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

What Was Tested

In this phase 2 trial, researchers set out to test Romiplostim.

It had 1 arm (groups): romiplostim (experimental).

The registry classes the interventions as drug.

Who Took Part

The registry lists 62 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: Adult patients ≥ 18 years old diagnosed with multiple myeloma (MM), any subtype of Hodgkin lymphoma (HL), or any subtype of non-Hodgkin lymphoma (NHL). Other conditioning regimens not listed above, or variations of the above conditioning regimens, may be allowed at the discretion of the principal investigator if the regimen is considered myeloablative. Adequate organ function is required, defined as follows:. AST, ALT, and alkaline phosphatase \< 3 times the upper limit of normal. Adequate performance status ECOG ≤ 2.

The full record lists 12 inclusion and 9 exclusion criteria; among the exclusions: patients with a previous diagnosis of a myeloid malignancy; patients for whom the treating oncologist will be using a non-standard platelet transfusion threshold during the ahct; patients who had been diagnosed with immune thrombocytopenic purpura (itp) at any time prior to the ahct are ineligible.

How the Study Was Run

Design: single-group and open-label.

Everyone knew when Romiplostim was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2020-07-14 with completion listed for 2023-06-08.

It ran at 7 sites in United States (7).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Number of Days Post HDT-AHCT Requiring Transfusions or Grade 4 CTCAE Thrombocytopenia (time frame: up to 42 days).

It also tracked 1 secondary outcome, for example Number of Platelet Transfusions Per Participant Issued During the AHCT Admission.

What This Means in Plain Language

Put simply, this is a phase 2 trial of Romiplostim in 62 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.