Treatment of Newly Diagnosed Elderly Patients With Multiple Myeloma
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.
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.
Condition or disease
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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study:
65 Years to 75 Years (Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Stage II or III multiple myeloma according to Durie and Salmon criteria.
Patients between 65 and 75 years of age
Previously untreated patients
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
HIV or hepatitis B or C positivity
Patients who had geographic, social or psychological conditions which might prevent adequate follow-up