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

NCT05560399 · Status: ACTIVE_NOT_RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2026-01-02

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Iberdomide

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.

DRUG

Elotuzumab

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.

DRUG

Dexamethasone

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

Sponsors & Collaborators

Principal Investigators

  • Samir Parekh, MBBS · Icahn school of medicine

  • Cesar Rodriguez, MD · Icahn School of Medicine

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-06
Primary Completion
2026-11-30
Completion
2026-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05560399 on ClinicalTrials.gov