Clinical trial · Interventional
Treatment of Newly Diagnosed Elderly Patients With Multiple Myeloma
Comparison of Melphalan-Prednisone(MP),MP-THALIDOMIDE,and Autologous Stem Cell Transplantation in the Treatment of Newly Diagnosed Elderly Patients With Multiple Myeloma.
NCT00367185CI-TRIAL-00000412completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
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 |
|---|---|---|---|
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Thalidomide | Drug | Thalidomide | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Overall survival
Secondary outcomes (4)
- measure
- Best response rate
- measure
- Progression-free survival
- measure
- Survival after progression
- measure
- Toxicity
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 65 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDFacon 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