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

Phase 3

Terminated

• Conditions: Newly Diagnosed, Multiple Myeloma
• Interventions: Drug: melphalan, prednisone, thalidomide; Drug: Thalidomide; Drug: melphalan, prednisone

• Registration Number: NCT00644306
• Lead Sponsor: Central Hospital, Nancy, France

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-04
• Study Completion: 2007-05
• Status Verified: 2008-03
• Study First Submitted: 2008-03-20
• Study First Submitted QC: 2008-03-20
• Last Update Submitted: 2008-03-20
• Study First Posted: 2008-03-26
• Last Update Posted: 2008-03-26

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 232

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	melphalan, prednisone	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
B	melphalan, prednisone, thalidomide	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
A	Thalidomide	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

Primary Outcome Measures

Name	Time	Method
overall Survival	May 2007

Secondary Outcome Measures

Name	Time	Method
Progression Free Survival	May 2007
Response rates	May 2007
Safety	May 2007

Trial Locations

Locations (1)

CHU Nancy - Brabois, rue du morvan; 🇫🇷 Vandoeuvre, France