Continuing Treatment for Participants Who Have Participated in a Prior Protocol Investigating Elotuzumab

Part of paid clinical trials in Tucson, Arizona.

Sponsor
Bristol-Myers Squibb
Study ID
NCT02719613
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Elotuzumab — DRUG
    Patients will continue to receive treatment with the investigational study drug by intravenous (IV) solution administration at the last dose and schedule received in the previous study.
  • Dexamethasone — DRUG
    Patients will continue to receive treatment with non-investigational study drug by oral tablet administration at the last dose and schedule received in the previous study.
  • Dexamethasone — DRUG
    Patients will continue to receive treatment with non-investigational study drug by intravenous (IV) solution administration at the last dose and schedule received in the previous study.
  • Lenalidomide — DRUG
    Patients will continue to receive treatment with non-investigational study drug by oral capsule administration at the last dose and schedule received in the previous study.
  • Bortezomib — DRUG
    Patients will continue to receive treatment with non-investigational study drug by intravenous (IV) or subcutaneous injection solution administration at the last dose and schedule received in the previous study.
  • Pomalidomide — DRUG
    Patients will continue to receive treatment with non-investigational study drug by oral capsule administration at the last dose and schedule received in the previous study.
  • Nivolumab — DRUG
    Patients will continue to receive treatment with the investigational study drug by intravenous (IV) solution administration at the last dose and schedule received in the previous study.

Study Details

The purpose of this study is to continue to provide elotuzumab and/or other study drugs to participants who have participated on a prior protocol investigating elotuzumab who are not able to receive commercial drug supply.

Key Dates

Start date
Jul 15, 2016
Status verified
Apr 2026
Primary completion
Feb 23, 2026
Completion
Feb 23, 2026

Study Design

Enrollment
67 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Elotuzumab
    This is a continuation roll-over study for patients receiving benefit from prior elotuzumab protocols. All participants will receive elotuzumab and/or other study drugs as per previous protocol.

Primary Outcome Measure

The number of participants who received at least one dose of elotuzumab or backbone therapy (other study drugs) and the duration of treatment will be collected. [ Time Frame: Maximum duration is until all participants have discontinued study drugs, or until all participants are treated for up to 2 years, unless BMS chooses to extend the study. ]

Locations (14)

FacilityCityStateZIPSite coordinators
Local Institution - 0020TucsonArizona85715-
Local Institution - 0017BakersfieldCalifornia93309-
Local Institution - 0022Fountain ValleyCalifornia92708-
Local Institution - 0016West HollywoodCalifornia90069-
Local Institution - 0019DenverColorado80218-
Local Institution - 0021JacksonvilleFlorida32256-
Local Institution - 0042St. PetersburgFlorida33705-
Local Institution - 0009AtlantaGeorgia30322-
Local Institution - 0003IndianapolisIndiana46260-
Local Institution - 0002BostonMassachusetts02215-
Local Institution - 0008St LouisMissouri63110-
Local Institution - 0004New YorkNew York10029-
Local Institution - 0001BethlehemPennsylvania18015-
Local Institution - 0018DallasTexas75231-

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