Iberdomide (Cc220) Maintenance After Asct in Newly Diagnosed MM Patients

Sponsor
Stichting European Myeloma Network
Study ID
NCT04564703
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Iberdomide — DRUG
    IBERDOMIDE (CC220) IN MAINTENANCE AFTER AUTOLOGOUS STEM CELL TRANSPLANTION IN NEWLY DIAGNOSED MULTIPLE MYELOMA PATIENTS

Study Details

This is a phase II study to evaluate the efficacy and safety of different doses of iberdomide continuous therapy as maintenancetreatment after transplant.

Key Dates

Start date
Feb 22, 2021
Status verified
Feb 2025
Primary completion
Jul 27, 2023
Completion
Dec 31, 2027

Study Design

Enrollment
160 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: cohort 1
    Iberdomide will be given orally at 1.3 mg/day, from day 1 to 21 of a 28-day cycle, continuously, until progressive disease (PD) or unacceptable toxicity.
  • Experimental: cohort 2
    Iberdomide will be given orally at 1.0 mg/day, from day 1 to 21 of a 28-day cycle, continuously, until progressive disease (PD) or unacceptable toxicity.
  • Experimental: cohort 3
    Iberdomide will be given orally at 0.75 mg/day, from day 1 to 21 of a 28-day cycle, continuously, until progressive disease (PD) or unacceptable toxicity.

Primary Outcome Measure

Efficacy: rate of improvement in response with iberdomide maintenance after autologous stem cell transplantation (ASCT) [ Time Frame: 6 months of treatment ]

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