Thalidomide to Patients With Previously Untreated Multiple Myeloma

Phase 3

Completed

• Conditions: Multiple Myeloma
• Interventions: Drug: thalidomide; Drug: placebo

• Registration Number: NCT00218855
• Lead Sponsor: Norwegian University of Science and Technology

Brief 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.

Detailed Description

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.

Study Timeline

• Study Start: 2002-01
• Study First Submitted: 2005-09-20
• Study First Submitted QC: 2005-09-20
• Study First Posted: 2005-09-22
• Primary Completion: 2007-04
• Study Completion: 2007-04
• Status Verified: 2014-03
• Last Update Submitted: 2014-03-06
• Last Update Posted: 2014-03-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 363

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	placebo	-
B	placebo	-
A	thalidomide	-
B	thalidomide	-

Primary Outcome Measures

Name	Time	Method
overall survival	october 2007

Secondary Outcome Measures

Name	Time	Method
Quality of life	october 2007
Time to response	october 2007
Frequency of response	october 2007
Time to progression	october 2007
Time to 2. response	october 2007
Frequency of 2. response	october 2007
Time to 2. progression	october 2007
Toxicity	october 2007
Time to definitive treatment failure	october 2007

Trial Locations

Locations (1)

Department of Haematology, St. Olavs hospital/NTNU; 🇳🇴 Trondheim, Norway