Study Combining Bortezomib With High Dose Melphalan to Treat Multiple Myeloma (Mel-Vel)
Multiple Myeloma
About this trial
This is an interventional treatment trial for Multiple Myeloma
Eligibility Criteria
Inclusion Criteria:
- A confirmed diagnosis of multiple myeloma
Show progression of disease after a previous cycle of dose-intense melphalan, or less than 25% decrease in paraprotein measured at 8 weeks after a prior cycle of dose-intense melphalan
- May have received intervening therapies for disease progression after dose-intense melphalan and enrollment in this protocol
- Age:18yrs-76yrs at time of melphalan administration
- Gender: There is no gender restriction
Availability of >2x10^6 autologous peripheral blood CD34+ cells/kg or a syngeneic donor meeting eligibility criteria for syngeneic donation
- Syngeneic transplantation is preferred
- For patients enrolled in the phase I part of this study, >1x10^6 autologous or syngeneic peripheral blood CD34+ cells/kg remaining in storage as "backup" in case of engraftment failure
- Recovery from complications of salvage therapy, if administered -
Exclusion Criteria:
- Diagnosis other than multiple myeloma
- Chemotherapy or radiotherapy within 28 days of initiating treatment in this study
- Prior dose-intense therapy within 56 days of initiating treatment in this study
- Uncontrolled bacterial,viral,fungal or parasitic infections
- Uncontrolled CNS metastases
- Known amyloid deposition in heart
Organ dysfunction
- LVEF<40% or cardiac failure not responsive to therapy
- FVC,FEV1,or DLCO<50% of predicted and/or receiving supplementary continuous oxygen
- Evidence of hepatic synthetic dysfunction, or total bilirubin>2x or AST>3x ULN
- Measured creatinine clearance <20ml/min
- Sensory peripheral neuropathy grade 4
- Karnofsky score<70% unless a result of bone disease directly caused by myeloma
- Life expectancy limited by another co-morbid illness
- History of another malignancy in remission <2yrs (other than basal cell carcinoma)
- Pregnant (women)or unwilling to use acceptable birth control methods (men or women) for twelve months after treatment
- Documented hypersensitivity to melphalan or bortezomib or any components of the formulation
- Patients unable or unwilling to provide consent
Sites / Locations
- Hackensack University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Experimental
Experimental
Phase I Cohort - Bortezomib 1 mg/m2
Phase I Cohort - Bortezomib 1.3 mg/m2
Phase I Cohort - Bortezomib 1.6 mg/m2
Phase II Cohort
Bortezomib at 1 mg/m2 on days -4 and -1 before transplantation with melphalan 200 mg/m2 given on day -2.
Bortezomib at 1.3 mg/m2 on days -4 and -1 before transplantation with melphalan 200 mg/m2 given on day -2.
Bortezomib at 1.6 mg/m2 on days -4 and -1 before transplantation with melphalan 200 mg/m2 given on day -2.
Bortezomib at 1.6 mg/m2 on days -4 and -1 before transplantation with melphalan 200 mg/m2 given on day -2.