Comparison of Melphalan-Prednisone (MP) to MP Plus Thalidomide in the Treatment of Newly Diagnosed Very Elderly Patients (> 75 Years) With Multiple Myeloma
Information source: Central Hospital, Nancy, France
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Newly Diagnosed, Multiple Myeloma
Intervention: Thalidomide (Drug); melphalan, prednisone (Drug); melphalan, prednisone, thalidomide (Drug)
Phase: Phase 3
Sponsored by: Central Hospital, Nancy, France
Official(s) and/or principal investigator(s):
Cyrille Hulin, MD, Principal Investigator, Affiliation: Hematology CHU Nancy and Intergroupe Francophone du Myelome (IFM)
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
Official title: Comparison of Melphalan-Prednisone (MP) to MP Plus Thalidomide in the Treatment of Newly Diagnosed Very Elderly Patients (> 75 Years) With Multiple Myeloma
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Primary outcome: overall Survival
Progression Free Survival
Minimum age: 75 Years.
Maximum age: N/A.
- Stage II or III multiple myeloma according to Durie and Salmon criteria, patients
older than 75 years, previously untreated patients.
- Prior history of another neoplasm (except basocellular cutaneous or cervical
- 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
- 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
Locations and Contacts
CHU Nancy - Brabois, rue du morvan, VANDOEUVRE 54511, France
Facon T, Mary JY, Hulin C, Benboubker L, Attal M, Pegourie B, Renaud M, Harousseau JL, Guillerm G, Chaleteix C, Dib M, Voillat L, Maisonneuve H, Troncy J, Dorvaux V, Monconduit M, Martin C, Casassus P, Jaubert J, Jardel H, Doyen C, Kolb B, Anglaret B, Grosbois B, Yakoub-Agha I, Mathiot C, Avet-Loiseau H; Intergroupe Francophone du Myelome. Melphalan and prednisone plus thalidomide versus melphalan and prednisone alone or reduced-intensity autologous stem cell transplantation in elderly patients with multiple myeloma (IFM 99-06): a randomised trial. Lancet. 2007 Oct 6;370(9594):1209-18.
Starting date: April 2002
Ending date: May 2007
Last updated: March 20, 2008