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Brief Title: A Study Evaluating the Safety, Pharmacokinetics, and Activity of Cevostamab in Participants With Relapsed or Refractory Multiple Myeloma
Official Title: An Open-Label, Multicenter, Phase Ib Trial Evaluating the Safety, Pharmacokinetics, and Activity of Cevostamab as Monotherapy and Cevostamab Plus Pomalidomide and Dexamethasone or Cevostamab Plus Daratumumab and Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma
Study ID: NCT04910568
Brief Summary: This Phase Ib, multicenter, open-label study will evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of cevostamab monotherapy, cevostamab plus pomalidomide and dexamethasone (Pd) or cevostamab plus daratumumab and dexamethasone (Dd) which will be administered to participants with relapsed or refractory multiple myeloma (R/R MM) via intravenous (IV) infusion.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
City of Hope, Duarte, California, United States
City of Hope - Lennar Foundation Cancer Center, Irvine, California, United States
Colorado Blood Cancer Institute (CBCI) at Presbyterian/ St. Luke's Medical Center, Denver, Colorado, United States
Winship Cancer Institute, Atlanta, Georgia, United States
Karmanos Cancer Institute., Detroit, Michigan, United States
Washington University School of Medicine, Saint Louis, Missouri, United States
Peter MacCallum Cancer Centre; Department of Haematology, Melbourne, Victoria, Australia
The Alfred Hospital; Malignant Haematology & Stem Cell Transplant Service, Melbourne, Victoria, Australia
Hamilton Health Sciences, Hamilton, Ontario, Canada
University Health Network; Princess Margaret Hospital; Medical Oncology Dept, Toronto, Ontario, Canada
Fakultni Nemocnice Ostrava; Klinika hematoonkologie FNO a LF OU, Ostrava, , Czechia
I Interni klinika; Vseobecna fakultni nemocnice, Prague 2, , Czechia
Rigshospitalet; Hæmatologisk Klinik, Klinisk Afprøvnings Team KAT, København Ø, , Denmark
Hôpital Saint-Louis; Service d'Hématologie, Paris, , France
CHU de Poitiers - La Miletrie; Oncologie hematologique - Pole Regional de Cancerologie, Poitiers, , France
CHU Pontchaillou; Service Hématologie, Rennes, , France
Rambam Medical Center; Heamatology & Bone Marrow Transplantation, Haifa, , Israel
Sourasky Medical Centre, Tel-Aviv, , Israel
ASST PAPA GIOVANNI XXIII; Ematologia, Bergamo, Lombardia, Italy
A.O. Spedali Civili Di Brescia-P.O. Spedali Civili;U.O. Ematologia, Brescia, Lombardia, Italy
National Hospital Organization Okayama Medical Center, Okayama, , Japan
The Cancer Institute Hospital of JFCR, Tokyo, , Japan
Yamagata University Hospital, Yamagata, , Japan
Seoul National University Hospital, Seoul, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
Uniwersyteckie Centrum Kliniczne; Kilnika Hematologii i Transplantologii, Oddzia? Wczesnych Faz, Gda?sk, , Poland
Pratia Onkologia Katowice, Katowice, , Poland
Uniwersytecki Szpital Kliniczny w Poznaniu; Oddzial Hematologii i Transplantacji Szpiku, Pozna?, , Poland
Hospital Universitari Vall d'Hebron; Servicio de Hematologia, Barcelona, , Spain
Hospital General Universitario Gregorio Marañon; Servicio de Hematología, Madrid, , Spain
University College London Hospitals NHS Foundation Trust; NIHR UCLH Clinical Research Facility, London, , United Kingdom
Name: Clinical Trials
Affiliation: Genentech, Inc.
Role: STUDY_DIRECTOR