Romiplostim in Increasing Low Platelet Counts in Patients With Multiple Myeloma Receiving Chemotherapy

What Was Tested

This registered phase 2 trial tested Romiplostim.

Romiplostim may cause the body to make platelets after chemotherapy.

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

The registry classes the interventions as biological.

More on the Plan

To evaluate the toxicity of romiplostim in this patient population by standard Common Toxicity Criteria (CTC).

OUTLINE: Patients receive romiplostim subcutaneously (SC) once weekly for up to 6 weeks.

After completion of study treatment, patients are followed up every 3 months for 1 year.

Who Took Part

The registry lists 5 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: Subject is not pregnant or breast feeding, and cannot become pregnant within 30 days after the end of treatment. Diagnosis of any stage of multiple myeloma based on standard criteria as follows:. Plasmacytomas on tissue biopsy. Monoclonal immunoglobulin present but of lesser magnitude than given under major criteria. Lytic bone lesions.

The full record lists 21 inclusion and 13 exclusion criteria; among the exclusions: POEMS syndrome (plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein \[M-protein\] and skin changes); plasma cell leukemia; receiving steroids daily for other medical conditions, e.g., asthma, systemic lupus erythematosus, rheumatoid arthritis.

How the Study Was Run

Design: single-group and open-label.

Being open-label, the Romiplostim study did not mask who received what.

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

It started in 2013-01 with completion listed for 2015-11.

It ran at 1 site in United States.

Its stated primary purpose is supportive care.

What Was Measured

The main thing measured (primary outcome): Percentage of Patients Who Have Responded (time frame: 8 weeks).

It also tracked 1 secondary outcome, for example Percentage of Patients Who Experienced Thrombosis or Marrow Fibrosis.

What This Means in Plain Language

Put simply, this is a phase 2 trial of Romiplostim in 5 people.

Its size is small, so on its own it can only give an early look.

It ended early (terminated); results are posted on the registry, and this page does not restate them.

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