This study will evaluate the efficacy, safety, and pharmacokinetics of cevostamab in participants with relapsed or refractory multiple myeloma (R/R MM) via intravenous (IV) infusion.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
90
Cevostamab will be administered by IV infusion in 21-day cycles.
Tocilizumab will be administered for the treatment of cytokine release syndrome (CRS) when necessary.
Objective Response Rate (ORR) as Determined by the Investigator
Time frame: Baseline up to approximately 2 years
Percentage of Participants with Adverse Events
Time frame: Baseline up to approximately 2 years
ORR as Determined by the Independent Review Committee (IRC)
Time frame: Baseline up to approximately 2 years
Duration of Response (DOR)
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
Overall Survival (OS)
Time frame: Baseline up until death from any cause (up to approximately 2 years)
Progression-free Survival (PFS)
Time frame: Baseline up to approximately 2 years
Time to First Response (for Participants who Achieve an Objective Response)
Time frame: Baseline up to approximately 2 years
Time to Best Response (for Participants who Achieve an Objective Response)
Time frame: Baseline up to approximately 2 years
Percentage of Participants Experiencing a Clinically Meaningful Improvement in the Fatigue Domain of the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Core-30 Questionnaire (QLQ-C30) and EORTC QLQ-MY20
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University of Colorado
Aurora, Colorado, United States
Mayo Clinic-Jacksonville
Jacksonville, Florida, United States
University of Maryland Greenebaum Cancer Center
Baltimore, Maryland, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Mayo Clinic - Rochester
Rochester, Minnesota, United States
Icahn School of Medicine at Mount Sinai (ISMMS)
New York, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Tennessee Oncology - Nashville
Nashville, Tennessee, United States
Hunstman Cancer Institute
Salt Lake City, Utah, United States
Calvary Mater Newcastle
Waratah, New South Wales, Australia
...and 17 more locations
Time frame: Baseline up to approximately 2 years
Time to Deterioration in the Fatigue Domain of the EORTC QLQ-C30 and/or Disease Symptoms Domain of the EORTC QLQ-MY20
Time frame: Baseline up to approximately 2 years
Serum Concentration of Cevostamab at Specified Timepoints
Time frame: At Cycles 1, 2, 3, 4, 6, 8 and every other cycle until the end of treatment up to approximately 2 years. Each cycle is 21-days.
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
Cytokine Release Syndrome (CRS) Following Administration of Tocilizumab
Time frame: Baseline up to approximately 2 years
Relationship Between Serum Concentration of Cevostamab and Cytokine Release
Time frame: Baseline up to approximately 2 years
Relationship Between Serum Concentration of Cevostamab and T Cell Number
Time frame: Baseline up to approximately 2 years
Relationship Between Serum Concentration of Cevostamab and T-cell Activation State
Time frame: Baseline up to approximately 2 years