Bortezomib in Treating Patients With Multiple Myeloma Who Have Undergone an Autologous Peripheral Blood Stem Cell Transplant
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 I multiple myeloma, stage II multiple myeloma, stage III multiple myeloma, refractory multiple myeloma
Eligibility Criteria
DISEASE CHARACTERISTICS: Diagnosis of multiple myeloma Must have completed high-dose melphalan and autologous peripheral blood stem cell transplantation Transplant must have been completed 30-120 days ago Must not be receiving maintenance therapy Patients must have received 200 mg/m² of melphalan intravenously as a conditioning regimen (no dose reduction allowed) No evidence of amyloidosis No available donor PATIENT CHARACTERISTICS: ECOG performance status (PS) 0-2 or Karnofsky PS 60-100% Absolute neutrophil count > 1,500/mm^3 Platelet count > 75,000/mm^3 Bilirubin ≤ 1.5 times upper limit of normal Transaminase ≤ 3 times upper limit of normal Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception Must have a negative HIV test No baseline neurological disease > grade I No cranial nerve palsy No demonstrated resistance to bortezomib No history of allergic reactions attributed to bortezomib, boron, or mannitol No cardiac arrhythmia No unstable angina pectoris No symptomatic congestive heart failure No ongoing or active infection No other uncontrolled illness No psychiatric illness or social situations that would limit compliance with study requirements PRIOR CONCURRENT THERAPY: See Disease Characteristics No other concurrent anticancer therapies or agents No other concurrent investigational agents Not receiving maintenance therapy after prior stem cell transplantation on another clinical trial
Sites / Locations
- Barbara Ann Karmanos Cancer Institute
Arms of the Study
Arm 1
Experimental
Bortezomib
Bortezomib is administered as a 5 second IV bolus on days 1, 4, 8,11 or 1,8 and 15 of a 21-35 days cycle (Depending on the Dosing schedule). The dosage will be calculated based on actual weight of the patient unless the actual weight is greater than 40% above the ideal body weight. In this instance the dosage will be based on the adjusted ideal body weight. The Adjusted IBW (kg) = IBW + 0.25 x (actual body weight - IBW). The dosage will be adjusted based on the safety and toxicity profile, until a MTD is determined.