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A phase 3 trial of Plitidepsin and Dexamethasone in Multiple myeloma, run by PharmaMar, completed.
Aplidin - Dexamethasone in Relapsed/Refractory Myeloma is a phase 3 interventional study registered as NCT01102426 by PharmaMar, with 255 participants recorded, started 2010-06 and reaching its primary completion in 2017-11. Interventions recorded: Plitidepsin, Dexamethasone. Conditions recorded: Relapsed/Refractory Multiple Myeloma.
Linked to the drug Plitidepsin because the registry names it among its interventions and Multiple myeloma among its conditions. Registry record only: no result has been read by an editor.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
255 enrolled.
95% CI 1.9 to 3.0; Figures from the ClinicalTrials.gov results section (first posted 2020-10-22), not from a publication · 95% CI 1.1 to 2.0
Source95% CI 13.1 to 26.9; Figures from the ClinicalTrials.gov results section (first posted 2020-10-22), not from a publication · 95% CI 2.0 to 18.0
Source95% CI 9.2 to 16.1; Figures from the ClinicalTrials.gov results section (first posted 2020-10-22), not from a publication · 95% CI 6.0 to 15.4
Source95% CI 16.8 to 29.8; Figures from the ClinicalTrials.gov results section (first posted 2020-10-22), not from a publication · 95% CI 0.7 to 10.1
Source| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Progression Free Survival (PFS) as Per Intention-to-treat (ITT)primary | Plitidepsin+Dexamethasone | 171 | 2.6 months | 0.65 (0.447 to 0.885) | 0.0054 | link |
| Dexamethasone | 84 | 1.7 months | ||||
| Percentage of Participants With Progression Free Survival (PFS) as Per Intention-to-treat (ITT) at 6 Monthsprimary | Plitidepsin+Dexamethasone | 171 | 20% | - | 0.0618 | link |
| Dexamethasone | 84 | 10% | ||||
| Overall Survival | Plitidepsin+Dexamethasone | 171 | 11.6 months | 0.797 (0.596 to 1.067) | 0.1261 | link |
| Dexamethasone | 84 | 8.9 months | ||||
| Overall Response Rate (Independent Review Committee) | Plitidepsin+Dexamethasone | 171 | 22.8% | - | <0.0001 | link |
| Dexamethasone | 84 | 3.6% |
Shares Plitidepsin, PharmaMar, Relapsed or refractory multiple myeloma, Multiple myeloma and the tag pipeline.
Shares Plitidepsin and the tag pipeline.
Shares Dexamethasone, Relapsed or refractory multiple myeloma, Multiple myeloma and the tag pipeline.
Shares Relapsed or refractory multiple myeloma, Multiple myeloma and the tag pipeline.
Shares Relapsed or refractory multiple myeloma, Multiple myeloma and the tag pipeline.
Shares Relapsed or refractory multiple myeloma, Multiple myeloma and the tag pipeline.
Shares Dexamethasone, Relapsed or refractory multiple myeloma, Multiple myeloma and the tag pipeline.
Shares Dexamethasone, Relapsed or refractory multiple myeloma, Multiple myeloma and the tag pipeline.