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)

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
Study ID
NCT06615479
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

  • Relapsed or Refractory Multiple Myeloma (RRMM)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • BMS-986393 — DRUG
    Specified dose on specified days
  • Cyclophosphamide — DRUG
    Specified dose on specified days
  • Fludarabine — DRUG
    Specified dose on specified days
  • Daratumumab — DRUG
    Specified dose on specified days
  • Pomalidomide — DRUG
    Specified dose on specified days
  • Dexamethasone — DRUG
    Specified dose on specified days
  • Carfilzomib — DRUG
    Specified dose on specified days

Study Details

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.

Key Dates

Start date
Mar 12, 2025
Status verified
Jun 2026
Primary completion
Dec 30, 2027
Completion
Jun 22, 2032

Study Design

Enrollment
440 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A
  • Active Comparator: Arm B

Primary Outcome Measure

Progression Free Survival (PFS) [ Time Frame: Up to 5 years after the last participant is randomized ]

Central Contacts

  • BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
    855-907-3286
    [email protected]
  • First line of the email MUST contain NCT # and Site #.

Locations (22)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35205
Susan Bal, Site 0071
205-934-1908
UCLA Hematology/Oncology - Santa MonicaLos AngelesCalifornia90404
Sarah Larson, Site 0032
310-829-5471
University of California, Irvine (UCI) Health - UC Irvine Medical CenterOrangeCalifornia92868
Stefan Ciurea, Site 0050
714-509-2290
Local Institution - 0223Washington D.C.District of Columbia20007
Site 0223
Baptist MD Anderson Cancer CenterJacksonvilleFlorida32207
Maxim Norkin, Site 0231
248-756-4524
University of Miami Hospital and Clinics, Sylvester Cancer CenterMiamiFlorida33136
Damian Green, Site 0130
000-000-0000
Local Institution - 0228OrlandoFlorida32803
Site 0228
Winship Cancer Institute, Emory UniversityAtlantaGeorgia30322
Nisha Joseph, Site 0058
502-608-5503
Louisiana State University Health Sciences ShreveportShreveportLouisiana71103
Shashank Cingam, Site 0218
505-272-4946
Boston Medical CenterBostonMassachusetts02118
Raphael Szalat, Site 0196
617-638-6428
Local Institution - 0219MinneapolisMinnesota55455
Site 0219
Weill Cornell Medical CollegeNew YorkNew York10065
Mateo Mejia Saldarriaga, Site 0229
646-962-6500
Local Institution - 0221Stony BrookNew York11794
Site 0221
Levine Cancer InstituteCharlotteNorth Carolina28204
Barry Paul, Site 0216
704-942-5953
Levine Cancer InstituteCharlotteNorth Carolina28204
Barry Paul, Site 0067
704-942-5953
Cleveland ClinicClevelandOhio44195
Sandra Mazzoni, Site 0193
216-445-2025
Fox Chase Cancer CenterPhiladelphiaPennsylvania19111
Asya Varshavsky-Yanovsky, Site 0097
Local Institution - 0232PittsburghPennsylvania15224
Site 0232
Local Institution - 0227CharlestonSouth Carolina29425
Site 0227
University of Texas MD Anderson Cancer CenterHoustonTexas77030
Oren Pasvolsky, Site 0184
832-728-1403
Huntsman Cancer InstituteSalt Lake CityUtah84112
Brian McClune, Site 0044
801-213-8480
Medical College of WisconsinMilwaukeeWisconsin53226
Othman Akhtar, Site 0195

Find similar trials in Birmingham, AL

By research site
University of Alabama at Birmingham· Birmingham, ALUCLA Hematology/Oncology - Santa Monica· Los Angeles, CAUniversity of California, Irvine (UCI) Health - UC Irvine Medical Center· Orange, CALocal Institution - 0223· Washington D.C., DCBaptist MD Anderson Cancer Center· Jacksonville, FLUniversity of Miami Hospital and Clinics, Sylvester Cancer Center· Miami, FL