NCT00002653

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known which combination chemotherapy regimen is most effective in treating older patients with multiple myeloma. PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy with or without cyclophosphamide and prednisone in treating older patients with multiple myeloma.

Trial Health

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Monitor

Trial Health Score

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

Enrollment
1,000

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, 1993

Completed
6.2 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
3.4 years until next milestone

First Posted

Study publicly available on registry

April 10, 2003

Completed
Last Updated

December 19, 2013

Status Verified

October 1, 2002

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

carmustineDRUG
cyclophosphamideDRUG
doxorubicin hydrochlorideDRUG
melphalanDRUG
prednisoneDRUG
radiation therapyRADIATION

Eligibility Criteria

Age65 Years - 74 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
DISEASE CHARACTERISTICS: * Diagnosis of multiple myeloma, defined by at least 2 of the following conditions: * Neoplastic cell infiltrate and/or microplasmacytomas by bone marrow sections or smears * Plasma cell infiltrates greater than 20% of marrow nucleated cells or, if less than 20%, objective evidence of monoclonality of the plasma cells required * Paraprotein in blood or urine * Definite lytic bone lesions (not osteoporosis) * Nonsecretory disease allowed in the presence of 1 of the following conditions: * Microplasmacytomas * Monoclonal plasmacytosis with immunoglobulin light-chain expression in cytoplasm * No equivocal myelomatosis, defined by the following criteria: * Minimal or no symptoms attributable to myelomatosis * Pretransfusion hemoglobin greater than 10 g/dL * Post-hydration creatinine less than 1.47 mg/dL * No osteolytic lesions except minimal lesions that do not threaten pathological fracture and are not associated with pain * Plasma cells less than 30% of marrow nucleated cells and marrow showing normal hematopoietic activity * Serum beta-2 microglobulin less than 4 mg/L * Less than 1 g of free light-chain excretion per 1 g of creatinine * No objective factors indicating progressive myelomatosis PATIENT CHARACTERISTICS: Age: * 65 to 74 * If under 65, higher priority is given to protocol MRC-LEUK-MYEL-VII unless entry into this study would be more appropriate Performance status: * Not specified Life expectancy: * Not specified Hematopoietic: * See Disease Characteristics * Neutrophil count at least 1,300/mm\^3 * Platelet count at least 75,000/mm\^3 Hepatic: * Not specified Renal: * See Disease Characteristics Other: * Ability to tolerate fluid intake of at least 3 L/day beginning at least 2 days before study entry * Afebrile and free of infection * No contraindication to therapy PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * No prior chemotherapy Endocrine therapy: * Prior or concurrent prednisolone at 30 mg/m2/day or less (or equivalent doses of other corticosteroids) for relief of fluid-unresponsive hypercalcemia allowed Radiotherapy: * Prior or concurrent minimal local radiotherapy to relieve persistent bone pain or cord compression allowed 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)

MRC Myelomatosis Trials Office

Birmingham, England, B15 2SZ, United Kingdom

Location

MeSH Terms

Conditions

Multiple MyelomaNeoplasms, Plasma Cell

Interventions

CarmustineCyclophosphamideDoxorubicinMelphalanPrednisoneRadiotherapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Nitrosourea CompoundsUreaAmidesOrganic ChemicalsNitroso CompoundsPhosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsPhosphoramidesOrganophosphorus CompoundsDaunorubicinAnthracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicPolycyclic CompoundsAminoglycosidesGlycosidesCarbohydratesPhenylalanineAmino Acids, AromaticAmino Acids, CyclicAmino AcidsAmino Acids, Peptides, and ProteinsPregnadienediolsPregnadienesPregnanesSteroidsFused-Ring CompoundsTherapeutics

Study Officials

  • M. T. Drayson, MD

    MRC Myelomatosis Trials Office

    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

April 10, 2003

Study Start

September 1, 1993

Last Updated

December 19, 2013

Record last verified: 2002-10

Locations

GB(1)