The main purpose of this study is to learn about the safety of linvoseltamab and to find out what is the best dose of linvoseltamab to give to patients with multiple myeloma and to look for any signs that linvoseltamab can effectively treat cancer. The study is looking at several other research questions, including: * Side effects that may be experienced by people receiving linvoseltamab * How linvoseltamab works in the body * How much linvoseltamab is present in the blood * How linvoseltamab may work to treat cancer
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
387
Administered per the protocol
Sylvester Comprehensive Cancer Center
Miami, Florida, United States
ACTIVE_NOT_RECRUITINGMoffitt Cancer Center - McKinley Drive
Tampa, Florida, United States
RECRUITINGEmory University Hospital
Atlanta, Georgia, United States
RECRUITINGIndiana University_Michigan Street
Indianapolis, Indiana, United States
Incidence of dose-limiting toxicities (DLTs) from the first dose through the end of the DLT observation period
Phase 1 and Phase 2 for Japanese cohort only
Time frame: Up to 28 days
Incidence and severity of treatment-emergent adverse events (TEAEs)
Phase 1 Note: Phase 1, part 2 is not applicable for US.
Time frame: Up to 5 years
Incidence and severity of adverse events of special interest (AESI)
Phase 1 Note: Phase 1, part 2 is not applicable for US.
Time frame: Up to 5 years
Assessment of the pharmacokinetics (PK) of linvoseltamab
Phase 1 part 2 Note: Phase 1, part 2 is not applicable for US.
Time frame: Up to 5 years
Concentrations of linvoseltamab in serum over time
Phase 2, for Japanese cohort only
Time frame: Up to 5 years
Objective response rate (ORR) as determined by an Independent Review Committee (IRC)
Phase 2, cohorts 1 and 2
Time frame: Up to 5 years
Incidence and severity of cytokine release syndrome (CRS) with linvoseltamab
Phase 2, cohort 3 Note: Phase 2, Cohort 3 is not applicable for US.
Time frame: Up to 5 years
ORR of IV linvoseltamab as assessed by investigator
Phase 2, cohort 3 Note: Phase 2, Cohort 3 is not applicable for US.
Time frame: Up to 5 years
Concentrations of linvoseltamab in the serum over time
Phase 1 part 1 and Phase 2 Note: Phase 2, Cohort 3 is not applicable for US.
Time frame: Up to 5 years
Incidence over time of anti-drug antibodies (ADAs) to linvoseltamab
Phase 1 and Phase 2 Note: Phase 1, part 2 and Phase 2, Cohort 3 is not applicable for US.
Time frame: Up to 5 years
Titer of anti-drug antibodies (ADAs) to linvoseltamab over time
Phase 1 and Phase 2 Note: Phase 1, part 2 and Phase 2, Cohort 3 is not applicable for US.
Time frame: Up to 5 years
Incidence of neutralizing antibodies (NAb) to linvoseltamab over time
Phase 1 and Phase 2 Note: Phase 1, part 2 and Phase 2, Cohort 3 is not applicable for US.
Time frame: Up to 5 years
Duration of response (DOR) as determined by an IRC, measured using the IMWG criteria
Phase 2, cohorts 1 and 2
Time frame: Up to 5 years
DOR as determined by an investigator, measured using the International Myeloma Working Group (IMWG) criteria
Phase 1 and Phase 2 Note: Phase 1, part 2 is not applicable for US.
Time frame: Up to 5 years
Progression-free survival (PFS) as determined by an IRC, measured using the IMWG criteria
Phase 2
Time frame: Up to 5 years
PFS as determined by an investigator, measured using the IMWG criteria
Phase 1 and Phase 2 Note: Phase 1, part 2 is not applicable for US.
Time frame: Up to 5 years
Rate of minimal residual disease (MRD) negative status, using the IMWG criteria
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Norton Cancer Institute
Louisville, Kentucky, United States
RECRUITINGC. S. Mott_University of Michigan
Ann Arbor, Michigan, United States
ACTIVE_NOT_RECRUITINGBarbara Ann Karmanos Cancer Center
Detroit, Michigan, United States
ACTIVE_NOT_RECRUITINGRutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States
ACTIVE_NOT_RECRUITINGIcahn School of Medicine at Mount Sinai
New York, New York, United States
RECRUITINGColumbia University Medical Center
New York, New York, United States
ACTIVE_NOT_RECRUITING...and 30 more locations
Phase 1 Note: Phase 1, part 2 is not applicable for US.
