Adjuvant Bortezomib Maintenance Therapy After Autologous Peripheral Stem Cell Transplantation in Treating Patients With Intermediate or Advanced Multiple Myeloma
Multiple Myeloma and Plasma Cell Neoplasm
About this trial
This is an interventional treatment trial for Multiple Myeloma and Plasma Cell Neoplasm focused on measuring stage II multiple myeloma, stage III multiple myeloma
Eligibility Criteria
Inclusion Criteria: Diagnosis of intermediate or advanced multiple myeloma meeting criteria for at least 1 2 following: Intermediate- to high-M-component production rates (immunoglobulin [Ig]G > 5 g/dL or immunoglobulin A (IgA) > 3 g/dL or urine M component > 4 g/24 hours) More than one osteolytic bone lesion or radiographic evidence of diffuse osteoporosis β-2 microglobulin > 3 Nonsecretory myeloma if bone marrow plasmacytosis is greater than 30% Must have undergone autologous peripheral blood stem cell transplantation within the past 3-4 months Age 18 to 69 years old Absolute neutrophil count ≥ 1,000/mm^3 Platelet count ≥ 30,000/mm^3 serum glutamate oxaloacetate transaminase (SGOT) or serum glutamate pyruvate transaminase (SGPT) ≤ 300 IU Bilirubin ≤ 2 mg/dL Creatinine ≤ 2.0 mg/dL Creatinine clearance ≥ 30 mL/min Negative pregnancy test Fertile patients must use effective contraception Exclusion Criteria: concurrent major cardiac disease that would preclude study participation concurrent major pulmonary disease that would preclude study participation pregnant or nursing peripheral neuropathy ≥ grade 2 history of hypersensitivity to bortezomib, boron, or mannitol concurrent major gastrointestinal or bladder disease that would preclude study participation concurrent major neurologic or psychiatric disease that would preclude study participation dementia or significantly altered mental status that would preclude giving informed consent prior interferon post-transplantation prior thalidomide post-transplantation prior chemotherapy post-transplantation prior radiotherapy post-transplantation prior investigational therapy post-transplantation prior bortezomib prior therapy for myeloma post-transplantation other concurrent anti-myeloma therapy other concurrent investigational therapy
Sites / Locations
- Jonsson Comprehensive Cancer Center at UCLA
Arms of the Study
Arm 1
Experimental
bortezomib