NCT00002599

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining bone marrow or peripheral stem cell transplantation with chemotherapy may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. Interferon alfa may interfere with the growth of cancer cells. It is not yet known whether a more intensive chemotherapy regimen plus stem cell or bone marrow transplant is more effective than standard chemotherapy in treating patients with myeloma. PURPOSE: Randomized phase III trial to compare the effectiveness of two different regimens of combination chemotherapy plus interferon alfa with or without high dose melphalan or bone marrow or peripheral stem cell transplantation in treating patients with previously untreated myeloma.

Trial Health

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Trial Health Score

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

Enrollment
750

participants targeted

Target at P75+ for phase_3

Geographic Reach
1 country

1 active site

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

September 1, 1994

Completed
5.2 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
4.6 years until next milestone

First Posted

Study publicly available on registry

May 21, 2004

Completed
Last Updated

December 19, 2013

Status Verified

May 1, 2007

First QC Date

November 1, 1999

Last Update Submit

December 18, 2013

Conditions

Multiple Myeloma and Plasma Cell Neoplasm

Keywords

stage I multiple myelomastage II multiple myelomastage III multiple myeloma

Interventions

filgrastimBIOLOGICAL
recombinant interferon alfaBIOLOGICAL
sargramostimBIOLOGICAL
carmustineDRUG
cyclophosphamideDRUG
doxorubicin hydrochlorideDRUG
melphalanDRUG
methylprednisoloneDRUG
prednisoneDRUG
vincristine sulfateDRUG
low-LET cobalt-60 gamma ray therapyRADIATION
low-LET photon therapyRADIATION

Eligibility Criteria

AgeUp to 64 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
DISEASE CHARACTERISTICS: Definite myeloma requiring chemotherapy and fulfilling at least 2 of the following criteria: Neoplastic plasma cell infiltrate and/or microplasmacytomas on bone marrow aspiration and/or trephine Paraprotein in blood and/or urine Definite lytic bone lesions (not simply osteoporosis) No equivocal myeloma (such patients should be registered with the Clinical Trial Service Unit, Oxford) PATIENT CHARACTERISTICS: Age: Under 65 Performance status: Not specified Hematopoietic: (following rehydration and treatment for infection, if necessary) ANC at least 1,000 Platelets at least 50,000 Hepatic: Not specified Renal: Renal insufficiency does not necessarily exclude (dose reduction may be applicable) Cardiovascular: No severe cardiac disease Past history of ischemic heart disease may exclude at the discretion of the investigator Pulmonary: No severe respiratory illness Other: Ability to tolerate at least 3 liters/day of fluid No life-threatening disease unrelated to myeloma Prior or concurrent psychiatric disorder may exclude at the discretion of the investigator No prior malignancy except: Nonmelanomatous skin tumors In situ carcinomas PRIOR CONCURRENT THERAPY: No prior therapy other than minimal local radiotherapy for relief of bone pain

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

Sponsors & Collaborators

Study Sites (1)

Leeds Teaching Hospital Trust

Leeds, England, LS1 3EX, United Kingdom

Location

MeSH Terms

Conditions

Multiple MyelomaNeoplasms, Plasma Cell

Interventions

FilgrastimInterferon-alphasargramostimCarmustineCyclophosphamideDoxorubicinMelphalanMethylprednisolonePrednisoneVincristine

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 IInterferonsNitrosourea CompoundsUreaAmidesOrganic ChemicalsNitroso CompoundsPhosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsPhosphoramidesOrganophosphorus CompoundsDaunorubicinAnthracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicPolycyclic CompoundsAminoglycosidesGlycosidesPhenylalanineAmino Acids, AromaticAmino Acids, CyclicAmino AcidsPrednisolonePregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPregnadienediolsVinca AlkaloidsSecologanin Tryptamine AlkaloidsIndole AlkaloidsAlkaloidsHeterocyclic CompoundsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingIndolizidinesIndolizines

Study Officials

  • J. A. Child, MD

    Leeds General Infirmary

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Purpose
TREATMENT
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

November 1, 1999

First Posted

May 21, 2004

Study Start

September 1, 1994

Last Updated

December 19, 2013

Record last verified: 2007-05

Locations

GB(1)