Time frame: Up to 5 years
Rate of MRD negative status
Phase 2 Note: Phase 2, Cohort 3 is not applicable for US.
Time frame: Up to 5 years
Overall survival (OS)
Phase 1 and Phase 2 Note: Phase 1, part 2 and Phase 2, Cohort 3 is not applicable for US.
Time frame: Up to 5 years
ORR as measured as determined by blinded IRC, as measured using the IMWG criteria
Phase 1, part 1 dose level 7 (DL7)
Time frame: Up to 5 years
ORR as determined by the investigator, measured using the IMWG criteria
Phase 1 and Phase 2 Note: Phase 1, part 2 is not applicable for US.
Time frame: Up to 5 years
Effects of linvoseltamab on health-related quality of life (HRQoL) and patient-reported symptoms and functioning per European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
Phase 2 The EORTC-QLQ-C30 is a 30-item subject self-report questionnaire composed of both multi-item and single scales, including global health status/quality of life, functional Scales (physical, role, emotional, cognitive, and social), symptom scales (fatigue, nausea and vomiting, and pain), and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Participants rate items on a 4-point scale, with 1 as "not at all" and 4 as "very much." Note: Phase 2, Cohort 3 is not applicable for US.
Time frame: Up to 5 years
Effects of linvoseltamab on HRQOL and patient-reported symptoms and functioning per Quality of Life Questionnaire-Multiple Myeloma module 20 [QLQ-MY20])
Phase 2 The EORTC QLQ-MY20 is a self -administered instrument to assess QoL in persons with MM. This 20-item questionnaire measures the following domains: symptom scales, including disease symptoms (6 items) and symptoms related to side effects of treatment (10 items); function scale and future perspective (3 items); and body image (1 item). A high score represents a high level of symptoms or problems. Note: Phase 2, Cohort 3 is not applicable for US.
Time frame: Up to 5 years
Effects of linvoseltamab on HRQOL and patient-reported symptoms and functioning per EuroQoL-5 Dimension-3 Level Scale [EQ-5D-3L])
Phase 2 The EQ-5D-3L is a self-administered generic standardized health status measure, consisting of an EQ-5D descriptive system and an EQ visual analog scale. The EQ-5D-3L descriptive system assesses 5 dimensions of health: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is rated on a 3-level scale: no problems, some problems, and extreme problems. The EQ visual analog scale component is a vertical visual analog scale used by patients to rate their health. Note: Phase 2, Cohort 3 is not applicable for US.
Time frame: Up to 5 years
Change in patient-reported global health status/QoL per EORTC QLQ-C30
Phase 2 Note: Phase 2, Cohort 3 is not applicable for US.
Time frame: Baseline up to Up to 5 years
Time to definitive deterioration in patient-reported global health status/QoL per EORTC QLQ-C30
Phase 2 Note: Phase 2, Cohort 3 is not applicable for US.
Time frame: Up to 5 years
Effects of linvoseltamab on general health status per EQ-5D-3L
Phase 2 Note: Phase 2, Cohort 3 is not applicable for US.
Time frame: Up to 5 years
Effects of linvoseltamab on patient-reported functions and symptoms per EORTC QLQ-C30
Phase 2 Note: Phase 2, Cohort 3 is not applicable for US.
Time frame: Up to 5 years
Effects of linvoseltamab on patient-reported functions and symptoms per QLQ-MY20
Phase 2 Note: Phase 2, Cohort 3 is not applicable for US.
Time frame: Up to 5 years
Incidence and severity of TEAEs with linvoseltamab
Phase 2 Note: Phase 2, Cohort 3 is not applicable for US.
Time frame: Up to 5 years
Incidence and severity of AESIs with linvoseltamab
Phase 2 Note: Phase 2, Cohort 3 is not applicable for US.
Time frame: Up to 5 years