Overview

This trial is active, not recruiting.

Condition myelodysplastic syndrome (mds)
Treatment darbepoetin alfa
Phase phase 3
Sponsor Amgen
Start date June 2014
End date April 2017
Trial size 9 participants
Trial identifier NCT02175277, 2013-000727-13, 20130113

Summary

This is a phase 3b, multi-centre, open-label, single-arm companion study to the MDS 20090160 study for the treatment of anaemic subjects with MDS. Subjects that complete the active-treatment period of the darbepoetin alfa MDS 20090160 study and meet the eligibility criteria may be enrolled into this study to continue treatment of darbepoetin alfa for up to 73 weeks or until progression to acute myelogenous leukemia (AML), whichever occurs first.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Open label
darbepoetin alfa
Darbepoetin Alfa will be given at 500 μg three-times per week/two-times per week. The first dose and dosing frequency on day 1 / week 1 should carry forward from the last dose and frequency from the parent study (darbepoetin alfa MDS 20090160 study) administered at week 70 / 71. The day 1 / week 1 visit should align within +10 days of the End of Active Treatment Period (EOATP) visit at week 72 / 73 from the darbepoetin alfa MDS 20090160 study. The investigator may choose to increase the dose of darbepoetin alfa with the maximum dose permitted of 500 μg two-times per week. Dose increases should follow a step-wise approach, (eg, 300 μg to 500 μg; 200 μg to 300 μg) with at least 8 weeks at a given dose before the dose may be increased.

Primary Outcomes

Measure
Subject incidence of treatment-emergent adverse events
time frame: up to 73 weeks

Secondary Outcomes

Measure
Disease progression to acute myeloid leukemia (AML)
time frame: up to 73 weeks
Mortality
time frame: up to 73 weeks

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: Subject or subject's legally acceptable representative has provided informed consent prior to any study-specific activities/ procedures being initiated; Subject must continue long term follow up within parent study (20090160); Subject must have an ongoing clinically relevant erythroid response as assessed by the Investigator using current response criteria (ie, International Working Group (IWG) response criteria); Exclusion Criteria: Transfusion dependence defined as receiving a total of ≥ 4 units of red blood cell (RBC) transfusion in the previous 8-week period prior to enrolment; Known diagnosis of acute myelogenous leukemia (AML) or marrow collagen fibrosis; Known refractory anaemia with excess blast-2 (RAEB-2); Known diagnosis of intermediate-2 or high risk MDS per International Prognostic Scoring System (IPSS); Subjects received thrombopoiesis-stimulating factors (eg, eltrombopag, romiplostim) in the MDS 20090160 study or planning to receive such agents during the study; Other protocol defined inclusion and exclusion criteria may apply.

Additional Information

Official title Single Arm, Companion Study to Myelodysplastic Syndrome (MDS) 20090160 Using Darbepoetin Alfa for the Treatment of Anaemic Subjects With Myelodysplastic Syndrome
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by Amgen.