NCT00075621

Tandem Autologous Stem Cell Transplantation in Treating Patients With Primary Systemic (AL) Amyloidosis

A Phase II Trial of Tandem Transplantation in AL Amyloidosis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 62 (actual)
• Sponsor: Boston Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

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 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.

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
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	autologous peripheral blood stem cell transplantation	autologous peripheral blood stem cell transplantation

Timeline

• Start date: 2000-08-01
• Primary completion: 2005-06-01
• Completion: 2020-09-04
• First posted: 2004-01-12
• Last updated: 2020-09-17

Locations

1 site across 1 country: United States