Melphalan and Filgrastim to Stimulate Peripheral Stem Cells in Patients With Multiple Myeloma

Multiple Myeloma and Plasma Cell Neoplasm Clinical Trial

Official title:

A Phase II Study Of Blood Stem Cell Mobilization With Intravenous Melphalan (60 MG/M2) + G-CSF In Patients With Multiple Myeloma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00008268
• Other study ID #: 00-067
• Secondary ID: CDR0000068392NCI
• Status: Completed
• Phase: Phase 2
• First received: January 6, 2001
• Last updated: June 17, 2013
• Start date: August 2000
• Est. completion date: June 2003

Study information

• Verified date: June 2013
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Melphalan and colony-stimulating factors such as filgrastim may increase the number of immune cells found in bone marrow or peripheral blood.

PURPOSE: Phase II trial to study the effectiveness of melphalan combined with filgrastim in stimulating peripheral stem cells in patients who have multiple myeloma.

Description:

OBJECTIVES:

• Determine the safety and efficacy of melphalan when used with filgrastim (G-CSF) for stem cell mobilization in patients with multiple myeloma.

• Analyze how this mobilization regimen affects parameters of stem cell (CD34+) mobilization and collection in these patients.

• Determine how this mobilization regimen affects disease status and clonotypic (i.e., tumor cell) contamination in stem cell components in these patients.

OUTLINE: Patients undergo peripheral blood stem cell (PBSC) mobilization consisting of melphalan IV on day 1 and filgrastim (G-CSF) subcutaneously beginning on day 2 and continuing until PBSC collection is complete.

Patients are followed at 1 month.

PROJECTED ACCRUAL: A total of 11-32 patients will be accrued for this study within 2 years.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: June 2003
• Est. primary completion date: June 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

DISEASE CHARACTERISTICS:

• Diagnosis of multiple myeloma

• Must have received induction therapy within the past 3 months

• Chemoresponsive disease

• Greater than 50% reduction of monoclonal paraprotein with reduction in marrow plasma cell infiltrate or greater than 50% reduction in marrow plasma cell infiltrate if disease is non-secretory

• No symptomatic pleural effusions

• Eligible for stem cell transplantation

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• ECOG 0-3 (ECOG 3 allowed only if due to bone disease or neuropathy)

Life expectancy:

• Not specified

Hematopoietic:

• Platelet count at least 150,000/mm^3

Hepatic:

• Bilirubin no greater than 2.5 mg/dL

Renal:

• Creatinine no greater than 2.5 mg/dL OR

• Creatinine clearance greater than 51 mL/min

Cardiovascular:

• No symptomatic cardiomyopathy

• No medically documented symptomatic cardiac arrhythmias within the past 60 days

• No New York Heart Association class III congestive heart failure

• No myocardial infarction within the past 6 months

Other:

• No other concurrent medical conditions that would preclude study

• No uncontrolled infections

• No other active malignancy within the past 5 years except for non-melanoma skin cancer

• Not pregnant

• Negative pregnancy test

• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• No prior stem cell mobilization or transplantation

Chemotherapy:

• See Disease Characteristics

• No more than 200 mg prior oral melphalan

Endocrine therapy:

• Not specified

Radiotherapy:

• No more than 3000 cGy of prior radiotherapy for myeloma

Surgery:

• Not specified

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Myeloma
• Multiple Myeloma and Plasma Cell Neoplasm
• Neoplasms, Plasma Cell
• Plasmacytoma

Intervention

Biological:
• filgrastim

Drug:
• melphalan

Locations

Country	Name	City	State
United States	Memorial Sloan-Kettering Cancer Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States,