Trials / Active Not Recruiting
Active Not RecruitingNCT04564703
Iberdomide (Cc220) Maintenance After Asct in Newly Diagnosed MM Patients
Phase II Study of Iberdomide (Cc220) Maintenance After Autologous Stem Cell Transplantation in Newly Diagnosed Multiple Myeloma Patients
- Status
- Active Not Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 160 (estimated)
- Sponsor
- Stichting European Myeloma Network · Network
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a phase II study to evaluate the efficacy and safety of different doses of iberdomide continuous therapy as maintenancetreatment after transplant.
Detailed description
This is a phase II study with two parallel cohorts of newly diagnosed multiple myeloma (NDMM) patients in at least partial response (PR) after induction with proteasome inhibitors (PIs) plus IMIDs and single or double ASCT Subjects will receive two dose levels of Iberdomide, they will be evaluated for efficacy and safety. In case, in one cohort will be registered unacceptable toxicity, a third cohort will be opened. Subjects will receive treatment until progression, intolerance or unacceptable toxicity. Subsequently subjects will be followed for 24 months. The maximum number of subjects is 130 for cohort 1 and 2, 160 in case a third cohort will be opened.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Iberdomide | IBERDOMIDE (CC220) IN MAINTENANCE AFTER AUTOLOGOUS STEM CELL TRANSPLANTION IN NEWLY DIAGNOSED MULTIPLE MYELOMA PATIENTS |
Timeline
- Start date
- 2021-02-22
- Primary completion
- 2023-07-27
- Completion
- 2027-12-01
- First posted
- 2020-09-25
- Last updated
- 2025-02-25
Locations
4 sites across 4 countries: France, Greece, Italy, Netherlands
Source: ClinicalTrials.gov record NCT04564703. Inclusion in this directory is not an endorsement.