische InstitutionHochschule -Hannover Universitair 0019Medisch Centrum Utrecht LocalInselspital Institution - 0186 Local Institution - 0171 Local Institution - 0205Bern
Study title-3 characters
[...] t Participants With Relapsed or Refractory and Lenalidomide-refractoryexposed Multiple Myeloma (QUINTESSENTIAL-2)
2025-06-30
Study Status, Contacts/Locations v10
Study sites125→126
2025-06-13
Study Status, Contacts/Locations v9
Completion date2032-07-21→2032-06-22
Study sites121→125
2025-05-19
Study Status, Contacts/Locations v8
Study sites123→121
2025-04-28
Study Status, Contacts/Locations v7
Study sites118→123
2025-04-05
Study Status, Contacts/Locations v6
Start dateestimated 2025-02-28→confirmed 2025-03-12
Study sites110→118
2025-02-26
Study Status, Contacts/Locations, References v5
Start date2025-02-15→2025-02-28
Study sites109→110
2025-01-23
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v4
Trial statusNot Yet Recruiting→Recruiting
Study sites111→109
2024-12-18
Study Status, Contacts/Locations v3
Study sites109→111
2024-11-20
Study Status, Contacts/Locations v2
Study sites106→109
2024-10-31
Study Status, Contacts/Locations v1
Study sites101→106
2024-09-24
Original filing
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.
Trial Details
NCT Number NCT06615479
Lead Sponsor Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
Collaborators: Celgene Corporation
Conditions Relapsed or Refractory Multiple Myeloma (RRMM)
Enrollment 440 participants
Start Date 2025-03-12
Primary Completion 2027-12-30 (estimated)
Study Completion 2032-06-22 (estimated)
Updated on ClinicalTrials.gov 2026-09-15