Spots Global Cancer Trial Database for Phase 1b/2 Study Testing Radium-223 Dichloride/Bortezomib/Dexamethasone Combination in Relapsed Multiple Myeloma
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Trial Identification
Brief Title: Phase 1b/2 Study Testing Radium-223 Dichloride/Bortezomib/Dexamethasone Combination 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: NCT02605356
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 of the phase 1b part 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. Randomization (1:1) in the phase 2 part will be stratified by: * Prior bortezomib treatment (yes, no) * Prior treatment (1 prior line of treatment, \>1 prior line of treatment) Approximately 30 subjects (10 subjects per cohort) will be enrolled in the phase 1b part of the study and approximately 196 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
, Scottsdale, Arizona, United States
, Little Rock, Arkansas, United States
, Encinitas, California, United States
, Metairie, Louisiana, United States
, Rockville, Maryland, United States
, New York, New York, United States
, Durham, North Carolina, United States
, Winston-Salem, North Carolina, United States
, Watertown, South Dakota, United States
, Seattle, Washington, United States
, Adelaide, South Australia, Australia
, Box Hill, , Australia
, Brugge, , Belgium
, Bruxelles - Brussel, , Belgium
, Bruxelles - Brussel, , Belgium
, Liege, , Belgium
, Yvoir, , Belgium
, Quebec, , Canada
, Tübingen, Baden-Württemberg, Germany
, München, Bayern, Germany
, Mainz, Rheinland-Pfalz, Germany
, Berlin, , Germany
, Athens, , Greece
, Rio / Patra, , Greece
, Afula, , Israel
, Haifa, , Israel
, Jerusalem, , Israel
, Ramat Gan, , Israel
, Zerifin, , Israel
, Bologna, Emilia-Romagna, Italy
, Reggio Emilia, Emilia-Romagna, Italy
, Milano, Lombardia, Italy
, Milano, Lombardia, Italy
, Novara, Piemonte, Italy
, Torino, Piemonte, Italy
, Cagliari, Sardegna, Italy
, Firenze, Toscana, Italy
, Pisa, Toscana, Italy
, Goyang-si, Gyeonggido, Korea, Republic of
, Daegu, , Korea, Republic of
, Jeollanam-do, , Korea, Republic of
, Seoul, , Korea, Republic of
, Seoul, , Korea, Republic of
, Seoul, , Korea, Republic of
, Seoul, , Korea, Republic of
, Badalona, Barcelona, Spain
, San Sebastián, Guipúzcoa, Spain
, Palma de Mallorca, Illes Baleares, Spain
, Barcelona, , Spain
, Barcelona, , Spain
, Madrid, , Spain
, Madrid, , Spain
, Sevilla, , Spain
, Valencia, , Spain
, Taichung, , Taiwan
, Taipei, , Taiwan
, Taipei, , Taiwan
, Taipei, , Taiwan
Contact Details
Name: Bayer Study Director
Affiliation: Bayer
Role: STUDY_DIRECTOR
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