A Study Evaluating the Pharmacokinetics, Safety, and Efficacy of Cevostamab in Chinese Participants With Relapsed or Refractory Multiple Myeloma
A Phase Ib, Open-Label, Single-Arm, Multicenter Trial Evaluating the Pharmacokinetics, Safety, and Efficacy of Cevostamab in Chinese Patients With Relapsed or Refractory Multiple Myeloma
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Phase
Phase
- Phase 1
Contacts and Locations
Study Contact
Study Contact
- Name: Reference Study ID Number: YO43835 https://forpatients.roche.com/
- Phone Number: 888-662-6728 (U.S. and Canada)
- Email: global-roche-genentech-trials@gene.com
Study Contact Backup
- Name: Fastest response: use the inquiry form. No email attachments. https://www.gene.com/contact-us/submit-medical-inquiry
Study Locations
-
-
-
Nanchang, China
- Recruiting
- The First Affiliated Hospital of Nanchang University
-
Wenzhou, China, 325035
- Recruiting
- The First Affiliated Hospital of Wenzhou Medical University
-
Wuhan, China, 430030
- Recruiting
- Tongji Hospital Tongji Medical College Huazhong University of Science and Technology
-
-
Guangdong
-
Guangzhou, Guangdong, China, 510555
- Recruiting
- Sun yat-sen University Cancer Center
-
-
Tianjin Municipality
-
Tianjin, Tianjin Municipality, China, 301636
- Recruiting
- Tianjin Institute of Hematology & Blood Diseases Hospital
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Documented diagnosis of MM based on standard International Myeloma Working Group (IMWG) criteria
- Evidence of progressive disease based on investigators determination of response by IMWG criteria on or after their last dosing regimen
- Current relapsed or refractory (R/R) disease status
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- Life expectancy of at least 12 weeks
- Agreement to protocol-specified assessments, including bone marrow biopsy and aspirate samples as detailed in the protocol
- Resolution of AEs from prior anti-cancer therapy to Grade =< 1 or better
- For female participants of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception during the treatment period and for at least 5 months after the final dose of cevostamab and for 3 months after the last dose of tocilizumab was administered
- For male participants: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agree to refrain from donating sperm during the treatment period and for at least 2 months after the final dose of tocilizumab (if applicable) to avoid exposing the embryo
Exclusion Criteria:
- Unable to comply with protocol-mandated hospitalization
- Pregnancy or breastfeeding, or intention of becoming pregnant during the study or within 5 months after the final dose of cevostamab or tocilizumab or within 3 months after the last dose of tocilizumab (if applicable)
- Prior treatment with cevostamab or another agent with the same target
- Prior use of any monoclonal antibody (mAb), radioimmunoconjugate, or ADC as anti-cancer therapy within 4 weeks before first study treatment, except for the use of non-myeloma therapy
- Prior treatment with systemic immunotherapeutic agents, including but not limited to, cytokine therapy and anti-CTLA-4, anti-PD-1, and anti-PD-L1
- Prior treatment with CAR-T cell therapy within 12 weeks before first cevostamab infusion
- Known treatment-related, immune-mediated adverse events associated with prior checkpoint inhibitors
- Treatment with radiotherapy, any chemotherapeutic agent, or treatment with any other anti-cancer agent within 4 weeks or 5 half-lives of the drug, whichever is shorter, prior to first study treatment
- Autologous stem cell transplantation (SCT) within 100 days prior to first study treatment
- Prior allogeneic SCT
- Prior solid organ transplantation
- History of autoimmune disease
- History of confirmed progressive multifocal leukoencephalopathy
- History of severe allergic or anaphylactic reactions to mAb therapy
- Known history of amyloidosis
- Lesions in proximity of vital organs that may develop sudden decompensation/deterioration in the setting of a tumor flare
- History of other malignancy within 2 years prior to screening, except those with negligible risk of metastasis or death, such as ductal carcinoma in situ not requiring chemotherapy, appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, low-grade, localized prostate cancer not requiring treatment or appropriately treated Stage I uterine cancer
- Current or past history of central nervous system (CNS) disease, such as stroke, epilepsy, CNS vasculitis, neurodegenerative disease, or CNS involvement by MM
- Significant cardiovascular disease that may limit a potential participant's ability to adequately respond to a cytokine release syndrome (CRS) event
- Symptomatic active pulmonary disease or requiring supplemental oxygen
- Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection at study enrollment, or any major episode of infection requiring treatment with IV (intravenous) antimicrobials where the last dose of IV antimicrobial was given within 14 days prior to first study treatment
- Active symptomatic COVID-19 infection at study enrollment or requiring treatment with IV antiviral where the last dose of IV antiviral treatment was given within 14 days prior to first study treatment.
