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A Safety and Efficacy Study to Evaluate AMG 531 Treatment in Subject With Myelodysplastic Syndrome Receiving Revlimid
Plain-language guide to NCT00418665: phase 2 randomized trial of Romiplostim, 39 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT00418665
- Phase
- phase 2
- Status
- completed
- Start
- 2006-12
- Completion (planned or actual)
- 2009-03
- Participants
- 39 (actual)
- Design
- randomized, double-blind, supportive_care
- Conditions studied
- Myelodysplastic Syndromes; Thrombocytopenia
- Results posted
- yes
What This Study Did, in Plain Language
What Was Tested
This registered phase 2 trial tested Romiplostim.
Subjects with MDS that are planned to receive at least four cycles of lenalidomide for treatment of their disease are appropriate to screen for this study.
It had five arms (groups): one (active comparator), Placebo Part B (placebo comparator), Placebo Part A (placebo comparator), one (active comparator) and one (active comparator).
The registry classes the interventions as biological and drug.
Who Took Part
The registry lists 39 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: Diagnosis of MDS by bone marrow biopsy based on the World Health Organization (WHO) classification. Low or Intermediate-1 risk category MDS using the IPSS. Eastern Cooperative Oncology (ECOG) performance status of 0-2. Subjects must be at least 18 years of age or older.
The full record lists 5 inclusion and 15 exclusion criteria; among the exclusions: prior exposure to \>3 cycles of lenalidomide; exposure to lenalidomide within the last 30 days; prior history of leukemia or aplastic anemia.
How the Study Was Run
Design: randomized, parallel-group and double-blind.
Random assignment meant chance, not the researchers, decided who got Romiplostim and who got the comparison, which limits bias.
The Romiplostim group and the comparison group ran side by side rather than switching.
Blinding on both sides kept the participants and researchers unaware of who received Romiplostim.
Those kept unaware of assignments: participant and investigator.
It started in 2006-12 with completion listed for 2009-03.
Its stated primary purpose is supportive care.
What Was Measured
It also tracked 3 secondary outcomes, for example Platelet Transfusion.
What This Means in Plain Language
Put simply, this is a phase 2, randomized trial of Romiplostim in 39 people.
Its size is small, so on its own it can only give an early look.
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.
Our Notes on the Compound
Romiplostim: A peptide-antibody fusion (peptibody) that activates the thrombopoietin receptor to raise platelet counts; sold as Nplate.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.