COMbination Regimens in MM Post AHCT to elimiNate MRD Utilizing IbERdomide

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
University of Alabama at Birmingham
Study ID
NCT05434689
Phase
PHASE1/PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

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

Interventions

  • Iberdomide — DRUG
    Iberdomide (Iber, CC-220) is a novel cereblon E3 ligase modulator (CELMoD) in development for treatment of multiple myeloma and other conditions.
  • Daratumumab — DRUG
    Anti-CD 38 monoclonal antibody established in the treatment of multiple myeloma
  • Dexamethasone — DRUG
    Corticosteroid active against multiple myeloma in combination with other agents
  • Carfilzomib — DRUG
    Second generation proteasome inhibitor with activity in multiple myeloma

Study Details

Similar to the paradigm established in other hematologic malignancies that are considered curable, the achievement of MRD(-) status is necessary for long term disease control in MM. The fact that the majority of patients remain MRD (+) after induction therapy and AHCT points to the opportunity to deploy novel agents with complementary mechanism of action and favorable toxicity profile to reach and maintain MRD (-) status. Given its favorable toxicity profile, the convenience of oral administration, and compelling single agent activity even in heavily pretreated MM, iberdomide is likely amenable to long term therapy in patients with high-risk of relapse/progression identified by the persistence of MRD(+). The investigators intend to develop combination(s) of iberdomide with other agents with complementary mechanism of action in the consolidation setting post AHCT in order to achieve and sustain MRD (-).

Key Dates

Start date
Jan 18, 2023
Status verified
May 2026
Primary completion
Aug 31, 2028
Completion
Aug 31, 2028

Study Design

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

Arms

  • Experimental: Iberdomide, Daratumumab and Dexamethasone (Regimen A)
    Iberdomide dosed according to cohort assignment days 1-21. Dexamethasone 40 mg oral or intravenously (20 mg for participants 70 or older) on days 1,8,15 and 22 Darartumumab and hyalurnonidase-fihj 1,800mg/30,000 units subcutaneously on days 1,8,15,22 (cycles 1,2) or on days 1,15 (cycles 3-6)
  • Experimental: Iberdomide, Carfilzomib, Daratumumab and Dexamethasone (Regimen B)
    Iberdomide dosed according to cohort assignment days 1-21. Dexamethasone 40 mg oral or intravenously (20 mg for participants 70 or older) on days 1,8,15 and 22 Darartumumab and hyalurnonidase-fihj 1,800mg/30,000 units subcutaneously on days 1,8,15,22 (cycles 1,2) or on days 1,15 (cycles 3-6) Carfilzomib dosed intravenously dosed according to cohort assignment on days 1, 8, 15 (Consistent with standard practice, the very first dose of carfilzomib (cycle 1 day 1) must be 20 mg/m\^2).

Primary Outcome Measure

Dose limiting toxicity [ Time Frame: One year ]

Locations (4)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35233-
Ohio State University Medical CollegeColumbusOhio43210-
Oregon Health and Science UniversityPortlandOregon97239-
University of WisconsinMadisonWisconsin53705-

Find similar trials in Birmingham, AL

By condition
Multiple myeloma
By specialty
OncologyBlood cancer
By research site
University of Alabama at Birmingham· Birmingham, ALOhio State University Medical College· Columbus, OHOregon Health and Science University· Portland, ORUniversity of Wisconsin· Madison, WI

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