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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 below

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 4 years for reporting.

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 more

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%

Vomiting

13%

Nausea

13%

Abdominal pain

13%

Dizziness

13%

Myalgia

12%

Asthenia

11%

Abdominal pain upper

11%

Influenza

10%

Hypertension

Dyspepsia

Influenza like illness

Musculoskeletal pain

Nasal congestion

Urticaria

Gastroenteritis

Nasopharyngitis

Toothache

Tonsillitis

Hyperuricaemia

Pain

Urinary tract infection

Viral upper respiratory tract infection

Neck pain

Osteoporosis

Spinal pain

Lethargy

Injection site pain

Menstruation irregular

Alanine aminotransferase increased

Constipation

Transfusion reaction

Liver iron concentration increased

Musculoskeletal chest pain

Fall

Anaemia

Deep vein thrombosis

Extramedullary haemopoiesis

Septic shock

Transient ischaemic attack

Cerebrovascular accident

Cholangitis

Cholecystitis acute

Cellulitis

Pneumonia

100%

80%

60%

40%

20%

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

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Bristol-Myers SquibbLead Sponsor

2,641 Previous Clinical Trials

4,129,964 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the FDA recognize Cohort 1: erythropoiesis-stimulating agents (ESA) as an approved treatment?

"Our team from Power has provided a safety rating of 3 for Cohort 1: ESA-naïve, as this is the third stage in the clinical trial process with prior research indicating both efficacy and safety."

Answered by AI

In what locations is this clinical experiment being conducted?

"Currently, 54 trial sites are enrolling patients in this medical study. These locations range from Eugene to Pittsburgh and Amarillo; it is suggested that individuals look for the nearest clinic to minimize travelling expenses if they choose to participate."

Answered by AI

Is this research endeavor presently recruiting participants?

"Per the clinicaltrials.gov listing, this trial is no longer accepting patient applications. The study was first posted on October 15th 2023 and last updated September 13th of the same year; however, 1709 other trials are still recruiting patients."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study to Assess Luspatercept in Lower-risk Myelodysplastic Syndrome Participants

2023. "A Study to Assess Luspatercept in Lower-risk Myelodysplastic Syndrome Participants". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06045689.