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Luspatercept for Myelodysplastic Syndrome (MAXILUS Trial)

Phase 3
Recruiting
Research Sponsored by Bristol-Myers Squibb
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participant had documented diagnosis of MDS according to World Health Organization (WHO) classification that met Revised International Prognostic Scoring System (IPSS-R) classification of very low-, low-, or intermediate-risk disease.
Participant has an Eastern Cooperative Oncology Group (ECOG) score of 0, 1, or 2.
Must not have
Participant has known history or diagnosis of AML.
Participant has known clinically significant anemia due to iron, vitamin B12, or folate deficiencies, or autoimmune or hereditary hemolytic anemia, or gastrointestinal bleeding.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Summary

This trial studies if a new drug can safely reduce the need for blood transfusions in people with low-risk Myelodysplastic Syndrome.

Who is the study for?
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.
What is being tested?
The study tests the effectiveness and safety of Luspatercept at its highest approved dose in participants with lower-risk MDS needing red blood cell transfusions. It aims to see how well this treatment works in improving their condition.
What are the potential side effects?
Possible side effects from Luspatercept may include tiredness, headache, muscle pains, joint pain, dizziness, nausea or vomiting. Side effects vary by individual and some may experience more than others.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My MDS is classified as very low, low, or intermediate risk.
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I am able to care for myself and perform daily activities.
Select...
I have received red blood cell transfusions as required by the study.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have been diagnosed with acute myeloid leukemia (AML).
Select...
I have anemia caused by a deficiency, autoimmune disorder, or bleeding.
Select...
My blood pressure is not controlled by medication.
Select...
I have had a stem cell transplant before.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Side effects data

From 2021 Phase 3 trial • 336 Patients • NCT02604433
42%
Upper respiratory tract infection
35%
Headache
32%
Back pain
23%
Arthralgia
22%
Bone pain
22%
Cough
21%
Pyrexia
18%
Oropharyngeal pain
18%
Diarrhoea
17%
Fatigue
16%
Pharyngitis
15%
Pain in extremity
13%
Abdominal pain
13%
Nausea
13%
Vomiting
13%
Myalgia
13%
Dizziness
12%
Asthenia
11%
Abdominal pain upper
11%
Influenza
10%
Hypertension
9%
Dyspepsia
9%
Influenza like illness
9%
Musculoskeletal pain
9%
Nasal congestion
8%
Nasopharyngitis
8%
Gastroenteritis
8%
Urticaria
7%
Toothache
7%
Tonsillitis
7%
Hyperuricaemia
6%
Pain
6%
Urinary tract infection
6%
Viral upper respiratory tract infection
6%
Neck pain
6%
Osteoporosis
5%
Constipation
5%
Injection site pain
5%
Transfusion reaction
5%
Alanine aminotransferase increased
5%
Spinal pain
5%
Lethargy
5%
Menstruation irregular
5%
Liver iron concentration increased
4%
Fall
4%
Musculoskeletal chest pain
2%
Anaemia
1%
Septic shock
1%
Extramedullary haemopoiesis
1%
Deep vein thrombosis
1%
Transient ischaemic attack
1%
Cerebrovascular accident
1%
Cholangitis
1%
Cholecystitis acute
1%
Cellulitis
1%
Pneumonia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Luspatercept + BSC
Placebo + BSC

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Cohort 2: ESA relapsed or refractoryExperimental Treatment1 Intervention
Group II: Cohort 1: erythropoiesis-stimulating agents (ESA) naïveExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Luspatercept
2018
Completed Phase 3
~1240

Find a Location

Who is running the clinical trial?

Bristol-Myers SquibbLead Sponsor
2,696 Previous Clinical Trials
4,098,971 Total Patients Enrolled
~46 spots leftby Jan 2026
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
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