An Investigational Immuno-therapy Study of Nivolumab, Pomalidomide and Dexamethasone Combinations in Patients With Multiple Myeloma

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Bristol-Myers Squibb
Study ID
NCT02726581
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Nivolumab — BIOLOGICAL
    Specified dose on specified days, IV (intravenous)
  • Elotuzumab — BIOLOGICAL
    Specified dose on specified days, IV
  • Pomalidomide — DRUG
    Specified dose on specified days, PO (by mouth)
  • Dexamethasone — DRUG
    Specified dose on specified days, PO

Study Details

The purpose of this study is to evaluate the safety and effectiveness of several combination therapies for Multiple Myeloma. Upon entry into the study, patients will be randomized (assigned by chance) to receive either: Group 1: nivolumab, pomalidomide and dexamethasone OR Group 2: pomalidomide and dexamethasone OR Group 3: nivolumab, elotuzumab, pomalidomide and dexamethasone. Enrollment is closed for all groups.

Key Dates

Start date
Aug 10, 2016
Status verified
Feb 2023
Primary completion
Mar 9, 2022
Completion
Mar 9, 2022

Study Design

Enrollment
170 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Investigational Arm
    Nivolumab, Pomalidomide and Dexamethasone Enrollment is closed for this arm
  • Active Comparator: Control Arm
    Pomalidomide and Dexamethasone Enrollment is closed for this arm
  • Experimental: Exploratory Arm
    Nivolumab, Elotuzumab, Pomalidomide and Dexamethasone Enrollment is closed for this arm

Primary Outcome Measure

Progression Free Survival (PFS) [ Time Frame: From randomization to the date of the first documented tumor progression or death due to any cause, whichever occurred first (Up to approximately 64 month) ]

Locations (72)

FacilityCityStateZIPSite coordinators
Local Institution - 0020BirminghamAlabama35294-3300-
Local Institution - 0160MobileAlabama36608-
Local Institution - 0163FayettevilleArkansas72703-
Local Institution - 0118BakersfieldCalifornia93309-
Local Institution - 0093CoronaCalifornia92879-
Local Institution - 0016Fountain ValleyCalifornia92708-
Local Institution - 0164La JollaCalifornia92037-
UC San Diego Moores Cancer CtrLa JollaCalifornia92093-0698-
Local Institution - 0138Los AngelesCalifornia90017-
Local Institution - 0155Los AngelesCalifornia90095-
Local Institution - 0117Redondo BeachCalifornia90277-
Local Institution - 0092RiversideCalifornia92501-
Coastal Integrative Cancer CareSan Luis ObispoCalifornia93401-
Local Institution - 0113Santa MariaCalifornia93454-
Colorado Blood Cancer InstituteDenverColorado80218-
Poudre Valley Health CareFort CollinsColorado80528-
Local Institution - 0116Grand JunctionColorado81501-
Yale University School Of MedicineNew HavenConnecticut06520-
Local Institution - 0147Washington D.C.District of Columbia20007-
Local Institution - 0011Boynton BeachFlorida33426-
Florida Cancer Specialists S.Fort MyersFlorida33916-
Local Institution - 0114HollywoodFlorida33021-
Cancer Specialists of North FLJacksonvilleFlorida32256-
Local Institution - 0082PensacolaFlorida32504-
Local Institution - 0126St. PetersburgFlorida33705-
Local Institution - 0130TallahasseeFlorida32308-
Local Institution - 0125West Palm BeachFlorida33401-
Local Institution - 0119AthensGeorgia30607-
Local Institution - 0009AtlantaGeorgia30318-
Local Institution - 0024AtlantaGeorgia30322-
Augusta UniversityAugustaGeorgia30912-
Local Institution - 0035ChicagoIllinois60612-
Local Institution - 0111Fort WayneIndiana46845-
Indiana University Cancer CtrIndianapolisIndiana46202-
Local Institution - 0018BethesdaMaryland20817-
Local Institution - 0006BaltimoreMassachusetts21229-
Local Institution - 0123WorcesterMassachusetts01655-
Local Institution - 0150YpsilantiMichigan48197-
Local Institution - 0137HattiesburgMississippi39401-
St. Louis Cancer Care, LlpBridgetonMissouri63044-
Local Institution - 0128Kansas CityMissouri64132-
Local Institution - 0049SpringfieldMissouri65806-
Washington UniversitySt LouisMissouri63110-
Local Institution - 0079LincolnNebraska68510-
Local Institution - 0076FlemingtonNew Jersey08822-
Local Institution - 0002HackensackNew Jersey07601-
Local Institution - 0095New BrunswickNew Jersey08903-
Local Institution - 0142ParamusNew Jersey07652-
Local Institution - 0010BuffaloNew York14263-
Broome Oncology LLCJohnson CityNew York13790-
Local Institution - 0017New YorkNew York10065-
Mount Sinai Medical CenterNew YorkNew York10029-
Local Institution - 0001DurhamNorth Carolina27710-
Local Institution - 0096Winston-SalemNorth Carolina27157-
Local Institution - 0012ColumbusOhio43219-
University Of OklahomaOklahoma CityOklahoma73104-
Local Institution - 0145PortlandOregon97213-
Local Institution - 0136LancasterPennsylvania17604-
Local Institution - 0021PhiladelphiaPennsylvania19104-
Local Institution - 0036SayrePennsylvania18840-
Local Institution - 0152GreenvilleSouth Carolina29605-
Local Institution - 0069GermantownTennessee38138-
Tennessee Oncology, PLLC - SCRI - PPDSNashvilleTennessee37203-
Baylor Research InstituteDallasTexas75246-
Local Institution - 0044HoustonTexas77090-
Local Institution - 0037San AntonioTexas78229-
Local Institution - 0046TempleTexas76508-0001-
Local Institution - 0022OgdenUtah84403-
Local Institution - 0153Salt Lake CityUtah84106-
Emily Couric Clinical Cancer CenterCharlottesvilleVirginia22908-
Virginia Cancer InstituteRichmondVirginia23230-
Local Institution - 0144SeattleWashington98108-

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