Actively Recruiting

Phase 2
All Genders
ID06115135

Study of Venetoclax with Isatuximab and Dexamethasone for Relapsed/Refractory Multiple Myeloma Patients with t(11;14) Chromosomal Marker

Led by Oncotherapeutics · Updated on 2025-01-16

39

Participants Needed

2

Research Sites

184 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating a combination treatment involving venetoclax, isatuximab, and dexamethasone for patients with relapsed or refractory multiple myeloma (MM) who have the t(11;14) chromosomal translocation. This phase 2 trial focuses on patients with this specific genetic marker, which is found in about 20% of MM cases, and aims to assess the safety and effectiveness of this combination after previous treatments have failed. The study builds on prior evidence that venetoclax, an oral BCL-2 protein inhibitor, shows activity in MM patients, especially those with t(11;14), and that monoclonal antibodies like isatuximab have demonstrated clinical benefits in this disease. Participants in the study will receive venetoclax orally at 400 mg daily during 28-day cycles, along with intravenous dexamethasone 40 mg weekly and isatuximab 10 mg/kg intravenously on a specific schedule—weekly during the first cycle and twice per cycle thereafter. This regimen is designed to evaluate how these drugs work together over time to control the disease. The isatuximab dosing schedule changes after the initial cycle to maintain treatment while reducing frequency. Throughout the 54-month study period, participants will be closely monitored for treatment-emergent adverse events to evaluate safety. Researchers will also measure response rates and clinical benefits to understand how well the combination works. Assessments include laboratory tests, imaging, and clinical evaluations to track disease status and side effects. The study includes ongoing safety follow-up and aims to provide long-term data on the combination therapy's impact on relapsed or refractory MM with the t(11;14) marker.

CONDITIONS

Official Title

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

Who Can Participate

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of multiple myeloma with either clonal bone marrow plasma cells >10% or biopsy-proven plasmacytoma
  • Evidence of active myeloma with at least one of the following: end organ damage (hypercalcemia, renal insufficiency, anemia, or bone lesions), ≥60% clonal plasma cells in bone marrow, serum free light chain ratio ≥100 with involved light chain ≥100 mg/L, or more than one focal lesion ≥5mm on MRI
  • Measurable multiple myeloma disease with specific monoclonal protein levels or involved serum free light chain levels
  • Presence of t(11;14) chromosomal translocation confirmed by FISH or cytogenetic analysis
  • Absolute neutrophil count ≥1.5 x 10^9/L
  • Platelet count ≥75 x 10^9/L
  • Hemoglobin ≥8.0 g/dL within 21 days prior to enrollment
  • Creatinine clearance ≥30 mL/min by Cockcroft-Gault method
  • Total bilirubin ≤2.0 mg/dL
  • AST and ALT ≤2 times the upper limit of normal
  • Serum potassium between 3.0 and 5.5 mEq/L
  • Female participants of childbearing potential must have a negative pregnancy test before starting treatment and agree to use effective contraception
  • ECOG performance status ≤2
  • Must have received at least one prior line of therapy including proteasome inhibitor, lenalidomide, and glucocorticosteroids
  • Documented progressive multiple myeloma per IMWG criteria
Not Eligible

You will not qualify if you...

  • History of intolerance to any study drugs
  • Presence of amyloidosis, POEMS syndrome, HIV infection, active hepatitis B or C, or significant cardiovascular disease including uncontrolled angina, severe arrhythmia, recent myocardial infarction within 6 months, or NYHA class ≥3 congestive heart failure
  • Major surgery within 4 weeks prior to screening
  • Acute infections requiring intravenous therapy within 14 days prior to screening
  • Uncontrolled diabetes or hypertension within 14 days prior to screening
  • Any other medical condition that could affect study participation as judged by the investigator
  • History of other active malignancies within past 3 years except certain treated cancers
  • Evidence of ongoing graft-versus-host disease after prior allogeneic stem cell transplant
  • Pregnant or breastfeeding women
  • Hypersensitivity to study medications or their components
  • Treatment with anti-CD38 antibodies within last 3 weeks or without at least minimal response
  • Prior treatment with venetoclax
  • Recent chemotherapy, corticosteroids (>20 mg prednisone or equivalent), immunotherapy, or proteasome inhibitors within 3 weeks
  • Extensive radiation therapy within 28 days; localized radiation allowed
  • Use of any other experimental drugs within 28 days
  • Use of moderate or strong CYP3A inhibitors or inducers within 7 days
  • Consumption of grapefruit, Seville oranges, or star fruit within 3 days prior to first dose
  • Use of certain anticancer biologic agents within 21 days prior to first dose
  • Concomitant medications requiring dose adjustments or exclusions such as warfarin and certain enzyme substrates or inhibitors

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 2 locations

1

Berenson Cancer Center

West Hollywood, California, United States, 90069

Actively Recruiting

2

Nebraska Cancer Specialists

Omaha, Nebraska, United States, 68130

Actively Recruiting

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Research Team

R

Richard Bailey

Y

Yohana Sebhat

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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Published Research Related To This Trial

Phase I Study of Venetoclax Plus Daratumumab and Dexamethasone, With or Without Bortezomib, in Patients With Relapsed or Refractory Multiple Myeloma With and Without t(11;14).

Nizar J Bahlis, Rachid Baz, Simon J Harrison...

https://pubmed.ncbi.nlm.nih.gov/34388020

Deep and sustained response after venetoclax therapy in a patient with very advanced refractory myeloma with translocation t(11;14).

Cyrille Touzeau, Steven Le Gouill, Béatrice Mahé...

https://pubmed.ncbi.nlm.nih.gov/28057737

Isatuximab plus pomalidomide and low-dose dexamethasone versus pomalidomide and low-dose dexamethasone in patients with relapsed and refractory multiple myeloma (ICARIA-MM): a randomised, multicentre, open-label, phase 3 study.

Michel Attal, Paul G Richardson, S Vincent Rajkumar...

https://pubmed.ncbi.nlm.nih.gov/31735560

Isatuximab, carfilzomib, and dexamethasone in relapsed multiple myeloma (IKEMA): a multicentre, open-label, randomised phase 3 trial.

Philippe Moreau, Meletios-Athanasios Dimopoulos, Joseph Mikhael...

https://pubmed.ncbi.nlm.nih.gov/34097854

Low dose venetoclax in combination with bortezomib, daratumumab, and dexamethasone for the treatment of relapsed/refractory multiple myeloma patients-a single-center retrospective study.

Bernard Regidor, Marissa-Skye Goldwater, Jessica Wang...

https://pubmed.ncbi.nlm.nih.gov/33987683