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
Mayo Clinic
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.
Description
PRIMARY OBJECTIVE: I. To estimate the recommended phase II dose (RP2D) of venetoclax that can be combined with standard dose daratumumab and dexamethasone (Dd) (Arm A), lenalidomide and dexamethasone (Rd) (Arm B) or daratumumab, lenalidomide and dexamethasone (DRd) (Arm C) in patients with t(11;14) multiple myeloma (MM). SECONDARY OBJECTIVES: I. To assess frequency and severity of treatment-emergent adverse events (TEAEs) graded per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v)5.0. II. To assess best response while on treatment per Inter…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * PRE-REGISTRATION: Diagnosis of active MM with bone marrow plasma cell fluorescence in situ hybridization (FISH) test run under an Investigational Device Exemption (IDE) demonstrating of t(11;14), either from time of diagnosis or confirmed with IDE at Mayo Clinic after time of diagnosis, during screening period for study. Note: Samples tested beyond 72 hours from the collection will not be considered adequate for trial enrollment * PRE-REGISTRATION: Group 1 - At least one prior line of therapy which did not include venetoclax * PRE-REGISTRATION: Group 2 - No more than 1 c…
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
Location
- Mayo Clinic in RochesterRochester, Minnesota