NCT00004903

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy and peripheral stem cell transplantation in treating patients who have multiple myeloma.

Trial Health

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Trial Health Score

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

Geographic Reach
1 country

2 active sites

Status
unknown

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

October 1, 1999

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 7, 2000

Completed
4.1 years until next milestone

First Posted

Study publicly available on registry

April 28, 2004

Completed
Last Updated

January 6, 2014

Status Verified

June 1, 2001

First QC Date

March 7, 2000

Last Update Submit

January 3, 2014

Conditions

Multiple Myeloma and Plasma Cell Neoplasm

Keywords

refractory multiple myelomastage I multiple myelomastage II multiple myelomastage III multiple myeloma

Interventions

filgrastimBIOLOGICAL
recombinant interferon alfaBIOLOGICAL
cisplatinDRUG
cyclophosphamideDRUG
cytarabineDRUG
etoposideDRUG
melphalanDRUG
peripheral blood stem cell transplantationPROCEDURE

Eligibility Criteria

AgeUp to 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: All stages of multiple myeloma Measurable disease manifested by monoclonal serum or urine globulins If nonsecretory, must have malignant plasma cells documented on bilateral bone marrow biopsy or isolated plasmacytomas Complete remission to induction chemotherapy allowed No progressive disease after standard induction therapy PATIENT CHARACTERISTICS: Age: Physiologic 65 and under Performance status: CALGB 0-1 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Bilirubin no greater than 2.0 mg/dL No active hepatitis with hepatitis C Renal: Creatinine less than 2.0 mg/dL OR Creatinine clearance at least 50 mL/min Cardiovascular: LVEF at least 45% No history of symptomatic coronary artery disease unless cleared after cardiology evaluation Pulmonary: FEV1 at least 60% predicted FEV1/FVC at least 60% Other: HIV negative Hepatitis B surface antigen negative PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics No more than 2 prior chemotherapy regimens, including induction Endocrine therapy: Not specified Radiotherapy: Not specified 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 (2)

Robert H. Lurie Comprehensive Cancer Center, Northwestern University

Chicago, Illinois, 60611, United States

Location

University of Chicago Cancer Research Center

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Conditions

Multiple MyelomaNeoplasms, Plasma Cell

Interventions

FilgrastimInterferon-alphaCisplatinCyclophosphamideCytarabineEtoposideMelphalanPeripheral Blood Stem Cell Transplantation

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 FactorsInterferon Type IInterferonsChlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum CompoundsPhosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsPhosphoramidesOrganophosphorus CompoundsCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsArabinonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesPodophyllotoxinTetrahydronaphthalenesNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicPolycyclic CompoundsGlucosidesGlycosidesPhenylalanineAmino Acids, AromaticAmino Acids, CyclicAmino AcidsHematopoietic Stem Cell TransplantationStem Cell TransplantationCell TransplantationCell- and Tissue-Based TherapyBiological TherapyTherapeuticsTransplantationSurgical Procedures, Operative

Study Officials

  • Jane N. Winter, MD

    Robert H. Lurie Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 7, 2000

First Posted

April 28, 2004

Study Start

October 1, 1999

Last Updated

January 6, 2014

Record last verified: 2001-06

Locations

US(2)