Bortezomib in Combination With CC-5013 in Patients With Relapsed/Refractory Multiple Myeloma
Refractory Multiple Myeloma, Relapsed Multiple Myeloma, Multiple Myeloma
About this trial
This is an interventional treatment trial for Refractory Multiple Myeloma focused on measuring Multiple Myeloma, bortezomib, Revlimid, CC-5013
Eligibility Criteria
Inclusion Criteria: Diagnosis of multiple myeloma based on standard diagnosis criteria: plasmacytomas on tissue biopsy; bone marrow plasmacytosis; monoclonal immunoglobulin spike on serum electrophoresis; lytic bone lesions. Must have relapsed or relapsed/refractory disease 18 years of age or older All baseline studies must be performed within 21 days of enrollment. ECOG performance status of 0 to 2 Exclusion Criteria: Renal insufficiency (serum creatinine levels > 2mg/dL) Concomitant therapy medications that include corticosteroids Peripheral neuropathy of Grade 3 or greater or painful Grade 2 Evidence of mucosal or internal bleeding and/or platelet refractory ANC < 1000 cells/mm3 Hemoglobin < 8.0 g/dL AST (SGOT and ALT) > 2 x ULN Intolerance to bortezomib or CC-5013 in the past or significant allergy to either compound, boron or mannitol Known hypersensitivity to thalidomide or the development of erythema nodosum Active infection or serious co-morbid medical condition Pregnant or breast-feeding women Prior malignancy with the last three years except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, in situ breast cancer, on in-situ prostate cancer
Sites / Locations
- H. Lee Moffitt Cancer Center
- Winship Cancer Center
- Beth Israel Deaconess Medical Center
- Dana-Farber Cancer Center
- University of Michigan
- St. Vincent's Comprehensive Cancer Center
Arms of the Study
Arm 1
Experimental
CC-5013 in combination with bortezomib
Participants will receive bortezomib intravenously on day 1,4,8 and 11 followed by 10 days of rest. CC-5013 will be given orally on days 1-14 followed by 7-days of rest. One cycle lasts 21 days.