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Completed

NCT Number: NCT00218855

Thalidomide to Patients With Previously Untreated Multiple Myeloma

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.

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Key information

Conditions

Multiple Myeloma Blood Protein Disorders Cardiovascular Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Paraproteinemias Vascular Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Department of Haematology, St. Olavs hospital/NTNU

Trondheim, N-7006, Norway

About this study

Thalidomide has recently emerged as an effective treatment for patients with myeloma refractory to conventional chemotherapy. So far only limited experience is available on thalidomide for newly diagnosed myeloma. Therefore the Nordic Myeloma Study Group decided to perform a trial comparing traditional melphalan-prednisone therapy with melphalan-prednisone + thalidomide/placebo. The study design is a multicentre double-blind randomised placebo-controlled trial. Mainly patients >65 years of age will be included since patients <65 years will be treated with high dose chemotherapy with autologous stem cell support. The primary end-point is overall survival. Secondary end-points are quality of life, response rate, time to response, response duration and toxicity.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with multiple myeloma in need of treatment

Exclusion criteria

  • Previous treatment against multiple myeloma
  • Need of high dose chemotherapy with autologous stem cell support
  • Women in fertile age
  • Psychiatric disease or mental reduction leading to lack of cooperation
  • Lack of consent
  • Life expectancy below 3 months
  • Active cancer of other etiology

Treatment and study plan

thalidomide

Drug

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.

Other names: thalidomide, Talix

Placebo

Drug

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.

Other names: no other names

Primary outcomes

  1. overall survival

    Time frame: october 2007

Secondary outcomes

  1. Quality of life

    Time frame: october 2007

  2. Time to response

    Time frame: october 2007

  3. Frequency of response

    Time frame: october 2007

  4. Time to progression

    Time frame: october 2007

  5. Time to 2. response

    Time frame: october 2007

  6. Frequency of 2. response

    Time frame: october 2007

  7. Time to 2. progression

    Time frame: october 2007

  8. Toxicity

    Time frame: october 2007

  9. Time to definitive treatment failure

    Time frame: october 2007

Sponsors and collaborators

Lead sponsor

Norwegian University of Science and Technology

Other

Collaborators

  • Nordic Myeloma Study Group, Germany
  • The Research Council of Norway

Registry information

Official study title

A Phase 3 Study With Randomization to Melphalan/Prednisone/Thalidomide Versus Melphalan/Prednisone/Placebo to Patients With Previously Untreated Multiple Myeloma

Important dates

Study start
2002
Primary completion
2007
Study completion
2007
First posted
Sep 22, 2005
Registry last updated
Mar 7, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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