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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 weeks
Treatment ~ Varies
Follow Up ~up to week 96
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to week 96 for reporting.

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 • 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

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.

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

Epoetin Alfa (Cancer Treatment) Clinical Trial Eligibility Overview. Trial Name: NCT05949684 — Phase 3
Myelodysplastic Syndrome Research Study Groups: Luspatercept, Epoetin Alfa
Myelodysplastic Syndrome Clinical Trial 2023: Epoetin Alfa Highlights & Side Effects. Trial Name: NCT05949684 — Phase 3
Epoetin Alfa (Cancer Treatment) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05949684 — Phase 3
~240 spots leftby Jun 2027