Iberdomide Maintenance Therapy in Patients With Multiple Myeloma

Part of paid clinical trials in Omaha, Nebraska.

Sponsor
University of Nebraska
Study ID
NCT05177536
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

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

Interventions

  • Iberdomide — DRUG
    Iberdomide is a novel potent cereblon E3 ligase modulator

Study Details

Lenalidomide maintenance therapy following autologous stem cell transplant (ASCT) is standard of care for patients with multiple myeloma. However, nearly all patients will experience disease relapse and lenalidomide's toxicity profile leads to treatment discontinuation in 30% of patients after one year. Iberdomide is a novel potent cereblon E3 ligase modulator with a favorable side effect profile. Investigators hypothesize that iberdomide maintenance therapy may result in at least 80% of subjects completing one year of maintenance. This study will determine the feasibility, safety and efficacy of iberdomide maintenance therapy post-autologous stem cell transplant (ASCT). Around day 100 after ASCT, patients will be assessed to determine study eligibility. Enrolled participants will take iberdomide pills by mouth on days 1-21 of each 28 day cycle. Physical exams, well-being status and blood and/or urine sampling will be conducted and evaluated before each cycle. Treatment will continue until disease progression or toxicity. Follow-up visits with similar testing will occur every 12 weeks until disease relapse or progression or another treatment for the disease is begun.The results from this study will inform the feasibility of pursuing a study comparing iberdomide to lenalidomide maintenance post-ASCT.

Key Dates

Start date
Jun 14, 2022
Status verified
Jun 2026
Primary completion
Jan 2, 2026
Completion
Jan 31, 2031

Study Design

Enrollment
40 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Iberdomide
    Iberdomide will be dosed at 1.0 mg orally daily on days 1-21 of a 28-day cycle

Primary Outcome Measure

Proportion of Participants Able to Complete a Minimum of One Year of Ttherapy [ Time Frame: 1 year ]

Locations (2)

FacilityCityStateZIPSite coordinators
University of Nebraska Medical CenterOmahaNebraska68198-
Roswell Park Cancer InstituteBuffaloNew York14263-

Find similar trials in Omaha, NE

By condition
Multiple myeloma
By specialty
OncologyBlood cancer
By research site
University of Nebraska Medical Center· Omaha, NERoswell Park Cancer Institute· Buffalo, NY

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