Status:
COMPLETED
Study Combining Bortezomib With High Dose Melphalan to Treat Multiple Myeloma
Lead Sponsor:
Hackensack Meridian Health
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18-76 years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of this study is to determine the tolerance and potential efficacy of combining dose intense melphalan with escalating doses of bortezomib in patients with multiple myeloma undergoing auto...
Detailed Description
Multiple myeloma is the second most common hematological malignancy that has affected approximately 40,000 Americans.Conventional chemotherapy has achieved limited control of this disease but studies ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT00784823
Start Date
January 1 2007
End Date
December 1 2013
Last Update
August 11 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601