The purpose of this study is to assess the safety, pharmacokinetics and tolerability, describe the dose-limiting toxicities (DLTs), and determine the maximum tolerated dose (MTD) or maximum administered dose (MAD \[in the absence of establishing the MTD\]) for single agent MEDI2228 in adult subjects with multiple myeloma who are either transplant ineligible or post autologous stem cell transplant and are relapsed/refractory.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
107
Single agent MEDI2228 will be administered to adult subjects with R/R MM. The study aims to evaluate up to 9 planned, sequentially ascending main dose levels
Adult subjects with R/R MM with measurable disease will be enrolled in the dose-expansion cohort at the dose selected for evaluation in the dose-expansion phase.
Research Site
Phoenix, Arizona, United States
Research Site
Jacksonville, Florida, United States
Research Site
Boston, Massachusetts, United States
Research Site
Occurrence of adverse events (AEs)
To assess by the occurrence of adverse events (AEs)
Time frame: From time of informed consent through 90 days post end of treatment
Occurrence of SAE (serious adverse events)
To assess the occurrence of serious adverse events (SAEs)
Time frame: From time of informed consent through 90 days post end of treatment
Occurrence of DLTs (dose limiting toxicities)
To assess by the occurrence of hematologic and non-hematologic toxicities, AEs, and abnormal laboratory results
Time frame: From time of informed consent through 90 days post end of treatment
Number of patients with changes in laboratory parameters from baseline
To assess serum chemistry, hematology, coagulation and urninalysis
Time frame: From time of informed consent and up to 21 days post end of treatment
Number of patients with changes in vital signs from baseline
To assess body temperature, blood pressure and heart rate
Time frame: From time of informed consent and up to 21 days post end of treatment
Number of patients with changes in elctrocardiogram (ECG) results from baseline
To assess using 12 lead ECG recordings
Time frame: From time of informed consent and up to 21 days post end of treatment
MEDI2228 maximum observed concentration for PK
To assess the pharmacokinetics of MEDI2228
Time frame: From time of informed consent through 60 days post end of treatment
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Boston, Massachusetts, United States
Research Site
Detroit, Michigan, United States
Research Site
Rochester, Minnesota, United States
Research Site
Charlotte, North Carolina, United States
Research Site
Fairfax, Virginia, United States
Research Site
Melbourne, Australia
Research Site
Athens, Greece
...and 1 more locations
MEDI2228 area under the concentration-time curve for PK
To assess the pharmacokinetics of MEDI2228
Time frame: From time of informed consent through 60 days post end of treatment
MEDI2228 clearance for PK
To assess the pharmacokinetics of Medi2228
Time frame: From time of informed consent through 60 days post end of treatment
MEDI2228 terminal half-life for PK
To assess the pharmacokinetics of MEDI2228
Time frame: From time of informed consent through 60 days post end of treatment
Number of subjects who develop anti-drug antibodies (ADAs)
To assess immunogenicity of MEDI2228
Time frame: From time of informed consents through 60 days post end of treatment
Objective response rate (ORR)
To assess the anti-tumor activity of MEDI2228
Time frame: From time of informed consent and up to three years after final patient is enrolled
Clinical benefit rate
To assess clinical benefit of MEDI2228
Time frame: From time of informed consent up to three years after final patient is enrolled
Duration of response (DoR)
To assess the anti-tumor activity of MEDI2228
Time frame: From time of informed consent and up to three years after final patient is enrolled
Progression free survival (PFS)
To assess the anti-tumor activity of MEDI2228
Time frame: From time of informed consent and up to three years after final patient is enrolled
Overall Survival (OS)
To assess the anti-tumor activity of MEDI2228
Time frame: From time of informed consent and up to three years after final patient is enrolled