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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-504367-16-00 | Other Identifier | EU CTR | |
| U1111-1283-8970 | Other Identifier | WHO |
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Business objectives have changed
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The purpose of this study is to determine the recommended dose and schedule, and evaluate the safety and preliminary efficacy of alnuctamab in combination with mezigdomide in participants with relapsed and/or refractory multiple myeloma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A | Experimental |
| |
| Arm B1 | Experimental |
| |
| Arm B2 | Experimental |
| |
| Arm C1 | Experimental |
| |
| Arm C2 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alnuctamab | Drug | Specified dose on specified days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events (AEs) | Up until 28 days after the last participant discontinues mezigdomide or 80 days after the last participant discontinues alnuctamab, whichever is longer (up to approximately 5 years) | |
| Number of participants with serious AEs (SAEs) | Up until 28 days after the last participant discontinues mezigdomide or 80 days after the last participant discontinues alnuctamab, whichever is longer (up to approximately 5 years) | |
| Number of participants with AEs leading to discontinuation | Up until 28 days after the last participant discontinues mezigdomide or 80 days after the last participant discontinues alnuctamab, whichever is longer (up to approximately 5 years) | |
| Number of deaths | Up until 28 days after the last participant discontinues mezigdomide or 80 days after the last participant discontinues alnuctamab, whichever is longer (up to approximately 5 years) | |
| Number of participants with Dose-limiting toxicities (DLTs) | Up until 28 days after the last participant discontinues mezigdomide or 80 days after the last participant discontinues alnuctamab, whichever is longer (up to approximately 5 years) | |
| Overall Response Rate (ORR) | Phase 2 only | From first participant enrollment until the last participant is no longer evaluable for response, or has progressed or the last survival follow-up (Up to approximately 5 years) |
| Measure | Description | Time Frame |
|---|---|---|
| Complete Response Rate (CRR) | From first participant enrollment until the last participant is no longer evaluable for response, or has progressed or the last survival follow-up (Up to approximately 5 years) | |
| Very Good Partial Response Rate (VGPRR) | From first participant enrollment until the last participant is no longer evaluable for response, or has progressed or the last survival follow-up (Up to approximately 5 years) |
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Inclusion Criteria:
Participant has a history of RRMM, and must:
Exclusion Criteria:
• Must not have previously received alnuctamab or mezigdomide.
Note: 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 - 0033 | Birmingham | Alabama | 35294 | United States | ||
| Local Institution - 0035 |
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| Label | URL |
|---|---|
| BMS Clinical Trial Information | 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/disclosure-commitment.html
See plan description
See plan description
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| Mezigdomide | Drug | Specified dose on specified days |
|
|
| Dexamethasone | Drug | Specified dose on specified days |
|
| Progression-free Survival (PFS) | From first participant enrollment until the last participant is no longer evaluable for response, or has progressed or the last survival follow-up (Up to approximately 5 years) |
| Time-to-Response (TTR) | From first participant enrollment until the last participant is no longer evaluable for response, or has progressed or the last survival follow-up (Up to approximately 5 years) |
| Duration of Response (DOR) | From first participant enrollment until the last participant is no longer evaluable for response, or has progressed or the last survival follow-up (Up to approximately 5 years) |
| Overall Survival (OS) | From first participant enrollment until the last participant is no longer evaluable for response, or has progressed or the last survival follow-up (Up to approximately 5 years) |
| ORR | Phase 1 only | From first participant enrollment until the last participant is no longer evaluable for response, or has progressed or the last survival follow-up (Up to approximately 5 years) |
| New Haven |
| Connecticut |
| 06511 |
| United States |
| Local Institution - 0018 | New York | New York | 10065 | United States |
| Local Institution - 0021 | Petah Tikva | Central District | 4910021 | Israel |
| Local Institution - 0030 | Ramat Gan | Central District | 5262100 | Israel |
| Local Institution - 0020 | Jerusalem | 9112001 | Israel |
| 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 |
|---|---|
| D003907 | Dexamethasone |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
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