Comparison of Melphalan-Prednisone(MP),MP-THALIDOMIDE,and Autologous Stem Cell Transplantation in the Treatment of Newly Diagnosed Elderly Patients With Multiple Myeloma.
65 Years
75 Years
Both
Multiple Myeloma
Trial Information
Comparison of Melphalan-Prednisone(MP),MP-THALIDOMIDE,and Autologous Stem Cell Transplantation in the Treatment of Newly Diagnosed Elderly Patients With Multiple Myeloma.
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Overall survival
Principal Investigator
Jean-Yves MARY
Investigator Role:
Study Director
Investigator Affiliation:
U717 INSERM universite Paris7, Hopital Saint-Louis, Paris, France
Authority:
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study ID:
IFM 99-06
NCT ID:
NCT00367185
Start Date:
May 2000
Completion Date:
October 2005
Related Keywords:
- Multiple Myeloma
- Multiple myeloma
- Elderly patients
- Thalidomide
- Autologous transplantation
- Multiple Myeloma
- Neoplasms, Plasma Cell
Name | Location |
|---|
