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This study will evaluate the pharmacokinetics (PK), safety, and efficacy of cevostamab in participants with relapsed or refractory (R/R) multiple myeloma (MM).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cevostamab | Experimental | Participants will receive cevostamab administered by intravenous (IV) infusion in 21-day cycles. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cevostamab | Drug | Cevostamab will be administered intravenously on a 21-day cycle. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Serum Concentration of Cevostamab at Specified Timepoints | Cycle 1 Day 1 (C1D1) up to approximately 2 years. Each cycle=21 days | |
| Percentage of Participants with Adverse Events | Baseline up to approximately 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | Baseline up to approximately 2 years | |
| Rate of Complete Response (CR) or Better | Baseline up to approximately 2 years | |
| Rate of Very Good Partial Response (VGPR) or Better |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Reference Study ID Number: YO43835 https://forpatients.roche.com/ No attachments to email below. | Contact | 888-662-6728 (U.S. and Canada) | 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 |
|---|---|---|---|---|---|---|
| Sun yat-sen University Cancer Center | Recruiting | Guangzhou | Guangdong | 510555 | China | |
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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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| Tocilizumab |
| Drug |
Tocilizumab will be administered for the treatment of cytokine release syndrome (CRS) when necessary. |
|
| Baseline up to approximately 2 years |
| Duration of Response (DOR) | Baseline up to approximately 2 years |
| Progression-free Survival (PFS) | Start of study treatment to first date of disease progression, relapse or death from any cause, whichever occurs first (up to approximately 2 years) |
| Time to First Response (for Participants who Achieve a Response of Partial Response (PR) or Better) | Baseline up to approximately 2 years |
| Time to Best Response (for Participants who Achieve a Response of PR or Better) | Baseline up to approximately 2 years |
| Overall Survival (OS) | Baseline up until death from any cause (up to approximately 2 years) |
| Minimal Residual Disease (MRD) Negativity (for Participants who Achieve a Response of CR or Better) | Baseline up to approximately 2 years |
| MRD Negativity (for all Efficacy-evaluable Participants) | Baseline up to approximately 2 years |
| Number of Anti-drug Antibody (ADAs) Against Cevostamab at Baseline | Baseline |
| Percentage of Participants with ADAs Against Cevostamab During the Study | Up to approximately 2 years |
| Number of Participants Reporting Presence, Frequency, Severity, and/or Degree of Interference with Daily Function of Symptomatic Treatment Toxicities Assessed by NCI Patient-Reported Outcomes Common Terminology Criteria for Adverse Events (PRO-CTCAE) | Up to approximately 2 years |
| Number of Participants Reporting Each Response Option for Treatment Side-effect Bother Single-item General Population, Question 5 (GP5) from the Functional Assessment of Cancer Therapy-General Questionnaire; (FACT-G) | Up to approximately 2 years |
| Tianjin Institute of Hematology & Blood Diseases Hospital |
| Recruiting |
| Tianjin |
| Tianjin Municipality |
| 301636 |
| China |
| The First Affiliated Hospital of Nanchang University | Recruiting | Nanchang | China |
| The First Affiliated Hospital of Wenzhou Medical University | Recruiting | Wenzhou | 325035 | China |
| Tongji Hospital Tongji Medical College Huazhong University of Science and Technology | Recruiting | Wuhan | 430030 | China |
| 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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