Status:
COMPLETED
Melphalan, Bortezomib, and Stem Cell Transplant in Treating Patients With Primary Systemic Amyloidosis
Lead Sponsor:
Boston Medical Center
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
RATIONALE: Giving melphalan and bortezomib before and after a stem cell transplant stops the growth of abnormal cells by stopping them from dividing or killing them. Giving colony-stimulating factors ...
Detailed Description
OBJECTIVES: * To determine if hematologic responses to high-dose melphalan and autologous stem cell transplantation increase with addition of bortezomib in the conditioning regimen in patients with p...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- DISEASE CHARACTERISTICS:
- Histologically confirmed primary systemic amyloidosis based on the following criteria:
- Amyloid light-chain disease
- Deposition of amyloid material by congo red stain showing characteristic green birefringence
- Monoclonal light chain protein (Bence Jones protein) in the serum or urine, immunohistochemical studies, or serum free light chain assay
- Evidence of tissue involvement other than carpal tunnel syndrome (i.e., positive immunohistochemical staining of bone marrow demonstrating clonal plasma cells); tissue amyloid deposits with anti-kappa or anti-lambda anti-serum; evidence for a plasma cell dyscrasia by serum/urine or bone marrow; or overwhelmingly convincing clinical features (e.g., macroglossia) associated with other systemic manifestations
- PATIENT CHARACTERISTICS:
- Southwest Oncology Group performance status 0-1
- Fertile patients must use effective contraception
- Left ventricular ejection fraction ≥ 45% by Echocardiogram within the past 60 days
- diffusion capacity of lung for carbon monoxide ≥ 50%
- PRIOR CONCURRENT THERAPY:
- Prior chemotherapy with alkylating agent allowed provided there is no morphological or cytogenetic evidence of myelodysplastic syndromes
- Prior total cumulative dose of oral melphalan \< 300 mg
- At least 4 weeks since prior cytotoxic therapy and fully recovered
- Exclusion criteria:
- No senile, secondary, localized, dialysis-related, or familial amyloidosis
- No overt multiple myeloma (\> 30% of bone marrow plasmacytosis, extensive \[\> 2\] lytic lesions, or hypercalcemia)
- Not pregnant or nursing
- No myocardial infarction within the past 6 months, congestive heart failure, or arrhythmia refractory to therapy
- No prior malignancy except for any of the following:
- Adequately treated basal cell or squamous cell skin cancer
- In situ cervical cancer
- Adequately treated stage I or II cancer currently in complete remission
- Any cancer from which the patient has been disease-free ≥ 5 years
- No advanced (grade 3-4) pre-existing neuropathy
- No HIV positivity
Exclusion
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2014
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00790647
Start Date
June 1 2008
End Date
November 1 2014
Last Update
February 6 2017
Active Locations (1)
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1
Boston University Cancer Research Center
Boston, Massachusetts, United States, 02118