39 Participants Needed

Venetoclax + Isatuximab + Dexamethasone for Multiple Myeloma

Recruiting at 1 trial location
HH
RB
YS
Overseen ByYohana Sebhat
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise

What You Need to Know Before You Apply

What is the purpose of this trial?

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

Will I have to stop taking my current medications?

The trial protocol does not specify if you must stop taking your current medications, but it does exclude certain treatments like chemotherapy, corticosteroids, and some other therapies within a few weeks before starting the study drugs. It's best to discuss your current medications with the study team to see if any adjustments are needed.

Is the combination of Venetoclax, Isatuximab, and Dexamethasone safe for treating multiple myeloma?

Venetoclax, when used with other drugs like dexamethasone, has shown acceptable safety in treating multiple myeloma, with some studies noting serious side effects like infections, especially at higher doses. However, lower doses have been better tolerated, particularly in patients with specific genetic markers.12345

What makes the drug combination of Venetoclax, Isatuximab, and Dexamethasone unique for treating multiple myeloma?

This drug combination is unique because Venetoclax targets a specific protein that helps cancer cells survive, making it particularly effective for multiple myeloma patients with a specific genetic marker (t(11,14)(q13;q32)). Isatuximab, an antibody, works by targeting and killing cancer cells, and when combined with Dexamethasone, it enhances the overall treatment effect, offering a novel approach compared to standard therapies.26789

What data supports the effectiveness of the drug Venetoclax when used in combination with Isatuximab and Dexamethasone for treating multiple myeloma?

Venetoclax has shown promising results in treating multiple myeloma, especially when combined with other drugs like bortezomib and dexamethasone, by inducing cell death in cancer cells. Isatuximab, when combined with other treatments, has also been effective in prolonging the time patients live without the disease getting worse and improving the response to treatment.23467

Who Is on the Research Team?

JB

James Berenson, MD

Principal Investigator

Oncotherapeutics

Are You a Good Fit for This Trial?

This trial is for adults with relapsed/refractory multiple myeloma, specifically those who have a certain genetic change (t(11;14)). Participants must have measurable levels of the disease and meet specific blood count and kidney function criteria. They cannot join if they've had recent major surgery or other conditions that could interfere with the study.

Inclusion Criteria

My tests confirm I have the t(11;14) genetic marker.
My bone marrow has more than 10% plasma cells or I have a confirmed plasmacytoma.
Your serum calcium concentration is greater than 2.75 mmol/L (11 mg/dL) or higher than 0.25 mmol/L (1 mg/dL) above the upper limit of normal range.
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive venetoclax, isatuximab, and dexamethasone in 28-day cycles

54 months
4 visits per 28-day cycle (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Venetoclax
Trial Overview The study tests Venetoclax combined with Isatuximab and Dexamethasone in patients whose multiple myeloma has returned after treatment or didn't respond to previous treatments. It's a phase 2 trial, which means it focuses on effectiveness and side effects.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: open-labelExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Oncotherapeutics

Lead Sponsor

Trials
23
Recruited
940+

Published Research Related to This Trial

In a phase 3 trial involving 291 patients with relapsed or refractory multiple myeloma, venetoclax combined with bortezomib and dexamethasone significantly improved progression-free survival compared to placebo, with a median of 22.4 months versus 11.5 months (hazard ratio 0.63).
Despite its efficacy, the venetoclax group experienced higher rates of serious treatment-emergent adverse events, particularly infections, leading to increased mortality, which underscores the need for careful patient selection for this treatment.
Venetoclax or placebo in combination with bortezomib and dexamethasone in patients with relapsed or refractory multiple myeloma (BELLINI): a randomised, double-blind, multicentre, phase 3 trial.Kumar, SK., Harrison, SJ., Cavo, M., et al.[2021]
Isatuximab, an anti-CD38 monoclonal antibody, significantly improves progression-free survival and tumor response when combined with pomalidomide and dexamethasone in patients with relapsed and refractory multiple myeloma, based on phase III studies.
The combination therapies involving isatuximab were generally well tolerated, maintaining health-related quality of life and showing a manageable safety profile without new safety concerns.
Isatuximab: A Review of Its Use in Multiple Myeloma.Frampton, JE.[2022]
Venetoclax, when combined with carfilzomib and dexamethasone, showed rapid initial effectiveness in two patients with multiple myeloma harboring the t(11,14)(q13;q32) genetic alteration, but the responses were short-lived, indicating a need for ongoing monitoring and potential adjustments in treatment.
The emergence of the t(11;14)(q13;q32) alteration during the disease progression highlights the importance of regular cytogenetic testing in multiple myeloma, as it can influence treatment strategies and outcomes in this challenging disease.
Venetoclax in combination with carfilzomib and dexamethasone in relapsed/refractory multiple myeloma harboring t(11,14)(q13;q32): two case reports and a review of the literature.Abuelgasim, KA., Alherz, N., Alhejazi, A., et al.[2021]

Citations

Venetoclax or placebo in combination with bortezomib and dexamethasone in patients with relapsed or refractory multiple myeloma (BELLINI): a randomised, double-blind, multicentre, phase 3 trial. [2021]
Isatuximab: A Review of Its Use in Multiple Myeloma. [2022]
Venetoclax in combination with carfilzomib and dexamethasone in relapsed/refractory multiple myeloma harboring t(11,14)(q13;q32): two case reports and a review of the literature. [2021]
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. [2020]
Efficacy and safety of venetoclax in patients with relapsed/refractory multiple myeloma: a meta-analysis. [2023]
Venetoclax in biomarker-selected multiple myeloma patients: Impact of exposure on clinical efficacy and safety. [2023]
Low dose venetoclax in combination with bortezomib, daratumumab, and dexamethasone for the treatment of relapsed/refractory multiple myeloma patients-a single-center retrospective study. [2021]
Isatuximab, carfilzomib, and dexamethasone in relapsed multiple myeloma (IKEMA): a multicentre, open-label, randomised phase 3 trial. [2022]
Efficacy of Isatuximab With Pomalidomide and Dexamethasone in Relapsed Myeloma: Results of a UK-Wide Real-World Dataset. [2022]
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