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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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 4 years
Awards & highlights
MAXILUS 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.Check my eligibility
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.See study design
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.
MAXILUS Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My MDS is classified as very low, low, or intermediate risk.
Select...
I am able to care for myself and perform daily activities.
Select...
I have received red blood cell transfusions as required by the study.
MAXILUS Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 4 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 4 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of participants who achieve red blood cell transfusion independence (RBC-TI) for 8 weeks with a simultaneous mean hemoglobin (Hb) increase of ≥ 1 g/dL from Week 1 to Week 24
Secondary outcome measures
Number of participants who achieve Hematological Improvement - Neutrophils (HI-N) per IWG-2018 over any consecutive 8-week period from Week 1 to Week 24, from Week 1 to Week 48, and Week 1 through EOT
Number of participants who achieve Hematological Improvement - Platelets (HI-P) per IWG-2018 over any consecutive 8-week period from Week 1 to Week 24, from Week 1 to Week 48, and Week 1 through EOT
Number of participants who achieve Hematological Improvement Erythroid (mHI-E) per International Working Group-2018 (IWG-2018) over any consecutive 8-week period from Week 1 to Week 24, from Week 1 to Week 48, and Week 1 through EOT
+15 moreSide effects data
From 2021 Phase 3 trial • 336 Patients • NCT0260443342%
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%
Vomiting
13%
Dizziness
13%
Nausea
13%
Abdominal pain
13%
Myalgia
12%
Asthenia
11%
Abdominal pain upper
11%
Influenza
10%
Hypertension
9%
Dyspepsia
9%
Influenza like illness
9%
Musculoskeletal pain
9%
Nasal congestion
8%
Urticaria
8%
Gastroenteritis
8%
Nasopharyngitis
7%
Toothache
7%
Tonsillitis
7%
Hyperuricaemia
6%
Pain
6%
Urinary tract infection
6%
Viral upper respiratory tract infection
6%
Neck pain
6%
Osteoporosis
5%
Spinal pain
5%
Lethargy
5%
Injection site pain
5%
Menstruation irregular
5%
Alanine aminotransferase increased
5%
Constipation
5%
Transfusion reaction
5%
Liver iron concentration increased
4%
Musculoskeletal chest pain
4%
Fall
2%
Anaemia
1%
Deep vein thrombosis
1%
Extramedullary haemopoiesis
1%
Septic shock
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
MAXILUS 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
~1050
Find a Location
Who is running the clinical trial?
Bristol-Myers SquibbLead Sponsor
2,650 Previous Clinical Trials
4,130,809 Total Patients Enrolled
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