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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00008268
First received: January 6, 2001
Last updated: June 17, 2013
Last verified: June 2013
  Purpose

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:

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.

  Eligibility

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

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00008268

Locations
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
Study Chair: Raymond L. Comenzo, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov 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
Plasmacytoma
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Melphalan
Lenograstim
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Myeloablative Agonists
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic

ClinicalTrials.gov processed this record on September 16, 2014