Status:
TERMINATED
Comparison of Melphalan-Prednisone (MP) to MP Plus Thalidomide in the Treatment of Newly Diagnosed Very Elderly Patients (> 75 Years) With Multiple Myeloma
Lead Sponsor:
Central Hospital, Nancy, France
Conditions:
Newly Diagnosed, Multiple Myeloma
Eligibility:
All Genders
75+ years
Phase:
PHASE3
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 additi...
Eligibility Criteria
Inclusion
- Stage II or III multiple myeloma according to Durie and Salmon criteria, patients older than 75 years, previously untreated patients.
Exclusion
- 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.
Key Trial Info
Start Date :
April 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2007
Estimated Enrollment :
232 Patients enrolled
Trial Details
Trial ID
NCT00644306
Start Date
April 1 2002
End Date
May 1 2007
Last Update
March 26 2008
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
CHU Nancy - Brabois, rue du morvan
Vandœuvre-lès-Nancy, France, 54511