Study of AMG 531 to Evaluate the Safety & Efficacy in Patients With Non-Hodgkin's Lymphoma

What Was Tested

The trial (phase 1, phase 2) is built around Romiplostim.

To determine the clinical safety and tolerability of AMG 531 administered following chemotherapy (R-HyperCVAD alternating with R-Ara-C/MTX) in patients with non-Hodgkin's lymphoma. 2.

It had seven arms (groups): one (experimental), one (experimental), one (experimental), Placebo (Arm A & Arm B) with Chemotherapy (placebo comparator) and one (experimental).

The registry classes the interventions as drug.

More on the Plan

Platelets are cells that help make the blood clot.

Researchers want to find out if AMG 531 can lower the risk and severity of this side effect.

AMG 531 is a protein that stimulates platelet production.

Before you can start treatment on this study, you will have what are called "screening tests." These tests will help the doctor decide if you are eligible to take part in the study.

Who Took Part

Enrollment: 50 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Patients age \>/= 18 years. Karnofsky Performance Scale \>/= 70. Patients (male and female) with childbearing potential (defined as not post-menopausal for 12 months or no previous surgical sterilization) must use adequate birth control. Institutional Review Board (IRB)-approved signed informed consent.

The full record lists 6 inclusion and 7 exclusion criteria; among the exclusions: pregnant or lactating women; history of central nervous system (cns) involvement; patients with history of deep vein thrombosis (dvt) or pulmonary embolus.

How the Study Was Run

Design: randomized, factorial and triple-blind.

Because people in this Romiplostim study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Blinding on both sides kept the participants and researchers unaware of who received Romiplostim.

Those kept unaware of assignments: participant, care provider and investigator.

It started in 2006-03 with completion listed for 2012-04.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Platelet (PLT) Nadir (time frame: Prior to start of treatment and then at least 2 times a week during treatment until end of cycle 2 (1 cycle = 21 days)). Days Platelets Count of < 100K/μL (time frame: Prior to start of treatment and then at least 2 times a week during treatment until end of cycle 2 (1 cycle = 21 days)).

What This Means in Plain Language

Put simply, this is a phase 1, phase 2, randomized trial of Romiplostim in 50 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Romiplostim compound page, all human trials.