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The purpose of this study is to establish a safe and tolerable dose of arlocabtagene autoleucel (BMS-986393) in combinations with alnuctamab, mezigdomide, iberdomide, and elranatamab in participants with relapsed and/or refractory multiple myeloma (RRMM).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A: BMS-986393 + Alnuctamab | Experimental |
| |
| Arm B: BMS-986393 + Mezigdomide | Experimental |
| |
| Arm C: BMS-986393 + Iberdomide | Experimental |
| |
| Arm D: BMS-986393 + Elranatamab | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-986393 | Drug | Specified dose on specified days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events (AEs) | Up to 2 years | |
| Incidence of serious adverse events (SAEs) | Up to 2 years | |
| Incidence of adverse events of special interest (AESI) | Up to 2 years | |
| Incidence of AEs leading to discontinuation | Up to 2 years | |
| Number of Deaths | Up to 2 years | |
| Establish recommended Phase 2 dose (RP2D) | Up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall response rate (ORR) | Up to 2 years | |
| Complete response rate (CRR) | Up to 2 years | |
| Very good partial response rate (VGPRR) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| BMS Study Connect Contact Center www.BMSStudyConnect.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/disclosurecommitment.html
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|
| Alnuctamab | Drug | Specified dose on specified days |
|
|
| Mezigdomide | Drug | Specified dose on specified days |
|
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| Iberdomide | Drug | Specified dose on specified days |
|
|
| Elranatamab | Drug | Specified dose on specified days |
|
|
| Up to 2 years |
| Maximum observed concentration (Cmax) of arlocabtagene autoleucel | Up to 2 years |
| Time of maximum observed concentration (tmax) of arlocabtagene autoleucel | Up to 2 years |
| Area under the concentration-time curve from time 0 to 28 days [AUC (0-28D)] of arlocabtagene autoleucel | Up to 2 years |
| Mayo Clinic in Arizona - Phoenix | Recruiting | Phoenix | Arizona | 85054 | United States |
|
| City of Hope Comprehensive Cancer Center | Recruiting | Duarte | California | 91010 | United States |
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| Mayo Clinic in Florida | Recruiting | Jacksonville | Florida | 32224 | United States |
|
| Northside Hospital | Recruiting | Atlanta | Georgia | 30342 | United States |
|
| Beth Israel Deaconess Medical Center | Recruiting | Boston | Massachusetts | 02215 | United States |
|
| Dana-Farber Cancer Institute | Recruiting | Boston | Massachusetts | 02215 | United States |
|
| Mayo Clinic in Rochester, Minnesota | Recruiting | Rochester | Minnesota | 55905 | United States |
|
| University Of Nebraska Medical Center | Recruiting | Omaha | Nebraska | 68198 | United States |
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| John Theurer Cancer Center at Hackensack University Medical Center | Recruiting | Hackensack | New Jersey | 07601 | United States |
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| Roswell Park Cancer Institute | Recruiting | Buffalo | New York | 14263 | United States |
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| Laura and Isaac Perlmutter Cancer Center | Recruiting | New York | New York | 10016 | United States |
|
| Local Institution - 0009 | Completed | New York | New York | 10032 | United States |
| Memorial Sloan Kettering Cancer Center | Recruiting | New York | New York | 10065 | United States |
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| Local Institution - 0023 | Withdrawn | Pittsburgh | Pennsylvania | 15232 | United States |
| Tennessee Oncology | Recruiting | Nashville | Tennessee | 37203 | United States |
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| University of Texas MD Anderson Cancer Center | Recruiting | Houston | Texas | 77030 | United States |
|
| Arthur J.E. Child Comprehensive Cancer Centre | Recruiting | Calgary | Alberta | T2N 5G2 | Canada |
|
| Princess Margaret Cancer Centre | Recruiting | Toronto | Ontario | M5G 2M9 | Canada |
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| 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 |
|---|---|
| C000624220 | iberdomide |
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