Clinical trial NCT02175277: Darbepoetin Alfa MDS Companion Protocol
Official title: Single Arm, Companion Study to Myelodysplastic Syndrome (MDS) 20090160 Using Darbepoetin Alfa for the Treatment of Anaemic Subjects With Myelodysplastic Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Myelodysplastic Syndrome (MDS)
Keywords: Myelodysplastic Syndrome (MDS)
Darbepoetin alfa
low risk MDS
intermediate-1 risk MDS
International Prognostic Scoring System (IPSS)
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2014-06-26
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants With Treatment-emergent Adverse Events
timeFrame: From first dose of darbepoetin alfa to 30 days after last dose; the maximum treatment duration was 73 weeks.
Secondary outcomes:
Other outcomes:
Locations:
city: Charleroi
country: Belgium
facility: Research Site
city: Leuven
country: Belgium
facility: Research Site
city: Liege
country: Belgium
facility: Research Site
city: Sint-Niklaas
country: Belgium
facility: Research Site
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References: