Status:
COMPLETED
Adjuvant Bortezomib Maintenance Therapy After Autologous Peripheral Stem Cell Transplantation in Treating Patients With Intermediate or Advanced Multiple Myeloma
Lead Sponsor:
Jonsson Comprehensive Cancer Center
Collaborating Sponsors:
Millennium Pharmaceuticals, Inc.
Conditions:
Multiple Myeloma and Plasma Cell Neoplasm
Eligibility:
All Genders
18-69 years
Phase:
PHASE1
PHASE2
Brief Summary
RATIONALE: Bortezomib may stop the growth of cancer cells by blocking the enzymes necessary for their growth. Giving bortezomib as maintenance therapy after autologous stem cell transplantation may ki...
Detailed Description
OBJECTIVES: * Determine response rate, as defined by resolution of bone marrow plasmacytosis and monoclonal paraproteinemia, in the first year after autologous peripheral blood stem cell transplantat...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2013
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00084747
Start Date
June 1 2004
End Date
January 1 2013
Last Update
August 17 2020
Active Locations (1)
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1
Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, California, United States, 90095-1781