Iberdomide Maintenance Therapy for Patients with Multiple Myeloma
Sponsor: University of Nebraska
ClinicalTrials ID:NCT05177536
This clinical trial is exploring the use of iberdomide as a maintenance therapy for patients with multiple myeloma who have undergone an autologous stem cell transplant (ASCT). The study aims to assess the safety and effectiveness of this treatment until the disease progresses or side effects occur.
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Program Overview
The purpose of this study is to evaluate the safety and effectiveness of iberdomide as a maintenance therapy for patients with multiple myeloma who have had an autologous stem cell transplant (ASCT). Participants will take iberdomide daily for 21 days in a 28-day cycle, continuing until the disease progresses or side effects become too severe. The study will include up to 38 participants and will help determine if a larger study comparing iberdomide to another drug, lenalidomide, is feasible.
Description
This phase II study is designed to test the feasibility, safety, and effectiveness of iberdomide as a maintenance therapy for patients with multiple myeloma who have undergone an autologous stem cell transplant (ASCT). Participants will take iberdomide at a dose of 1.0 mg by mouth daily for 21 days in a 28-day cycle. Treatment will continue until the disease progresses or side effects become too severe. Up to 38 participants will be enrolled in the study. The results will help determine if a larger phase III study comparing iberdomide to lenalidomide as a maintenance therapy after ASCT is feasible.
Eligibility Criteria
Inclusion Criteria
- Be 18 years or older (19 in Nebraska) and able to provide informed consent.
- Have a documented history of active multiple myeloma with measurable disease at diagnosis.
- Have started induction therapy within 12 months of registration and not experienced disease progression after initial therapy.
- Have undergone ASCT with high-dose melphalan and be in partial response or better at day 80-110 post-ASCT.
- Have an ECOG performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
- Women of childbearing potential must have two negative pregnancy tests before starting treatment and agree to ongoing pregnancy testing and use of effective contraception.
- Men must agree to use a condom during sexual contact with women of childbearing potential and refrain from donating sperm during and after treatment.
- All participants must agree to refrain from donating blood during and after treatment and follow the Pregnancy Prevention Program requirements.
Exclusion Criteria
- Participation in another clinical study with an investigational product within the last 28 days.
- Women who are pregnant, nursing, or planning to become pregnant during the study.
- Significant medical or psychiatric conditions that would prevent participation.
- Disease progression after ASCT before registration.
- Nonsecretory multiple myeloma or plasma cell leukemia.
- Certain laboratory abnormalities or serious kidney impairment.
- Peripheral neuropathy of grade 2 or higher.
- Gastrointestinal disease affecting medication absorption.
- History of other cancers unless disease-free for 5 years, with some exceptions.
- History of severe allergic reactions to similar drugs.
- Recent use of certain treatments or medications, including strong CYP3A4/5 inhibitors or inducers.
- Positive test for HIV, hepatitis B, or active hepatitis A or C.
- Prior therapy with iberdomide.
- Inability or unwillingness to follow required thromboembolism prevention measures.
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