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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 5 years
Awards & highlights
ELEMENT-MDS Trial Summary
This trial aims to compare two treatments for anemia in adults with a certain type of bone marrow disease who haven't yet had transfusions.
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.Check my eligibility
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.See study design
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.
ELEMENT-MDS Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 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 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 outcome measures
Change from baseline in self-reported HRQoL assessed by the European quality of life questionnaire 5-dimension (EQ-5D-5L)
Change from baseline in subscales of self-reported health-related quality-of-life (HRQoL) assessed by the Functional Assessment of Cancer Therapy - Anemia (FACT-An)
Duration of median hematologic improvement in erythroid response(mHI-E) in participants with an increase from baseline in mean Hb values of ≥1.5g/dL in any continuous 16-week interval within 48-week treatment period in absence of transfusion
+25 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%
Nausea
13%
Abdominal pain
13%
Dizziness
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
ELEMENT-MDS 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
~1050
Find a Location
Who is running the clinical trial?
Bristol-Myers SquibbLead Sponsor
2,641 Previous Clinical Trials
4,129,704 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many physical sites are carrying out this research endeavor?
"This clinical trial is being conducted at 98 sites, including Fountain Valley, Oxnard and Whittier. To reduce the demand for travel associated with participation in this medical study, it's recommended to find a location nearest you."
Answered by AI
Has the FDA sanctioned Luspatercept as a viable therapy?
"Luspatercept has been given a safety rating of 3 due to multiple rounds of data supporting efficacy and the fact that this is now in Phase 3 trials."
Answered by AI
Is it possible to enroll in this experiment presently?
"The information released on clinicaltrials.gov suggests that this study is not currently recruiting patients, with the initial posting made on August 15th, 2023 and last edited July 10th of the same year. Nonetheless, there are 1,849 other studies actively taking on participants at this moment in time."
Answered by AI
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