Romiplostim for Chemotherapy-Induced Low Platelet Count
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests romiplostim, a drug that boosts platelet production, in adults with certain cancers undergoing chemotherapy. It aims to help these patients maintain their chemotherapy schedule by increasing their platelet counts. Romiplostim has shown effectiveness in increasing platelet counts in patients with low platelet levels due to chemotherapy.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. However, it does mention that certain investigational drugs or treatments cannot be taken concurrently, so it's best to discuss your specific medications with the trial team.
How does the drug romiplostim differ from other treatments for low platelet count due to chemotherapy?
Romiplostim is unique because it is a thrombopoietin receptor agonist, which means it stimulates the body's production of platelets by mimicking a natural protein that encourages platelet growth. Unlike other treatments, it is administered as a weekly injection and is specifically designed to increase platelet counts in patients who have not responded well to other therapies.12345
What data supports the effectiveness of the drug Romiplostim for treating low platelet counts caused by chemotherapy?
Research shows that Romiplostim, originally approved for immune thrombocytopenia, has been used off-label for chemotherapy-induced low platelet counts. In a study, 51% of patients achieved a significant increase in platelet count within a week, suggesting its potential effectiveness for this condition.13467
Who Is on the Research Team?
MD
Principal Investigator
Amgen
Are You a Good Fit for This Trial?
Adults over 18 with advanced or recurrent NSCLC, breast, or ovarian cancer eligible for chemotherapy can join. They must have low platelet counts due to chemo and be able to undergo at least 3 more cycles. Exclusions include HIV, recent heart issues, other cancers within 5 years (with exceptions), active infections, certain blood disorders, and unwillingness to use contraception.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive romiplostim or placebo during chemotherapy cycles to assess efficacy in treating chemotherapy-induced thrombocytopenia
Follow-up
Participants are monitored for safety and effectiveness after treatment
Long-term Follow-up
Participants are monitored for secondary malignancies, adverse events, and other long-term outcomes
What Are the Treatments Tested in This Trial?
Interventions
- Romiplostim
Find a Clinic Near You
Who Is Running the Clinical Trial?
Amgen
Lead Sponsor
Robert A. Bradway
Amgen
Chief Executive Officer since 2012
MBA from Harvard Business School
Paul Burton
Amgen
Chief Medical Officer since 2023
MD from University of London, PhD in Molecular and Cellular Biology from Imperial College London