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Combination Chemotherapy With or Without Thalidomide in Treating Patients With Multiple Myeloma

NCT00028886 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 450

Last updated 2013-09-17

No results posted yet for this study

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Thalidomide may stop the growth of cancer cells by stopping blood flow to the cancer. Peripheral blood stem cell transplant using stem cells from the patient or a donor may be able to replace immune cells that were destroyed by chemotherapy used to kill cancer cells. The donated stem cells may also help destroy any remaining cancer cells (graft-versus-tumor effect). It is not yet known whether chemotherapy followed by peripheral blood stem cell transplant is more effective with or without thalidomide in treating multiple myeloma.

PURPOSE: This randomized phase III trial is studying giving combination chemotherapy with thalidomide to see how well it works compared with giving combination chemotherapy without thalidomide in treating patients with multiple myeloma.

Conditions

  • Multiple Myeloma and Plasma Cell Neoplasm

Interventions

BIOLOGICAL

filgrastim

BIOLOGICAL

recombinant interferon alfa

DRUG

cyclophosphamide

DRUG

dexamethasone

DRUG

doxorubicin hydrochloride

DRUG

melphalan

DRUG

thalidomide

DRUG

vincristine sulfate

PROCEDURE

bone marrow ablation with stem cell support

PROCEDURE

peripheral blood stem cell transplantation

Sponsors & Collaborators

  • Commissie Voor Klinisch Toegepast Onderzoek

    lead OTHER

Principal Investigators

  • H. Lokhorst, MD, PhD · UMC Utrecht

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-03-31

Countries

  • Belgium
  • Netherlands

Study Locations

More Related Trials

Entities

Drugs

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 NCT00028886 on ClinicalTrials.gov