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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

TypeNameDescription
DRUGIberdomideIBERDOMIDE (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.

Iberdomide (Cc220) Maintenance After Asct in Newly Diagnosed MM Patients (NCT04564703) · Clinical Trials Directory