Open-label Study Comparing Iberdomide, Daratumumab and Dexamethasone (IberDd) Versus Daratumumab, Bortezomib, and Dexamethasone (DVd) in Participants With Relapsed or Refractory Multiple Myeloma (RRMM)

Part of paid clinical trials in Hot Springs, Arkansas.

Sponsor
Celgene
Study ID
NCT04975997
Phase
PHASE3
Status
Active Not Recruiting

Conditions

Eligibility Criteria

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

Interventions

  • Dexamethasone — DRUG
    Oral dexamethasone 40mg on days 1, 8, 15, 22 of a 28-day cycle
  • Daratumumab — DRUG
    Subcutaneous Daratumumab 1800mg on Days 1, 8, 15 and 22 for Cycles 1 to 2, on Days 1 and 15 for Cycles 3 to 6, and then on Day 1 for Cycle 7+ of a 28-day cycle
  • Bortezomib — DRUG
    Subcutaneous Bortezomib 1.3 mg/m2 on Days 1, 4, 8 and 11 of each 21-day cycle for a total of 8 cycles.
  • Iberdomide — DRUG
    Oral Iberdomide 1.0mg on Days 1 to 21 of a 28-day cycle
  • Iberdomide — DRUG
    Oral Iberdomide 1.3mg on Days 1 to 21 of a 28-day cycle
  • Iberdomide — DRUG
    Oral Iberdomide 1.6mg on Days 1 to 21 of a 28-day cycle
  • Dexamethasone — DRUG
    Oral dexamethasone 20mg on days 1,2, 4,5,8,9,11,12 of a 21-day cycle from cycles 1-8
  • Daratumumab — DRUG
    Subcutaneous daratumumab 1800mg Cycles 1 to 3 on Days 1, 8, 15 of a 21-day cycle, Cycles 4 to 8 on Day 1 of a 21-day cycle and Cycles 9+ on Day 1 of a 28-day cycle.

Study Details

This is a multicenter, two-stage, randomized, controlled, open-label, Phase 3 study comparing the efficacy and safety of iberdomide in combination with dexamethasone and daratumumab (IberDd) versus daratumumab, bortezomib, and dexamethasone (DVd) in participants with relapsed or refractory multiple myeloma (RRMM).

Key Dates

Start date
Jun 23, 2022
Status verified
Mar 2026
Primary completion
Nov 16, 2027
Completion
Jun 25, 2032

Study Design

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

Arms

  • Experimental: Daratumumab in combination with Iberdomide and dexamethasone - Dose 1
    Participants will receive oral iberdomide, subcutaneous daratumumab and oral dexamethasone.
  • Experimental: Daratumumab in combination with Iberdomide and dexamethasone - Dose 2
  • Experimental: Daratumumab in combination with Iberdomide and dexamethasone - Dose 3
  • Active Comparator: Daratumumab in combination with dexamethasone and bortezomib
    Participants will receive subcutaneous daratumumab, bortezomib and oral dexamethasone

Primary Outcome Measure

Progression-free Survival (PFS) [ Time Frame: Up to approximately 5 years ]

Locations (43)

FacilityCityStateZIPSite coordinators
Local Institution - 035Hot SpringsArkansas71913-
Local Institution - 641CerritosCalifornia90703-2679-
Local Institution - 681Fountain ValleyCalifornia92708-
Local Institution - 047Los AngelesCalifornia90033-
Local Institution - 684NewportCalifornia92663-
Local Institution - 033New HavenConnecticut06511-
Local Institution - 029Fort MyersFlorida33901-
Local Institution - 693OcalaFlorida34471-6950-
Local Institution - 028St. PetersburgFlorida33705-
Local Institution - 045TamaracFlorida33321-2909-
Local Institution - 034West Palm BeachFlorida33401-
Local Institution - 685WestonFlorida33331-3609-
Local Institution - 018AtlantaGeorgia30322-
Local Institution - 640Elk Grove VillageIllinois60007-3363-
Local Institution - 697DyerIndiana46311-1596-
Local Institution - 040LouisvilleKentucky40207-
Local Institution - 041AlexandriaLouisiana71301-3841-
Local Institution - 027Baton RougeLouisiana70809-3675-
Local Institution - 682Baton RougeLouisiana70808-4300-
Local Institution - 698BaltimoreMaryland21204-6826-
Local Institution - 014BethesdaMaryland20817-
Local Institution - 688ColumbiaMaryland21044-3128-
Local Institution - 010BostonMassachusetts02215-
Local Institution - 009WorcesterMassachusetts01655-
Local Institution - 645BurnsvilleMinnesota55337-6749-
Local Institution - 031Kansas CityMissouri64132-
Local Institution - 046BillingsMontana59102-6746-
Local Institution - 015SummitNew Jersey07901-
Local Institution - 691New YorkNew York10016-
Local Institution - 039DurhamNorth Carolina27705-
Local Institution - 038CincinnatiOhio45220-
Local Institution - 008ClevelandOhio44195-
Local Institution - 037ClevelandOhio44109-
Local Institution - 036ColumbusOhio43214-
Local Institution - 680TulsaOklahoma74146-6236-
Local Institution - 043PortlandOregon97239-
Local Institution - 030ChattanoogaTennessee37404-
Local Institution - 021NashvilleTennessee37203-
Local Institution - 687AustinTexas78705-1165-
Local Institution - 695HoustonTexas77025-
Local Institution - 642Newport NewsVirginia23606-3069-
Local Institution - 643RoanokeVirginia24014-2419-
Local Institution - 025MadisonWisconsin53705-

Find similar trials in Hot Springs, AR

By condition
Multiple myeloma
By specialty
OncologyBlood cancer
By research site
Local Institution - 035· Hot Springs, ARLocal Institution - 641· Cerritos, CALocal Institution - 681· Fountain Valley, CALocal Institution - 047· Los Angeles, CALocal Institution - 684· Newport, CALocal Institution - 033· New Haven, CT

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