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Combination Chemotherapy and Interferon Alfa With or Without Bone Marrow or Peripheral Stem Cell Transplantation in Treating Patients With Myeloma

NCT00002599 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 750

Last updated 2013-12-19

No results posted yet for this study

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.

Conditions

  • Multiple Myeloma and Plasma Cell Neoplasm

Interventions

BIOLOGICAL

filgrastim

BIOLOGICAL

recombinant interferon alfa

BIOLOGICAL

sargramostim

DRUG

carmustine

DRUG

cyclophosphamide

DRUG

doxorubicin hydrochloride

DRUG

melphalan

DRUG

methylprednisolone

DRUG

prednisone

DRUG

vincristine sulfate

RADIATION

low-LET cobalt-60 gamma ray therapy

RADIATION

low-LET photon therapy

Sponsors & Collaborators

Principal Investigators

  • J. A. Child, MD · Leeds General Infirmary

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT

Eligibility

Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1994-09-30

Countries

  • United Kingdom

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00002599 on ClinicalTrials.gov