A Study to Assess Luspatercept in Lower-risk Myelodysplastic Syndrome Participants
- Registration Number
- NCT06045689
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
The purpose of this study is to evaluate the efficacy and safety of Luspatercept when administered at the maximum approved dose in low-risk Myelodysplastic Syndrome participants who require red blood cell transfusions.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 100
- Participant had documented diagnosis of MDS according to World Health Organization (WHO) classification that met Revised International Prognostic Scoring System (IPSS-R) classification of very low-, low-, or intermediate-risk disease.
- Participant has an Eastern Cooperative Oncology Group (ECOG) score of 0, 1, or 2.
- Participant must have red blood cell transfusions according to study criteria.
- Participant has known clinically significant anemia due to iron, vitamin B12, or folate deficiencies, or autoimmune or hereditary hemolytic anemia, or gastrointestinal bleeding.
- Participant has had a prior allogeneic or autologous stem cell transplant.
- Participant has known history or diagnosis of AML.
- Participant has uncontrolled hypertension.
Other protocol-defined inclusion/exclusion criteria apply
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cohort 1: erythropoiesis-stimulating agents (ESA) naïve Luspatercept - Cohort 2: ESA relapsed or refractory Luspatercept -
- Primary Outcome Measures
Name Time Method Number of participants who achieve red blood cell transfusion independence (RBC-TI) for 8 weeks with a simultaneous mean hemoglobin (Hb) increase of ≥ 1 g/dL from Week 1 to Week 24 Up to week 24
- Secondary Outcome Measures
Name Time Method Number of participants who have a time from first dose to first onset of RBC-TI ≥ 8-, 12-, and 16-weeks from Week 1 to Week 24, from Week 1 to Week 48, and from Week 1 through EOT Up to 2 years Number of participants with an increase from baseline in Hb values of ≥ 1.0 g/dL over any consecutive 16-week period in absence of RBC transfusions from Week 1 to Week 24, from Week 1 to Week 48, and from Week 1 through EOT Up to 2 years Number of participants with a mean change in total RBC units transfused over a fixed 16-week period from Week 9 to Week 24 and from Week 33 to Week 48 Up to week 48 Number of participants with adverse events (AEs) Up to 2 years Number of participants with a change in subscale scores of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) from Week 1 to Week 48 and from baseline through EOT Up to 2 years Number of participants who achieve RBC-TI over any consecutive 8-week period from Week 1 to Week 24, from Week 1 to Week 48, and from Week 1 to EOT Up to 2 years Number of participants who achieve RBC-TI over any consecutive 12-, 16-, and 24-week periods from Week 1 to Week 24, from Week 1 to Week 48 and from Week 1 through EOT Up to 2 years Number of participants with change in serum ferritin (SF) over a 16-week period from Week 9 to Week 24 and from Week 33 to Week 48 Up to week 48 Number of participants with a maximum duration of RBC-TI for participants who achieve RBC TI ≥ 8- and 16-week period from Week 1 to Week 24 and from Week 1 to EOT Up to 2 years Number of participants with an increase from baseline in mean hemoglobin (Hb) values of ≥ 1.0 g/dL over any consecutive 8-week period in absence of RBC transfusions from Week 1 to Week 48 and from Week 1 through EOT Up to 2 years Number of participants with an increase from baseline in Hb values of ≥ 1.5 g/dL over any consecutive 8-, and 16-week periods in absence of RBC transfusions from Week 1 to Week 24, from Week 1 to Week 48, and from Week 1 through EOT Up to 2 years Number of participants who achieve Hematological Improvement Erythroid (mHI-E) per International Working Group-2018 (IWG-2018) over any consecutive 8-week period from Week 1 to Week 24, from Week 1 to Week 48, and Week 1 through EOT Up to 2 years Number of participants who achieve Hematological Improvement - Platelets (HI-P) per IWG-2018 over any consecutive 8-week period from Week 1 to Week 24, from Week 1 to Week 48, and Week 1 through EOT Up to 2 years Number of participants with change in mean daily dose of iron chelation therapy (ICT) over a 16-week period from Week 9 to Week 24 and from Week 33 to Week 48 Up to week 48 Number of participants with acute myeloid leukemia (AML) progression Up to 4 years Time to AML progression Up to 4 years Time from treatment start date to death due to any cause Up to 4 years Number of participants who achieve Hematological Improvement - Neutrophils (HI-N) per IWG-2018 over any consecutive 8-week period from Week 1 to Week 24, from Week 1 to Week 48, and Week 1 through EOT Up to 2 years
Trial Locations
- Locations (64)
Auxilio Mutuo Cancer Center
🇵🇷San Juan, Puerto Rico
ICO l'Hospitalet - Hospital Duran i Reynals
🇪🇸L'Hospitalet de Llobregat, Barcelona, Spain
Hospital Universitario Vall d'Hebron - PPDS
🇪🇸Barcelona, Spain
Hospital Universitario Germans Trias i Pujol
🇪🇸Barcelona, Spain
Hospital Universitario Virgen de Las Nieves
🇪🇸Granada, Spain
Hospital Universitario La Princesa
🇪🇸Madrid, Spain
CHU de Ourense - H. Santa Maria Nai
🇪🇸Ourense, Spain
Complejo Asistencial Universitario de Salamanca - H. Clinico
🇪🇸Salamanca, Spain
Hospital Clinico Universitario de Valencia
🇪🇸Valencia, Spain
Hospital Universitari i Politecnic La Fe de Valencia
🇪🇸Valencia, Spain
Pratia Onkologia Katowice - PRATIA - PPDS
🇵🇱Katowice, Poland
Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi
🇵🇱Lodz, Poland
Specjalistyczny Szpital im. Alfreda Sokolowskiego
🇵🇱Wałbrzych, Poland
Cancer and Blood Specialty Clinic
🇺🇸Los Alamitos, California, United States
Local Institution - 0048
🇺🇸San Diego, California, United States
Smilow Cancer Hospital at Yale New Haven
🇺🇸New Haven, Connecticut, United States
Local Institution - 0042
🇺🇸Miami, Florida, United States
Florida Cancer Specialists - NORTH - SCRI - PPDS
🇺🇸Saint Petersburg, Florida, United States
Florida Cancer Specialists - SOUTH - SCRI - PPDS
🇺🇸Wellington, Florida, United States
University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States
Mercy Health - Paducah Medical Oncology and Hematology
🇺🇸Paducah, Kentucky, United States
Local Institution - 0012
🇺🇸Worcester, Massachusetts, United States
Henry Ford Hospital
🇺🇸Detroit, Michigan, United States
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States
Dartmouth Hitchcock Medical Center
🇺🇸Lebanon, New Hampshire, United States
Atlantic Hematology Oncology
🇺🇸Morristown, New Jersey, United States
Icahn School of Medicine at Mount Sinai
🇺🇸New York, New York, United States
Local Institution - 0057
🇺🇸Durham, North Carolina, United States
Local Institution - 0060
🇺🇸Cleveland, Ohio, United States
Local Institution - 0006
🇺🇸Columbus, Ohio, United States
Local Institution - 0061
🇺🇸Oklahoma City, Oklahoma, United States
Oncology Associates of Oregon, P.C.
🇺🇸Eugene, Oregon, United States
West Penn Hospital
🇺🇸Pittsburgh, Pennsylvania, United States
Texas Oncology - Amarillo
🇺🇸Amarillo, Texas, United States
Local Institution - 0022
🇺🇸Huntsville, Texas, United States
Wheeling Hospital Schiffler Cancer Center
🇺🇸Wheeling, West Virginia, United States
Froedtert and The Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States
UZ Leuven- Gasthuisberg Campus
🇧🇪Leuven, Vlaams Brabant, Belgium
AZ Delta- Campus Rumbeke
🇧🇪Roeselare, West-Vlaanderen, Belgium
Local Institution - 0064
🇨🇿Brno, Jihomoravský Kraj, Czechia
Vseobecna Fakultni Nemocnice V Praze-U Nemocnice 499/2
🇨🇿Praha 2, Praha, Hlavní Mesto, Czechia
Ustav hematologie a krevni transfuze
🇨🇿Praha, Praha, Hlavní Mesto, Czechia
CHU de Nice Archet I
🇫🇷Nice, Alpes-Maritimes, France
CHU de Poitiers
🇫🇷Poitiers, Vienne, France
CHU d'Angers
🇫🇷Angers, France
CHU de Grenoble Alpes - Hôpital Michallon
🇫🇷Grenoble cedex 09, France
AP-HP - Hôpital Saint-Louis
🇫🇷Paris, France
Hospices Civils de Lyon - Hôpital Lyon Sud
🇫🇷Pierre-Bénite, France
Hôpital Bretonneau
🇫🇷Tour Cedex01, France
Klinikum rechts der Isar der Technischen Universitaet Muenchen
🇩🇪München, Bayern, Germany
Studienzentrum am Raschplatz GbR
🇩🇪Hannover, Niedersachsen, Germany
Local Institution - 0037
🇩🇪Gütersloh, Nordrhein-Westfalen, Germany
Universitatsklinikum Leipzig
🇩🇪Leipzig, Sachsen, Germany
Grande Ospedale Metropolitano Bianchi-Melacrino-Morelli - PO Riuniti
🇮🇹Reggio Calabria, Calabria, Italy
Azienda Ospedaliera Universitaria Federico II
🇮🇹Napoli, Campania, Italy
Fondazione PTV Policlinico Tor Vergata
🇮🇹Roma, Lazio, Italy
Fondazione IRCCS Policlinico San Matteo
🇮🇹Pavia, Lombardia, Italy
IRCCS Istituto Clinico Humanitas
🇮🇹Rozzano (MI), Milano, Italy
Azienda Ospedaliero Universitaria Maggiore della Carità
🇮🇹Novara, Piemonte, Italy
Azienda Ospedaliera Ordine Mauriziano di Torino
🇮🇹Torino, Piemonte, Italy
Azienda Ospedaliera Universitaria Careggi
🇮🇹Firenze, Toscana, Italy
Local Institution - 0002
🇵🇱Wroclaw, Dolnoslaskie, Poland
Local Institution - 0030
🇵🇱Lublin, Lubelskie, Poland
MTZ Clinical Research Powered by PRATIA - PPDS
🇵🇱Warszawa, Mazowieckie, Poland