Actively Recruiting
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
Led by Mayo Clinic · Updated on 2025-12-24
100
Participants Needed
1
Research Sites
247 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of active multiple myeloma with t(11;14) confirmed by bone marrow plasma cell FISH test
- At least one prior therapy not including venetoclax for relapsed patients; newly diagnosed patients may have had no more than one cycle of common myeloma treatment
- Not being considered for stem cell transplant if newly diagnosed
- Age 18 years or older
- Creatinine clearance of at least 30 mL/min
- Absolute neutrophil count of at least 1000/uL without growth factors
- Platelet count of at least 75,000/uL (or 50,000/uL if marrow plasma cells > 50%) without transfusion
- Hemoglobin level of at least 8.0 g/dL (transfusions allowed)
- Total bilirubin less than or equal to 1.5 times upper limit of normal (or up to 2.5 mg/dL for Gilbert's syndrome)
- ALT and AST levels less than or equal to 3 times upper limit of normal
- Alkaline phosphatase less than or equal to 750 U/L
- Measurable disease by serum monoclonal protein ≥ 1.0 g/dL, urine monoclonal protein ≥ 200 mg/24h, or abnormal serum free light chain levels
- ECOG performance status 0, 1, or 2
- Able to provide informed consent and complete questionnaires
- Negative pregnancy test within 7 days for women of childbearing potential
- Willing to use strict birth control measures during and after treatment
- Male participants agree to refrain from donating sperm or use contraception during and 28 days after lenalidomide
- Life expectancy of at least 12 weeks
- Willing to return for follow-up visits and provide bone marrow samples
- Willing to follow the Revlimid REMS program requirements (except Group 2 Arm A)
You will not qualify if you...
- History of active cancer within past 2 years except certain treated cancers like carcinoma in situ, basal cell carcinoma, localized squamous cell carcinoma, asymptomatic prostate cancer, or prior malignancy treated with curative intent
- Receiving other chemotherapy or investigational therapies (bisphosphonates allowed)
- Major surgery within 14 days before registration
- Conditions or lab abnormalities that may interfere with trial participation or safety
- Known HIV infection
- Use of strong/moderate CYP3A inhibitors or inducers within 28 days prior to registration
- Known allergy to study drugs or their components
- Participation in other clinical trials within 30 days prior to registration
- Known gastrointestinal disease or procedures that affect oral drug absorption or tolerance
- Heart failure above New York Heart Association class II
- Positive hepatitis C antibody or RNA test within 3 months prior to first treatment dose (except resolved infections with negative RNA test)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Actively Recruiting
Research Team
C
Clinical Trials Referral Office
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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