Study of Venetoclax with Isatuximab and Dexamethasone for Treating Relapsed or Refractory Multiple Myeloma
Sponsor: Oncotherapeutics
ClinicalTrials ID:NCT06115135
This clinical trial is testing a combination of three drugs—Venetoclax, Isatuximab, and Dexamethasone—to see if they can help treat patients with multiple myeloma that has returned or not responded to previous treatments, especially those with a specific genetic marker.
Patient Parameters
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Program Overview
The study aims to find out if a combination of Venetoclax, Isatuximab, and Dexamethasone can effectively treat patients with multiple myeloma that has come back or is resistant to other treatments. This is particularly focused on patients with a genetic marker called t(11;14).
Description
Multiple myeloma (MM) is a type of cancer that affects certain white blood cells in the bone marrow. Even with recent treatment advances, many patients eventually need new options because their cancer becomes resistant to current therapies. This study is exploring a new combination of drugs to help these patients.
Venetoclax is a drug that targets a protein called BCL-2, which helps cancer cells survive. It has shown promise in treating multiple myeloma, especially in patients with a specific genetic change known as t(11;14). Isatuximab is a type of drug called a monoclonal antibody that targets a protein on cancer cells, and Dexamethasone is a steroid that helps reduce inflammation and cancer cell growth.
The study will test if this combination can help patients whose multiple myeloma has returned or not responded to other treatments. Researchers will look at how safe and effective this treatment is, especially for those with the t(11;14) genetic marker. Participants will receive these drugs and be monitored for their response and any side effects.
Eligibility Criteria
Inclusion Criteria
- Diagnosed with multiple myeloma based on specific medical criteria.
- Currently have multiple myeloma with measurable disease.
- Show the t(11;14) genetic marker in their cancer cells.
- Have adequate blood cell counts and organ function.
- Women of childbearing potential must use effective birth control and have a negative pregnancy test before starting treatment.
- Men must agree to use condoms during sexual contact with women of childbearing potential.
- Have an ECOG performance score of 2 or less, meaning they are fully active or have some restrictions but can still do light work.
- Have received at least one prior treatment for multiple myeloma, including specific types of drugs.
- Currently have progressive multiple myeloma according to specific criteria.
Exclusion Criteria
- History of intolerance to any of the study drugs.
- Have certain other medical conditions, such as amyloidosis, POEMS syndrome, or active infections like HIV or hepatitis.
- Have significant heart disease or have had major surgery recently.
- Have other active cancers within the past three years, with some exceptions.
- Have ongoing graft-versus-host disease if they had a prior stem cell transplant.
- Are pregnant or breastfeeding.
- Have had recent treatment with certain drugs, including anti-CD38 antibodies or Venetoclax.
- Have used certain medications or foods that interact with the study drugs within a specified time before starting the study.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Berenson Cancer Center | 90069 | West Hollywood | California |
| Nebraska Cancer Specialists | 68130 | Omaha | Nebraska |
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