Spots Global Cancer Trial Database for Dose Escalation Study of Talquetamab in Participants With Relapsed or Refractory Multiple Myeloma
The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.
Trial Identification
Brief Title: Dose Escalation Study of Talquetamab in Participants With Relapsed or Refractory Multiple Myeloma
Official Title: A Phase 1, First-in-Human, Open-Label, Dose Escalation Study of Talquetamab, a Humanized GPRC5D x CD3 Bispecific Antibody, in Subjects With Relapsed or Refractory Multiple Myeloma
Study ID: NCT03399799
Conditions
Interventions
Study Description
Brief 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 \[Dose Expansion\]).
Detailed Description: 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.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of Alabama Birmingham, Birmingham, Alabama, United States
City of Hope, Duarte, California, United States
University of Colorado Cancer Center, Aurora, Colorado, United States
Mount Sinai Medical Center, New York, New York, United States
Tennessee Oncology, Nashville, Tennessee, United States
Centre Hospitalier Universitaire de Liege Domaine Universitaire du Sart Tilman, Liege, , Belgium
VU Medisch Centrum, Amsterdam, , Netherlands
UMCU, Utrecht, , Netherlands
Hosp. Univ. Germans Trias I Pujol, Badalona, , Spain
Hosp. Univ. Fund. Jimenez Diaz, Madrid, , Spain
Clinica Univ. de Navarra, Pamplona, , Spain
Hosp. Quiron Madrid Pozuelo, Pozuelo De Alarcon, Madrid, , Spain
Hosp. Clinico Univ. de Salamanca, Salamanca, , Spain
Contact Details
Name: Janssen Research & Development, LLC Clinical Trial
Affiliation: Janssen Research & Development, LLC
Role: STUDY_DIRECTOR
Take Control of Your Skin and Body Changes Today.
Try out Spots for free, set up only takes 2 mins.
Join others from around the world:
