- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03277105
A Study of Subcutaneous Versus (vs.) Intravenous Administration of Daratumumab in Participants With Relapsed or Refractory Multiple Myeloma
March 11, 2024 updated by: Janssen Research & Development, LLC
A Phase 3 Randomized, Multicenter Study of Subcutaneous vs. Intravenous Administration of Daratumumab in Subjects With Relapsed or Refractory Multiple Myeloma
The purpose of this study is to show that subcutaneous (SC) administration of daratumumab co-formulated with recombinant human hyaluronidase PH20 (Dara SC) is non-inferior to intravenous (IV) administration of daratumumab (Dara IV) in terms of the overall response rate (ORR) and maximum trough concentration (Ctrough).
Study Overview
Detailed Description
The study population will consist of adults diagnosed with multiple myeloma who have received at least 3 prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory drug (IMiD), or whose disease is refractory to both a PI and an IMiD.
The study consists of 3 phases: a screening phase (up to 28 days), a treatment phase, and a follow-up phase.
Efficacy, pharmacokinetics, immunogenicity, biomarkers and safety will be assessed at scheduled time.
Follow-up will continue until the end of the data collection period, approximately 24 months after the last participant was randomized or when the median overall survival for both arms has been reached, whichever occurs first.
The primary hypotheses is that the ORR and maximum Ctrough for Dara SC 1800 milligram (mg) are not inferior to the ORR and maximum Ctrough, respectively, for Dara IV 16 mg per kilogram (mg/kg) in participants with multiple myeloma who have received at least 3 prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory drug (IMiD), or whose disease is refractory to both a PI and an IMiD.
Study Type
Interventional
Enrollment (Actual)
522
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Camperdown, Australia, 2050
- Royal Prince Alfred Hospital
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Fitzroy, Australia, 3065
- St. Vincent's Hospital Melbourne
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Melbourne, Australia, 3004
- Alfred Health
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Murdoch, Australia, 6150
- Fiona Stanley Hospital
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Nedlands, Australia, 6009
- Sir Charles Gairdner Hospital
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Waratah, Australia, 2298
- Calvary Mater Newcastle Hospital
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Woodville South, Australia, 5011
- The Queen Elizabeth Hospital
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Woolloongabba, Australia, 4102
- Princess Alexandra Hospital
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Barretos, Brazil, 14784-400
- Fundação Pio XII
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Florianopolis, Brazil, 88034-000
- Centro de Pesquisa e Ensino em Oncologia de Santa Catarina - CEPEN
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Jau, Brazil, 17210-080
- Fundacao Doutor Amaral Carvalho
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Joinville, Brazil, 89201-260
- Instituto Joinvilense de Hematologia e Oncologia Ltda-Centro de Hematologia e Oncologia
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Passo Fundo, Brazil, 99010-090
- Associacao Hospitalar Beneficente Sao Vicente de Paulo - Hospital Sao Vicente de Paulo
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Porto Alegre, Brazil, 90035-903
- Hospital das Clinicas de Porto Alegre
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Rio de Janeiro, Brazil, 22775-001
- Instituto de Educação, Pesquisa e Gestão em Saúde
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Salvador, Brazil, 45995-000
- CEHON
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Sao Jose do Rio Preto, Brazil, 15090-000
- Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto - Hospital de Base
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São Paulo, Brazil, 05403-010
- Hospital Das Clinicas Da Faculdade De Medicina Da USP
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São Paulo, Brazil, 01455-010
- Clinica Sao Germano
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Alberta
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Calgary, Alberta, Canada, T2N 4N2
- Tom Baker Cancer Centre
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Edmonton, Alberta, Canada, T6G 1Z2
- Cross Cancer Institute
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British Columbia
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Vancouver, British Columbia, Canada, V5Z 1M9
- The Gordon & Leslie Diamond Health Care Center
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Nova Scotia
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Halifax, Nova Scotia, Canada, B3H 1V7
- QEII Health Sciences Centre
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Ontario
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London, Ontario, Canada, N6A 5W9
- Victoria Hospital
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Toronto, Ontario, Canada, M5G 1X6
- Princess Margaret Hospital
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Quebec
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Québec, Quebec, Canada, G1R 2J6
- CHU de Québec -L'Hôtel-Dieu de Québec
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Brno, Czechia, 625 00
- Fakultni nemocnice Brno
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Hradec Kralove, Czechia, 500 05
- Fakultni nemocnice Hradec Kralove
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Olomouc, Czechia, 779 00
- Fakultní nemocnice Olomouc
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Ostrava, Czechia, 70852
- Fakultni nemocnice Ostrava
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Plzen, Czechia, 323 00
- Fakultni nemocnice Plzen, Hemato-onkologicke oddeleni
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Praha 10, Czechia, 100 34
