Spots Global Cancer Trial Database for Dose Escalation Study of Teclistamab, a Humanized BCMA*CD3 Bispecific Antibody, in Participants With Relapsed or Refractory Multiple Myeloma
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Trial Identification
Brief Title: Dose Escalation Study of Teclistamab, a Humanized BCMA*CD3 Bispecific Antibody, in Participants With Relapsed or Refractory Multiple Myeloma
Official Title: A Phase 1, First-in-Human, Open-Label, Dose Escalation Study of Teclistamab, a Humanized BCMA x CD3 Bispecific Antibody in Subjects With Relapsed or Refractory Multiple Myeloma
Study ID: NCT03145181
Conditions
Study Description
Brief Summary: 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.
Detailed Description: 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.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
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
Levine Cancer Institute, Charlotte, North Carolina, United States
University of Pennsylvania, Philadelphia, Pennsylvania, United States
Centre hospitalier Lyon-Sud, Pierre Benite cedex, , 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
Clinica Univ. de Navarra, Pamplona, , Spain
Hosp. Clinico Univ. de Salamanca, Salamanca, , Spain
Haematology Centre, R 51, Stockholm, , Sweden
Contact Details
Name: Janssen Research & Development, LLC Clinical Trial
Affiliation: Janssen Research & Development, LLC
Role: STUDY_DIRECTOR
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