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Brief Title: A Study of Combination of Daratumumab and Velcade (Bortezomib) Melphalan-Prednisone (DVMP) Compared to Velcade Melphalan-Prednisone (VMP) in Participants With Previously Untreated Multiple Myeloma
Official Title: A Phase 3, Randomized, Controlled, Open-label Study of VELCADE (Bortezomib) Melphalan-Prednisone (VMP) Compared to Daratumumab in Combination With VMP (D-VMP), in Subjects With Previously Untreated Multiple Myeloma Who Are Ineligible for High-dose Therapy
Study ID: NCT02195479
Brief Summary: The purpose of this study is to determine if the addition of daratumumab to velcade (bortezomib) melphalan-prednisone (VMP) will prolong progression-free survival (PFS) compared with VMP alone in participants with previously untreated multiple myeloma who are ineligible for high dose chemotherapy and autologous stem cell transplant (ASCT).
Detailed Description: The study consists of 3 phases: Screening Phase (within 21 days prior to randomization), Treatment Phase (Cycle 1 Day 1 to discontinuation of all study treatment), and Follow-up Phase (from discontinuation of all study treatment up to death, lost to follow up, withdrawal of consent, or the study ends, whichever occurs first). Treatment phase will include 2 treatments (Treatment A: participants will receive Velcade MelphalanPrednisone (VMP) alone and Treatment B: participants will receive daratumumab in combination with VMP).Two interim analyses are planned. The first will be to evaluate safety after a total of approximately 100 participants have been treated for at least 2 cycles or discontinued the study treatment. The second will be to evaluate cumulative interim safety and efficacy data, and will be performed when approximately 216 PFS events have been accumulated. The final OS analysis will occur when approximately 382 deaths have occurred. Efficacy will be primarily measured by comparison of PFS between the two treatment arms. Participants' safety will be monitored throughout the study.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
, California City, California, United States
, Corona, California, United States
, Fountain Valley, California, United States
, Los Angeles, California, United States
, Hialeah, Florida, United States
, Orange Park, Florida, United States
, Chicago, Illinois, United States
, Springfield, Missouri, United States
, Cleveland, Ohio, United States
, Fredericksburg, Virginia, United States
, Buenos Aires, , Argentina
, Ciudad Autonoma Buenos Aires, , Argentina
, Córdoba, , Argentina
, Santa Fe, , Argentina
, Adelaide, , Australia
, Bendigo, , Australia
, Camperdown N/a, , Australia
, Geelong, , Australia
, Gosford, , Australia
, Greenslopes, , Australia
, Hobart, , Australia
, North Adelaide, , Australia
, Parkville, , Australia
, Antwerpen, , Belgium
, Antwerp, , Belgium
, Brussel, , Belgium
, Charleroi, , Belgium
, Gent, , Belgium
, Kortrijk, , Belgium
, Roeselare, , Belgium
, Turnhout, , Belgium
, Yvoir, , Belgium
, Barretos, , Brazil
, Cuiaba - Mount, , Brazil
, Fortaleza, , Brazil
, Goiania, , Brazil
, Natal, , Brazil
, Porto Alegre, , Brazil
, Ribeirao Preto, , Brazil
, Rio de Janeiro, , Brazil
, Sao Paulo, , Brazil
, São Paulo, , Brazil
, Pleven, , Bulgaria
, Plovdiv, , Bulgaria
, Sofia, , Bulgaria
, Varna, , Bulgaria
, Vratsa, , Bulgaria
, Zadar, , Croatia
, Zagreb, , Croatia
, Brno, , Czechia
, Hradec Kralove, , Czechia
, Olomouc, , Czechia
, Ostrava-Poruba, , Czechia
, Praha 10, , Czechia
, Praha 2, , Czechia
, Tbilisi, , Georgia
, Berlin, , Germany
, Dortmund, , Germany
, Karlsruhe, , Germany
, Potsdam, , Germany
, Saarbrücken, , Germany
, Stuttgart, , Germany
, Würzburg, , Germany
, Athens Attica, , Greece
, Athens, , Greece
, Patra, , Greece
, Thessaloniki, , Greece
, Budapest, , Hungary
, Debrecen, , Hungary
, Kaposvar, , Hungary
, Pecs N/a, , Hungary
, Chiba, , Japan
, Hitachi, , Japan
, Kanazawa, , Japan
, Kawasaki, , Japan
, Kobe, , Japan
, Kurume, , Japan
, Matsuyama, , Japan
, Nagoya, , Japan
, Narita, , Japan
, Ohgaki, , Japan
, Okayama, , Japan
, Osaka, , Japan
, Sendai-shi, , Japan
, Shibukawa, , Japan
, Shibuya, , Japan
, Tachikawa, , Japan
, Toyohashi, , Japan
, Busan, , Korea, Republic of
, Gyeonggi-do, , Korea, Republic of
, Hwasun, , Korea, Republic of
, Incheon, , Korea, Republic of
, Seongnam, , Korea, Republic of
, Seoul, , Korea, Republic of
, Skopje, , North Macedonia
, Bialystok, , Poland
, Bydgoszcz, , Poland
, Chorzow, , Poland
, Gdansk, , Poland
, Legnica, , Poland
, Lublin, , Poland
, Opole, , Poland
, Slupsk, , Poland
, Warszawa Ul, , Poland
, Warszawa, , Poland
, Wroclaw, , Poland
, Lisboa, , Portugal
, Lisbon, , Portugal
, Porto, , Portugal
, Brasov, , Romania
, Bucharest, , Romania
, Iasi, , Romania
, Arkhangelsk, , Russian Federation
, Dzerzhinsk, , Russian Federation
, Ekaterinbourg, , Russian Federation
, Nizhny Novgorod, , Russian Federation
, Ryazan, , Russian Federation
, Saint-Petersburg, , Russian Federation
, Saratov, , Russian Federation
, Sochi, , Russian Federation
, St Petersburg, , Russian Federation
, Volgograd, , Russian Federation
, Belgrade, , Serbia
, Nis, , Serbia
, Novi Sad, , Serbia
, Sremska Kamenica, , Serbia
, Zemun, , Serbia
, Andalucía, , Spain
, Badalona, , Spain
, Barcelona, , Spain
, Córdoba, , Spain
, Girona, , Spain
, La Laguna, , Spain
, Madrid, , Spain
, Maranon, , Spain
, Murcia N/a, , Spain
, Ourense, , Spain
, Pamplona, , Spain
, Salamanca, , Spain
, Sevilla, , Spain
, Toledo, , Spain
, Valencia, , Spain
, Zaragoza, , Spain
, Altindag, , Turkey
, Ankara, , Turkey
, Aydin, , Turkey
, Izmir, , Turkey
, Kayseri, , Turkey
, Samsun, , Turkey
, Tekirdag, , Turkey
, Cherkassy, , Ukraine
, Dnepropetrovsk, , Ukraine
, Ivano-Frankivsk, , Ukraine
, Kharkov, , Ukraine
, Khmelnitskiy, , Ukraine
, Lviv, , Ukraine
, Zaporizhzhia, , Ukraine
, Birmingham, , United Kingdom
, Cambridge, , United Kingdom
, Colchester, , United Kingdom
, Harlow, , United Kingdom
, Leicester, , United Kingdom
, London, , United Kingdom
, Manchester, , United Kingdom
, Woolwich, , United Kingdom
Name: Janssen Research & Development, LLC Clinical Trial
Affiliation: Janssen Research & Development, LLC
Role: STUDY_DIRECTOR