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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-509635-89 | Other Identifier | EU CTR |
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The purpose of this study is to assess the safety, tolerability, and efficacy of BMS-986158 alone and in combination with either Ruxolitinib or Fedratinib in participants with Dynamic International Prognostic Scoring System (DIPSS)-intermediate or high risk blood cancer. Part 1 consists of BMS-986158 in combination with either Ruxolitinib or Fedratinib and Part 2 consists of BMS-986158 in combination with either Ruxolitinib or Fedratinib and BMS-986158 alone.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1A: BMS-986158 + Ruxolitinib | Experimental |
| |
| Part 1B: BMS-986158 + Fedratinib | Experimental |
| |
| Part 2A1: BMS-986158 + Ruxolitinib | Experimental |
| |
| Part 2B1: BMS-986158 + Fedratinib | Experimental |
| |
| Part 2B2: BMS-986158 Mono and/or (BMS-986158 + Fedratinib), if applicable | Experimental |
| |
| Part 2A2 Add-On: BMS-986158 + Ruxolitinib | Experimental |
| |
| Part 2A3: BMS-986158 + Ruxolitinib | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-986158 | Drug | Specified dose on specified days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events (AEs) | Up to 52 months | |
| Incidence of serious adverse events (SAEs) | Up to 52 months | |
| Incidence of AEs meeting protocol-defined dose-limiting toxicity (DLT) criteria | Up to 26 months | |
| Incidence of AEs leading to discontinuation | Up to 52 months | |
| Incidence of death | Up to 52 months |
| Measure | Description | Time Frame |
|---|---|---|
| Response rate defined as proportion of participants with SVR ≥ 35% by MRI (preferred) or CT (if MRI is contraindicated and if CT is allowed by local guidelines) assessed by BICR | Up to 175 days | |
| Response rate defined as proportion of participants with SVR ≥ 25% by MRI (preferred) or CT (if MRI is contraindicated and if CT is allowed by local guidelines) assessed by BICR |
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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 - 0069 | Newport Beach | California | 92663 | United States | ||
| Local Institution - 0090 |
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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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|
| Ruxolitinib | Drug | Specified dose on specified days |
|
|
| Fedratinib | Drug | Specified dose on specified days |
|
| Up to 175 days |
| Symptom response rate (SRR) based on total symptom score (TSS) measured by Myelofibrosis Symptom Assessment Form (MFSAF) | Up to 175 days |
| Additional measures based on TSS measured by MFSAF | Up to 175 days |
| Lake Mary |
| Florida |
| 32746 |
| United States |
| Local Institution - 0043 | New Orleans | Louisiana | 70112 | United States |
| Local Institution - 0038 | Worcester | Massachusetts | 01655 | United States |
| Local Institution - 0033 | Ann Arbor | Michigan | 48109 | United States |
| Local Institution - 0045 | Hackensack | New Jersey | 07601 | United States |
| Local Institution - 0076 | Chapel Hill | North Carolina | 27514 | United States |
| Local Institution - 0042 | Pittsburgh | Pennsylvania | 15224 | United States |
| Local Institution - 0036 | Blacktown | New South Wales | 2148 | Australia |
| Local Institution - 0032 | Wollongong | New South Wales | 2500 | Australia |
| Local Institution - 0007 | East Melbourne | Victoria | 3002 | Australia |
| Local Institution - 0006 | Heidelberg | Victoria | 3084 | Australia |
| Local Institution - 0041 | Nedlands | Western Australia | 6009 | Australia |
| Local Institution - 0015 | West Perth | Western Australia | 6005 | Australia |
| Local Institution - 0030 | Brest | 29200 | France |
| Local Institution - 0008 | Marseille | 13273 | France |
| Local Institution - 0027 | Nice | 06202 | France |
| Local Institution - 0011 | Paris | 75010 | France |
| Local Institution - 0010 | Villejuif | 94800 | France |
| Local Institution - 0068 | Erding | Bavaria | 85435 | Germany |
| Local Institution - 0039 | Essen | North Rhine-Westphalia | 45122 | Germany |
| Local Institution - 0040 | Chemnitz | Saxony | 09116 | Germany |
| Local Institution - 0035 | Halle | Saxony-Anhalt | 06120 | Germany |
| Local Institution - 0050 | Lübeck | Schleswig-Holstein | 23538 | Germany |
| Local Institution - 0061 | Chaïdári | Attikí | 12462 | Greece |
| Local Institution - 0047 | Thessaloniki | Thessaloníki | 570 10 | Greece |
| Local Institution - 0086 | Beersheba | Southern District | 8410101 | Israel |
| Local Institution - 0016 | Jerusalem | 9112001 | Israel |
| Local Institution - 0018 | Petah Tikva | 4910021 | Israel |
| Local Institution - 0017 | Ramat Gan | 5262100 | Israel |
| Local Institution - 0019 | Tel Aviv | 6423906 | Israel |
| Local Institution - 0003 | Bologna | 40138 | Italy |
| Local Institution - 0002 | Brescia | 25123 | Italy |
| Local Institution - 0001 | Florence | 50134 | Italy |
| Local Institution - 0012 | Verona | 37134 | Italy |
| Local Institution - 0077 | Słupsk | Pomeranian Voivodeship | 76-200 | Poland |
| Local Institution - 0062 | Gdansk | 80-952 | Poland |
| Local Institution - 0052 | Bucuresti | Cluj | 022328 | Romania |
| Local Institution - 0083 | Bucharest | 050098 | Romania |
| Local Institution - 0051 | Cluj-Napoca | 400015 | Romania |
| Local Institution - 0049 | Seongnam | Kyǒnggi-do | 13620 | South Korea |
| Local Institution - 0048 | Seoul | Seoul-teukbyeolsi [Seoul] | 05505 | South Korea |
| Local Institution - 0053 | Seoul | Seoul-teukbyeolsi [Seoul] | 06591 | South Korea |
| Local Institution - 0020 | Badalona | Barcelona [Barcelona] | 08916 | Spain |
| Local Institution - 0029 | Santander | Cantabria | 39008 | Spain |
| Local Institution - 0054 | Madrid | Madrid, Comunidad de | 28034 | Spain |
| Local Institution - 0026 | Madrid | 28041 | Spain |
| Local Institution - 0021 | Salamanca | 37007 | Spain |
| Local Institution - 0094 | Valencia | 46026 | Spain |
| ID | Term |
|---|---|
| D055728 | Primary Myelofibrosis |
| ID | Term |
|---|---|
| D009196 | Myeloproliferative Disorders |
| D001855 | Bone Marrow Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| C540383 | ruxolitinib |
| C528327 | fedratinib |
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