Actively Recruiting

Phase 2
All Genders
ID06115135

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

Led by Oncotherapeutics · Updated on 2025-01-16

39

Participants Needed

2

Research Sites

87 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to evaluate the safety and effectiveness of combining venetoclax, isatuximab, and dexamethasone for patients with relapsed or refractory multiple myeloma (MM) who have the t(11;14) chromosomal marker. MM is a cancer of B-cells that often becomes resistant to treatment, requiring new therapies. Venetoclax targets the BCL-2 protein, which is highly expressed in patients with t(11;14), while isatuximab is an antibody therapy targeting CD38, both of which have shown promise in prior studies. Participants receive venetoclax orally at 400 mg daily for 28 days per cycle, dexamethasone 40 mg intravenously once a week (with some doses possibly given by mouth), and isatuximab intravenously on days 1, 8, 15, and 22 during the first cycle, then on days 1 and 15 in subsequent 28-day cycles. This open-label phase 2 trial focuses on patients who have had at least three prior therapies and currently show disease progression. The study aims to determine safety by tracking side effects and dose-limiting toxicities. During the study, participants will be monitored for treatment-emergent adverse events and response rates over up to 54 months. Researchers will assess measures such as overall response rate, clinical benefit rate, progression-free survival, time to progression, and overall survival. Regular laboratory tests, imaging, and clinical evaluations will be conducted to follow disease status and safety throughout treatment and follow-up periods.

CONDITIONS

Brief 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 at least 10% clonal bone marrow plasma cells or biopsy-proven plasmacytoma
  • Evidence of active myeloma with end organ damage, 60% or greater bone marrow plasma cells, serum free light chain ratio of 100 or greater, or multiple focal MRI lesions
  • Measurable disease defined by monoclonal protein levels or involved free light chain levels
  • Presence of t(11;14) translocation confirmed by FISH or cytogenetics
  • 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
  • Total bilirubin ≤ 2.0 mg/dL
  • AST and ALT ≤ 2 times upper limit of normal
  • Serum potassium between 3.0 and 5.5 mEq/L
  • Female participants of childbearing potential must have negative pregnancy tests and agree to strict contraception measures
  • ECOG performance score ≤ 2
  • Must have received at least one prior line of therapy including a proteasome inhibitor, lenalidomide, and glucocorticosteroids
  • Documented progressive multiple myeloma per IMWG criteria
Not Eligible

You will not qualify if you...

  • History of intolerance to study drugs
  • Conditions such as amyloidosis, POEMS syndrome, active hepatitis B or C, HIV infection, significant cardiovascular disease, recent major surgery, acute infections requiring IV therapy, uncontrolled diabetes or hypertension
  • Other active malignancies within past 3 years except certain cured cancers
  • Ongoing graft-versus-host disease after allogeneic stem cell transplant
  • Pregnancy or breastfeeding
  • Hypersensitivity to study medications or excipients
  • Treatment with anti-CD38 antibodies within last 3 weeks or without at least minimal response
  • Prior treatment with venetoclax
  • Recent chemotherapy, corticosteroids >20 mg/day, immunotherapy, extensive radiation, experimental drugs, or certain enzyme inhibitors before study drug start
  • Consumption of grapefruit, Seville oranges, or star fruit within 3 days prior to study drug
  • Use of certain anticancer biologics or chemotherapy within specific timeframes prior to study
  • Use of strong or moderate CYP3A inhibitors or inducers during ramp-up phase without dose adjustments
  • Use of medications such as warfarin, P-gp substrates, BCRP substrates, and others affecting drug metabolism during study

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Repeated 28-day cycles until disease progression or discontinuation.

Participants receive venetoclax daily by mouth, dexamethasone once weekly, and isatuximab intravenously on specified days during each 28-day cycle to treat their multiple myeloma.

Weekly visits during the first cycle and twice-monthly visits during subsequent cycles

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