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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00321711
Other study ID # 20050232
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date October 1, 2006
Est. completion date October 19, 2009

Study information

Verified date September 2018
Source Amgen
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 69
Est. completion date October 19, 2009
Est. primary completion date October 19, 2009
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Diagnosis of MDS by bone marrow biopsy based on the World Health Organization (WHO) classification - Low, Intermediate-1 or Intermediate-2 risk category MDS using the IPSS (International Prognostic Scoring System) - Planned to receive either azacytidine 75 mg/m2 by subcutaneous administration each day for 7 days or decitabine 20 mg/m2 by intravenous administration each day for 5 days for at least 4 cycles Exclusion Criteria:

- 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

Study Design


Intervention

Drug:
Placebo
Subjects in the control group will receive a placebo subcutaneous injection on a weekly basis during the 4 cycle treatment period.
Biological:
AMG 531 (Romiplostim)
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.
Drug:
Azacitidine
hypomethylating agent
Decitabine
hypomethylating agent

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Amgen

References & 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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Hypomethylating Agent Dose Reduction and Delay Due to Thrombocytopenia Occurrence of hypomethylating agent dose reduction and delay due to thrombocytopenia Treatment period (up to 20 weeks)
Secondary Achieving an Overall Response (Complete or Partial Response, CR or PR) at the End of the Treatment Period CR = decrease in bone marrow blast (=5%) and improvement in peripheral blood counts (Hgb = 11 g/dL, platelets = 100x10^9/L, neutrophils = 1x10^9/L, peripheral blasts=0%). PR = improvement in peripheral blood counts plus a decrease in bone marrow blasts =50% but not =5, or decrease in International Prognostic Scoring System score. Treatment period (up to 20 weeks)
Secondary Platelet Transfusion Occurrence of one or more platelet transfusions from study day 1 through the interim follow-up visit (16 weeks) Study day 1 through the interim follow-up visit (up to 20 weeks)
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