A Study to Assess Luspatercept in Lower-risk Myelodysplastic Syndrome Participants

Myelodysplastic Syndromes Clinical Trial

— MAXILUS  

Official title:

A Phase 3b, Open-label Study Evaluating the Efficacy and Safety of Luspatercept (BMS-986346/ACE-536) Initiated at Maximum Approved Dose in LR-MDS With IPSS-R Very Low-, Low-, or Intermediate-risk Who Require RBC Transfusions (MAXILUS)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06045689
• Other study ID #: CA056-1060
• Status: Recruiting
• Phase: Phase 3
• Start date: October 5, 2023
• Est. completion date: December 30, 2027

Study information

• Verified date: June 2024
• Source: Bristol-Myers Squibb
• Contact: BMS Study Connect www.BMSStudyconnect.com
• Phone: 855-907-3286
• Email: Clincal.Trials[@]bms.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 30, 2027
• Est. primary completion date: January 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion 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

Related Conditions & MeSH terms

• Myelodysplastic Syndromes
• Preleukemia
• Syndrome

Intervention

Drug:
• Luspatercept
Specified dose on specified days.

Locations

Country	Name	City	State
Belgium	Local Institution - 0016	Leuven	Vlaams Brabant
Belgium	AZ Delta-Brugsesteenweg 90	Roeselare	West-Vlaanderen
Czechia	Ustav hematologie a krevni transfuze	Praha	Praha, Hlavní Mesto
Czechia	Vseobecna Fakultni Nemocnice V Praze-U Nemocnice 499/2	Praha 2	Praha, Hlavní Mesto
France	CHU d'Angers	Angers
France	CHU de Grenoble Alpes - Hôpital Michallon	Grenoble cedex 09
France	CHU de Nice Archet I	Nice	Alpes-Maritimes
France	AP-HP - Hôpital Saint-Louis	Paris
France	Hospices Civils de Lyon - Hôpital Lyon Sud	Pierre-Bénite
France	CHU de Poitiers	Poitiers	Vienne
France	Hôpital Bretonneau	Tour Cedex01
Germany	Local Institution - 0037	Gütersloh	Nordrhein-Westfalen
Germany	Studienzentrum am Raschplatz GbR	Hannover	Niedersachsen
Germany	Local Institution - 0009	Leipzig	Sachsen
Germany	Local Institution - 0013	München	Bayern
Italy	Azienda Ospedaliera Universitaria Careggi	Firenze	Toscana
Italy	Local Institution - 0062	Napoli	Campania
Italy	Azienda Ospedaliero Universitaria Maggiore della Carità	Novara	Piemonte
Italy	Fondazione IRCCS Policlinico San Matteo	Pavia	Lombardia
Italy	Local Institution - 0021	Reggio Calabria	Calabria
Italy	Fondazione PTV Policlinico Tor Vergata	Roma	Lazio
Italy	Local Institution - 0029	Rozzano (MI)	Milano
Italy	Azienda Ospedaliera Ordine Mauriziano di Torino	Torino	Piemonte
Poland	Pratia Onkologia Katowice - PRATIA - PPDS	Katowice
Poland	Local Institution - 0049	Lodz
Poland	Local Institution - 0030	Lublin	Lubelskie
Poland	Specjalistyczny Szpital im. Alfreda Sokolowskiego	Walbrzych
Poland	MTZ Clinical Research Powered by PRATIA - PPDS	Warszawa	Mazowieckie
Poland	Local Institution - 0002	Wroclaw	Dolnoslaskie
Puerto Rico	Auxilio Mutuo Cancer Center	San Juan
Spain	Hospital Universitario Vall d'Hebron - PPDS	Barcelona
Spain	Local Institution - 0052	Barcelona
Spain	Hospital Universitario Virgen de Las Nieves	Granada
Spain	Local Institution - 0017	L'Hospitalet de Llobregat	Barcelona
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	Local Institution - 0063	Valencia
United States	Texas Oncology - Amarillo	Amarillo	Texas
United States	Local Institution - 0060	Cleveland	Ohio
United States	James Cancer Hospital and Solove Research Institute - 460 W 10th Ave	Columbus	Ohio
United States	Henry Ford Hospital	Detroit	Michigan
United States	Local Institution - 0057	Durham	North Carolina
United States	Oncology Associates of Oregon, P.C.	Eugene	Oregon
United States	North Houston Cancer Clinics - Huntsville	Huntsville	Texas
United States	University of Kansas Medical Center	Kansas City	Kansas
United States	Dartmouth Hitchcock Medical Center	Lebanon	New Hampshire
United States	Cancer and Blood Specialty Clinic	Los Alamitos	California
United States	Local Institution - 0042	Miami	Florida
United States	Froedtert and The Medical College of Wisconsin	Milwaukee	Wisconsin
United States	Local Institution - 0058	Morristown	New Jersey
United States	Smilow Cancer Hospital at Yale New Haven	New Haven	Connecticut
United States	Icahn School of Medicine at Mount Sinai	New York	New York
United States	Local Institution - 0061	Oklahoma City	Oklahoma
United States	Mercy Health - Paducah Medical Oncology and Hematology	Paducah	Kentucky
United States	West Penn Hospital	Pittsburgh	Pennsylvania
United States	Local Institution - 0059	Saint Louis	Missouri
United States	Florida Cancer Specialists - NORTH - SCRI - PPDS	Saint Petersburg	Florida
United States	Local Institution - 0048	San Diego	California
United States	Florida Cancer Specialists - SOUTH - SCRI - PPDS	Wellington	Florida
United States	Wheeling Hospital Schiffler Cancer Center	Wheeling	West Virginia
United States	Local Institution - 0012	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Belgium,  Czechia,  France,  Germany,  Italy,  Poland,  Puerto Rico,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Number of participants with adverse events (AEs)		Up to 2 years
Secondary	Number of participants with acute myeloid leukemia (AML) progression		Up to 4 years
Secondary	Time to AML progression		Up to 4 years
Secondary	Time from treatment start date to death due to any cause		Up to 4 years
Secondary	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

External Links

•   BMS Clinical Trial Information
•   BMS Clinical Trial Patient Recruiting