NCT00321711

Brief Summary

The purpose of this study is to evaluate the effect of Romiplostim (AMG 531) on the incidence of clinically significant thrombocytopenic events (grade 3 or 4 and/or receipt of platelet transfusions) in subjects with low or intermediate risk Myelodysplastic Syndrome (MDS) receiving hypomethylating agents. It is hypothesized that Romiplostim administration, at the appropriate dose and schedule, will result in reduction in the incidence of clinically significant thrombocytopenic events in low or intermediate risk MDS subjects receiving hypomethylating agents.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
69

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Oct 2006

Typical duration for phase_2

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 2, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 4, 2006

Completed
5 months until next milestone

Study Start

First participant enrolled

October 1, 2006

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 19, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 19, 2009

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

April 5, 2011

Completed
Last Updated

October 17, 2018

Status Verified

September 1, 2018

Enrollment Period

3.1 years

First QC Date

May 2, 2006

Results QC Date

November 18, 2010

Last Update Submit

September 20, 2018

Conditions

MDSMyelodysplastic SyndromesThrombocytopenia

Keywords

MDSMyelodysplastic SyndromesRefractory CytopeniasThrombocytopenia

Outcome Measures

Primary Outcomes (1)

  • Occurrence of a Clinically Significant Thrombocytopenic Event

    Occurrence of a clinically significant thrombocytopenic event within the participant, defined as any platelet count obtained from day 15 of cycle 1 through the end of the interim follow-up visit that was less than 50 x 10\^9/L or receipt of platelet transfusions at any time through the interim follow-up visit.

    Treatment period (up to 20 weeks)

Secondary Outcomes (3)

  • Hypomethylating Agent Dose Reduction and Delay Due to Thrombocytopenia

    Treatment period (up to 20 weeks)

  • Achieving an Overall Response (Complete or Partial Response, CR or PR) at the End of the Treatment Period

    Treatment period (up to 20 weeks)

  • Platelet Transfusion

    Study day 1 through the interim follow-up visit (up to 20 weeks)

Study Arms (5)

Dose level 1 500 AMG 531 (Part A - azacitidine)

ACTIVE COMPARATOR

500 mcg AMG 531 weekly via subcutaneous injection + 75 mg/m2 azacitidine for 4 cycles

Biological: AMG 531 (Romiplostim)Drug: Azacitidine

Dose level 1 750 AMG 531 (Part B - decitabine)

ACTIVE COMPARATOR

750 mcg AMG 531 weekly via subcutaneous injection + 20 mg/m2 decitabine for 4 cycles

Biological: AMG 531 (Romiplostim)Drug: Decitabine

Dose level 2 750 AMG 531 (Part A - azacitidine)

ACTIVE COMPARATOR

750 mcg AMG 531 weekly via subcutaneous injection + 75 mg/m2 azacitidine for 4 cycles

Biological: AMG 531 (Romiplostim)Drug: Azacitidine

Placebo (Part A - azacitidine)

PLACEBO COMPARATOR

Placebo weekly via subcutaneous injection + 75 mg/m2 azacitidine for 4 cycles

Drug: PlaceboDrug: Azacitidine

Placebo (Part B - decitabine)

PLACEBO COMPARATOR

Placebo weekly via subcutaneous injection + 20 mg/m2 decitabine for 4 cycles

Drug: PlaceboDrug: Decitabine

Interventions

PlaceboDRUG

Subjects in the control group will receive a placebo subcutaneous injection on a weekly basis during the 4 cycle treatment period.

Placebo (Part A - azacitidine)Placebo (Part B - decitabine)
AMG 531 (Romiplostim)BIOLOGICAL

AMG 531 (Romiplostim) will be administered weekly by subcutaneous injection at a dose of 500 or 750 μg during Part A and 750 μg during Part B for the 4 cycle treatment period, depending on randomization.

Dose level 1 500 AMG 531 (Part A - azacitidine)Dose level 1 750 AMG 531 (Part B - decitabine)Dose level 2 750 AMG 531 (Part A - azacitidine)
AzacitidineDRUG

hypomethylating agent

Dose level 1 500 AMG 531 (Part A - azacitidine)Dose level 2 750 AMG 531 (Part A - azacitidine)Placebo (Part A - azacitidine)
DecitabineDRUG

hypomethylating agent

Dose level 1 750 AMG 531 (Part B - decitabine)Placebo (Part B - decitabine)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • Prior exposure to \>3 cycles hypomethylating agents
  • Prior history of leukemia or aplastic anemia
  • Prior history of bone marrow transplantation
  • Prior malignancy (other than in situ cervical cancer or basal cell cancer of the skin) unless treated with curative intent and without evidence of disease for ³ 3 years before randomization
  • Active or uncontrolled infections
  • Unstable angina, congestive heart failure \[NYHA (New York Heart Association) \> class II\], uncontrolled hypertension \[diastolic \> 100 mmHg\], uncontrolled cardiac arrhythmia, or recent (within 1 year) myocardial infarction
  • History of arterial thrombosis ( eg, stroke or transient ischemic attack) in the past year
  • History of venous thrombosis that currently requires anti-coagulation therapy
  • Received IL-11 within 4 weeks of screening
  • Less than 4 weeks since receipt of any therapeutic drug or device that is not FDA approved for any indication
  • Have previously received any other thrombopoietic growth factor

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Greenberg PL, Garcia-Manero G, Moore M, Damon L, Roboz G, Hu K, Yang AS, Franklin J. A randomized controlled trial of romiplostim in patients with low- or intermediate-risk myelodysplastic syndrome receiving decitabine. Leuk Lymphoma. 2013 Feb;54(2):321-8. doi: 10.3109/10428194.2012.713477. Epub 2012 Nov 15.

    PMID: 22906162BACKGROUND

  • Kantarjian HM, Giles FJ, Greenberg PL, Paquette RL, Wang ES, Gabrilove JL, Garcia-Manero G, Hu K, Franklin JL, Berger DP. Phase 2 study of romiplostim in patients with low- or intermediate-risk myelodysplastic syndrome receiving azacitidine therapy. Blood. 2010 Oct 28;116(17):3163-70. doi: 10.1182/blood-2010-03-274753. Epub 2010 Jul 14.

    PMID: 20631375BACKGROUND

Related Links

MeSH Terms

Conditions

Myelodysplastic SyndromesThrombocytopeniaCytopenia

Interventions

romiplostimAzacitidineDecitabine

Condition Hierarchy (Ancestors)

Bone Marrow DiseasesHematologic DiseasesHemic and Lymphatic DiseasesBlood Platelet Disorders

Intervention Hierarchy (Ancestors)

Aza CompoundsOrganic ChemicalsCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsNucleosidesNucleic Acids, Nucleotides, and NucleosidesRibonucleosides

Results Point of Contact

Title
Study Director
Organization
Amgen Inc.
866-572-6436

Study Officials

  • MD

    Amgen

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 2, 2006

First Posted

May 4, 2006

Study Start

October 1, 2006

Primary Completion

October 19, 2009

Study Completion

October 19, 2009

Last Updated

October 17, 2018

Results First Posted

April 5, 2011

Record last verified: 2018-09