RecruitingPhase 2NCT06115135

A Study of Venetoclax in Combination With Isatuximab and Dexamethasone for Relapsed/Refractory Multiple Myeloma

A Phase 2 Study of Venetoclax in Combination With Isatuximab and Dexamethasone for Relapsed/Refractory Multiple Myeloma Patients With t(11;14)


Sponsor

Oncotherapeutics

Enrollment

39 participants

Start Date

Jun 20, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

A phase 2 study of venetoclax in combination with isatuximab and dexamethasone for relapsed/refractory multiple myeloma patients with t(11;14)


Eligibility

Plain Language Summary

Simplified for easier understanding

This study tests a three-drug combination — venetoclax, isatuximab, and dexamethasone — in patients with multiple myeloma (a blood cancer) that has come back or stopped responding to previous treatments. This combination targets cancer cells in multiple ways to overcome drug resistance. **You may be eligible if:** - You have a confirmed diagnosis of multiple myeloma - Your cancer has relapsed (come back) or is refractory (stopped responding) to prior treatment - You have received at least one prior line of therapy - You have adequate organ function - You are in generally acceptable health **You may NOT be eligible if:** - You have never been treated for myeloma - You have active, uncontrolled infections - You have certain heart, liver, or kidney problems - You are pregnant or breastfeeding - You have had prior treatment with venetoclax 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

DRUGVenetoclax

All subjects in Dose Level 0 will receive 1) venetoclax, PO, at 400 mg every day (QD) on Days 1-28 of a 28-day cycle, 2) dexamethasone 40 mg IV, once weekly on Days 1, 8, 15, and 22 of a 28-day cycle; and 3) isatuximab 10mg/kg, IV, on Days 1, 8, 15, and 22 of the first 28-day cycle, and then Days 1 and 15 during subsequent 28-day cycles.


Locations(2)

Berenson Cancer Center

West Hollywood, California, United States

Nebraska Cancer Specialists

Omaha, Nebraska, United States

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NCT06115135


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