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

• Status: Terminated
• Trial end date: 2007-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Central Hospital, Nancy, France
• Treatments: Melphalan; Prednisone; Thalidomide

Criteria

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.