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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-504657-13-00 | EU Trial (CTIS) Number |
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The purpose of the study is to evaluate safety and tolerability of the combination of cevostamab plus elranatamab and also determine the recommended Phase II regimen (RP2R) for the study treatment. The study consists of a safety lead-in stage, and an expansion stage.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Safety Lead-In Cohort | Experimental | Participants will receive cevostamab, intravenously (IV), in combination with elranatamab, subcutaneously (SC), with step-up dosing of each drug in pre-phase following which they will receive elranatamab, at the assigned dose as a SC injection until disease progression or unacceptable toxicity. Participants will also receive cevostamab at the assigned dose as IV infusion until disease progression or unacceptable toxicity or up to 1 year on treatment, whichever occurs first. |
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| Dose Expansion Cohort (Combined Therapy) | Experimental | Participants will receive cevostamab, IV, in combination with elranatamab, SC, with step-up dosing in pre-phase following which they will receive elranatamab, at the assigned dose as a SC injection until disease progression or unacceptable toxicity. Participants will also receive cevostamab at the assigned dose as IV infusion until disease progression or unacceptable toxicity or up to 1 year on treatment, whichever occurs first. |
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| Dose Expansion Cohort (Monotherapy) | Experimental | Participants will receive elranatamab SC, with step-up dosing in pre-phase following which they will receive elranatamab, at the assigned dose as a SC injection until disease progression or unacceptable toxicity. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cevostamab | Drug | Cevostamab solution for infusion will be administered as IV as specified in each treatment arm. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number 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). The severity of CRS, immune effector cell-associated neurotoxicity syndrome (ICANS) and hemophagocytic lymphohistiocytosis (HLH) will be graded based on the American Society for Transplantation and Cellular Therapy (ASTCT) Grading Scales. | From signing of informed consent up to end of study (EOS) (approximately 36 months) |
| Recommended Phase II Regimen (RP2R) | Up to approximately 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) as Determined by the Investigator per International Myeloma Working Group (IMWG) Criteria | Up to approximately 36 months | |
| Complete Response (CR)/ Stringent Complete Response (sCR) Rate as Determined by the Investigator per IMWG Criteria |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| GO43979 https://forpatients.roche.com/ No attachments to email below. | Contact | 888-662-6728 (U.S. Only) | global-roche-genentech-trials@gene.com | |
| Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal Prince Alfred Hospital | Recruiting | Camperdown | New South Wales | 2050 | Australia | |
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| Label | URL |
|---|---|
| Please use this form to submit your questions for a faster response: https://www.gene.com/contact-us/submit-medical-inquiry. Do not include or attach any medical records when emailing or completing the form. A nurse will respond within 24 business hours. | View source |
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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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| Elranatamab | Drug | Elranatamab solution for injection will be administered SC as specified in each treatment arm. |
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| Tocilizumab | Drug | Tocilizumab will be used as rescue medication for participants who experience a cytokine release syndrome (CRS) event. |
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| Up to approximately 36 months |
| Rate of Very Good Partial Response (VGPR) or Better, as Determined by the Investigator per IMWG Criteria | Up to approximately 36 months |
| Progression-Free Survival as Determined by the Investigator per IMWG Criteria | Up to approximately 36 months |
| Duration of Response (DOR) as Determined by the Investigator (for Participants who Achieve a Response of Partial Response (PR) or Better) | Up to approximately 36 months |
| Time to First Response (for Participants who Achieve a Response of PR or Better) | Up to approximately 36 months |
| Time to Best Response (for Participants who Achieve a Response of PR or Better) | Up to approximately 36 months |
| Overall Survival (OS) | Up to approximately 36 months |
| Serum Concentration of Cevostamab at Specified Timepoints | Up to approximately 36 months |
| Serum Concentration of Elranatamab at Specified Timepoints | Up to approximately 36 months |
| Number of Participants with Anti-Drug Antibody (ADA) Against Cevostamab | Up to approximately 36 months |
| Number of Participants with ADA Against Elranatamab | Up to approximately 36 months |
| Calvary Mater Newcastle |
| Recruiting |
| Waratah |
| New South Wales |
| 2298 |
| Australia |
| Royal Adelaide Hospital;Haematology Clinical Trials Unit | Recruiting | Adelaide | South Australia | 5000 | Australia |
| St. Vincent's Hospital Melbourne | Recruiting | Melbourne | Victoria | 3065 | Australia |
| The Alfred Hospital | Recruiting | Prahan | Victoria | 3181 | Australia |
| The Chaim Sheba Medical Center - PPDS | Recruiting | Ramat Gan | Central District | 5262100 | Israel |
| Rambam Health Care Campus | Recruiting | Haifa | 3109600 | Israel |
| Hadassah University Hospital - Ein Kerem | Recruiting | Jerusalem | 9112001 | Israel |
| Tel Aviv Sourasky Medical Center PPDS | Recruiting | Tel Aviv | 6423906 | Israel |
| The Catholic University of Korea - Seoul St. Mary's Hospital (Kangnam St. Mary's Hospital) | Recruiting | Seocho | 06591 | South Korea |
| Seoul National University Hospital | Recruiting | Seoul | 03080 | South Korea |
| Severance Hospital, Yonsei University Health System | Recruiting | Seoul | 03722 | South Korea |
| Asan Medical Center. | Recruiting | Seoul | 05505 | South Korea |
| Samsung Medical Center - PPDS | Recruiting | Seoul | 06351 | South Korea |
| ID | Term |
|---|---|
| D012008 | Recurrence |
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| 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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