Ignite Creation Date:
2025-12-24 @ 7:44 PM
Ignite Modification Date:
2025-12-29 @ 5:43 AM
Study NCT ID:
NCT04564703
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-02-25
First Post:
2020-09-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Iberdomide (Cc220) Maintenance After Asct in Newly Diagnosed MM Patients
Sponsor:
Stichting European Myeloma Network
Organization:
Study Overview
Official Title:
Phase II Study of Iberdomide (Cc220) Maintenance After Autologous Stem Cell Transplantation in Newly Diagnosed Multiple Myeloma Patients
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: