Isatuximab, Carfilzomib, and Pomalidomide for the Treatment of Relapsed or Refractory Multiple Myeloma

Recurrent Plasma Cell Myeloma Clinical Trial

Official title: A Single-Arm Phase II Study of Isatuximab With Carfilzomib and Pomalidomide in Relapsed or Refractory Multiple Myeloma

Status Active, not recruiting

Clinical Trial Summary

This phase II trial studies the effect of isatuximab, carfilzomib, and pomalidomide in treating patients with multiple myeloma that has come back (relapsed) or does not respond to treatment (refractory). Isatuximab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Carfilzomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Chemotherapy drugs, such as pomalidomide, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving isatuximab, carfilzomib, and pomalidomide may help treat patients with multiple myeloma.

Clinical Trial Description

PRIMARY OBJECTIVE:

I. To assess the rate of response following treatment with isatuximab combined with carfilzomib and pomalidomide (isatuximab [Isa] carfilzomib [Car] pomalidomide [Pom]).

SECONDARY OBJECTIVES:

I. To evaluate the safety profile of the IsaCarPom combination. II. To assess duration of disease response following treatment with the IsaCarPom regimen.

III. To assess depth of IsaCarPom treatment as it relates to timing of subsequent therapies.

IV. To assess progression-free survival associated with IsaCarPom. V. To assess overall survival associated with IsaCarPom.

EXPLORATORY OBJECTIVE:

I. To molecularly assess the depth of IsaCarPom treatment by measuring minimal residual disease (MRD).

OUTLINE:

Patients receive isatuximab intravenously (IV) over 30-60 minutes on days 1, 8, 15, and 22 of cycle 1, and days 1 and 15 of subsequent cycles, carfilzomib IV over 10 to 30 minutes on days 1, 8, 15, and pomalidomide orally (PO) once daily (QD) on days 1-21. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 12 weeks for up to 24 months. ;

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell
• Recurrent Plasma Cell Myeloma
• Refractory Plasma Cell Myeloma

• NCT number: NCT04850599
• Study type: Interventional
• Source: OHSU Knight Cancer Institute
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: June 14, 2022
• Completion date: February 21, 2029