This study will evaluate the pharmacokinetics (PK), safety, and efficacy of cevostamab in participants with relapsed or refractory (R/R) multiple myeloma (MM).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Cevostamab will be administered intravenously on a 21-day cycle.
Tocilizumab will be administered for the treatment of cytokine release syndrome (CRS) when necessary.
Sun yat-sen University Cancer Center
Guangzhou, Guangdong, China
RECRUITINGTianjin Institute of Hematology & Blood Diseases Hospital
Tianjin, Tianjin Municipality, China
RECRUITINGThe First Affiliated Hospital of Nanchang University
Nanchang, China
Serum Concentration of Cevostamab at Specified Timepoints
Time frame: Cycle 1 Day 1 (C1D1) up to approximately 2 years. Each cycle=21 days
Percentage of Participants with Adverse Events
Time frame: Baseline up to approximately 2 years
Objective Response Rate (ORR)
Time frame: Baseline up to approximately 2 years
Rate of Complete Response (CR) or Better
Time frame: Baseline up to approximately 2 years
Rate of Very Good Partial Response (VGPR) or Better
Time frame: Baseline up to approximately 2 years
Duration of Response (DOR)
Time frame: Baseline 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)
Time to First Response (for Participants who Achieve a Response of Partial Response (PR) or Better)
Time frame: 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
Overall Survival (OS)
Time frame: Baseline up until death from any cause (up to approximately 2 years)
Reference Study ID Number: YO43835 https://forpatients.roche.com/
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The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, China
RECRUITINGTongji Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, China
RECRUITINGMinimal Residual Disease (MRD) Negativity (for Participants who Achieve a Response of CR or Better)
Time frame: Baseline up to approximately 2 years
MRD Negativity (for all Efficacy-evaluable Participants)
Time frame: Baseline up to approximately 2 years
Number of Anti-drug Antibody (ADAs) Against Cevostamab at Baseline
Time frame: Baseline
Percentage of Participants with ADAs Against Cevostamab During the Study
Time frame: 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
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