NCT06518551

Elotuzumab + Iberdomide + Dexamethasone Post Ide-Cel in RRMM

A Phase I/II Study of Elotuzumab and Iberdomide and Dexamethasone Post Idecabtagene Vicleucel in Relapsed and Refractory Multiple Myeloma

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 49 (estimated)
• Sponsor: Omar Nadeem, MD · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The aim of this research study is to evaluate the efficacy of Elotuzumab and Iberdomide therapy post-Idecabtagene Vicleucel in participants with relapsed and refractory multiple myeloma. The names of the study drugs involved in this study are: * Iberdomide (a type of cereblon E3 ligase modulator) * Elotuzumab (a type of monoclonal antibody) * Dexamethasone (a type of steroid)

Detailed description

This is a phase I/II, open-label, non-randomized, single-stage study to evaluate the efficacy of Elotuzumab and Iberdomide therapy post-Idecabtagene Vicleucel in participants with relapsed and refractory multiple myeloma. Iberdomide has demonstrated some antitumor activity in laboratory studies. The U.S. Food and Drug Administration (FDA) has approved Elotuzumab as a treatment option for Multiple Myeloma. Dexamethasone, also FDA approved, is a type of steroid and is usually combined with other chemotherapy for the treatment of blood cancers, such as myeloma and leukemias. The U.S. Food and Drug Administration (FDA) has not approved Iberdomide as a treatment for Multiple Myeloma. The research study procedures include screening for eligibility, study treatment visits, bone marrow biopsies, blood and urine tests, electrocardiograms (ECGs), X-rays, and Positron Emission Tomography (PET) scans, Computerized Tomography (CT) scans, or Magnetic Resonance Imaging (MRI) scans. It is expected about 49 people will take part in this research study. Bristol-Myers Squibb and Celgene, a BMS company, are supporting this research study by providing study drug and providing funding for the trial.

Conditions

• Myeloma
• Multiple Myeloma
• Refractory Multiple Myeloma

Interventions

Type	Name	Description
DRUG	Elotuzumab	Humanized, recombinant IgG1 monoclonal antibody, 400- and 300-mg single-use vials, via intravenous (into the vein) infusion per protocol.
DRUG	Iberdomide	A cereblon E3 ligase modulator, 0.15mg, 0.2mg, 0.3mg, 0.45mg, 0.6, and 0.75 mg strength capsule taken orally per protocol.
DRUG	Dexamethasone	Synthetic adrenocortical steroid, 2 and 4 mg tablets, taken orally per standard of care.

Timeline

• Start date: 2024-11-01
• Primary completion: 2029-12-31
• Completion: 2034-12-31
• First posted: 2024-07-24
• Last updated: 2025-12-11

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study