Darbepoetin Alfa MDS Companion Protocol

Amgen9 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Myelodysplastic Syndrome (MDS)

Interventions

Darbepoetin AlfaDRUG

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).

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (4)

Research Site

Charleroi, Belgium

Research Site

Leuven, Belgium

Research Site

Liège, Belgium

Research Site

Sint-Niklaas, Belgium

Outcomes

Primary Outcomes

Number of Participants With Treatment-emergent Adverse Events

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.

Time frame: From first dose of darbepoetin alfa to 30 days after last dose; the maximum treatment duration was 73 weeks.

Data from ClinicalTrials.gov

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