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Thalidomide to Patients With Previously Untreated Multiple Myeloma

NCT00218855 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 363

Last updated 2014-03-07

No results posted yet for this study

Summary

The purpose of this study is to test the effect of thalidomide in patients with multiple myeloma. The patients receive either thalidomide or a placebo tablet (neither patient nor doctor know which of these are given) in addition to the ordinary chemotherapeutic drug against multiple myeloma. We will find out for how long time the patients will stay free of the disease and for how long time they will live, and can evaluate whether thalidomide is a beneficial drug against this disease.

Conditions

Interventions

DRUG

thalidomide

tablets thalidomide start 100 mg x 2 escalating to 200 mg x 2 until plateau phase. Maintenance 100 mg x 2 until relapse. The same procedure is repeated by first relapse.

DRUG

placebo

100 mg x 2 mg tablets escalating to 200 mg x 2 until plateau phase. Maintenance 100 mg x 2 until relapse. This procedure is repeated by first relapse.

Sponsors & Collaborators

  • The Research Council of Norway

    collaborator OTHER

  • Nordic Myeloma Study Group, Germany

    collaborator UNKNOWN

  • Norwegian University of Science and Technology

    lead OTHER

Principal Investigators

  • Anders Waage, MD · Department of Haematology, St. Olavs hospital/NTNU, N-7006 Trondheim

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-01-31
Primary Completion
2007-04-30
Completion
2007-04-30

Countries

  • Norway

Study Locations

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Entities

Drugs
Diseases

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 NCT00218855 on ClinicalTrials.gov