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

Status: Recruiting
Location: See all (166) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Participant has documented diagnosis of MDS according to World Health Organization (WHO) 2016 that meet IPSS-R classification of very low, low, or intermediate-risk disease, (intermediate-risk of ≤ 3.5 IPSS-R score) confirmed via bone marrow aspirate and:.

• i) \< 5% blasts in bone marrow and \< 1% blasts in peripheral blood.

• Participant is not transfusion dependent (NTD) based on IWG2018 criteria.

• Participant is erythropoiesis-stimulating agent naive. Participants may be randomized at the investigator's discretion if the participant received no more than 2 prior doses of epoetin alfa, epoetin alfa biosimilar, or darbepoetin alfa, with the last dose at least 8 weeks prior to randomization.

• Participant has a baseline endogenous serum erythropoietin (sEPO) level of ≤ 500 U/L.

• Participant has symptoms of anemia:.

• i) Participant records a severity score of moderate or greater on at least 1 PGI-S item of fatigue, weakness, shortness of breath, or dizziness performed during the screening period.

• Participant has a baseline Hb concentration prior to randomization of ≤ 9.5 g/dL. The baseline Hb will be calculated using the mean of the two lowest available Hb measurements within 16 weeks prior to randomization and must include at least one central lab Hb reading done within the screening period (no more than 35 days before randomization). The two Hb measurements must have been performed at least seven days apart. Hb levels less than 21 days following RBC transfusion should not be used. Split samples for local assessments are not required.

Locations
United States
California
Community Cancer Institute
RECRUITING
Clovis
Compassionate Cancer Care Medical Group
RECRUITING
Fountain Valley
Local Institution - 0095
WITHDRAWN
Fresno
Cancer and Blood Specialty Clinic
RECRUITING
Los Alamitos
UCLA Hematology/Oncology - Westwood (Building 200 Suite 120)
RECRUITING
Los Angeles
St. Joseph Hospital
RECRUITING
Orange
Ventura County Hematology Oncology Specialists
RECRUITING
Oxnard
John Muir Health - Behring Pavilion
RECRUITING
Walnut Creek
Colorado
Local Institution - 0098
WITHDRAWN
Fort Collins
Connecticut
Hartford Hospital (HH)
RECRUITING
Hartford
Yale-New Haven Hospital
RECRUITING
New Haven
Florida
Halifax Health Medical Center
NOT_YET_RECRUITING
Daytona Beach
Local Institution - 0230
WITHDRAWN
Daytona Beach
Florida Cancer Specialists - South
RECRUITING
Fort Myers
Baptist MD Anderson Cancer Center
RECRUITING
Jacksonville
D&H Cancer Research Center LLC
RECRUITING
Margate
BRCR Global
RECRUITING
Plantation
Florida Cancer Specialists - North
RECRUITING
St. Petersburg
Advanced Research
RECRUITING
Tamarac
Moffitt Cancer Center
RECRUITING
Tampa
Hawaii
Local Institution - 0240
NOT_YET_RECRUITING
Honolulu
Illinois
Northwestern Memorial Hospital
RECRUITING
Chicago
Orchard Healthcare Research Inc.
RECRUITING
Skokie
Indiana
Northwest Cancer Centers, P.C.
RECRUITING
Dyer
Kentucky
Local Institution - 0232
WITHDRAWN
Pikeville
Louisiana
Our Lady of the Lake RMC
RECRUITING
Baton Rouge
Pontchartrain Cancer Center
RECRUITING
Covington
Local Institution - 0097
WITHDRAWN
New Orleans
Maryland
American Oncology Partners, PA
RECRUITING
Bethesda
Minnesota
Metro-Minnesota Community Clinical Oncology
RECRUITING
Saint Louis Park
Mississippi
Hattiesburg Clinic Hematology/Oncology
RECRUITING
Hattiesburg
New Jersey
John Theurer Cancer Center at Hackensack University Medical Center
RECRUITING
Hackensack
Ohio
The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive Cancer Center
RECRUITING
Columbus
Tennessee
University of Tennessee Medical Center
RECRUITING
Knoxville
Texas
University of Texas MD Anderson Cancer Center
RECRUITING
Houston
Virginia
VCU Health Adult Outpatient Pavillion
RECRUITING
Richmond
Blue Ridge Cancer Care
RECRUITING
Roanoke
Washington
Kadlec Clinic Hematology and Oncology
RECRUITING
Kennewick
Local Institution - 0213
WITHDRAWN
Seattle
Other Locations
Argentina
Centro Medico Barrio Parque
RECRUITING
Buenos Aires
Hospital Británico de Buenos Aires
RECRUITING
Buenos Aires
Instituto Alexander Fleming
RECRUITING
Buenos Aires
Australia
Blacktown Hospital
RECRUITING
Blacktown
Royal Prince Alfred Hospital
RECRUITING
Camperdown
Monash Health
RECRUITING
Clayton
Coffs Harbour Health Campus
RECRUITING
Coffs Harbour
Pindara Private Hospital
RECRUITING
Gold Coast
Austin Health
RECRUITING
Heidelberg
Brazil
Hospital Universitario Walter Cantidio
RECRUITING
Fortaleza
Hospital São Lucas da PUCRS
RECRUITING
Porto Alegre
HEMORIO
RECRUITING
Rio De Janeiro
Hospital das Clinicas FMUSP
RECRUITING
São Paulo
Canada
Arthur J.E. Child Comprehensive Cancer Centre
RECRUITING
Calgary
Victoria Hospital & Children's Hospital - London Health Sciences Centre
RECRUITING
London
Sunnybrook Health Sciences Centre
RECRUITING
Toronto
St. Paul's Hospital
RECRUITING
Vancouver
Chile
Bradfordhill
RECRUITING
Santiago
Clínica Inmunocel
RECRUITING
Santiago
Enroll SpA
RECRUITING
Santiago
FALP
RECRUITING
Santiago
China
Beijing Peking Union Medical College Hospital
RECRUITING
Beijing
Peking University People's Hospital
RECRUITING
Beijing
Local Institution - 0043
COMPLETED
Changchun
Xiangya Hospital Central South University
RECRUITING
Changsha
Local Institution - 0075
COMPLETED
Chengdu
Local Institution - 0223
COMPLETED
Chongqing
Local Institution - 0096
WITHDRAWN
Fuzhou Fujian
Local Institution - 0031
WITHDRAWN
Guangzhou
The first Affiliated Hospital, Zhejiang University School of Medicine
RECRUITING
Hangzhou
The First Hospital of Harbin
RECRUITING
Harbin
Local Institution - 0109
ACTIVE_NOT_RECRUITING
Hefei
The First Affiliated Hospital of Nanchang University
RECRUITING
Nanchang
Jiangsu Province Hospital
RECRUITING
Nanjing
Local Institution - 0281
NOT_YET_RECRUITING
Ningbo
The Affiliated Hospital of Qingdao University
RECRUITING
Qingdao
Shanghai Sixth People's Hospital
RECRUITING
Shanghai
The First Hospital of China Medical University
RECRUITING
Shenyang
The Second Afilliated Hospital of Hebei Medical University
RECRUITING
Shijiazhuang
The First Affiliated Hospital of Soochow University
RECRUITING
Suzhou
Institute of hematology&blood disease hospital
RECRUITING
Tianjin
The First Affiliated Hospital of Wenzhou Medical University
RECRUITING
Wenzhou
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
RECRUITING
Wuhan
Shaanxi provincial people's hospital
RECRUITING
Xi’an
Local Institution - 0220
COMPLETED
Xiamen
People's Hospital of Henan Province
RECRUITING
Zhengzhou
Colombia
Hospital Pablo Tobon Uribe
RECRUITING
Medellín
Oncomédica S.A.S
RECRUITING
Montería
Fundación Cardiovascular de Colombia
RECRUITING
Piedecuesta
Sociedad De Oncologia Y Hematologia Del Cesar
RECRUITING
Valledupar
France
Centre Hospitalier Universitaire d'Angers
RECRUITING
Angers
Chu Grenoble Alpes
RECRUITING
La Tronche
Centre Hospitalier Universitaire de Nice - Hôpital l'Archet
RECRUITING
Nice
Hôpital Saint-Louis
RECRUITING
Paris
CHU Bordeaux Haut-Leveque
RECRUITING
Pessac
Institut Universitaire du Cancer Toulouse - Oncopole - CHU de TOULOUSE
RECRUITING
Toulouse
Centre Hospitalier Régional Universitaire de Tours - Hôpital Bretonneau
RECRUITING
Tours
Centre Hospitalier Régional Universitaire de Nancy - Hôpitaux de Brabois
RECRUITING
Vandœuvre-lès-nancy
Gustave Roussy
RECRUITING
Villejuif
Germany
Local Institution - 0028
COMPLETED
Berlin
Praxis fur Hamatologie und Onkologie
RECRUITING
Berlin
Universitaetsklinikum Duesseldorf
RECRUITING
Düsseldorf
Onkologie Erding
RECRUITING
Erding
Universitätsklinikum Jena
RECRUITING
Jena
Local Institution - 0250
WITHDRAWN
Kempten (allgäu)
InVO Institut für Versorgungsforschung in der Onkologie
RECRUITING
Koblenz
Universitätsklinikum Leipzig
RECRUITING
Leipzig
Local Institution - 0255
NOT_YET_RECRUITING
Lübeck
Gemeinschaftspraxis für Hämatologie und Onkologie Münster
RECRUITING
Münster
Kliniken Ostalb, Stauferklinikum
RECRUITING
Mutlangen
Gemeinschaftspraxis Dres. med. Björn Schöttker & Dominik Pretscher
RECRUITING
Würzburg
Greece
University General Hospital of Alexandroupoli
RECRUITING
Alexandroupoli
General Hospital of Athens G. Gennimatas
RECRUITING
Athens
General Hospital of Athens Laiko
RECRUITING
Athens
Attikon General University Hospital
RECRUITING
Chaïdári
Local Institution - 0242
WITHDRAWN
Pátrai
University Hospital of Patras
RECRUITING
Pátrai
Hong Kong Special Administrative Region
Local Institution - 0034
WITHDRAWN
Hksar
Hungary
Semmelweis Egyetem
RECRUITING
Budapest
Heves Vármegyei Markhot Ferenc Oktatókórház és Rendelőintézet
RECRUITING
Eger
Szabolcs Szatmár Bereg Vármegyei Oktatókórház
RECRUITING
Nyíregyháza
India
Hemato Oncology Clinic
RECRUITING
Ahmedabad
Local Institution - 0273
WITHDRAWN
Ahmedabad
Local Institution - 0177
NOT_YET_RECRUITING
Bengaluru
Institute of Medical Sciences and Sum Hospital
RECRUITING
Bhubaneswar
Local Institution - 0185
WITHDRAWN
Hyderabad
All India Institute of Medical Sciences
RECRUITING
New Delhi
Local Institution - 0186
WITHDRAWN
New Delhi
Rajiv Gandhi Cancer Institute And Research Centre
RECRUITING
New Delhi
Italy
IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola
RECRUITING
Bologna
Azienda Ospedaliera Universitaria Careggi
RECRUITING
Florence
ASST Grande Ospedale Metropolitano Niguarda
RECRUITING
Milan
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
RECRUITING
Milan
Grande Ospedale Metropolitano - Presidio Morelli
RECRUITING
Reggio Calabria
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore
RECRUITING
Roma
Fondazione Policlinico Tor Vergata
RECRUITING
Rome
Humanitas
RECRUITING
Rozzano
Azienda Ospedaliera Ordine Mauriziano di Torino
RECRUITING
Turin
Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Roma
RECRUITING
Verona
Japan
Local Institution - 0126
WITHDRAWN
Amagasaki
Local Institution - 0123
WITHDRAWN
Kitakyushu-shi
Local Institution - 0124
WITHDRAWN
Nagasaki
Local Institution - 0122
WITHDRAWN
Osaka
Local Institution - 0125
WITHDRAWN
Ōsaka-sayama
Local Institution - 0120
WITHDRAWN
Sagamihara
Local Institution - 0117
WITHDRAWN
Sapporo
Local Institution - 0118
WITHDRAWN
Sendai
Local Institution - 0121
WITHDRAWN
Shimotsuga
Local Institution - 0119
WITHDRAWN
Tokyo
Mexico
Hematológica Alta Especialidad SC, consultorio 830
RECRUITING
Huixquilucan
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
RECRUITING
Mexico City
Centro de Investigacion Clinica de Oaxaca
RECRUITING
Oaxaca City
Unidad Médica Onco-hematológica
RECRUITING
Puebla City
Poland
Uniwersyteckie Centrum Kliniczne
RECRUITING
Gdansk
Pratia Onkologia Katowice
RECRUITING
Katowice
Specjalistyczny Szpital im. dra Alfreda Sokołowskiego w Wałbrzychu
RECRUITING
Wałbrzych
MTZ Clinical Research powered by Pratia
RECRUITING
Warsaw
Puerto Rico
Auxilio Mutuo Cancer Center
RECRUITING
San Juan
Local Institution - 0237
WITHDRAWN
San Juan
Spain
Hospital Universitari Vall d'Hebron
RECRUITING
Barcelona
Hospital Universitario Virgen Nieves
RECRUITING
Granada
Institut Català d'Oncologia - L'Hospitalet
RECRUITING
L'hospitalet De Llobregat
Hospital La Princesa
RECRUITING
Madrid
Hospital Universitario Central de Asturias
RECRUITING
Oviedo
Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca
RECRUITING
Salamanca
Hospital Universitario Virgen Del Rocio
RECRUITING
Seville
Hospital Clinico de Valencia
RECRUITING
Valencia
Contact Information
Primary
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
Clinical.Trials@bms.com
855-907-3286
Backup
First line of the email MUST contain the NCT# and Site #.
Time Frame
Start Date: 2023-10-24
Estimated Completion Date: 2030-03-11
Participants
Target number of participants: 360
Treatments
Experimental: Luspatercept
Active_comparator: Epoetin Alfa
Related Therapeutic Areas
Sponsors
Leads: Bristol-Myers Squibb

This content was sourced from clinicaltrials.gov

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