RecruitingPhase 1NCT06042725

MC210808 Venetoclax in Combination With Lenalidomide and Dexamethasone (Ven-Rd), Daratumumab and Dexamethasone (Ven-Dd), or Daratumumab-Lenalidomide-Dexamethasone (Ven-DRd) for the Treatment of Multiple Myeloma

Phase I Clinical Trial of Bcl2 Inhibitor Venetoclax in Combination With Lenalidomide and Dexamethasone (Ven-Rd), Daratumumab and Dexamethasone (Ven-Dd), or Daratumumab-Lenalidomide-Dexamethasone (Ven-DRd) in t(11;14) Multiple Myeloma


Sponsor

Mayo Clinic

Enrollment

100 participants

Start Date

Mar 4, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This phase I trial tests the safety, side effects, and best dose of venetoclax in combination with lenalidomide and dexamethasone, daratumumab and dexamethasone, or daratumumab, lenalidomide, and dexamethasone in treating patients with multiple myeloma. Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Lenalidomide is a drug that is similar to thalidomide, and is used to treat multiple myeloma and certain types of anemia. Lenalidomide belongs to the family of drugs called angiogenesis inhibitors. Dexamethasone is in a class of medications called corticosteroids. It is used to reduce inflammation and lower the body's immune response to help lessen the side effects of chemotherapy drugs. Daratumumab is in a class of medications called monoclonal antibodies. It binds to a protein called CD38, which is found on some types of immune cells and cancer cells, including myeloma cells. Daratumumab may block CD38 and help the immune system kill cancer cells. Adding venetoclax to the other drug combinations may allow control of the cancer than is possible with the current treatments.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding venetoclax (a targeted cancer drug) to standard multiple myeloma treatment regimens can improve outcomes in patients whose myeloma has a specific genetic feature called t(11;14), which may make their cancer particularly responsive to venetoclax. **You may be eligible if...** - You have been diagnosed with active multiple myeloma - Your myeloma has been confirmed to have the t(11;14) chromosomal change by a specialized genetic test - Group 1: You have received at least one prior treatment that did not include venetoclax - Group 2: You have received no more than 1 cycle of any myeloma treatment and are not a candidate for stem cell transplant **You may NOT be eligible if...** - You do not have the t(11;14) genetic finding - You have severe liver problems or other serious organ dysfunction - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREBiospecimen Collection

Undergo optional collection of blood samples

PROCEDUREBone Marrow Aspiration

Undergo bone marrow aspiration

PROCEDUREBone Marrow Biopsy

Undergo bone marrow biopsy

PROCEDUREChest Radiography

Undergo chest x-ray

PROCEDUREComputed Tomography

Undergo PET/CT

BIOLOGICALDaratumumab

Given SC

DRUGDexamethasone

Given PO

DRUGLenalidomide

Given PO

PROCEDURELow Dose Computed Tomography of the Whole Body

Undergo WBLDCT

PROCEDUREMagnetic Resonance Imaging

Undergo MRI

PROCEDUREPositron Emission Tomography

Undergo PET/CT

DRUGVenetoclax

Given PO

PROCEDUREX-Ray Imaging

Undergo x-rays

OTHERQuestionnaire Administration

Ancillary studies


Locations(1)

Mayo Clinic in Rochester

Rochester, Minnesota, United States

View Full Details on ClinicalTrials.gov

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NCT06042725


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