Status:
COMPLETED
Treatment of Newly Diagnosed Elderly Patients With Multiple Myeloma
Lead Sponsor:
University Hospital, Lille
Conditions:
Multiple Myeloma
Eligibility:
All Genders
65-75 years
Phase:
PHASE3
Brief Summary
In multiple myeloma, combination chemotherapy with melphalan plus prednisone has been used since the 1960s and is regarded as the standard of care in elderly patients. We assess whether the addition o...
Detailed Description
Trial design This multicenter, randomized, controlled trial is conducted by the French Myeloma Intergroup(IFM) in elderly patients with previously untreated multiple myeloma. The primary objectives of...
Eligibility Criteria
Inclusion
- Stage II or III multiple myeloma according to Durie and Salmon criteria.
- Patients between 65 and 75 years of age
- Previously untreated patients
Exclusion
- Prior history of another neoplasm (except basocellular cutaneous or cervical epithelioma)
- Primary or associated amyloidosis
- 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
- HIV or hepatitis B or C positivity
- Patients who had geographic, social or psychological conditions which might prevent adequate follow-up
Key Trial Info
Start Date :
May 1 2000
Trial Type :
INTERVENTIONAL
End Date :
October 1 2005
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT00367185
Start Date
May 1 2000
End Date
October 1 2005
Last Update
August 22 2006
Active Locations (1)
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1
Lille University Hospital
Lille, France, 59037