Multiple Myeloma Clinical Trial
Tandem Autologous Stem Cell Transplantation in Treating Patients With Primary Systemic (AL) Amyloidosis
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 transplantation works in treating patients with primary systemic (AL) amyloidosis.
Full 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 response (CR) to CR in these patients.
Determine the overall survival of patients treated with this regimen.
OUTLINE:
First transplantation: Patients receive filgrastim (G-CSF) subcutaneously once daily beginning 3 days before the initiation of stem cell collection and continuing until the day before the completion of stem cell collection. Patients may undergo bone marrow harvest if an inadequate number of peripheral blood stem cells are collected.
Patients receive high-dose melphalan IV over 20 minutes on days -3 and -2. Patients undergo autologous stem cell transplantation (ASCT) on day 0.
Second transplantation: Within 6-12 months after the first ASCT, patients not achieving a complete response receive high-dose melphalan IV over 20 minutes on days -3 and -2 and a second ASCT on day 0.
Treatment continues in the absence of unacceptable toxicity.
Patients are followed at 3 and 6 months, 1 year, and then annually thereafter.
PROJECTED ACCRUAL: A total of 62 patients will be accrued for this study within 2-3 years.
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There is 1 Location for this study
Boston Massachusetts, 02118, United States
How clear is this clinincal trial information?
Please confirm you are a US based health care provider:
Yes, I am a health care Provider No, I am not a health care providerSign Up Now.
Take Control of Your Disease Journey.
Sign up now for expert patient guides, personalized treatment options, and cutting-edge insights that can help you push for the best care plan.