NCT00008268

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Aug 2000

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2000

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 6, 2001

Completed
2.1 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2003

Completed
Last Updated

June 18, 2013

Status Verified

June 1, 2013

Enrollment Period

2.8 years

First QC Date

January 6, 2001

Last Update Submit

June 17, 2013

Conditions

Multiple Myeloma and Plasma Cell Neoplasm

Keywords

stage I multiple myelomastage II multiple myelomastage III multiple myeloma

Interventions

filgrastimBIOLOGICAL
melphalanDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Multiple MyelomaNeoplasms, Plasma Cell

Interventions

FilgrastimMelphalan

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

Granulocyte Colony-Stimulating FactorColony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological FactorsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsPhenylalanineAmino Acids, AromaticAmino Acids, CyclicAmino Acids

Study Officials

  • Raymond L. Comenzo, MD

    Memorial Sloan Kettering Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 6, 2001

First Posted

January 27, 2003

Study Start

August 1, 2000

Primary Completion

June 1, 2003

Study Completion

June 1, 2003

Last Updated

June 18, 2013

Record last verified: 2013-06

Locations

US(1)