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

This study has been completed.
National Cancer Institute (NCI)
Information provided by:
Memorial Sloan Kettering Cancer Center Identifier:
First received: January 6, 2001
Last updated: June 17, 2013
Last verified: June 2013

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.

Condition Intervention Phase
Multiple Myeloma and Plasma Cell Neoplasm
Biological: filgrastim
Drug: melphalan
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: A Phase II Study Of Blood Stem Cell Mobilization With Intravenous Melphalan (60 MG/M2) + G-CSF In Patients With Multiple Myeloma

Resource links provided by NLM:

Further study details as provided by Memorial Sloan Kettering Cancer Center:

Study Start Date: August 2000
Study Completion Date: June 2003
Primary Completion Date: June 2003 (Final data collection date for primary outcome measure)
Detailed Description:


  • 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.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No


  • 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



  • 18 and over

Performance status:

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

Life expectancy:

  • Not specified


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


  • Bilirubin no greater than 2.5 mg/dL


  • Creatinine no greater than 2.5 mg/dL OR
  • Creatinine clearance greater than 51 mL/min


  • 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


  • 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


Biologic therapy:

  • No prior stem cell mobilization or transplantation


  • See Disease Characteristics
  • No more than 200 mg prior oral melphalan

Endocrine therapy:

  • Not specified


  • No more than 3000 cGy of prior radiotherapy for myeloma


  • Not specified
  Contacts and Locations
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Please refer to this study by its identifier: NCT00008268

United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
National Cancer Institute (NCI)
Study Chair: Raymond L. Comenzo, MD Memorial Sloan Kettering Cancer Center
  More Information Identifier: NCT00008268     History of Changes
Other Study ID Numbers: 00-067  CDR0000068392  NCI-G00-1895 
Study First Received: January 6, 2001
Last Updated: June 17, 2013
Health Authority: United States: Federal Government

Keywords provided by Memorial Sloan Kettering Cancer Center:
stage I multiple myeloma
stage II multiple myeloma
stage III multiple myeloma

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Blood Protein Disorders
Cardiovascular Diseases
Hematologic Diseases
Hemorrhagic Disorders
Hemostatic Disorders
Immune System Diseases
Immunoproliferative Disorders
Lymphoproliferative Disorders
Neoplasms by Histologic Type
Vascular Diseases
Alkylating Agents
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Myeloablative Agonists
Physiological Effects of Drugs processed this record on May 25, 2016