Thalidomide to Patients With Previously Untreated Multiple Myeloma

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Multiple Myeloma

Intervention / Treatment
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* Drug: thalidomide
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: A<br> | Drug: thalidomide<br>* 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.<br>* Other names: thalidomide, Talix;Drug: placebo<br>* 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.<br>* Other names: no other names;|
| Active Comparator: B<br> | Drug: thalidomide<br>* 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.<br>* Other names: thalidomide, Talix;Drug: placebo<br>* 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.<br>* Other names: no other names;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival |  | october 2007 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Multiple Myeloma, Phase 3, randomised, double blind study, thalidomide