A Study of Elotuzumab in Combination With Pomalidomide and Low Dose Dexamethasone and Elotuzumab in Combination With Nivolumab in Patients With Multiple Myeloma Relapsed or Refractory to Prior Treatment With Lenalidomide.

Part of paid clinical trials in Mobile, Alabama.

Sponsor
Bristol-Myers Squibb
Study ID
NCT02612779
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Elotuzumab — DRUG
  • Pomalidomide — DRUG
  • Dexamethasone — DRUG
  • Nivolumab — DRUG

Study Details

Study of elotuzumab in combination with pomalidomide and low dose dexamethasone (EPd Cohort) and elotuzumab in combination with nivolumab (EN Cohort) to assess the safety and efficacy of these combination therapies for treatment of relapsed or refractory MM patients.

Key Dates

Start date
Feb 9, 2016
Status verified
Jun 2021
Primary completion
Jul 29, 2019
Completion
Jun 12, 2020

Study Design

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

Arms

  • Experimental: Elotuzumab + Pomalidamide + Low Dose Dexamethasone (EPd)
    patients will receive treatment with elotuzumab in combination with pomalidomide and low-dose dexamethasone. Patients are eligible to receive Nivolumab at progression.
  • Experimental: Elotuzumab + Nivolumab (EN)
    Patients will receive treatment with a combination of elotuzumab and nivolumab

Primary Outcome Measure

Progression Free Survival (PFS) [ Time Frame: From first dose to study completion date (up to approximately 50 months) ]

Locations (22)

FacilityCityStateZIPSite coordinators
Southern Cancer CenterMobileAlabama36607-
Sansum Clinic - USORSanta BarbaraCalifornia93105-
Colorado Blood Cancer Institute - PPDSDenverColorado80218-
Rocky Mountain Cancer Centers (Williams) - USORDenverColorado80218-
Florida Cancer Specialists - EAST - SCRI - PPDSSt. PetersburgFlorida33705-
Florida Cancer Specialists - NORTH - SCRI - PPDSSt. PetersburgFlorida33705-
Illinois Cancer CarePeoriaIllinois61615-
American Oncology Partners of Maryland, PABethesdaMaryland20817-
Bay Hematology OncologyEastonMaryland21601-
University of MichiganAnn ArborMichigan48109-
Barbara Ann Karmanos Cancer CenterDetroitMichigan48201-
Washington UniversitySt LouisMissouri63110-
Mount Sinai Medical CenterNew YorkNew York10029-
Greenville Health SystemGreenvilleSouth Carolina29615-
Avera Health CareSioux FallsSouth Dakota57105-
Jones Clinic PCGermantownTennessee38138-
Tennessee Oncology NASH - SCRI - PPDSNashvilleTennessee37203-
Texas Oncology (Loop) - USORSan AntonioTexas78217-
Virginia Cancer Specialists (Leesburg) - USORLeesburgVirginia20176-
Swedish Medical CenterSeattleWashington98104-
Cancer Care NorthwestSpokane ValleyWashington99216-
Aurora Health CareBurlingtonWisconsin53105-

Find similar trials in Mobile, AL

By condition
Multiple myeloma
By specialty
OncologyBlood cancer
By research site
Southern Cancer Center· Mobile, ALSansum Clinic - USOR· Santa Barbara, CAColorado Blood Cancer Institute - PPDS· Denver, CORocky Mountain Cancer Centers (Williams) - USOR· Denver, COFlorida Cancer Specialists - EAST - SCRI - PPDS· St. Petersburg, FLFlorida Cancer Specialists - NORTH - SCRI - PPDS· St. Petersburg, FL

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