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Cancer Treatment
Epoetin Alfa vs Luspatercept for Myelodysplastic Syndrome (ELEMENT-MDS 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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to week 96
Awards & highlights
Summary
This trial is testing two treatments, Luspatercept and epoetin alfa, to see which is better for treating anemia in adults with certain types of myelodysplastic syndromes (MDS). The participants have not used similar treatments before and do not need regular blood transfusions. Luspatercept helps red blood cells mature, while epoetin alfa increases their production.
Who is the study for?
This trial is for adults with Myelodysplastic Syndrome (MDS) who have anemia but don't need blood transfusions. They should not have had previous treatments with erythropoiesis-stimulating agents, and their MDS should be classified as very low to intermediate-risk. Participants must also experience moderate symptoms of fatigue or other related issues due to anemia.
What is being tested?
The study compares Luspatercept against Epoetin Alfa in treating anemia caused by MDS in participants who haven't used similar drugs before. It aims to see which drug is more effective and safer for patients who aren't dependent on blood transfusions.
What are the potential side effects?
Possible side effects of Luspatercept may include tiredness, muscle aches, dizziness, high blood pressure, and bone pain. Epoetin Alfa could cause joint pain, injection site reactions, headache, or increased risk of blood clots.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to week 96
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to week 96
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of participants with lower-risk non-transfusion dependent myelodysplastic syndromes (NTD-MDS) who converted to Transfusion Dependence (TD) during any continuous 16-week interval within the 96-week treatment period
Secondary study objectives
Number of participants with a neutrophil response at Week 24, Week 48 and Week 96
Number of participants with a platelet response at Week 24, Week 48 and Week 96
Side 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%
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
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: LuspaterceptExperimental Treatment1 Intervention
Group II: Epoetin AlfaActive Control1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Luspatercept
2018
Completed Phase 3
~1240
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Luspatercept enhances erythroid maturation, aiding in the development and maturation of red blood cells, while Epoetin Alfa stimulates red blood cell production by mimicking erythropoietin. These treatments are vital for Myelodysplastic Syndrome patients as they address the hematologic deficiencies of the syndrome, improving symptoms, reducing transfusion needs, and enhancing quality of life.
Lenalidomide: Myelodysplastic syndromes with del(5q) and beyond.
Lenalidomide: Myelodysplastic syndromes with del(5q) and beyond.
Find a Location
Who is running the clinical trial?
Bristol-Myers SquibbLead Sponsor
2,680 Previous Clinical Trials
4,124,708 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My average hemoglobin level was 9.5 g/dL or less before joining the study.My MDS developed after treatment for another disease.I have been diagnosed with acute myeloid leukemia (AML).I have had pure red cell aplasia or antibodies against erythropoietin.My MDS is classified as very low, low, or intermediate-risk according to WHO.I have never been treated with drugs to stimulate red blood cell production.I feel moderately or more fatigued, weak, short of breath, or dizzy.I have had a stroke, clot, or similar event in the past 6 months.
Research Study Groups:
This trial has the following groups:- Group 1: Luspatercept
- Group 2: Epoetin Alfa
Awards:
This trial has 2 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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