search
Back to results

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

Primary Purpose

Multiple Myeloma and Plasma Cell Neoplasm

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
filgrastim
melphalan
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Myeloma and Plasma Cell Neoplasm focused on measuring stage I multiple myeloma, stage II multiple myeloma, stage III multiple myeloma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Memorial Sloan-Kettering Cancer Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
January 6, 2001
Last Updated
June 17, 2013
Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
National Cancer Institute (NCI)
search

1. Study Identification

Unique Protocol Identification Number
NCT00008268
Brief Title
Melphalan and Filgrastim to Stimulate Peripheral Stem Cells in Patients With Multiple Myeloma
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 Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
August 2000 (undefined)
Primary Completion Date
June 2003 (Actual)
Study Completion Date
June 2003 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma and Plasma Cell Neoplasm
Keywords
stage I multiple myeloma, stage II multiple myeloma, stage III multiple myeloma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
filgrastim
Intervention Type
Drug
Intervention Name(s)
melphalan

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raymond L. Comenzo, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Memorial Sloan-Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs