RECRUITING

ELEMENT-MDS: A Study to Compare the Efficacy and Safety of Luspatercept in Participants With Myelodysplastic Syndrome (MDS) and Anemia Not Receiving Blood Transfusions

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Conditions

Myelodysplastic SyndromesLuspaterceptBMS-986346ACE-536Myelodysplastic SyndromeEpoetin alfaErythropoietin stimulating agent (ESA)Myelodysplastic Syndromes (MDS)Anaemia

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of the study is to compare the efficacy and safety of Luspatercept vs epoetin alfa in the treatment of anemia in adults due to IPSS-R very low, low, intermediate-risk MDS in ESA-naïve participants who are non-transfusion dependent (NTD).

Official Title

A Phase 3, Open-label, Randomized Study to Compare the Efficacy and Safety of Luspatercept (ACE-536) vs Epoetin Alfa for the Treatment of Anemia Due to Revised International Prognostic Scoring System (IPSS-R) Very Low, Low, or Intermediate-Risk Myelodysplastic Syndrome (MDS) in Erythropoiesis-Stimulating Agent (ESA)-Naive Participants Who Are Non-Transfusion Dependent (NTD): The "ELEMENT-MDS" Trial

Quick Facts

Study Start:2023-10-24
Study Completion:2030-03-11
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05949684

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
CONTACT
855-907-3286
Clinical.Trials@bms.com
First line of the email MUST contain the NCT# and Site #.
CONTACT

Principal Investigator

Bristol-Myers Squibb
STUDY_DIRECTOR
Bristol-Myers Squibb

Study Locations (Sites)

Community Cancer Institute
Clovis, California, 93611
United States
John Muir Medical Center - Concord Campus
Concord, California, 94520
United States
Compassionate Cancer Care Medical Group
Fountain Valley, California, 92708
United States
Local Institution - 0095
Fresno, California, 93703
United States
Cancer and Blood Specialty Clinic
Los Alamitos, California, 90720
United States
Local Institution - 0258
Los Angeles, California, 90095
United States
Local Institution - 0247
Orange, California, 92868
United States
Ventura County Hematology Oncology Specialists
Oxnard, California, 93030
United States
Local Institution - 0098
Fort Collins, Colorado, 80528
United States
Hartford Hospital (HH)
Hartford, Connecticut, 06102
United States
Yale-New Haven Hospital
New Haven, Connecticut, 06510
United States
Halifax Health Medical Center
Daytona Beach, Florida, 32114
United States
Local Institution - 0230
Daytona Beach, Florida, 32114
United States
Florida Cancer Specialists - South
Fort Myers, Florida, 33901
United States
Baptist MD Anderson Cancer Center
Jacksonville, Florida, 32207
United States
D&H Cancer Research Center LLC
Margate, Florida, 33063
United States
BRCR Global
Plantation, Florida, 33322
United States
Florida Cancer Specialists - North
Saint Petersburg, Florida, 33705
United States
Advanced Research
Tamarac, Florida, 33321
United States
Local Institution - 0106
Tampa, Florida, 33612
United States
Local Institution - 0240
Honolulu, Hawaii, 96813
United States
Local Institution - 0272
Chicago, Illinois, 60611
United States
Orchard Healthcare Research Inc.
Skokie, Illinois, 60077
United States
Local Institution - 0270
Dyer, Indiana, 46311
United States
Local Institution - 0232
Pikeville, Kentucky, 41501
United States
Our Lady of the Lake RMC
Baton Rouge, Louisiana, 70808
United States
Pontchartrain Cancer Center
Covington, Louisiana, 70433
United States
Local Institution - 0097
New Orleans, Louisiana, 70112
United States
American Oncology Partners of Maryland, PA
Bethesda, Maryland, 20817
United States
Metro-Minnesota Community Clinical Oncology
Saint Louis Park, Minnesota, 55426
United States
Hattiesburg Clinic Hematology/Oncology
Hattiesburg, Mississippi, 39401
United States
John Theurer Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, 07601
United States
The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
United States
University of Tennessee Medical Center
Knoxville, Tennessee, 37920
United States
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
United States
Local Institution - 0236
Richmond, Virginia, 23219
United States
Blue Ridge Cancer Care
Roanoke, Virginia, 24014
United States
Kadlec Clinic Hematology and Oncology
Kennewick, Washington, 99336
United States
Local Institution - 0213
Seattle, Washington, 98133
United States

Collaborators and Investigators

Sponsor: Bristol-Myers Squibb

  • Bristol-Myers Squibb, STUDY_DIRECTOR, Bristol-Myers Squibb

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-10-24
Study Completion Date2030-03-11

Study Record Updates

Study Start Date2023-10-24
Study Completion Date2030-03-11

Terms related to this study

Keywords Provided by Researchers

  • Luspatercept
  • BMS-986346
  • ACE-536
  • Myelodysplastic Syndrome
  • Epoetin alfa
  • Erythropoietin stimulating agent (ESA)
  • Myelodysplastic Syndromes (MDS)
  • Anaemia

Additional Relevant MeSH Terms

  • Myelodysplastic Syndromes