NCT00644306

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
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 232 (actual)
• Sponsor: Central Hospital, Nancy, France · Academic / Other
• Sex: All
• Age: 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Newly Diagnosed, Multiple Myeloma

Interventions

Type	Name	Description
DRUG	Thalidomide	100 mg/day continuously for 18 months
DRUG	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
DRUG	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

Timeline

• Start date: 2002-04-01
• Completion: 2007-05-01
• First posted: 2008-03-26
• Last updated: 2008-03-26

Locations

1 site across 1 country: France