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This study will evaluate safety, pharmacokinetics (PK), clinical activity and pharmacodynamics (PD) of RO7851624 in participants with RRMM who are triple-class exposed (treated with proteasome inhibitors [PIs], immunomodulators [IMiDs], and anti-cluster of differentiation 38 [anti-CD38] monoclonal antibodies), and have limited remaining standard treatment options due to refractoriness, intolerance, or multiple prior therapies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RO7851624 | Experimental | Participants will receive RO7851624 in a dose escalation stage followed by a dose expansion stage. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RO7851624 | Drug | Participants will receive RO7851624 as per the schedule described in the protocol. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Adverse Events (AEs) | Up to approximately 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Serum Concentration of RO7851624 | Up to approximately 2 years | |
| Objective Response Rate (ORR) | Up to approximately 2 years | |
| Complete Response (CR) Rate/ Stringent Complete Response (sCR) Rate) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Reference Study ID Number: GO46140 https://forpatients.roche.com/ | Contact | 888-662-6728 (U.S. and Canada) | global-roche-genentech-trials@gene.com | |
| Fastest response: use the inquiry form. No email attachments. 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 |
|---|---|---|---|---|---|---|
| Peter MacCallum Cancer Center | Recruiting | Parkville | Victoria | 3052 | 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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| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
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| Up to approximately 2 years |
| Rate of Very Good Partial Response (VGPR) Rate or Better | Up to approximately 2 years |
| Progression-Free Survival (PFS) | Up to approximately 2 years |
| Duration of Response (DOR) | Up to approximately 2 years |
| Time to First Response | Up to approximately 2 years |
| Time to Best Response | Up to approximately 2 years |
| Percentage of Participants With Anti-Drug Antibodies (ADAs) Against RO7851624 at Baseline and During the Study | Baseline, up to approximately 2 years |
| Recommended Dose and Regimen of RO7851624 | Up to approximately 2 years |
| 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 |