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The purpose of this study is to find out if BP2202 is safe and can treat participants with Relapsed/Refractory Multiple Myeloma.
Part A of the study will evaluate the safety and tolerability of BP2202 and determine recommended phase 2 dose. Part B of the study will further evaluate safety and explore the potential anti-myeloma activity of BP2202 at recommended phase 2 dose.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BP2202 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BP2202 | Biological | Intravenous infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of dose-limiting toxicities (DLTs; Part A) | Number of participants who experienced a DLT. DLTs include specifically defined adverse events (AEs) considered to be related to BP2202 | Up to 4 weeks |
| Incidence of adverse events (AEs; Parts A and B) | Number of participants who experienced AEs, adverse events of special interest (AESIs), or serious adverse events (SAEs) | Up to approximately 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate (Parts A and B) | Up to approximately 1 year | |
| Duration of Response (DoR) (Parts A and B) | The time from the first objective response (sCR, CR, VGPR or PR) to the first documented PD according to IMWG criteria or death. |
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Inclusion Criteria:
Exclusion Criteria:
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| Up to approximately 1 year |
| Disease Control Rate (DCR) (Parts A and B) | Number of participants who achieved a best response of sCR, CR, VGPR, PR or SD according to IMWG criteria. | Up to approximately 1 year |
| 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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