NCT00006232

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known which combination chemotherapy regimen is more effective for multiple myeloma. PURPOSE: This randomized phase III trial is comparing two combination chemotherapy regimens to see how well they work in treating patients with stage II or stage III multiple myeloma.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Oct 1996

Longer than P75 for phase_3

Geographic Reach
1 country

12 active sites

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, 1996

Completed
3.9 years until next milestone

First Submitted

Initial submission to the registry

September 11, 2000

Completed
2.4 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
4.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2007

Completed
Last Updated

May 15, 2013

Status Verified

March 1, 2007

First QC Date

September 11, 2000

Last Update Submit

May 14, 2013

Conditions

Multiple Myeloma and Plasma Cell Neoplasm

Keywords

stage II multiple myelomastage III multiple myeloma

Outcome Measures

Primary Outcomes (1)

  • Comparison of response rates

Secondary Outcomes (2)

  • Time to achieve a maximal response

  • Duration of response

Interventions

dexamethasoneDRUG
doxorubicin hydrochlorideDRUG
idarubicinDRUG
vincristine sulfateDRUG

Eligibility Criteria

AgeUp to 75 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Diagnosis of stage II or III multiple myeloma * No prior therapy except local radiotherapy to bone lesions * No indolent multiple myeloma * No monoclonal gammopathy of unknown significance PATIENT CHARACTERISTICS: Age: * 75 and under Performance status: * Not specified Life expectancy: * Not specified Hematopoietic: * Not specified Hepatic: * Bilirubin no greater than 2.34 mg/dL Renal: * No end stage renal failure (creatinine greater than 5.65 mg/dL after rehydration) * No requirement for dialysis Other: * No other medical condition that would preclude intensive treatment * Not pregnant or nursing * Fertile patients must use effective contraception * No other prior malignancy PRIOR CONCURRENT THERAPY: Biologic therapy * See Disease Characteristics Chemotherapy * See Disease Characteristics Endocrine therapy * See Disease Characteristics Radiotherapy * Concurrent local radiotherapy allowed for painful lesions or lesions that appear likely to lead to an imminent fracture Surgery * See Disease Characteristics

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

Sponsors & Collaborators

Study Sites (12)

Birmingham Heartlands Hospital

Birmingham, England, B9 5SS, United Kingdom

Location

Addenbrooke's Hospital at Cambridge University Hospitals NHS Foundation Trust

Cambridge, England, CB2 2QQ, United Kingdom

Location

Royal Liverpool and Broadgreen Hospitals NHS Trust

Liverpool, England, L7 8XP, United Kingdom

Location

New Cross Hospital

Wolverhampton, England, WV10 0QP, United Kingdom

Location

Centre for Cancer Research and Cell Biology at Belfast City Hospital

Belfast, Northern Ireland, BT9 7AB, United Kingdom

Location

Aberdeen Royal Infirmary

Aberdeen, Scotland, AB25 2ZN, United Kingdom

Location

Vale Of Leven D G Hospital

Alexandria, Scotland, G83 0UA, United Kingdom

Location

Dumfries Royal Infirmary

Dumfries, Scotland, DG1 4AP, United Kingdom

Location

Ninewells Hospital and Medical School

Dundee, Scotland, DD1 9SY, United Kingdom

Location

West of Scotland Cancer Centre

Glasgow, Scotland, G11 6NT, United Kingdom

Location

Royal Infirmary - Castle

Glasgow, Scotland, G4 0SF, United Kingdom

Location

Royal Alexandra Hospital

Paisley, Scotland, United Kingdom

Location

MeSH Terms

Conditions

Multiple MyelomaNeoplasms, Plasma Cell

Interventions

DexamethasoneDoxorubicinIdarubicinVincristine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, FluorinatedDaunorubicinAnthracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsAminoglycosidesGlycosidesCarbohydratesVinca AlkaloidsSecologanin Tryptamine AlkaloidsIndole AlkaloidsAlkaloidsHeterocyclic CompoundsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingIndolizidinesIndolizines

Study Officials

  • Gordon Cook, MD, PhD

    Leeds Cancer Centre at St. James's University Hospital

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

September 11, 2000

First Posted

January 27, 2003

Study Start

October 1, 1996

Study Completion

August 1, 2007

Last Updated

May 15, 2013

Record last verified: 2007-03

Locations

GB(12)