RecruitingPhase 2NCT04835129

Isatuximab, Pomalidomide, Elotuzumab and Dexamethasone in Relapsed and/or Refractory Multiple Myeloma

A Multisite, Phase II Study of Isatuximab, Pomalidomide, Elotuzumab and Dexamethasone in Relapsed and/or Refractory Multiple Myeloma


Sponsor

Medical College of Wisconsin

Enrollment

53 participants

Start Date

Jan 10, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

This is a multicenter, open-label phase II study in subjects with relapsed and/or refractory multiple myeloma with at least two prior lines of therapy. The main study consists of three phases: a 28-day screening phase, treatment phase that consists of 28-day cycles of isatuximab with elotuzumab, pomalidomide, and dexamethasone and a follow-up phase.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a four-drug combination — isatuximab, pomalidomide, elotuzumab, and dexamethasone — for people with multiple myeloma (a blood cancer) that has returned or stopped responding to at least two prior treatments. Each drug works through a different mechanism, and combining them may overcome resistance. **You may be eligible if...** - You are 18 years or older - You have multiple myeloma that returned or stopped responding to at least 2 prior treatment regimens, including lenalidomide and a proteasome inhibitor - Your myeloma is measurable by blood or urine protein tests - You are in reasonably good health (ECOG score 0–2) **You may NOT be eligible if...** - You have not tried at least two prior treatments - Your myeloma is not measurable - You have poor organ function (heart, kidneys, liver) - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGIsatuximab (for run-in portion)

10 mg/kg IV on days 2, 8, 15, 22 of cycle 2 and days 1 and 15 of subsequent cycles.

DRUGIsatuximab (for expansion)

10 mg/kg IV on days 2, 8, 15, 22 of cycle 1 and days 1 and 15 of subsequent cycles.

DRUGPomalidomide

4 mg PO days 1-21 of each cycle.

DRUGElotuzumab

10 mg/kg on days 1, 8, 15, 22 of cycles 1 and 2; 20 mg/kg on day 1 of subsequent cycles.

DRUGDexamethasone

40 mg (20 mg if \>75 years) PO or IV on days 1, 8,15 and 22 of each cycle.


Locations(2)

The University of Alabama at Birmingham

Birmingham, Alabama, United States

Froedtert Hospital & the Medical College of Wisconsin

Milwaukee, Wisconsin, United States

View Full Details on ClinicalTrials.gov

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NCT04835129


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