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The purpose of this study is to evaluate the effectiveness and safety of Arlocabtagene Autoleucel (BMS-986393) in participants with relapsed or refractory multiple myeloma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arlocabtagene Autoleucel Cohort 1 | Experimental |
| |
| Arlocabtagene Autoleucel Cohort 2 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Arlocabtagene Autoleucel | Biological | Specified dose on specified days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cohort 1: Best overall response (BOR) of partial response (PR) or better | The number and percent of participants achieving BOR of partial response (PR) or better in quadruple class exposed participants received at least 4 prior lines of therapy (LOT) | Up to approximately 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| BOR of partial response (PR) or better | The number and percent of participants achieving BOR of PR in quadruple class exposed participants received at least 3 prior LOT | Up to approximately 5 years |
| Best overall response (BOR) of complete response (CR) including stringent complete response (sCR) |
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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 | 35294-3300 | 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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The number and percent of participants achieving complete response (CR) [including stringent complete response sCR] in participants having received at least 3 prior lines of therapy (LOT) |
| Up to approximately 5 years |
| Minimal residual disease (MRD) negative status | Up to approximately 5 years |
| Time from BMS-986393 infusion to first documentation of response of partial response (PR) or better according to the International Myeloma Working Group (IMWG) Response Criteria assessed by an independent review committee (IRC) | Up to approximately 5 years |
| Duration of response (DOR) assessed by an IRC | Median DOR for responders only as estimated using Kaplan-Meier method and frequencies of participants who progressed, died, and were censored | Up to approximately 5 years |
| Progression-free survival (PFS) | Up to approximately 5 years |
| Overall survival (OS) | Up to approximately 5 years |
| Overall response rate (ORR) assessed by an Investigator | Up to approximately 5 years |
| Complete response rate (CRR) assessed by an Investigator | Up to approximately 5 years |
| Time to response (TTR) assessed by an Investigator | Up to approximately 5 years |
| Duration of response (DOR) assessed by an Investigator | Up to approximately 5 years |
| Progression-free survival (PFS) with BOR according to the IMWG Response Criteria assessed by Investigator | Up to approximately 5 years |
| Maximum observed plasma concentration (Cmax) | Up to approximately 5 years |
| Area under the concentration-time curve (AUC) | Up to approximately 5 years |
| Time of maximum observed plasma concentration (Tmax) | Up to approximately 5 years |
| Mean changes from baseline in European Organization for Research and Treatment of Cancer - Quality of Life C30 (EORTC QLQ-C30) selected subscales | Up to approximately 5 years |
| Incidence of healthcare resource utilization (HCRU) events during treatment and during post-treatment follow-up | Up to approximately 5 years |
| Banner MD Anderson Cancer Center | Recruiting | Gilbert | Arizona | 85234 | United States |
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| University of Arkansas for Medical Sciences | Recruiting | Little Rock | Arkansas | 72205 | United States |
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| UCLA Hematology/Oncology - Westwood (Building 200 Suite 214) | Recruiting | Los Angeles | California | 90095 | United States |
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| UCSF Helen Diller Medical Center at Parnassus Heights | Recruiting | San Francisco | California | 94143 | United States |
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| Colorado Blood Cancer Institute | Recruiting | Denver | Colorado | 80218 | United States |
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| Mayo Clinic in Florida | Recruiting | Jacksonville | Florida | 32224 | United States |
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| Miami Cancer Institute at Baptist Health, Inc. | Recruiting | Miami | Florida | 33176 | United States |
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| Moffitt Cancer Center | Recruiting | Tampa | Florida | 33612 | United States |
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| Winship Cancer Institute of Emory University | Recruiting | Atlanta | Georgia | 30322 | United States |
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| Northside Hospital | Recruiting | Atlanta | Georgia | 30342 | United States |
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| Northwestern Memorial Hospital | Recruiting | Chicago | Illinois | 60611 | United States |
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| University of Chicago Medical Center | Recruiting | Chicago | Illinois | 60637 | United States |
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| University of Iowa | Recruiting | Iowa City | Iowa | 52242 | United States |
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| The University of Kansas Cancer Center - Westwood | Recruiting | Westwood | Kansas | 66205 | United States |
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| Norton Women's and Children's Hospital | Recruiting | Louisville | Kentucky | 40207 | United States |
