Aplidin - Dexamethasone in Relapsed/Refractory Myeloma
Summary
Study of Plitidepsin in combination with dexamethasone versus dexamethasone alone in patients with relapsed/refractory multiple myeloma.
Timeline
- Start
- 2010-06
- Primary completion
- 2017-11
- Completion
- 2017-11
Outcome
Sources disagree · no verdict is set; each source's reading is shown below
registry MEDIAN Plitidepsin+Dexamethasone: 2.6 (1.9 to 3.0) months reads as mixed primary results NCT01102426 ↗
registry analysis (superiority test); Plitidepsin+Dexamethasone vs Dexamethasone; p =0.0054; Hazard Ratio (HR) 0.65 (95% CI 0.447 to 0.885) reads as mixed primary results NCT01102426 ↗
registry analysis (superiority test); Plitidepsin+Dexamethasone vs Dexamethasone; p = 0.0618; Normal approximation reads as mixed primary results NCT01102426 ↗
release “已經達到該研究臨床主要目標(primary end point)” reads as met primary endpoint com.tw ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dexamethasone | Small molecule | 40 mg | Oral |
| Subject | Plitidepsin | Peptide | 5 mg/m2 | Intravenous |