Comparison of Melphalan-Prednisone (MP) to MP Plus Thalidomide in the Treatment of Newly Diagnosed Very Elderly Patients (> 75 Years) With Multiple Myeloma (IFM 01/01)

Central Hospital, Nancy, France

Status and phase

Terminated

Phase 3

Conditions

Newly Diagnosed, Multiple Myeloma

Treatments

Drug: melphalan, prednisone, thalidomide

Drug: melphalan, prednisone

Drug: Thalidomide

Study type

Interventional

Funder types

Other

Identifiers

NCT00644306

University Hospital, Nancy

Details and patient eligibility

About

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.

Enrollment

232 patients

Sex

All

Ages

75+ years old

Volunteers

No Healthy Volunteers

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.