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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1: erythropoiesis-stimulating agents (ESA) naïve | Experimental |
| |
| Cohort 2: ESA relapsed or refractory | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Luspatercept | Drug | Specified dose on specified days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 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 |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria apply
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution - 0051 | Los Alamitos | California | 90720-3309 | United States | ||
| Local Institution - 0033 |
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| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| BMS Clinical Trial Patient Recruiting | View source |
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BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
See Plan Description
See Plan Description
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| 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 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 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 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 ≥ 1.0 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 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 - 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 |
| 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 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 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 adverse events (AEs) | Up to 2 years |
| 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 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 |
| New Haven |
| Connecticut |
| 06510 |
| United States |
| Local Institution - 0055 | St. Petersburg | Florida | 33705 | United States |
| Local Institution - 0056 | Wellington | Florida | 33414 | United States |
| Local Institution - 0020 | Kansas City | Kansas | 66160-8500 | United States |
| Local Institution - 0025 | Paducah | Kentucky | 42003-7915 | United States |
| Local Institution - 0011 | Detroit | Michigan | 48202 | United States |
| Local Institution - 0059 | St Louis | Missouri | 63110 | United States |
| Local Institution - 0058 | Morristown | New Jersey | 07960-6136 | United States |
| Local Institution - 0032 | New York | New York | 10029 | United States |
| Local Institution - 0054 | Eugene | Oregon | 97401-6043 | United States |
| Local Institution - 0036 | Pittsburgh | Pennsylvania | 15224 | United States |
| Local Institution - 0043 | Amarillo | Texas | 79106-1781 | United States |
| Local Institution - 0022 | Huntsville | Texas | 77340-4101 | United States |
| Local Institution - 0031 | Wheeling | West Virginia | 26003 | United States |
| Local Institution - 0003 | Milwaukee | Wisconsin | 53226 | United States |
| Local Institution - 0016 | Leuven | Vlaams Brabant | 3000 | Belgium |
| Local Institution - 0008 | Roeselare | West-Vlaanderen | 8800 | Belgium |
| Local Institution - 0023 | Prague | Praha, Hlavní Mesto | 128 20 | Czechia |
| Local Institution - 0004 | Prague | Praha, Hlavní Mesto | 128 21 | Czechia |
| Local Institution - 0041 | Nice | Alpes-Maritimes | 06202 | France |
| Local Institution - 0001 | Poitiers | Vienne | 86021 | France |
| Local Institution - 0026 | Angers | 49933 | France |
| Local Institution - 0007 | Grenoble | 38 38043 | France |
| Local Institution - 0046 | Paris | 75475 | France |
| Local Institution - 0053 | Pierre-Bénite | 69495 | France |
| Local Institution - 0044 | Tour Cedex01 | 37044 | France |
| Local Institution - 0013 | München | Bavaria | 81675 | Germany |
| Local Institution - 0040 | Hanover | Lower Saxony | 30161 | Germany |
| Local Institution - 0009 | Leipzig | Saxony | 04103 | Germany |
| Local Institution - 0021 | Reggio Calabria | Calabria | 89124 | Italy |
| Local Institution - 0062 | Naples | Campania | 80131 | Italy |
| Local Institution - 0050 | Rome | Lazio | 00133 | Italy |
| Local Institution - 0015 | Pavia | Lombardy | 27100 | Italy |
| Local Institution - 0029 | Rozzano (MI) | Milano | 20089 | Italy |
| Local Institution - 0014 | Novara | Piedmont | 28100 | Italy |
| Local Institution - 0045 | Turin | Piedmont | 10128 | Italy |
| Local Institution - 0024 | Florence | Tuscany | 50139 | Italy |
| Local Institution - 0049 | Lódz | Lódzkie | 93-513 | Poland |
| Local Institution - 0010 | Warsaw | Masovian Voivodeship | 02-172 | Poland |
| Local Institution - 0034 | Katowice | 40-519 | Poland |
| Local Institution - 0035 | Wałbrzych | 58-309 | Poland |
| Local Institution - 0047 | San Juan | 00917 | Puerto Rico |
| Local Institution - 0017 | L'Hospitalet de Llobregat | Barcelona | 08908 | Spain |
| Local Institution - 0005 | Barcelona | 08035 | Spain |
| Local Institution - 0052 | Barcelona | 08916 | Spain |
| Local Institution - 0039 | Granada | 18014 | Spain |
| Local Institution - 0038 | Madrid | 28006 | Spain |
| Local Institution - 0027 | Ourense | 32005 | Spain |
| Local Institution - 0028 | Salamanca | 37007 | Spain |
| Local Institution - 0018 | Valencia | 46010 | Spain |
| Local Institution - 0063 | Valencia | 46026 | Spain |
| ID | Term |
|---|---|
| D009190 | Myelodysplastic Syndromes |
| D000740 | Anemia |
| ID | Term |
|---|---|
| D001855 | Bone Marrow Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| C000621232 | luspatercept |
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