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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-506003-26-00 | Other Identifier | EU CTR |
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The purpose of this study is to assess BMS-986453 in participants with relapsed and/or refractory multiple myeloma (RRMM).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Administration of BMS-986453 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-986453 | Drug | Specified dose on specified days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with treatment-emergent adverse events (AEs) | Up to 4 years | |
| Number of participants with serious adverse events (SAEs) | Up to 4 years | |
| Number of participants with AEs leading to discontinuation | Up to 4 years | |
| Number of participants with AEs leading to death | Up to 4 years | |
| Number of participants with dose-limiting toxicities (DLTs) | Up to 4 years |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed concentration (Cmax) | Up to 4 years | |
| Time of maximum observed concentration (Tmax) | Up to 4 years | |
| Area under the blood concentration-time curve from time zero to 28 days after dosing (AUC(0-28D)) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| BMS Clinical Trials Contact Center www.BMSClinicalTrials.com | Contact | 855-907-3286 | Clinical.Trials@bms.com | |
| First line of the email MUST contain NCT # and Site #. | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Recruiting | Birmingham | Alabama | 35294 | United States |
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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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| Fludarabine |
| Drug |
Specified dose on specified days |
|
|
| Cyclophosphamide | Drug | Specified dose on specified days |
|
|
| Up to 4 years |
| Overall response rate (ORR) | Up to 4 years |
| Complete response rate (CRR) | Up to 4 years |
| Number of participants with very good partial response (VGPR) or better | Up to 4 years |
| Progression-free survival (PFS) | Up to 4 years |
| Overall survival (OS) | Up to 4 years |
| Time to response (TTR) | Up to 4 years |
| Time to complete response (TTCR) | Up to 4 years |
| Duration of response (DOR) | Up to 4 years |
| Duration of complete response (DOCR) | Up to 4 years |
| Persistence of BMS-986453 in peripheral blood | Defined as a transgene count greater than or equal to the lower limit of detection (LLOD) | Up to 4 years |
| Expansion rate | Defined as Cmax divided by Tmax | Up to 4 years |
| City of Hope Comprehensive Cancer Center | Recruiting | Duarte | California | 91010 | United States |
|
| UCSF Helen Diller Medical Center at Parnassus Heights | Recruiting | San Francisco | California | 94143 | United States |
|
| Stanford University Medical Center | Recruiting | Stanford | California | 94305 | United States |
|
| Colorado Blood Cancer Institute | Recruiting | Denver | Colorado | 80218 | United States |
|
| Yale Cancer Center | Recruiting | New Haven | Connecticut | 06520 | United States |
|
| Moffitt Cancer Center | Recruiting | Tampa | Florida | 33612 | United States |
|
| Dana-Farber Cancer Institute | Recruiting | Boston | Massachusetts | 02215 | United States |
|
| Icahn School of Medicine at Mount Sinai | Recruiting | New York | New York | 10029 | United States |
|
| Memorial Sloan Kettering Cancer Center | Recruiting | New York | New York | 10065 | United States |
|
| Local Institution - 0008 | Not yet recruiting | Nashville | Tennessee | 37203 | United States |
|
| Tennessee Oncology | Recruiting | Nashville | Tennessee | 37203 | United States |
|
| Swedish Medical Center | Recruiting | Seattle | Washington | 98104 | United States |
|
| Hôpital Saint-Louis | Recruiting | Paris | 75010 | France |
|
| Universitaetsklinikum Koeln | Recruiting | Cologne | 50937 | Germany |
|
| Universitaetsklinikum Heidelberg | Recruiting | Heidelberg | D-69120 | Germany |
|
| Universitaetsklinikum Wuerzburg | Recruiting | Würzburg | 97080 | Germany |
|
| Clinica Universidad de Navarra | Recruiting | Pamplona | Navarre | 31008 | Spain |
|
| Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca | Recruiting | Salamanca | 37007 | Spain |
|
| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C024352 | fludarabine |
| C042382 | fludarabine phosphate |
| D003520 | Cyclophosphamide |
| ID | Term |
|---|---|
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
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