- Fakultni nemocnice Kralovske Vinohrady
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Praha 2, Czechia, 128 08
- Vseobecna fakultni nemocnice v Praze - I. interni klinika - klinika hematologie
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Caen, France, 14033
- CHU Caen - Côte de Nacre
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Lille Cedex, France, 59000
- Hôpital Claude Huriez
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Nantes Cedex 1, France, 44093
- CHU de NANTES Hotel Dieu
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Pessac, France, 33604
- CHU de Boreaux
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Pierre-Bénite, France, 69495
- Centre Hospitalier Lyon-Sud
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Poitiers, France, 86021
- CHU Poitiers - Hôpital la Milétrie
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Vandoeuvre Les Nancy, France, 54511
- CHU Nancy Brabois
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Athens Attica, Greece, 115 28
- Alexandra General Hospital of Athens
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Hadera, Israel, 38100
- Hillel Yaffe Medical Center - Oncology
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Haifa, Israel, 3436212
- Carmel Medical Center
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Haifa, Israel, 31096
- Rambam Med.Center - Hematology Institute
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Jerusalem, Israel, 91120
- Hadassah Medical Center
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Petah Tikva, Israel, 49100
- Rabin Medical Center Beilinson Campus
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Ramat Gan, Israel, 52621
- Sheba Medical Center Tel Hashomer
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Tel Aviv, Israel, 64239
- Tel Aviv Sourasky Medical Center
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Bologna, Italy, 40138
- Policlinico Sant'Orsola Malpighi
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Milano, Italy, 20133
- Fondazione IRCCS Istituto Nazionale dei Tumori
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Palermo, Italy, 90146
- Ospedale Villa Sofia-Cervello
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Pavia, Italy, 27100
- Fondazione IRCCS Policlinico San Matteo
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Piacenza, Italy, 29121
- Azienda USL di Piacenza
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Roma, Italy, 00168
- Policlinico Universitario Agostino Gemelli
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Roma, Italy, 00161
- Università di Roma La Sapienza
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Torino, Italy, 10126
- A.O.U. Citta della Salute e della Scienza
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Fukuoka, Japan, 814-0180
- Fukuoka University Hospital
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Fukuyama, Japan, 720-0001
- Chugoku Central Hospital
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Gifu, Japan, 503-8502
- Ogaki Municipal Hospital
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Gunma, Japan, 371-0034
- Gunma University Hospital
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Hyogo, Japan, 650-0047
- Kobe City Medical Center General Hospital
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Iwate, Japan, 020-8505
- Iwate Medical University Hospital
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Kyoto, Japan, 602-8566
- University Hospital Kyoto Perfectural University of Medicine
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Matsuyama, Japan, 790-8524
- Matsuyama Red Cross Hospital
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Nagoya, Japan, 467-8602
- Nagoya City University Hospital
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Nagoya, Japan, 466-8650
- Japanese Red Cross Nagoya Daini Hospital
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Niigata, Japan, 951-8566
- Niigata Cancer Center Hospital
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Okayama, Japan, 701-1192
- National Hospital Organization Okayama Medical Center
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Osaka, Japan, 565-0871
- Osaka University Hospital
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Sendai-City, Japan, 983-8520
- National Hospital Organization Sendai Medical Center
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Shibukawa, Japan, 377-0280
- National Hospital Organization Shibukawa Medical Center
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Shibuya, Japan, 150-8935
- Japanese Red Cross Medical Center
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Busan, Korea, Republic of, 49241
- Pusan National University Hospital
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Goyang-Si, Korea, Republic of, 10408
- National Cancer Center
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Incheon, Korea, Republic of, 21565
- Gachon University Gil Medical Center
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Seoul, Korea, Republic of, 03722
- Severance Hospital
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Seoul, Korea, Republic of, 05505
- Asan Medical Center
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Seoul, Korea, Republic of, 06351
- Samsung Medical Center
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Seoul, Korea, Republic of, 06591
- The Catholic University of Korea Seoul St. Mary'S Hospital
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Ulsan, Korea, Republic of, 44033
- Ulsan University Hospital
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Brzozow, Poland, 36-200
- Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny im Ks B Markiewicza
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Bydgoszcz, Poland, 85-168
- Szpital Uniwersytecki nr 2 im. Jana Biziela w Bydgoszczy
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Chorzów, Poland, 41-500
- Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespol Szpitali Miejskich
