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Venetoclax, Isatuximab, and Dexamethasone for Relapsed/Refractory Multiple Myeloma

This study is testing a combination of three medicines – venetoclax, isatuximab, and dexamethasone – for people with multiple myeloma that has come back (relapsed) or isn't responding to other treatments (refractory). Venetoclax works by targeting a protein called BCL-2, which is often high in multiple myeloma, especially in patients with a specific genetic change called t(11;14). Isatuximab is a monoclonal antibody, and dexamethasone is a steroid commonly used in cancer treatment. The study aims to see how safe and effective this combination is, measuring things like side effects and how many patients respond to the treatment. To join, you must have a diagnosis of multiple myeloma with specific criteria, including a certain percentage of plasma cells in your bone marrow or a biopsy-proven tumor. The study plans to enroll 39 participants.

Study design
This is a Phase 2 interventional study, meaning all participants will receive the study treatment. It plans to enroll 39 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for safety and how well the treatment works for up to 54 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06115135

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

Recruiting
PHASE2All AgesInterventionalTreatment
Oncotherapeutics
~39 participants
Updated 2025-01-16 on ClinicalTrials.gov
What's tested:Venetoclax

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of Treatment-Emergent Adverse Events [Safety]
Measured over [Time Frame: 54 months]
+2 more outcomes measured

Conditions

Multiple Myeloma in Relapse
Multiple Myeloma, Refractory

Explore related trials

Multiple Myelomat(11;14)

Where it's being run

2 sites across 2 states
California1
Nebraska1

Study leadership

  • James Berenson, MD · PRINCIPAL_INVESTIGATOR · Oncotherapeutics

Who to contact

Richard Bailey
[email protected]
(310) 464-2190
Email the study team

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What this trial measures

  • Incidence of Treatment-Emergent Adverse Events [Safety][Time Frame: 54 months]

    Safety will be measured by counting the occurrence of adverse events throughout the study, graded via Common Terminology Criteria for Adverse Events (CTCAE) v 5.0 criteria

  • Overall response rate (ORR) as a measure of efficacy[Time Frame: 54 months]

    To assess the overall response rate (ORR = CR + VGPR + PR)

  • Clinical benefit rate (CBR) as a measure of efficacy[Time Frame: 54 months]

    (CBR = CR + VGPR + PR + MR)