Spots Global Cancer Trial Database for Study Testing Radium-223 Dichloride in Relapsed Multiple Myeloma
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Trial Identification
Brief Title: Study Testing Radium-223 Dichloride in Relapsed Multiple Myeloma
Official Title: A Phase 1b/2 Trial to Evaluate the Safety and Efficacy of Radium-223 Dichloride (BAY88-8223) in Combination With Bortezomib and Dexamethasone in Early Relapsed Multiple Myeloma
Study ID: NCT02928029
Conditions
Study Description
Brief Summary: This study will be conducted in 2 parts. The phase 1b part will be an international, phase 1b, open-label, dose-escalation assessment of radium-223 dichloride administered with bortezomib and dexamethasone in subjects with relapsed multiple myeloma. The primary endpoint is to determine the optimal dose of radium-223 dichloride in combination with bortezomib/dexamethasone for the Phase 2 portion of the study. The phase 2 part will be an international, phase 2, double-blind, randomized, placebo-controlled assessment of radium-223 dichloride versus placebo administered with bortezomib and dexamethasone, in subjects with relapsed multiple myeloma. Up to 12 subjects in all dose cohorts combined will be treated in the phase 1b part of the study. Up to approximately 100 subjects will be enrolled in the phase 2 part of the study.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Pacific Oncology/Hematology Associates, Encinitas, California, United States
Wake Forest Baptist Health, Winston-Salem, North Carolina, United States
Fred Hutchinson Cancer Research Center, Seattle, Washington, United States
National Cancer Center, Goyang-si, Gyeonggido, Korea, Republic of
Seoul National University Hospital, Seoul, , Korea, Republic of
Hospital Universitari Son Espases, Palma de Mallorca, Illes Baleares, Spain
Hospital Universitario Virgen del Rocío, Sevilla, , Spain
Contact Details
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