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.
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 is a phase II study to 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. Prior to each 28 day cycle, enrolled participants will have health evaluations, well-being assessment and lab tests. Blood and/or urine will be collected for routine tests, disease status and drug effects. Participants will take iberdomide pills by mouth at 1.0 mg PO daily on days 1-21 of each cycle. Treatment will continue until disease progression or toxicity. Participants on study drug at year 1 \& 2 will have bone marrow biopsies to assess the disease. Follow-up visits with similar testing will occur every 12 weeks until disease relapse or progression or another treatment for the disease is begun. Study objectives include determination of the proportion of participant completing one year of maintenance treatment, median progression free survival (PFS), minimal residual disease (MRD)-negativity rate at one year post-study drug initiation, sustained MRD-negativity rate, rate of conversion from MRD-positive to negative; overall survival (OS); and safety profile. The results from this study will inform the feasibility of pursuing a phase 3 study comparing iberdomide to lenalidomide maintenance post-ASCT.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Iberdomide is a novel potent cereblon E3 ligase modulator
University of Nebraska Medical Center
Omaha, Nebraska, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
Proportion of Participants Able to Complete a Minimum of One Year of Ttherapy
The number of eligible participants who remain on study receiving iberdomide for at least one year without disease progression among all eligible study participants who began protocol treatment will be determined.
Time frame: 1 year
Median Progression-free Survival
Progression-free survival (PFS) for all participants will be determined. This defined as the time from enrollment to documentation of disease progression, using 2016 International Myeloma Working Group (IMWG) Response Criteriacriteria, or death without disease progression.
Time frame: 5 years
Minimal Residual Disease-negativity Rate at Day 100
An estimate of the Minimal Residual Disease (MRD)-negativity rate at day 100 post-initiation of maintenance therapy will be made.
Time frame: 100 Days
Minimal Residual Disease-negativity Rate at One Year
An estimate of the Minimal Residual Disease (MRD)-negativity rate at one year post-initiation of maintenance therapy will be made.
Time frame: 1 year
Minimal Residual Disease-negativity Rate at Two Years
An estimate of the Minimal Residual Disease (MRD)-negativity rate at two years post-initiation of maintenance therapy will be made.
Time frame: 2 years
Sustained Minimal Residual Disease-negativity Rate
The sustained Minimal Residual Disease (MRD)-negativity rate, defined as MRD-negativity at study entry and at one year post-initiation of maintenance therapy will be determined.
Time frame: 1 year
Rate of Conversion From Minimal Residual Disease-positive to Minimal Residual Disease-negative
The percentage of participants found to be Minimal Residual Disease (MRD) positive at enrollment and MRD negative at one year post-initiation of maintenance therapy among participants meeting the criteria for MRD-positivity at enrollment will be determined.
Time frame: 1 year
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