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| ID | Type | Description | Link |
|---|---|---|---|
| 2022-001204-18 | EudraCT Number | ||
| 2023-505212-38-00 | Other Identifier | EU CT Number |
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The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and activity of XmAb24306 in combination with cevostamab in participants with relapsed/refractory multiple myeloma (R/R MM) who have received a minimum of three prior treatments, including at least one immunomodulatory drug (IMiD), one proteasome inhibitor (PI), and one anti-CD38 monoclonal antibody.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A: Dose-Escalation and Expansion: XmAb24306+Cevostamab | Experimental | Participants will receive escalating doses of XmAb24306 with a fixed dose regimen for cevostamab up to the maximum tolerated dose (MTD). After dose escalation has been completed, up to two expansion cohorts each investigating different XmAb24306 doses in combination with cevostamab may be enrolled. |
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| Arm B: Single-Agent Cevostamab Expansion | Experimental | Participants will receive cevostamab alone. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cevostamab | Drug | Cevostamab will be administered intravenously on a 28-day cycle, for up to one year of treatment depending on clinical response. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants with Adverse Events (AEs) | Adverse events will be reported according to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0), and Cytokine Release Syndrome (CRS), will be graded based on the American Society for Transplantation and Cellular Therapy (ASTCT) criteria. | Up to approximately 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Serum Concentration of XmAb24306 | Up to approximately 3 years | |
| Serum Concentration of Cevostamab | Up to approximately 3 years | |
| Objective Response Rate (ORR) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal Adelaide Hospital | Adelaide | South Australia | 5000 | Australia | ||
| Peter Maccallum Cancer Centre |
For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\_sharing
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|
| XmAb24306 | Drug | XmAb24306 will be administered intravenously on a 28-day cycle, for up to one year of treatment depending on clinical response. |
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| Tocilizumab | Drug | Tocilizumab will be administered for the treatment of cytokine release syndrome (CRS) when necessary. |
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ORR will be determined by the investigator according to International Myeloma Working Group (IMWG) criteria. |
| Up to approximately 3 years |
| Rate of Complete Response (CR)/ Stringent Complete Response (sCR) | Rate of CR/sCR will be determined by the investigator. | Up to approximately 3 years |
| Rate of Very Good Partial Response (VGPR) | Rate of VGPR will be determined by the investigator. | Up to approximately 3 years |
| Percentage of Participants With Anti-Drug Antibodies (ADA) to XmAb24306 and Cevostamab | Up to approximately 3 years |
| Melbourne |
| Victoria |
| 3000 |
| Australia |
| Alfred Hospital | Melbourne | Victoria | 3004 | Australia |
| Sygehus Lillebaelt - Vejle Sygehus | Vejle | 7100 | Denmark |
| Evangelismos General Hospital of Athens | Athens | 106 76 | Greece |
| University of Athens, Hematological Clinic, | Athens | 115 28 | Greece |
| Rabin Medical Center-Beilinson Campus | Petah Tikva | 4941492 | Israel |
| Tel Aviv Sourasky Medical Center PPDS | Tel Aviv | 64239 | Israel |
| Oslo University Hospital Rikshospitalet | Oslo | N - 0424 | Norway |
| Severance Hospital, Yonsei University | Seoul | 03722 | South Korea |
| Asan Medical Center - PPDS | Seoul | 05505 | South Korea |
| Clinica Universidad de Navarra | Pamplona | Navarre | 31008 | Spain |
| Hospital Universitari i Politecnic La Fe de Valencia | Valencia | 46026 | 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 |
|---|---|
| C502936 | tocilizumab |
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