Status:
COMPLETED
Tandem Autologous Stem Cell Transplantation in Treating Patients With Primary Systemic (AL) Amyloidosis
Lead Sponsor:
Boston Medical Center
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
RATIONALE: Autologous stem cell transplantation may be effective treatment for primary systemic (AL) amyloidosis. PURPOSE: This phase II trial is studying how well tandem (two) autologous stem cell t...
Detailed Description
OBJECTIVES: * Determine the tolerability of tandem autologous stem cell transplantation in patients with AL amyloidosis. * Determine whether this regimen can convert a hematologic non-complete respon...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed AL amyloidosis, meeting 1 of the following criteria:
- Plasma cell dyscrasia, evidenced by 1 of the following:
- Monoclonal protein in the serum or urine by immunofixation electrophoresis
- Plasmacytosis of the bone marrow with monoclonal staining for kappa or lambda light chain isotype
- Macroglossia with at least 1 other site having biopsy proven amyloidosis and absence of a mutant transthyretin is ruled out
- PATIENT CHARACTERISTICS:
- Age
- 18 to 65
- Performance status
- SWOG 0-2
- Life expectancy
- At least 1 year
- Hematopoietic
- Not specified
- Hepatic
- Not specified
- Renal
- Not specified
- Cardiovascular
- LVEF ≥ 45% by MUGA or echocardiogram
- Pulmonary
- DLCO ≥ 50%
- Other
- Not pregnant or nursing
- Fertile patients must use effective contraception
- Able to tolerate 2 courses of high-dose therapy
- HIV negative
- PRIOR CONCURRENT THERAPY:
- Biologic therapy
- Not specified
- Chemotherapy
- Prior alkylating agent chemotherapy allowed provided there is no morphologic or cytogenetic evidence of myelodysplastic syndromes
- Prior total cumulative oral melphalan dose \< 300 mg
- Endocrine therapy
- Not specified
- Radiotherapy
- Not specified
- Surgery
- Not specified
- Other
- At least 4 weeks since prior cytotoxic therapy and recovered
Exclusion
- No senile, secondary, localized, dialysis-related, or familial amyloidosis
- No overt multiple myeloma (e.g., greater than 30% bone marrow plasmacytosis, extensive \[more than 2\] lytic lesions, hypercalcemia)
- Cardiovascular
- No myocardial infarction within the past 6 months
- No congestive heart failure
- No arrhythmia refractory to therapy
- No evidence of symptomatic transient ischemic attacks or strokes
- No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer currently in complete remission
Key Trial Info
Start Date :
August 1 2000
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 4 2020
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT00075621
Start Date
August 1 2000
End Date
September 4 2020
Last Update
September 17 2020
Active Locations (1)
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1
Cancer Research Center at Boston Medical Center
Boston, Massachusetts, United States, 02118