A Study of Iberdomide (CC-220) in Combination With Elotuzumab and Dexamethasone for Relapsed/Refractory Multiple Myeloma

Part of paid clinical trials in New York, New York.

Sponsor
Icahn School of Medicine at Mount Sinai
Study ID
NCT05560399
Phase
EARLY_PHASE1
Status
Active Not Recruiting

Conditions

Eligibility Criteria

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

Interventions

  • Iberdomide — DRUG
    Route of administration: oral pill. Schedule: Taken Once daily on days 1-21. Dose: will be tested at 1 mg, 1.3 mg, and 1.6mg. 1mg dose may be reduced to 0.75mg if not tolerated.
  • Elotuzumab — DRUG
    Route of administration: IV Dose: 10 mg/kg for cycles 1 and 2. 20 mg/kg for cycle 3 and beyond. Schedule: Days 1, 8, 15, and 22 for cycles 1 and 2. Then taken on Day 1 (every 28 days) of each cycle thereafter.
  • Dexamethasone — DRUG
    Route of administration: Oral pill or IV Dose: 36 mg within 24 hrs of day 1 of each cycle and day 8, 15, and 22 of cycle 1 and 2. 40 mg on days 8, 15, 22 of cycle 3 and all subsequent cycles. (20 mg for \> 75 years old). Schedule: On days that Elotuzumab is administered, Dexamethasone to be taken 28mg orally (for ≤75 years old) or 8mg orally (for \> 75 years old) between 3 and 24 hours before Elotuzumab plus 8 mg IV between 45 and 90 minutes before Elotuzumab for all patients. On days that Elotuzumab is not administered but a dose of Dexamethasone is scheduled (Days 8, 15, and 22 of cycle 3 and all subsequent cycles), 40 mg orally for ≤75 years older and 20 mg for

Study Details

This is a single-arm, open-label study evaluating the safety, tolerability and efficacy of Iberdomide (CC-220) in combination with Elotuzumab and Dexamethasone in patients with RRMM. The researchers hypothesize that the combination of Iberdomide and Elotuzumab will synergize to promote myeloma cell death, resulting in an overall response rate of at least 53%, with an acceptable safety profile. Patients will be enrolled in a 3+3 dose escalation cohort to evaluate the safety of this combination and to establish the MTD (maximum tolerated dose). The MTD will be the dose for the patients enrolled in dose expansion cohort. A total maximum of 37 patients will be recruited: maximum 18 patients will be recruited in the dose escalation phase, followed by an additional 19 patients in the dose expansion cohort for a total of 25 patients treated at the MTD.

Key Dates

Start date
Feb 6, 2023
Status verified
Dec 2025
Primary completion
Nov 30, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
7 participants (estimated)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Iberdomide, Elotuzumab and Dexamethasone
    Dose-Finding: Patients will be enrolled in a 3+3 dose escalation cohort. Dose-Expansion: additionally enrolled patients at the recommended maximum tolerated dose of Iberdomide as was determined in Part 1 (Dose-Finding Phase).

Primary Outcome Measure

Iberdomide dose limiting toxicity [ Time Frame: 28 days ]

Locations (1)

FacilityCityStateZIPSite coordinators
Icahn School of MedicineNew YorkNew York10029-

Find similar trials in New York, NY

By condition
Multiple myeloma
By specialty
OncologyBlood cancer
By research site
Icahn School of Medicine· New York, NY

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