Luspatercept for Myelodysplastic Syndrome
(MAXILUS Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
The purpose of this study is to evaluate the efficacy and safety of Luspatercept when administered at the maximum approved dose in low-risk Myelodysplastic Syndrome participants who require red blood cell transfusions.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the drug Luspatercept for treating myelodysplastic syndrome?
Luspatercept has been shown to significantly reduce the need for red blood cell transfusions in patients with myelodysplastic syndromes, with 38% of patients achieving transfusion independence compared to 13% with a placebo. This suggests that Luspatercept can effectively help manage anemia in these patients.12345
Who Is on the Research Team?
Bristol-Myers Squibb
Principal Investigator
Bristol-Myers Squibb
Are You a Good Fit for This Trial?
This trial is for people with low-risk Myelodysplastic Syndrome (MDS) who need regular red blood cell transfusions. They should be relatively active and able to care for themselves (ECOG score of 0-2). People can't join if they have certain types of anemia, acute myeloid leukemia (AML), uncontrolled high blood pressure, or a history of stem cell transplant.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Luspatercept at the maximum approved dose for low-risk Myelodysplastic Syndrome
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Luspatercept
Luspatercept is already approved in United States, European Union for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
Bristol-Myers Squibb
Lead Sponsor
Christopher Boerner
Bristol-Myers Squibb
Chief Executive Officer since 2023
PhD in Business Administration from the Haas School of Business, University of California, Berkeley; BA in Economics and History from Washington University in St. Louis
Deepak L. Bhatt
Bristol-Myers Squibb
Chief Medical Officer since 2024
MD from Yale University; MSc in Clinical Epidemiology from the University of Pennsylvania