| March 20, 2008 |
| March 20, 2008 |
| April 2002 |
| |
| overall Survival [ Time Frame: May 2007 ] [ Designated as safety issue: Yes ] |
| Same as current |
| No Changes Posted |
- Progression Free Survival [ Time Frame: May 2007 ] [ Designated as safety issue: No ]
- Response rates [ Time Frame: May 2007 ] [ Designated as safety issue: No ]
- Safety [ Time Frame: May 2007 ] [ Designated as safety issue: Yes ]
|
| Same as current |
| |
| Comparison of Melphalan-Prednisone (MP) to MP Plus Thalidomide in the Treatment of Newly Diagnosed Very Elderly Patients (> 75 Years) With Multiple Myeloma |
| Comparison of Melphalan-Prednisone (MP) to MP Plus Thalidomide in the Treatment of Newly Diagnosed Very Elderly Patients (> 75 Years) With Multiple Myeloma |
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. |
| |
| Phase III |
| Interventional |
| Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study |
| Newly Diagnosed, Multiple Myeloma |
- Drug: Thalidomide
- Drug: melphalan, prednisone
- Drug: melphalan, prednisone, thalidomide
|
- Placebo Comparator: 12 cycles every 6 weeks :melphalan 0.2 mg/kg day 1 to 4, prednisone 2 mg/kg/d day 1 to 4 plus placebo 100mg/d continuously for 18 months
- Active Comparator: 12 cycles every 6 weeks :melphalan 0.2 mg/kg day 1 to 4, prednisone 2 mg/kg/d day 1 to 4 plus thalidomide 100mg/d continuously for 18 months
|
| 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. |
| |
| Terminated |
| 232 |
| May 2007 |
|
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.
|
| Both |
| 75 Years and older |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| France |
| |
| NCT00644306 |
| Hulin Cyrille, Intergroupe Francophone du Myélome (IFM) |
| University Hospital, Nancy |
| Central Hospital, Nancy, France |
|
| Principal Investigator: |
Cyrille Hulin, MD |
Hematology CHU Nancy and Intergroupe Francophone du Myelome (IFM) |
|
|
| Central Hospital, Nancy, France |
| March 2008 |
