Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

New York, New York 10021


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.

Study summary:

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.


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 is Available At:

Original ID:




Secondary ID:


Study Acronym:

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

Overall Status:


Study Phase:

Phase 2



Minimum Age:

18 Years

Maximum Age:


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Memorial Sloan-Kettering Cancer Center

Oversight Authority:

United States: Federal Government

Reasons Why Stopped:

Study Type:


Study Design:

Primary Purpose: Treatment

Number of Arms:


Number of Groups:


Total Enrollment:


Enrollment Type:

Overall Contact Information

Official Name:Raymond L. Comenzo, MD
Study Chair
Memorial Sloan-Kettering Cancer Center

Study Dates

Start Date:August 2000
Completion Date:June 2003
Completion Type:Actual
Primary Completion Date:June 2003
Primary Completion Type:Actual
Verification Date:June 2013
Last Changed Date:June 17, 2013
First Received Date:January 6, 2001

Study Outcomes

There are no available Study Outcomes

Study Interventions

Intervention Type:Biological
Intervention Type:Drug

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Memorial Sloan-Kettering Cancer Center
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Cancer Institute (NCI)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.

This study is not currently recruiting Study Participants. The form below is not enabled.