Selinexor, Venetoclax, and Dexamethasone (XVenD) in t(11;14)-Positive Relapsed/Refractory Multiple Myeloma (SELVEDge Study)
University of Miami
Summary
The purpose of this research is to determine whether the combination of selinexor, venetoclax, and dexamethasone therapy can increase anti-cancer effects in patients with translocation 11;14-positive (t(11;14)), relapsed/refractory myeloma (RRMM).
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Patients must have a documented diagnosis of multiple myeloma defined by the International Myeloma Working Group Criteria (IMWG).5 Patients at initial diagnosis must have had a serum M-protein ≥ 3 g/dL and/or bone marrow plasma cells ≥10%, and at least one of the following: 1. Anemia: Hemoglobin ≤10 g/dL, or 2. Renal failure: serum creatinine ≥ 2.0 mg/dL, or 3. Hypercalcemia: Ca ≥10.5 mg/dL, or 4. Lytic bone lesions on X-ray, CT, or Positron emission tomography/Computed Tomography (PET/CT), or 5. ≥ 2 focal lesions on spinal magnetic resonance imaging (MR…
Interventions
- DrugSelinexor
Selinexor tablets will be administered orally (PO) once per day at assigned dosage and frequency per protocol.
- DrugVenetoclax
Venetoclax tablets will be administered orally (PO) once per day at assigned dosage and frequency per protocol.
- DrugDexamethasone
Dexamethasone tablets will be administered orally (PO) once per day at assigned dosage and frequency per protocol.
Locations (3)
- University of Miami, Lennar Foundation Medical CenterCoral Gables, Florida
- University of Miami, Sylvester Comprehensive Cancer Center at Deerfield BeachDeerfield Beach, Florida
- University of Miami, Sylvester Comprehensive Cancer CenterMiami, Florida