Comparison of Melphalan-Prednisone (MP) to MP Plus Thalidomide in the Treatment of Newly Diagnosed Very Elderly Patients (> 75 Years) With Multiple Myeloma

Study Overview
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Brief Summary
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In multiple myeloma, combination chemotherapy with melphalan plus prednisone has been usedsince the 1960s and is regarded as the standard of care in very elderly patients. We assess whether the addition of thalidomide at 100 mg/day to this combination would improve survival.

Official Title
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Comparison of Melphalan-Prednisone (MP) to MP Plus Thalidomide in the Treatment of Newly Diagnosed Very Elderly Patients (> 75 Years) With Multiple Myeloma

Conditions
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Newly Diagnosed, Multiple Myeloma

Intervention / Treatment
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* Drug: Thalidomide
* Drug: melphalan, prednisone
* Drug: melphalan, prednisone, thalidomide


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Stage II or III multiple myeloma according to Durie and Salmon criteria, patients older than 75 years, previously untreated patients. Exclusion Criteria: Prior history of another neoplasm (except basocellular cutaneous or cervical epithelioma) Primary or associated amyloïdosis World Health organisation performance index of at least 3 Significant renal insufficiency with creatinine serum levels of 5.0 mg per deciliter or more Cardiac or hepatic dysfunction Cerebral circulatory insufficiency Absolute contraindication to corticosteroids Peripheral neuropathy clinically significant History of venous thrombosis during the last 6 months HIV or hepatitis B or C positivity Patients who had geography, social, or psychological conditions which might prevent adequate follow-up.

Ages Eligible for Study
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Minimum Age: 75 Years

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: A<br>12 cycles every 6 weeks :melphalan 0.2 mg/kg day 1 to 4, prednisone 2 mg/kg/d day 1 to 4 plus placebo 100mg/d continuously for 18 months | Drug: Thalidomide<br>* 100 mg/day continuously for 18 months<br>Drug: melphalan, prednisone<br>* 12 cycles every 6 weeks :melphalan 0.2 mg/kg day 1 to 4, prednisone 2 mg/kg/d day 1 to 4 plus placebo 100mg/d continuously for 18 months<br>* Other names: Alkeran, cortancyl;|
| Active Comparator: B<br>12 cycles every 6 weeks :melphalan 0.2 mg/kg day 1 to 4, prednisone 2 mg/kg/d day 1 to 4 plus thalidomide 100mg/d continuously for 18 months | Drug: melphalan, prednisone, thalidomide<br>* 12 cycles every 6 weeks :melphalan 0.2 mg/kg day 1 to 4, prednisone 2 mg/kg/d day 1 to 4 plus thalidomide 100mg/d continuously for 18 months<br>* Other names: Alkeran, cortancyl;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall Survival |  | May 2007 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression Free Survival |  | May 2007 | 
| Response rates |  | May 2007 | 
| Safety |  | May 2007 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Multiple Myeloma, very elderly patients, thalidomide