360 Participants Needed

Epoetin Alfa vs Luspatercept for Myelodysplastic Syndrome

(ELEMENT-MDS Trial)

Recruiting at 262 trial locations
BS
Fl
BC
Overseen ByBMS Clinical Trials Contact Center www.BMSClinicalTrials.com
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Bristol-Myers Squibb
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, it does mention that participants should not have received more than 2 doses of certain anemia treatments recently.

What data supports the effectiveness of the drug Epoetin Alfa for Myelodysplastic Syndrome?

Epoetin alfa has been used successfully to treat anemia in patients with chronic kidney disease and chemotherapy-related anemia, improving their quality of life by increasing hemoglobin levels.12345

How do the drugs Epoetin Alfa and Luspatercept differ from other treatments for myelodysplastic syndrome?

Epoetin Alfa and Luspatercept are unique because they target different pathways to stimulate red blood cell production in patients with myelodysplastic syndrome, a condition where the bone marrow doesn't produce enough healthy blood cells. Epoetin Alfa is a synthetic form of erythropoietin (a hormone that promotes red blood cell production), while Luspatercept works by enhancing the maturation of red blood cells, offering a novel approach compared to traditional treatments.678910

Research Team

BS

Bristol-Myers Squibb

Principal Investigator

Bristol-Myers Squibb

Eligibility Criteria

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.

Inclusion Criteria

My average hemoglobin level was 9.5 g/dL or less before joining the study.
Participant has a baseline endogenous serum erythropoietin (sEPO) level of ≤ 500 U/L
Participant is not transfusion dependent (NTD) based on IWG2018 criteria
See 3 more

Exclusion Criteria

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.
See 1 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Luspatercept or Epoetin Alfa for the treatment of anemia in MDS

96 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • Epoetin Alfa
  • Luspatercept
Trial OverviewThe 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.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: LuspaterceptExperimental Treatment1 Intervention
Group II: Epoetin AlfaActive Control1 Intervention

Epoetin Alfa is already approved in United States, European Union, Canada for the following indications:

🇺🇸
Approved in United States as Epogen for:
  • Anemia associated with chronic kidney disease
  • Anemia related to HIV infection
  • Anemia in patients with cancer on chemotherapy
  • Reduction of allogeneic blood transfusions in surgery patients
🇪🇺
Approved in European Union as Eprex for:
  • Anemia associated with chronic kidney disease
  • Anemia in adult patients with non-myeloid malignancies receiving chemotherapy
  • Anemia in HIV-infected patients at risk of transfusion due to chronic disease
🇨🇦
Approved in Canada as Eprex for:
  • Anemia associated with chronic kidney disease
  • Anemia in patients with cancer on chemotherapy
  • Anemia in HIV-infected patients

Find a Clinic Near You

Who Is Running the Clinical Trial?

Bristol-Myers Squibb

Lead Sponsor

Trials
2,731
Recruited
4,127,000+
Headquarters
New York City, USA
Known For
Oncology & Cardiovascular
Top Products
Eliquis, Opdivo, Revlimid, Orencia
Christopher Boerner profile image

Christopher Boerner

Bristol-Myers Squibb

Chief Executive Officer since 2023

PhD in Business Administration from the Haas School of Business, University of California, Berkeley; BA in Economics and History from Washington University in St. Louis

Deepak L. Bhatt profile image

Deepak L. Bhatt

Bristol-Myers Squibb

Chief Medical Officer since 2024

MD from Yale University; MSc in Clinical Epidemiology from the University of Pennsylvania

Findings from Research

Eprex, which contains epoetin alfa, has been successfully marketed in France under the name Binocrit, indicating its availability as a treatment option.
This development suggests that Binocrit may provide similar therapeutic benefits as Eprex, potentially improving patient access to this important medication.
Epoetin alfa: biosimilar. Copied, with biosimilar status.[2015]
The study estimated a mean maintenance dose conversion ratio (DCR) of approximately 330.6 to 375.6 units of epoetin alfa to 1 microgram of darbepoetin alfa in nondialyzed patients with chronic kidney disease, indicating a higher DCR than previously reported.
This research utilized advanced methods to account for the nonproportional dose relationship between the two erythropoiesis-stimulating agents, providing a more accurate basis for economic evaluations in switching treatments for anemia in chronic renal failure.
Empirical methods to calculate an erythropoiesis-stimulating agent dose conversion ratio in nondialyzed patients with chronic kidney disease.Horowitz, J., Agarwal, A., Huang, F., et al.[2023]
Anaemia is a common issue in cancer patients that can negatively impact their quality of life and life expectancy, making effective treatment important.
Epoetin alfa and darbepoetin alfa are promising alternatives to blood transfusions for managing anaemia in cancer patients, as they have been effective in treating anaemia in patients with chronic renal failure.
Epoetins and [symbol: see text] darbepoetin alfa in malignant disease.[2015]

References

Epoetin alfa: biosimilar. Copied, with biosimilar status. [2015]
Empirical methods to calculate an erythropoiesis-stimulating agent dose conversion ratio in nondialyzed patients with chronic kidney disease. [2023]
Epoetins and [symbol: see text] darbepoetin alfa in malignant disease. [2015]
Retrospective observational study of patients with chemotherapy-related anemia receiving erythropoietic agents. [2015]
A cross-sectional immunosurveillance study of anti-EPO antibody levels in CRF patients receiving epoetin alfa in 5 Ontario Renal Centers. [2019]
European Medicines Agency approval summary: Zaltrap for the treatment of patients with oxaliplatin-resistant metastatic colorectal cancer. [2021]
Safety and Efficacy of Ziv-Aflibercept in the Treatment of Refractory Diabetic Macular Edema. [2022]
Intravitreal Aflibercept in Diabetic Macular Edema: Long-Term Outcomes. [2017]
Effects of exenatide long-acting release on cardiovascular events and mortality in patients with type 2 diabetes: a systematic review and meta-analysis of randomized controlled trials. [2019]
Two-year outcomes of the APOLLON observational study of intravitreal aflibercept monotherapy in France in patients with diabetic macular edema. [2022]