Thalidomide and Prednisone After Autologous Stem Cell Transplantation Multiple Myeloma

NCT00049673 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 332

Last updated 2023-09-13

Study results available
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Summary

RATIONALE: Thalidomide may stop the growth of multiple myeloma by stopping blood flow to the tumor. It is not yet known whether combining thalidomide with prednisone and giving them after autologous stem cell transplantation may be effective in treating multiple myeloma.

PURPOSE: This randomized phase III trial is studying thalidomide and prednisone to see how well they work compared to observation in treating patients who have undergone stem cell transplantation for multiple myeloma.

Conditions

  • Multiple Myeloma and Plasma Cell Neoplasm

Interventions

DRUG

prednisone

Given orally

DRUG

thalidomide

Given orally

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH
  • Eastern Cooperative Oncology Group

    collaborator NETWORK
  • NCIC Clinical Trials Group

    lead NETWORK

Principal Investigators

  • A. Keith Stewart, MD · Mayo Clinic

  • Martha Q. Lacy, MD · Mayo Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-10-15
Primary Completion
2011-10-19
Completion
2013-09-19
FDA Drug
Yes

Countries

  • Canada

Study Locations

More Related Trials

Entities

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 NCT00049673 on ClinicalTrials.gov