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Gdynia, Poland, 81-519
- Szpitale Pomorskie Sp z o o
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Krakow, Poland, 31-501
- Szpital Uniwersytecki w Krakowie
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Legnica, Poland, 59-220
- Wojewodzki Szpital Specjalistyczny w Legnicy
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Lublin, Poland, 20-081
- Samodzielny Publiczny Szpital Kliniczny nr 1 w Lublinie
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Poznan, Poland, 60-569
- Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego
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Warszawa, Poland, 02-781
- Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy
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Dzerzhinsk, Russian Federation, 606019
- Emergency Hospital of Dzerzhinsk
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Ekaterinburg, Russian Federation, 620137
- Ekaterinburg City Clinical Hospital # 7
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Moscow, Russian Federation, 125284
- S.P. Botkin Moscow City Clinical Hospital
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Moscow, Russian Federation, 129301
- City Clinical Hospital # 40
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Nizny Novgorod, Russian Federation, 603126
- Nizhniy Novgorod Region Clinical Hospital
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Penza, Russian Federation, 440071
- Penza Regional Oncology Dispensary
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Ryazan, Russian Federation, 390039
- Ryazan Regional Clinical Hospital
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Saint-Petersburg, Russian Federation, 123182
- Saint Petersburg City Hospital #15
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Samara, Russian Federation, 443095
- Samara Region Clinical Hospital
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St-Petersburg, Russian Federation, 191024
- Clinical Research Institute of Hematology and Transfusiology
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Syktyvkar, Russian Federation, 167904
- Oncology Dispensary of Komi Republic
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Badalona, Spain, 08916
- Hosp. Univ. Germans Trias I Pujol
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Barcelona, Spain, 08036
- Hosp. Clinic de Barcelona
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Girona, Spain, 17007
- Hosp. Univ. Dr. Josep Trueta
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Granada, Spain, 18014
- Hosp. Univ. Virgen de Las Nieves
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La Laguna, Spain, 38320
- Hosp. Univ. de Canarias
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Leon, Spain, 24008
- Hosp. de Leon
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Madrid, Spain, 28041
- Hosp. Univ. 12 de Octubre
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Madrid, Spain, 28007
- Hosp. Gral. Univ. Gregorio Maranon
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Madrid, Spain, 28031
- Hosp. Univ. Infanta Leonor
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Pamplona, Spain, 31008
- Clinica Univ. de Navarra
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Pozuelo de Alarcon, Spain, 28223
- Hosp. Quiron Madrid Pozuelo
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Salamanca, Spain, 37007
- Hosp. Clinico Univ. de Salamanca
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Valencia, Spain, 46017
- Hosp. Univ. Dr. Peset
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Falun, Sweden, 79182
- Falu lasarett
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Helsingborg, Sweden, 25187
- Helsingborgs lasarett
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Huddinge, Sweden, 141 86
- Karolinska University Hospital, Huddinge
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Lund, Sweden, 222 41
- Skånes Universitetssjukhus
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Umea, Sweden, 907 46
- Norrlands University Hospital
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Uppsala, Sweden, SE-751 85
- Akademiska sjukhuset
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Changhua, Taiwan, 50006
- Chang-Hua Christian Hospital
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Taichung City, Taiwan, 40447
- China Medical University Hospital
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Taichung,, Taiwan, 40705
- Taichung Veterans General Hospital
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Tainan, Taiwan, 704
- National Cheng Kung University Hospital
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Taipei, Taiwan, 10048
- National Taiwan University Hospital
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Taoyuan, Taiwan, 33305
- Chang Gung Memorial Hospital
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Cherkasy, Ukraine, 18009
- Communal Nonprofit Enterprise 'Cherkasy Regional Oncology Dispensary Of Cherkasy Regional Council'
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Dnepropetrovsk, Ukraine, 49102
- Dnepropetrovsk City Clinical Hospital #4, Regional Hematology Center
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Ivano-Frankivsk, Ukraine, 76008
- Ivano-Frankivsk Regional Clinical Hospital
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Kharkiv, Ukraine, 61024
- SI Grigoriev Institute for Medical Radiology National Academy of Medical Science of Ukraine
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Kiev, Ukraine, 03022
- National Cancer Institute, Dept. of chemotherapy of hemoblastosis
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Kiev, Ukraine, 03115
- Kiev Marrow Transplantation Center, Bone Marrow Transplantation Department
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Kiev, Ukraine, 03115
- State Institution 'National Scientific Center for Radiation Medicine of NAMS of Ukraine'
