drugset
drugset / Trial / NCT02335268

Validation of a Predictive Model of Response to Romiplostim in Patients With IPSS Low or Intermediate-1 Risk MDS and Thrombocytopenia

NCT02335268 ↗

Phase 2 Completed 77 enrolled Gesellschaft fur Medizinische Innovation - Hamatologie und Onkologie mbH Amgen · collab
Non-randomizedParallel-groupOpen-labelTreatment

Summary

There are currently no licensed drugs in the EU to treat thrombocytopenia in MDS patients classified as IPSS low/int-1. Prior studies with romiplostim (a TPO receptor agonist) in MDS found that baseline concentration of TPO as well as transfusion history were predictive of subsequent response in a retrospective model. The current prospective study has the aim to explore whether both pretreatment variables (endogenous TPO, TPO-level, platelet transfusion history) can predict the response to subsequent short-term treatment with romiplostim.

Timeline

Start
2015-05-21
Primary completion
2021-07-01
Completion
2021-07-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Romiplostim Peptide — —

Indications

myelodysplastic syndrome