Spots Global Cancer Trial Database for A Study of the Combination of Talquetamab and Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma
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Trial Identification
Brief Title: A Study of the Combination of Talquetamab and Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma
Official Title: A Phase 1b/2 Dose Escalation and Expansion Study of the Combination of the Bispecific T Cell Redirection Antibodies Talquetamab and Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma
Study ID: NCT04586426
Conditions
Study Description
Brief Summary: The purpose of this study is to identify the recommended Phase 2 regimen(s) (RP2R\[s\]) and schedule for the study treatment (Part 1), to characterize the safety of the RP2R(s) for the study treatment (Part 2) and to evaluate the anticancer activity of talquetamab + teclistamab in participants with relapsed or refractory multiple myeloma and extramedullary disease (EMD) (Part 3).
Detailed Description: Multiple myeloma is a malignant plasma cell disorder characterized by production of monoclonal proteins (M proteins), which are comprised of pathologic immunoglobulins (Ig) or fragments of such, which have subsequently lost their normal function. Rationale for combining talquetamab and teclistamab is the targeting of multiple proteins on the surface of multiple myeloma cells resulting in cell lysis. 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 \[EOT\] visit); and a post-treatment follow-up phase (after end of treatment and up to 16 weeks after last dose of study drug(s) for each participant). End of study is defined as 2 years after the last participant has received his or her initial dose of the treatment combination. Total duration of study is Approximately 5 years. Efficacy, safety, pharmacokinetics (PK), immunogenicity, and biomarkers will be assessed at specified time points during this study. Participants safety and study conduct will be monitored throughout the study.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of Alabama at Birmingham, Comprehensive Cancer Center, Birmingham, Alabama, United States
University of Arkansas for Medical Sciences, Little Rock, Arkansas, United States
Colorado Blood Cancer Institute, Denver, Colorado, United States
Emory University, Atlanta, Georgia, United States
Mayo Clinic, Rochester, Minnesota, United States
Washington University in St. Louis, Saint Louis, Missouri, United States
Mount Sinai Medical Center, New York, New York, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
Atrium Health, Charlotte, North Carolina, United States
Wake Forest University Baptist Medical Center (WFUBMC) - Comprehensive Cancer Center, Winston-Salem, North Carolina, United States
Cleveland Clinic, Cleveland, Ohio, United States
Oregon Health And Science University, Portland, Oregon, United States
The University of Texas MD Anderson Cancer Center, Houston, Texas, United States
St. Vincent's Hospital Melbourne, Fitzroy, , Australia
Royal Perth Hospital, Perth, , Australia
Tom Baker Cancer Centre, Calgary, Alberta, Canada
Alberta Health Services, Edmonton, Alberta, Canada
Princess Margaret Cancer Centre University Health Network, Toronto, Ontario, Canada
McGill University Health Centre, Montreal, Quebec, Canada
Hadassah Medical Center, Jerusalem, , Israel
Sheba Medical Center, Ramat Gan, , Israel
Tel-Aviv Sourasky Medical Center, Tel-Aviv, , Israel
Kanazawa University Hospital, Kanazawa, , Japan
Nagoya City University Hospital, Nagoya, , Japan
Osaka University Hospital, Osaka, , Japan
Tohoku University Hospital, Sendai shi, , Japan
Japanese Red Cross Medical Center, Shibuya, , Japan
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
Hosp. Univ. Germans Trias I Pujol, Badalona, , Spain
Hosp. Clinic de Barcelona, Barcelona, , Spain
Inst. Cat. Doncologia-H Duran I Reynals, L Hospitalet De Llobregat, , Spain
Hosp. Univ. Fund. Jimenez Diaz, Madrid, , Spain
UNIV. HOSP. October 12, Madrid, , Spain
Clinica Univ. de Navarra, Pamplona, , Spain
Hosp. Clinico Univ. de Salamanca, Salamanca, , Spain
Hosp. Univ. Marques de Valdecilla, Santander, , Spain
Contact Details
Name: Janssen Research & Development, LLC Clinical Trial
Affiliation: Janssen Research & Development, LLC
Role: STUDY_DIRECTOR
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