Dose Escalation Study of Talquetamab in Participants With Relapsed or Refractory Multiple Myeloma
18 Years and older, Male and Female
CR108404 (primary)
NCI-2018-00367
64407564MMY1001
2017-002400-26
Summary
The purpose of this study is to characterize the safety of Talquetamab and to determine the
recommended Phase 2 dose(s) (RP2Ds) and dosing schedule assessed to be safe for Talquetamab
(Part 1 [Dose Escalation]) and to further characterize the safety of Talquetamab at the
recommended Phase 2 dose(s) (RP2Ds) (Part 2 [Dose Expansion]).
Objectives
The study will be conducted in 2 parts: dose escalation and dose expansion. The study will
evaluate safety, tolerability, pharmacokinetics and preliminary antitumor activity of
Talquetamab administered to adult participants with relapsed or refractory multiple myeloma.
The overall safety of the study drug will be assessed by physical examinations, Eastern
Cooperative Oncology Group performance status, laboratory tests, vital signs,
electrocardiograms, adverse event monitoring, and concomitant medication usage. Disease
evaluations will include peripheral blood and bone marrow assessments at screening (performed
within 28 days) and to confirm stringent complete response (sCR), complete response (CR), or
relapse from CR. The end of study (study completion) is defined as the last study assessment
for the last participant in the study. Study record NCT04634552 is Phase 2 part of this study
and study record NCT03399799 is Phase 1 part of this study.
Eligibility
- Documented initial diagnosis of multiple myeloma according to International Myeloma Working Group (IMWG) diagnostic criteria
- Part 1: Participants with measurable multiple myeloma who have progressed on, or could not tolerate, all available established therapies. Part 2: Participants with multiple myeloma measurable by central laboratory assessment who have progressed on, or could not tolerate, all available established therapies; Serum monoclonal paraprotein (M-protein) level greater than or equal to (>=) 1.0 gram per deciliter (g/dL) or urine M-protein level >=200 milligram per 24 hours (mg/24 h) or light chain multiple myeloma without measurable disease in the serum or the urine: serum immunoglobulin free light chain (FLC) >= 10 mg/dL and abnormal serum immunoglobulin kappa lambda FLC ratio; If central laboratory assessments are not available, relevant local laboratory measurements must exceed the minimum required level by at least 25%
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
- Women of childbearing potential must have a negative pregnancy test at screening and prior to the first dose of study drug using a highly sensitive pregnancy test either serum (Beta human chorionic gonadotropin [beta-hCG]) or urine
- Sign an informed consent form (ICF) indicating that he or she understands the purpose of and procedures required for the study, and is willing to and able participate in the study. Consent is to be obtained prior to the initiation of any study-related tests or procedures that are not part of standard-of-care for the participant's disease
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