Overview

This trial is active, not recruiting.

Condition multiple myeloma
Treatments filgrastim, melphalan, autologous peripheral blood stem cell transplantation
Phase phase 2
Sponsor Boston Medical Center
Start date August 2000
End date June 2005
Trial size 62 participants
Trial identifier NCT00075621, BUMC-2000-0279, CDR0000347381

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Other)
Drug: filgrastim 16 mg/kg/day for 3 days prior to stem cell collection, through day before last collection Drug: melphalan 200 mg/kg over 2 days Procedure/Surgery: autologous peripheral blood stem cell transplantation autologous peripheral blood stem cell transplantation
filgrastim
16 mg/kg/day for 3 days prior to stem cell collection, through day before last collection
melphalan alkeran
200 mg/kg over 2 days
autologous peripheral blood stem cell transplantation
autologous peripheral blood stem cell transplantation

Primary Outcomes

Measure
safety
time frame: 100 days, 6 months, and annual

Secondary Outcomes

Measure
Efficacy
time frame: one year

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

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

Additional Information

Official title A Phase II Trial of Tandem Transplantation in AL Amyloidosis
Principal investigator Vaishali Sanchorawala, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by Boston Medical Center.