A Study to Determine the Recommended Dose and Regimen and to Evaluate the Safety and Preliminary Efficacy of CC-92480 in Combination With Standard Treatments in Participants With Relapsed or Refractory Multiple Myeloma (RRMM) and Newly Diagnosed Multiple Myeloma (NDMM)

Part of paid clinical trials in Denver, Colorado.

Sponsor
Celgene
Study ID
NCT03989414
Phase
PHASE1/PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

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

Interventions

  • CC-92480 — DRUG
    Specified dose on specified days
  • Bortezomib — DRUG
    Specified dose on specified days
  • Dexamethasone — DRUG
    Specified dose on specified days
  • Daratumumab — DRUG
    Specified dose on specified days
  • Carfilzomib — DRUG
    Specified dose on specified days
  • Elotuzumab — DRUG
    Specified dose on specified days
  • Isatuximab — DRUG
    Specified dose on specified days
  • Carfilzomib — DRUG
    Specified dose on specified days

Study Details

The purpose of this study is to evaluate the safety and preliminary efficacy of CC-92480 in combination with standard treatments.

Key Dates

Start date
Sep 30, 2019
Status verified
Oct 2024
Primary completion
Nov 30, 2026
Completion
Nov 30, 2026

Study Design

Enrollment
424 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort A: CC-92480 with bortezomib and dexamethasone
  • Experimental: Cohort C: CC-92480 with carfilzomib and dexamethasone
  • Experimental: Cohort H: CC-92480 with elotuzumab and dexamethasone
  • Experimental: Cohort I: CC-92480 with isatuximab and dexamethasone
  • Experimental: Cohort D: CC-92480 with bortezomib and dexamethasone
  • Experimental: Cohort F: CC-92480 with carfilzomib and dexamethasone
  • Experimental: Cohort J: CC-92480 with elotuzumab and dexamethasone
  • Experimental: Cohort K: CC-92480 with isatuximab and dexamethasone
  • Experimental: Cohort G: CC-92480 with bortezomib and dexamethasone
  • Experimental: Subcohort B1: CC-92480 with daratumumab and dexamethasone
  • Experimental: Subcohort B2: CC-92480 with daratumumab and dexamethasone
  • Experimental: Subcohort B3: CC-92480 with daratumumab and dexamethasone
  • Experimental: Subcohort E1: CC-92480 with daratumumab and dexamethasone
  • Experimental: Subcohort E2: CC-92480 with daratumumab and dexamethasone
  • Experimental: Subcohort E3: CC-92480 with daratumumab and dexamethasone

Primary Outcome Measure

Recommended Dose [ Time Frame: Up to approximately 3 years ]

Locations (16)

FacilityCityStateZIPSite coordinators
Local Institution - 119DenverColorado80218-
Local Institution - 104TampaFlorida33612-
Local Institution - 108AtlantaGeorgia30322-
Local Institution - 107ChicagoIllinois60637-
Local Institution - 112ChicagoIllinois60611-
Local Institution - 101BostonMassachusetts02115-
Local Institution - 117BostonMassachusetts02114-
Local Institution - 118BostonMassachusetts02215-
Local Institution - 113DetroitMichigan48201-
Local Institution - 106RochesterMinnesota55905-
Hackensack University Medical CenterHackensackNew Jersey07601-
Local Institution - 110Winston-SalemNorth Carolina27157-
Local Institution - 115ColumbusOhio43210-
Local Institution - 114NashvilleTennessee37203-
Local Institution - 116HoustonTexas77030-
Swedish Cancer InstituteSeattleWashington98104-

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