OncoMatch/Clinical Trials/NCT06042725
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
Is NCT06042725 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including Daratumumab and Dexamethasone for multiple myeloma.
Treatment: Daratumumab · Dexamethasone · Lenalidomide · Venetoclax — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Multiple Myeloma
Biomarker criteria
Required: CCND1 t(11;14)
FISH test...demonstrating of t(11;14)
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: BCL2 inhibitor (venetoclax)
Exception: Group 1 - at least one prior line of therapy which did not include venetoclax
Group 1 - At least one prior line of therapy which did not include venetoclax
Cannot have received: any commonly used myeloma regimen
Exception: Group 2 - No more than 1 cycle for newly diagnosed MM
Group 2 - No more than 1 cycle of any commonly used myeloma regimen for treatment of newly diagnosed MM
Cannot have received: stem cell transplant
Exception: Group 2, newly diagnosed only
Patient is not being considered for stem cell transplant (group 2, newly diagnosed only)
Lab requirements
Blood counts
ANC ≥ 1000/uL (without growth factor support); Platelet count ≥ 75000/uL (≥ 50,000/uL if marrow plasma cells > 50%); Hemoglobin ≥ 8.0 g/dL (transfusion permitted)
Kidney function
Calculated creatinine clearance (Cockcroft-Gault) ≥ 30 mL/min
Liver function
Total bilirubin ≤ 1.5 x ULN (Gilbert's syndrome allowed if ≤ 2.5 mg/dL); ALT and AST ≤ 3 x ULN; Alkaline phosphatase ≤ 750 U/L
Calculated creatinine clearance (using Cockcroft-Gault equation) ≥ 30 mL/min; ANC ≥ 1000/uL (without growth factor support); Platelet count ≥ 75000/uL (≥ 50,000/uL if marrow plasma cells > 50%); Hemoglobin ≥ 8.0 g/dL (transfusion permitted); Total bilirubin ≤ 1.5 x ULN (Gilbert's syndrome allowed if ≤ 2.5 mg/dL); ALT and AST ≤ 3 x ULN; Alkaline phosphatase ≤ 750 U/L
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Mayo Clinic in Rochester · Rochester, Minnesota
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