Iberdomide (Cc220) Maintenance After Asct in Newly Diagnosed MM Patients (NCT04564703) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Iberdomide (Cc220) Maintenance After Asct in Newly Diagnosed MM Patients
France, Greece, Italy160 participantsStarted 2021-02-22
Plain-language summary
This is a phase II study to evaluate the efficacy and safety of different doses of iberdomide continuous therapy as maintenancetreatment after transplant.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Have two negative pregnancy tests as verified by the Investigator prior to starting study treatment. She must agree to ongoing pregnancy testing during the course of the study, and after end of study treatment. This applies even if the subject practices true abstinence\* from heterosexual contact.
. Either commit to true abstinence\* from heterosexual contact (which must be reviewed on a monthly basis and source documented) or agree to use, and be able to comply with two forms of contraception: one highly effective, and one additional effective (barrier) measure of contraception without interruption 28 days prior to starting investigational product, during the study treatment (including dose interruptions), and for at least 28 days after the last dose of CC-220, 90 days after the last dose of cyclophosphamide, whichever is longer. Contraception requirements are detailed in Appendix H.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is testing iberdomide as a maintenance therapy after an autologous stem cell transplant — is a stem cell transplant still the right path for my situation, and if so, could maintenance with iberdomide be something worth discussing for after my transplant?
2Since this is a Phase 2 trial, the safety and effectiveness data are still being gathered — what do we know so far about how well patients are tolerating iberdomide at maintenance doses, and are there side effects I should be especially aware of?
3One of the main things this trial is measuring is how often patients need dose reductions or have to stop iberdomide altogether — what does that tell us about how manageable this drug might be to take long-term?
4The trial is actively enrolling but no longer recruiting new participants — does that mean there are still ways for me to access iberdomide maintenance, such as through expanded access or other studies, if my doctor thinks it could be a good fit?
5How does iberdomide maintenance compare to standard maintenance options like lenalidomide after a stem cell transplant, and is there a reason my care team might prefer one over the other given my specific diagnosis?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Efficacy: rate of improvement in response with iberdomide maintenance after autologous stem cell transplantation (ASCT)
Timeframe: 6 months of treatment
2
Rate of dose reductions/discontinuations with iberdomide maintenance after ASCT