Spots Global Cancer Trial Database for A Study of Talquetamab in Participants With Relapsed or Refractory Multiple Myeloma
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Trial Identification
Brief Title: A Study of Talquetamab in Participants With Relapsed or Refractory Multiple Myeloma
Official Title: A Phase 1/2, 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: NCT04634552
Conditions
Interventions
Study Description
Brief Summary: The purpose of this study is to evaluate the efficacy and safety of talquetamab in participants with relapsed or refractory multiple myeloma at the recommended Phase 2 dose(s) (RP2Ds) (Part 3).
Detailed Description: Multiple myeloma is a malignant plasma cell disorder characterized by osteolytic lesions, increased susceptibility to infections, hypercalcemia, and renal failure. Talquetamab is a humanized immunoglobulin G4 proline, alanine, alanine (IgG4PAA) bispecific antibody designed to target G protein-coupled receptor family C group 5-member D (GPRC5D) and the CD3 molecule found on T lymphocytes (T cell). This study consists of 3 periods: screening phase (up to 28 days), treatment phase (start of study drug administration and continues until the completion of the end of treatment \[EOT (30 days (+ 7 days)\] visit); and a post-treatment follow-up phase (until the end of study unless the participant has died, is lost to follow up or has withdrawn consent). Total duration of study is up to 2 years (after the last participant receives their first dose). Safety, pharmacokinetics (PK), laboratory tests, and questionnaire will be assessed at specified time points during this study. Participants safety and study conduct will be monitored throughout the study. The corresponding study (NCT03399799) is the Phase 1 part of the study and TALMMY1001- Part 3 is the Phase 2 part of the 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
University of Arkansas for Medical Sciences, Little Rock, Arkansas, United States
City of Hope, Duarte, California, United States
Emory University - Winship Cancer Institute, Atlanta, Georgia, United States
University of Chicago, Chicago, Illinois, United States
Norton Cancer Institute, Louisville, Kentucky, United States
University of Michigan Health System, Ann Arbor, Michigan, United States
Washington University School of Medicine, Saint Louis, Missouri, United States
NYU Langone Health, New York, New York, United States
Mount Sinai Medical Center, New York, New York, United States
University of Rochester Medical Center, Rochester, New York, United States
Providence Portland Medical Center, Portland, Oregon, United States
Tennessee Oncology, Nashville, Tennessee, United States
UCL - Saint Luc, Brussels, , Belgium
UZ Antwerpen, Edegem, , Belgium
UZ Leuven, Leuven, , Belgium
CHU de Liège - Domaine Universitaire du Sart Tilman, Liège, , Belgium
Peking University Third Hospital, Beijing, , China
Sun Yat-Sen University Cancer Center, Guangzhou, , China
The 1St Affiliated Hospital of Medical College Zhejiang University, Hangzhou, , China
The 1St Affiliated Hospital of Medical College Zhejiang University, Hangzhou, , China
First Affiliated Hospital SooChow University, Su Zhou, , China
Institute of Hematology & Blood Disease Hospital Chinese Academy of Medical Science, Tianjin, , China
The First Affiliated Hospital of Xian Jiaotong University, XI An Shi, , China
The Second Affiliated Hospital of Xi'an Jiaotong University, Xi'an, , China
CHU Henri Mondor, Creteil, , France
CHU de Montpellier, Hopital Saint-Eloi, Montpellier, , France
C.H.U. Hotel Dieu - France, Nantes, , France
CHU de Bordeaux - Hospital Haut-Leveque, Pessac cedex, , France
Centre hospitalier Lyon-Sud, Pierre Benite cedex, , France
Pôle IUC Oncopole CHU, Toulouse cedex 9, , France
Charite Campus Benjamin Franklin, Berlin, , Germany
Universitaetsklinikum Heidelberg, Heidelberg, , Germany
Universitaetsklinikum Muenster, Muenster, , Germany
Universitatsklinikum Wurzburg, Wuerzburg, , Germany
Rambam Medical Center, Haifa, , Israel
Carmel Medical Center, Haifa, , Israel
Hadassah Medical Center, Jerusalem, , Israel
Sheba Medical Center, Ramat Gan, , Israel
Tel Aviv Sourasky Medical Center, Tel Aviv, , Israel
Kameda General Hospital, Chiba, , Japan
Fukuoka University Hospital, Fukuoka, , Japan
Ogaki Municipal Hospital, Gifu, , Japan
Teine Keijinkai Hospital, Hokkaido, , Japan
Kobe City Medical Center General Hospital, Hyogo, , Japan
Dokkyo Medical University Saitama Medical Center, Koshigaya, , Japan
Kumamoto University Hospital, Kumamoto, , Japan
Kurashiki Central Hospital, Kurashiki, , Japan
National Hospital Organization Matsumoto Medical Center, Matsumoto, , Japan
National Hospital Organization Okayama Medical Center, Okayama, , Japan
Japanese Red Cross Osaka Hospital, Osaka, , Japan
Hiroshima West Medical Center, Otake, , Japan
Iwate Medical University Hospital, Shiwa-gun, , Japan
Chonnam National University Hwasun Hospital, Jeollanam-do, , Korea, Republic of
Seoul National University Hospital, Seoul, , Korea, Republic of
Severance Hospital, Yonsei University Health System, Seoul, , Korea, Republic of
Asan Medical Center, Seoul, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
The Catholic University of Korea Seoul St. Mary's Hospital, Seoul, , Korea, Republic of
VU Medisch Centrum, Amsterdam, , Netherlands
UMCU, Utrecht, , Netherlands
Uniwersyteckie Centrum Kliniczne, Gdansk, , Poland
Narodowy Instytut Onkologii im.Marii Sklodowskiej Curie Panstwowy Instytut BadawczyOddz. w Gliwicach, Gliwice, , Poland
Uniwersytecki Szpital Kliniczny w Poznaniu, Poznan, , Poland
Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy, Warszawa, , Poland
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu, Wroclaw, , Poland
Hosp. Univ. Germans Trias I Pujol, Badalona, , Spain
Hosp. Univ. Vall D Hebron, Barcelona, , Spain
Inst. Cat. Doncologia-H Duran I Reynals, Barcelona, , Spain
Hosp. Univ. Fund. Jimenez Diaz, Madrid, , Spain
Hosp. Univ. 12 de Octubre, Madrid, , Spain
Hosp. Univ. Virgen de La Arrixaca, Murcia, , Spain
Clinica Univ. de Navarra, Pamplona, , Spain
Hosp. Quiron Madrid Pozuelo, Pozuelo de Alarcon, , Spain
Hosp. Clinico Univ. de Salamanca, Salamanca, , Spain
Hosp. Univ. Marques de Valdecilla, Santander, , Spain
Hosp. Virgen Del Rocio, Sevilla, , Spain
Contact Details
Name: Janssen Research & Development, LLC Clinical Trial
Affiliation: Janssen Research & Development, LLC
Role: STUDY_DIRECTOR
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