Determination of Safe and Effective Dose of Romiplostim (AMG 531) in Subjects With Myelodysplastic Syndrome (MDS)Receiving Hypomethylating Agents

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

69 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-10-01

Study Completion Date

2009-10-19

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Determination of Safe Dose of Romiplostim (AMG 531) in Patients With Myelodysplastic Syndromes (MDS)

NCT00303472

Thrombocytopenia MDS Myelodysplastic Syndromes +1 more

COMPLETED PHASE2

Romiplostim Treatment of Thrombocytopenia in Subjects With Low or Intermediate-1 Risk Myelodysplastic Syndrome (MDS)

NCT00614523

MDS Myelodysplastic Syndromes Thrombocytopenia

COMPLETED PHASE2

A Safety and Efficacy Study to Evaluate AMG 531 Treatment in Subject With Myelodysplastic Syndrome Receiving Revlimid

NCT00418665

Myelodysplastic Syndromes Thrombocytopenia

COMPLETED PHASE2

Using Romiplostim to Treat Low Platelet Counts Following Chemotherapy and Autologous Hematopoietic Cell Transplantation in People With Blood Cancer

NCT04478123

Multiple Myeloma Hodgkin Lymphoma Non-Hodgkin Lymphoma +1 more

COMPLETED PHASE2

Dose/ Schedule Finding Trial of Romiplostim for Chemotherapy-Induced Thrombocytopenia (CIT) in Non-Small Cell Lung Cancer (NSCLC)

NCT00413283

Lung Cancer Chemotherapy-Induced Thrombocytopenia Non-Small Cell Lung Cancer +5 more

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

MDS Myelodysplastic Syndromes Thrombocytopenia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

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

Group Type ACTIVE_COMPARATOR

AMG 531 (Romiplostim)

Intervention Type 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.

Azacitidine

Intervention Type DRUG

hypomethylating agent

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

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

Group Type ACTIVE_COMPARATOR

AMG 531 (Romiplostim)

Intervention Type 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.

Decitabine

Intervention Type DRUG

hypomethylating agent

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

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

Group Type ACTIVE_COMPARATOR

AMG 531 (Romiplostim)

Intervention Type 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.

Azacitidine

Intervention Type DRUG

hypomethylating agent

Placebo (Part A - azacitidine)

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Azacitidine

Intervention Type DRUG

hypomethylating agent

Placebo (Part B - decitabine)

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Decitabine

Intervention Type DRUG

hypomethylating agent

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Placebo

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

Intervention Type DRUG

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.

Intervention Type BIOLOGICAL

Azacitidine

hypomethylating agent

Intervention Type DRUG

Decitabine

hypomethylating agent

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No