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| Local Institution - 0065 | Withdrawn | Baltimore | Maryland | 21218 | United States |
| Massachusetts General Hospital | Recruiting | Boston | Massachusetts | 02114 | United States |
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| Dana-Farber Cancer Institute | Recruiting | Boston | Massachusetts | 02215 | United States |
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| Mayo Clinic in Rochester, Minnesota | Recruiting | Rochester | Minnesota | 55905 | United States |
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| Washington University School of Medicine | Recruiting | St Louis | Missouri | 63110 | United States |
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| Rutgers Cancer Institute of New Jersey | Recruiting | New Brunswick | New Jersey | 08901 | United States |
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| Roswell Park Cancer Institute | Recruiting | Buffalo | New York | 14263 | United States |
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| Icahn School of Medicine at Mount Sinai | Recruiting | New York | New York | 10029 | United States |
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| Memorial Sloan Kettering Cancer Center | Recruiting | New York | New York | 10065 | United States |
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| University of North Carolina Medical Center | Recruiting | Chapel Hill | North Carolina | 27599-7305 | United States |
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| Local Institution - 0067 | Withdrawn | Charlotte | North Carolina | 28204 | United States |
| Oncology Hematology Care | Recruiting | Cincinnati | Ohio | 45242 | United States |
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| The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive Cancer Center | Recruiting | Columbus | Ohio | 43210 | United States |
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| Oregon Health and Science University | Recruiting | Portland | Oregon | 97239 | United States |
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| Sidney Kimmel Cancer Center - Jefferson Health | Recruiting | Philadelphia | Pennsylvania | 19107 | United States |
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| Tennessee Oncology | Recruiting | Nashville | Tennessee | 37203 | United States |
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| Vanderbilt University Medical Center | Recruiting | Nashville | Tennessee | 37232 | United States |
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| Local Institution - 0069 | Withdrawn | Austin | Texas | 78704 | United States |
| UT Southwestern Medical Center | Recruiting | Dallas | Texas | 75390 | United States |
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| University of Texas MD Anderson Cancer Center | Recruiting | Houston | Texas | 77030 | United States |
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| Methodist HealthCare System of San Antonio Clinical Trials Office, Texas Transplant Institute | Recruiting | San Antonio | Texas | 78229 | United States |
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| LDS Hospital | Recruiting | Salt Lake City | Utah | 84143 | United States |
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| Virginia Oncology Associates | Recruiting | Norfolk | Virginia | 23502 | United States |
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| Fred Hutchinson Cancer Center | Recruiting | Seattle | Washington | 98109 | United States |
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| University of Wisconsin Carbone Cancer Center - University Hospital | Recruiting | Madison | Wisconsin | 53792 | United States |
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| Royal Prince Alfred Hospital | Recruiting | Camperdown | New South Wales | 2050 | Australia |
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| Royal Brisbane and Women's Hospital | Recruiting | Brisbane | Queensland | 4029 | Australia |
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| The Alfred Hospital | Recruiting | Melbourne | Victoria | 3004 | Australia |
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| St Vincent's Hospital | Recruiting | Melbourne | Victoria | 3065 | Australia |
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| Arthur J.E. Child Comprehensive Cancer Centre | Recruiting | Calgary | Alberta | T2N 5G2 | Canada |
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| McGill University Health Centre | Recruiting | Montreal | Quebec | H4A 3J1 | Canada |
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| Nagoya City University Hospital | Recruiting | Nagoya | Aichi-ken | 467-8602 | Japan |
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| Hyogo Medical University Hospital | Recruiting | Nishinomiya | Hyōgo | 663-8501 | Japan |
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| Chiba University Hospital | Recruiting | Chiba | 260-8677 | Japan |
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| University Hospital,Kyoto Prefectural University of Medicine | Recruiting | Kyoto | 602-8566 | Japan |
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| Japanese Red Cross Medical Center | Recruiting | Tokyo | 150-8935 | Japan |
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| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| D012008 | Recurrence |
| 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 |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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