Clinical trial · Interventional
Comparison of Melphalan-Prednisone (MP) to MP Plus Thalidomide in the Treatment of Newly Diagnosed Very Elderly Patients (> 75 Years) With Multiple Myeloma
NCT00644306CI-TRIAL-00001366IFM 01/01terminatedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): survival advantage demonstrated
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Newly Diagnosed, Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| melphalan, prednisone | Drug | — | UNRESOLVED |
| melphalan, prednisone, thalidomide | Drug | — | UNRESOLVED |
| Thalidomide | Drug | Thalidomide | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- PLACEBO_COMPARATOR
- label
- A
- description
- 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
- interventionNames
- Drug: Thalidomide
- Drug: melphalan, prednisone
- type
- ACTIVE_COMPARATOR
- label
- B
- description
- 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
- interventionNames
- Drug: melphalan, prednisone, thalidomide
Primary outcomes (1)
- measure
- overall Survival
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (1)
- BACKGROUNDFacon 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. doi: 10.1016/S0140-6736(07)61537-2. PMID 17920916