Multiple myeloma (MM) accounts for more than 10% of all blood cancers and 1% of all cancers. The purpose of this study is to assess how safe lemzoparlimab is and how lemzoparlimab moves through the body of adult participants with MM when given with or without dexamethasone, and in combination with other anti-myeloma regimens. Adverse events and change in disease activity will be assessed. Lemzoparlimab is an investigational drug being developed for the treatment of relapsed/refractory (R/R) MM. Study doctors put the participants in groups called treatment arms. Two different dose levels of lemzoparlimab will be explored. Each treatment arm receives a different treatment combination depending on stage of the study and eligibility. This study will include a dose escalation phase to determine the best dose of lemzoparlimab, followed by a dose expansion phase to confirm the dose. Approximately 163 adult participants with R/R MM will be enrolled in the study in approximately 60 sites worldwide. In the Dose Escalation arms, participants will receive intravenous (IV) lemzoparlimab with or without dexamethasone (oral/IV) in combination with pomalidomide (oral) or carfilzomib (IV) or subcutaneous (SC) daratumumab in 28-day cycles. In the Dose Expansion arms, participants will receive lemzoparlimab (IV) alone or with dexamethasone (oral/IV) in combination with pomalidomide (oral) or carfilzomib (IV) or daratumumab (SC) in 28-day cycles. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests and side effects.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
8
Intravenous (IV) infusion
Oral tablet or IV infusion/injection
IV infusion
Oral capsule
Subcutaneous (SC) injection
Sylvester Comprehensive Cancer Center /ID# 228817
Miami, Florida, United States
Moffitt Cancer Center /ID# 229939
Tampa, Florida, United States
Norton Cancer Institute - St Matthews /ID# 229319
Louisville, Kentucky, United States
Tulane Cancer Center Clinic /ID# 229832
New Orleans, Louisiana, United States
University of Michigan Comprehensive Cancer Center Michigan Medicine /ID# 229309
Ann Arbor, Michigan, United States
Dose Limiting Toxicities (DLTs) of Lemzoparlimab With or Without Dexamethasone and in Combination With Anti-myeloma Regimens in Participants With Relapsed/Refractory (R/R) Multiple Myeloma (MM)
DLT events as described in the protocol will be assessed.
Time frame: Up to 28 days after study drug administration
Percentage of Participants Achieving Best Overall Response of Documented Partial Response (PR) or Better
Best overall response is defined as achieving documented PR or better at two consecutive disease assessments during the study, according to International Myeloma Working Group (IMWG) 2016 criteria.
Time frame: Up to approximately 2 years
Progression Free Survival (PFS)
PFS is defined as the time from the first dose of study drug to the first documented progressive disease (PD) or death due to any cause, whichever occurs first.
Time frame: Up to approximately 2 years
Duration of Response (DOR)
DOR is defined as the time from first documented response (PR or better) to the first documented PD or death due to MM, whichever occurs first.
Time frame: Up to approximately 2 years
Time to Progression (TTP)
TTP is defined as the time from the first dose of study drug to the first documented PD or death due to MM, whichever occurs first.
Time frame: Up to approximately 2 years
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Henry Ford Health System /ID# 230341
Detroit, Michigan, United States
Rutgers Cancer Institute of New Jersey /ID# 230174
New Brunswick, New Jersey, United States
Columbia University Medical Center /ID# 229971
New York, New York, United States
Duke University Hospital /ID# 229564
Durham, North Carolina, United States
Wake Forest Baptist Health /ID# 229996
Winston-Salem, North Carolina, United States
...and 22 more locations