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

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

January 9, 2004

Last Updated Date

February 6, 2009

Start Date ^†

August 2000

Current Primary Outcome Measures ^†

Original Primary Outcome Measures ^†

Change History

Complete list of historical versions of study NCT00075621 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Original Secondary Outcome Measures ^†

Descriptive Information

Brief Title ^†

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

Official Title ^†

A Phase II Trial of Tandem Transplantation in AL Amyloidosis

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 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.

Study Phase

Phase II

Study Type ^†

Interventional

Study Design ^†

Treatment, Open Label

Condition ^†

Multiple Myeloma and Plasma Cell Neoplasm

Intervention ^†

Biological: filgrastim
Drug: melphalan
Procedure: autologous bone marrow transplantation
Procedure: peripheral blood stem cell transplantation

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Active, not recruiting

Enrollment ^†

Completion Date

Primary Completion Date

Eligibility 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
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)

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
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

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
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

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

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00075621

Responsible Party

Secondary IDs ^††

BUMC-2000-0279

Study Sponsor ^†

Boston Medical Center

Collaborators ^††

Investigators ^†

Principal Investigator:

Vaishali Sanchorawala, MD

Boston Medical Center

Information Provided By

National Cancer Institute (NCI)

Verification Date

May 2005

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.