Clinical trial · Interventional
A Randomized Study With Oral Melphalan + Prednisone (MP) Versus Melphalan, + Prednisone + Thalidomide (MPT) for Newly Diagnosesd Elderly Patients With Multiple Myeloma
NCT01274403CI-TRIAL-00004274completedPhase 2ClinicalTrials.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)
The aim of the study is to compare efficacy and toxicity of melphalan and prednisone versus meplhalan, prednisone and Thalidomide in elderly patients with multiple myeloma or patients with multiple myeloma but not eligible for high dose treatment with stem cells support.
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 |
|---|---|---|---|
| Melphalan, Prednisone and Thalidomide | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Melphalan, prednisone plus Thalidomide
- interventionNames
- Drug: Melphalan, Prednisone and Thalidomide
- type
- ACTIVE_COMPARATOR
- label
- Melphalan and Prednisone
- interventionNames
- Drug: Melphalan, Prednisone and Thalidomide
Primary outcomes (2)
- measure
- To assess the efficacy
- timeFrame
- from 8 to 12 months
- description
- To compare the percentage of response in term of complete response, partial response, minimal and stable disease in the 2 arms o treatment
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * newly diagnosed of multiple myeloma. * Age \> 65 years * ECOG \<= 3 * Written informed consent given at the time of randomization * Patients with age \<= 65 but not eligible for high dose treatment with stem cells support Exclusion Criteria: * ECOG \> 3 * current neoplasm.. * contraindications to use thalidomide * peripheral neurophaty
References
Publications (0)
Data not yet available
No reference posted for this study.