NCT00003490

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. GM-CSF may make cancer cells more sensitive to the effects of chemotherapy. Combining more than one drug with GM-CSF may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy, consisting of cyclophosphamide plus vincristine, following GM-CSF in treating patients with multiple myeloma that has not responded to previous treatment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Oct 1998

Longer than P75 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

October 1, 1998

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
3.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2003

Completed
10 months until next milestone

First Posted

Study publicly available on registry

May 21, 2004

Completed
Last Updated

December 4, 2013

Status Verified

March 1, 2001

First QC Date

November 1, 1999

Last Update Submit

December 3, 2013

Conditions

Multiple Myeloma and Plasma Cell Neoplasm

Keywords

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

Interventions

sargramostimBIOLOGICAL
cyclophosphamideDRUG
prednisoneDRUG
vincristine sulfateDRUG

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: Histologically proven multiple myeloma Pancytopenia related to multiple myeloma allowed Failed or progressed after at least 2 chemotherapy or biologic therapy regimens PATIENT CHARACTERISTICS: Age: 16 and over Performance status: Not specified Life expectancy: Not specified Hematopoietic: Platelet count at least 50,000/mm3 Absolute neutrophil count at least 750/mm3 Hepatic: SGOT/SGPT less than 3 times upper limit of normal Bilirubin less than 5.0 mg/dL Renal: Not specified Other: No active infection requiring intravenous antibiotics Not HIV positive Not pregnant or nursing Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics May have failed prior bone marrow transplant No other concurrent colony stimulating factors Concurrent immunoglobulin allowed Chemotherapy: See Disease Characteristics Concurrent pamidronate allowed Endocrine therapy: Not specified Radiotherapy: Concurrent standard radiation therapy to treat extra-skeletal and/or skeletal tumor sites allowed Surgery: Not specified Other: Concurrent epoetin alfa for anemia allowed

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

Sponsors & Collaborators

Study Sites (1)

Cleveland Clinic Cancer Center

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Multiple MyelomaNeoplasms, Plasma Cell

Interventions

sargramostimCyclophosphamidePrednisoneVincristine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Phosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsPhosphoramidesOrganophosphorus CompoundsPregnadienediolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsVinca AlkaloidsSecologanin Tryptamine AlkaloidsIndole AlkaloidsAlkaloidsHeterocyclic CompoundsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingIndolizidinesIndolizines

Study Officials

  • Mohamad A. Hussein, MD

    The Cleveland Clinic

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 1, 1999

First Posted

May 21, 2004

Study Start

October 1, 1998

Study Completion

August 1, 2003

Last Updated

December 4, 2013

Record last verified: 2001-03

Locations

US(1)