- Positive and quantifiable Epstein-Barr virus (EBV) polymerase chain reaction (PCR) or cytomegalovirus (CMV) PCR prior to first study treatment
- Known or suspected chronic active EBV infection
- Known history of hemophagocytic lymphohistiocytosis (HLH) or macrophage activation syndrome (MAS)
- Known history of Grade >=3 CRS or immune effector cell-associated neurotoxicity syndrome (ICANS) with prior bispecific therapies
- Recent major surgery within 4 weeks prior to first study treatment
- Positive serologic or PCR test results for acute or chronic hepatitis B virus (HBV) infection
- Acute or chronic hepatitis C virus (HCV) infection
- Known history of human immunodeficiency virus (HIV) seropositivity
- Administration of a live, attenuated vaccine within 4 weeks before first study treatment or anticipation that such a live attenuated vaccine will be required during the study
- Treatment with systemic immunosuppressive medications, with the exception of corticosteroid treatment <= 10 mg/day prednisone or equivalent, within 2 weeks prior to first study treatment
- History of illicit drug or alcohol abuse within 12 months prior to screening, in the investigator's judgment
- Any medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes the participant's safe participation in and completion of the study, or which could affect compliance with the protocol or interpretation of results
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: Cevostamab
Participants will receive cevostamab administered by intravenous (IV) infusion in 21-day cycles.
|
Tocilizumab will be administered for the treatment of cytokine release syndrome (CRS) when necessary.
Cevostamab will be administered intravenously on a 21-day cycle.
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Percentage of Participants with Adverse Events
Time Frame: Baseline up to approximately 2 years
|
Baseline up to approximately 2 years
|
|
Serum Concentration of Cevostamab at Specified Timepoints
Time Frame: Cycle 1 Day 1 (C1D1) up to approximately 2 years. Each cycle=21 days
|
Cycle 1 Day 1 (C1D1) up to approximately 2 years. Each cycle=21 days
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Number of Anti-drug Antibody (ADAs) Against Cevostamab at Baseline
Time Frame: Baseline
|
Baseline
|
|
Objective Response Rate (ORR)
Time Frame: Baseline up to approximately 2 years
|
Baseline up to approximately 2 years
|
|
Duration of Response (DOR)
Time Frame: Baseline up to approximately 2 years
|
Baseline up to approximately 2 years
|
|
Rate of Complete Response (CR) or Better
Time Frame: Baseline up to approximately 2 years
|
Baseline up to approximately 2 years
|
|
Rate of Very Good Partial Response (VGPR) or Better
Time Frame: Baseline up to approximately 2 years
|
Baseline up to approximately 2 years
|
|
Overall Survival (OS)
Time Frame: Baseline up until death from any cause (up to approximately 2 years)
|
Baseline up until death from any cause (up to approximately 2 years)
|
|
Percentage of Participants with ADAs Against Cevostamab During the Study
Time Frame: Up to approximately 2 years
|
Up to approximately 2 years
|
|
Progression-free Survival (PFS)
Time Frame: Start of study treatment to first date of disease progression, relapse or death from any cause, whichever occurs first (up to approximately 2 years)
|
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)
Time Frame: Baseline up to approximately 2 years
|
Baseline up to approximately 2 years
|
|
Time to Best Response (for Participants who Achieve a Response of PR or Better)
Time Frame: Baseline up to approximately 2 years
|
Baseline up to approximately 2 years
|
|
Minimal Residual Disease (MRD) Negativity (for Participants who Achieve a Response of CR or Better)
Time Frame: Baseline up to approximately 2 years
|
Baseline up to approximately 2 years
|
|
MRD Negativity (for all Efficacy-evaluable Participants)
Time Frame: Baseline up to approximately 2 years
|
Baseline 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)
Time Frame: Up to approximately 2 years
|
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)
Time Frame: Up to approximately 2 years
|
Up to approximately 2 years
|
Collaborators and Investigators
Sponsor
Sponsor
Investigators
Investigators
- Study Director: Clinical Trials, Hoffmann-La Roche
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Vascular Diseases
- Cardiovascular Diseases
- Neoplasms
- Immune System Diseases
- Neoplasms by Histologic Type
- Hematologic Diseases
- Lymphoproliferative Disorders
- Immunoproliferative Disorders
- Neoplasms, Plasma Cell
- Hemostatic Disorders
- Paraproteinemias
- Blood Protein Disorders
- Hemorrhagic Disorders
- Hemic and Lymphatic Diseases
- Multiple Myeloma
- tocilizumab
Other Study ID Numbers
Other Study ID Numbers
- YO43835
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Multiple Myeloma
-
NCT07622862Not yet recruitingMultiple Myeloma Progression | Multiple Myeloma Refractory
-
NCT07456605RecruitingMultiple Myeloma in Relapse | Multiple Myeloma Refractory
-
NCT03428373Active, not recruitingMultiple Myeloma in Relapse | Multiple Myeloma With Failed Remission | Multiple Myeloma Stage I | Multiple Myeloma Progression | Multiple Myeloma Stage II | Multiple Myeloma Stage III
-
NCT07637526Not yet recruiting
-
NCT07359014Recruiting
-
NCT00849251TerminatedStage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple Myeloma
-
NCT00182663CompletedStage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple Myeloma
-
NCT01534143TerminatedStage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple Myeloma
-
NCT00310024CompletedStage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple Myeloma
Clinical Trials on Tocilizumab
-
NCT07595900Not yet recruitingGranulomatous Mastitis | Granulomatous Lobular Mastitis
-
NCT05640271RecruitingSickle Cell Disease | Acute Chest Syndrome
-
NCT07254637Not yet recruitingCalcium Pyrophosphate Deposition Disease
-
NCT07263776Active, not recruiting
-
NCT03970226Active, not recruitingAdamantinomatous Craniopharyngioma
-
NCT01782235CompletedPrimary Sjögren's Syndrome (pSS)
-
NCT05233397RecruitingAdamantinomatous Craniopharyngioma | Recurrent Adamantinomatous Craniopharyngioma
-
NCT04412772Terminated