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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00008268
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : June 18, 2013
National Cancer Institute (NCI)
Information provided by:
Memorial Sloan Kettering Cancer Center

Brief 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.

Condition or disease Intervention/treatment Phase
Multiple Myeloma and Plasma Cell Neoplasm Biological: filgrastim Drug: melphalan Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
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
Study Start Date : August 2000
Actual Primary Completion Date : June 2003
Actual Study Completion Date : June 2003

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00008268

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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)
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Study Chair: Raymond L. Comenzo, MD Memorial Sloan Kettering Cancer Center

Layout table for additonal information Identifier: NCT00008268    
Other Study ID Numbers: 00-067
CDR0000068392 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: June 18, 2013
Last Verified: June 2013
Keywords provided by Memorial Sloan Kettering Cancer Center:
stage I multiple myeloma
stage II multiple myeloma
stage III multiple myeloma
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic