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Darbepoetin Alfa MDS Companion Protocol

Primary Purpose

Myelodysplastic Syndrome (MDS)

Status
Completed
Phase
Phase 3
Locations
Belgium
Study Type
Interventional
Intervention
Darbepoetin Alfa
Sponsored by
Amgen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myelodysplastic Syndrome (MDS) focused on measuring Myelodysplastic Syndrome (MDS), Darbepoetin alfa, low risk MDS, intermediate-1 risk MDS, International Prognostic Scoring System (IPSS)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Research Site
  • Research Site
  • Research Site
  • Research Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Darbepoetin Alfa

Arm Description

Participants received darbepoetin alfa for up to 73 weeks or until progression to acute myeloid leukemia (AML), whichever occurred first.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
June 24, 2014
Last Updated
October 15, 2018
Sponsor
Amgen
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1. Study Identification

Unique Protocol Identification Number
NCT02175277
Brief Title
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

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
June 12, 2014 (Actual)
Primary Completion Date
March 20, 2017 (Actual)
Study Completion Date
March 20, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Amgen

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myelodysplastic Syndrome (MDS)
Keywords
Myelodysplastic Syndrome (MDS), Darbepoetin alfa, low risk MDS, intermediate-1 risk MDS, International Prognostic Scoring System (IPSS)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Darbepoetin Alfa
Arm Type
Experimental
Arm Description
Participants received darbepoetin alfa for up to 73 weeks or until progression to acute myeloid leukemia (AML), whichever occurred first.
Intervention Type
Drug
Intervention Name(s)
Darbepoetin Alfa
Other Intervention Name(s)
Aranesp®
Intervention Description
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).
Primary Outcome Measure Information:
Title
Number of Participants With Treatment-emergent Adverse Events
Description
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MD
Organizational Affiliation
Amgen
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Charleroi
ZIP/Postal Code
6000
Country
Belgium
Facility Name
Research Site
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Research Site
City
Liege
ZIP/Postal Code
4000
Country
Belgium
Facility Name
Research Site
City
Sint-Niklaas
ZIP/Postal Code
9100
Country
Belgium

12. IPD Sharing Statement

Links:
URL
http://www.amgentrials.com
Description
AmgenTrials clinical trials website

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Darbepoetin Alfa MDS Companion Protocol

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