Treatment of Newly Diagnosed Elderly Patients With Multiple Myeloma

University Hospital, Lille

Status and phase

Completed

Phase 3

Conditions

Multiple Myeloma

Treatments

Drug: Thalidomide

Study type

Interventional

Funder types

Other

Identifiers

NCT00367185

IFM 99-06

Details and patient eligibility

About

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 of thalidomide to this combination or adapted high-dose chemotherapy, using a melphalan 100 mg/m2 -based regimen, would improve survival.

Full 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 the study are to compare the efficacy and safety of MP with MP-Thalidomide or with MEL100 (intermediate-dose melphalan 100 mg/m2 - based treatment). The secondary objective is to compare the efficacy of MP-Thalidomide vs MEL100.

Sex

All

Ages

65 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Stage II or III multiple myeloma according to Durie and Salmon criteria.
Patients between 65 and 75 years of age
Previously untreated patients

Exclusion criteria

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