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

Part of paid clinical trials in West Hollywood, California.

Sponsor
Oncotherapeutics
Study ID
NCT06115135
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Multiple Myeloma in Relapse
  • Multiple Myeloma, Refractory

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • Venetoclax — DRUG
    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.

Study Details

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

Key Dates

Start date
Jun 20, 2024
Status verified
Jan 2025
Primary completion
Apr 30, 2026
Completion
Dec 31, 2027

Study Design

Enrollment
39 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: open-label
    This is a Phase 2, multicenter, open-label study evaluating the safety and efficacy of venetoclax in combination with isatuximab and dexamethasone among RRMM patients who show the t(11;14) marker and currently show PD and have received at least 3 prior lines of therapy for multiple myeloma. 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 where day 8 and 22 doses may be administered PO; 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. The primary safety analysis will focus on determining the DLTs for the study regimen, and occurrence of AEs throughout the study.

Primary Outcome Measure

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

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Berenson Cancer CenterWest HollywoodCalifornia90069
Marceya Soto
[email protected]
310-623-1218
Victor Tellez
[email protected]
310-623-1218
James Berenson, MD (PRINCIPAL_INVESTIGATOR)
Nebraska Cancer SpecialistsOmahaNebraska68130
Ashley Servais, MPH
[email protected]
402-955-2691
Joel Michalski, MD, PhD (PRINCIPAL_INVESTIGATOR)

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Berenson Cancer Center· West Hollywood, CANebraska Cancer Specialists· Omaha, NE

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