Darbepoetin Alfa MDS Companion Protocol

The primary objective of the study was to provide required access of investigational product (darbepoetin alfa) beyond the end of the active treatment period (EOATP) of the darbepoetin alfa MDS 20090160 (NCT01362140) study for patients who had continued demonstration of benefit from darbepoetin alfa treatment and to describe the safety of longer-term use in this patient population.

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Key information

Conditions

Myelodysplastic Syndrome (MDS) Bone Marrow Diseases Hematologic Diseases Hemic and Lymphatic Diseases Myelodysplastic Syndromes

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Research Site, Charleroi, Belgium

About this study

This is a phase 3b, multi-centre, open-label, single-arm companion study to the MDS 20090160 study (NCT01362140) for the treatment of anaemic patients with MDS. Participants who completed the active-treatment period of the darbepoetin alfa MDS 20090160 study and met the eligibility criteria could 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

darbepoetin alfa

Drug

The first dose of darbepoetin alfa was the same as that administered at the last dosing visit of the active treatment period in Study 20090160. Doses could be increased up to a maximum of 500 μg every two weeks (Q2W).

Other names: Aranesp®

Primary outcomes

Number of Participants With Treatment-emergent Adverse Events

Time frame: From first dose of darbepoetin alfa to 30 days after last dose; the maximum treatment duration was 73 weeks.
Adverse events (AEs) were graded for severity according to the Common Terminology Criteria for Adverse Events (CTCAE), version 4.0, where Grade 1 indicates a mild AE, Grade 2 indicates a moderate AE, Grade 3 indicates severe or medically significant but not immediately life-threatening and Grade 4 indicates life-threatening consequences; urgent intervention indicated.

A serious adverse event was defined as an adverse event that met at least one of the following serious criteria:
- fatal
- life threatening
- required in-patient hospitalization or prolongation of existing hospitalization
- resulted in persistent or significant disability/incapacity
- congenital anomaly/birth defect
- other medically important serious event The investigator assessed whether each adverse events was related to darbepoetin alfa.

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Registry information

Official study title

Single Arm, Companion Study to Myelodysplastic Syndrome (MDS) 20090160 Using Darbepoetin Alfa for the Treatment of Anaemic Subjects With Myelodysplastic Syndrome

Important dates

Study start: 2014
Primary completion: 2017
Study completion: 2017
First posted: Jun 26, 2014
Registry last updated: Nov 14, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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