The purpose of this study is to identify the recommended Phase 2 dose(s) (RP2Ds) and schedule assessed to be safe for Teclistamab and to characterize the safety and tolerability of Teclistamab at the RP2Ds.
The study will be conducted in 2 parts, separately for IV and SC administration: dose escalation (Part 1) and dose expansion (Part 2). It will evaluate safety, tolerability, pharmacokinetics and preliminary antitumor activity of Teclistamab 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 2 years after the last participant in Part 3 has received his or her initial dose of teclistamab. Study record NCT04557098 is Phase 2 part of this study and study record NCT03145181 is Phase 1 part of this study.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
302
Participants will receive IV infusion of Teclistamab.
Participants will receive SC injection of Teclistamab.
City of Hope
Duarte, California, United States
Colorado Blood Cancer Institute
Denver, Colorado, United States
Icahn School of Medicine at Mount Sinai Program for the Protection of Human Subjects
New York, New York, United States
Dose Limiting Toxicity (DLT)
The Dose Limiting Toxicities (DLTs) are based on drug related adverse events and defined as any of the following events: hematological / non hematological toxicity of Grade 3 or higher.
Time frame: Up to Day 28
Number of Participants With Adverse Events (AEs) as a Measure of Safety and Tolerability
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.
Time frame: Up to 7 years and 3 months
Teclistamab Serum Concentrations
Concentration assessment will be done to evaluate the effect of Teclistamab.
Time frame: Up to 8 weeks
Number of Participants with Teclistamab Antibodies
Antibodies to Teclistamab will be assessed to evaluate potential immunogenicity.
Time frame: Up to 8 weeks
Preliminary Antitumor Activity of Teclistamab at the RP2D(s) in Part 2
Preliminary antitumor activity of Teclistamab will be done using the International Myeloma Working Group (IMWG) response criteria.
Time frame: Up to End of Treatment (Approximately 91 days)
Biomarker Assessment
Biomarker assessment may be done to evaluate the effect of Teclistamab.
Time frame: Up to 8 weeks
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Levine Cancer Institute
Charlotte, North Carolina, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Hospices Civils de Lyon HCL
Lyon, France
CHRU Tours Hopital Bretonneau
Tours, France
VU Medisch Centrum
Amsterdam, Netherlands
Hosp. Univ. Germans Trias I Pujol
Badalona, Spain
Hosp Clinic de Barcelona
Barcelona, Spain
...and 3 more locations