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Lviv, Ukraine, 79044
- Institute of Blood Pathology and Transfusion Medicine of AMS of Ukraine
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Mykolaiv, Ukraine, 54000
- Mykolaiv Regional Clinical Hospital
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Poltava, Ukraine, 36011
- Ukrainian Medical Stomatological Academy, Poltava Regional Clinical Hospital
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Blackpool, United Kingdom, FY3 8NR
- Blackpool Victoria Hospital
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Bournemouth, United Kingdom, BH7 7DW
- Royal Bournemouth Hospital
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Leicester, United Kingdom, LE1 5WW
- Leicester Royal Infirmary - Haematology
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London, United Kingdom, SE1 9RT
- Guys St Thomas Hospital
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London, United Kingdom, EC1A 7BE
- St Bartholomew's Hospital
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Manchester, United Kingdom, M20 9BX
- Christie Hospital NHS Trust
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Nottingham, United Kingdom, NG5 1PB
- Nottingham City Hospital
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Surrey, United Kingdom, SM2 5PT
- Royal Marsden Hospital
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Wolverhampton, United Kingdom, WV10 0QP
- New Cross Hospital
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Massachusetts
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Boston, Massachusetts, United States, 02215-5418
- Dana-Farber Cancer Institute
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North Carolina
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Charlotte, North Carolina, United States, 28204
- Levine Cancer Institute
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Evidence of a response (Partial response [PR] or better based on investigator's determination of response by international myeloma working group [IMWG] criteria) to at least 1 prior treatment regimen
- Received at least 3 prior lines of therapy including a proteasome inhibitor (PI) (greater than or equal to [>=] 2 cycles or 2 months of treatment) and an immunomodulatory drug (IMiD) (>=2 cycles or 2 months of treatment) in any order during the course of treatment (except for participants who discontinued either of these treatments due to a severe allergic reaction within the first 2 cycles/months). A single line of therapy may consist of 1 or more agents, and may include induction, hematopoietic stem cell transplantation, and maintenance therapy. Radiotherapy, bisphosphonate, or a single short course of corticosteroids (no more than the equivalent of dexamethasone 40 milligram/day [mg/day] for 4 days) would not be considered prior lines of therapy
Documented multiple myeloma as defined by the criteria below:
- Multiple myeloma diagnosis according to the IMWG diagnostic criteria
Measurable disease at Screening as defined by any of the following:
- Serum M-protein level >=1.0 gram per deciliter (g/dL) or urine M-protein level >=200 mg/24 hours; or
- Light chain multiple myeloma without measurable disease in the serum or the urine: Serum immunoglobulin free light chain (FLC) >=10 mg/dL and abnormal serum immunoglobulin kappa lambda FLC ratio
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2
- Meet the clinical laboratory criteria as specified in the protocol
- Women of childbearing potential must have a negative urine or serum pregnancy test at screening within 14 days prior to randomization
Exclusion Criteria:
- Received daratumumab or other anti-CD38 therapies previously
- Received anti-myeloma treatment within 2 weeks or 5 pharmacokinetic half-lives of the treatment, whichever is longer, before the date of randomization. The only exception is emergency use of a short course of corticosteroids (equivalent of dexamethasone 40 mg/day for a maximum of 4 days) before treatment
- Received autologous stem cell transplant within 12 weeks before the date of randomization, or the participant has previously received allogeneic stem cell transplant (regardless of timing)
- Plans to undergo a stem cell transplant prior to progression of disease on this study (these participants should not be enrolled to reduce disease burden prior to transplant)
- History of malignancy (other than multiple myeloma) unless all treatment of that malignancy was completed at least 2 years before consent and the patient has no evidence of disease. Further exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or breast, or other non-invasive lesion, that in the opinion of the investigator, with concurrence with the sponsor's medical monitor, is considered cured with minimal risk of recurrence within 3 years
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Dara SC
Participants will receive a fixed dose of daratumumab as 1800 milligram (mg) subcutaneously (Dara SC) co-formulated with recombinant human hyaluronidase (rHuPH20) 2000 Unit per milliliter (U/mL), once weekly in Cycle 1 and 2, every 2 weeks in Cycle 3 to 6, every 4 weeks in Cycle 7 and thereafter until disease progression, unacceptable toxicity or the end of study.
The duration for each cycle is 4 weeks.
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Participants will receive a fixed dose of Dara SC as 1800 mg daratumumab with rHuPH20 2000 U/mL, once weekly in Cycle 1 and 2, every 2 weeks in Cycle 3 to 6, every 4 weeks in Cycle 7 and thereafter until disease progression, unacceptable toxicity or the end of study.
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Active Comparator: Dara IV
Participants will receive daratumumab for intravenous infusion (Dara IV) 16 mg/kg once weekly in Cycle 1 and 2, every 2 weeks in Cycle 3 to 6, every 4 weeks on Day 1 in Cycle 7 and thereafter until disease progression, unacceptable toxicity or the end of study.
The duration for each cycle is 4 weeks.
For Participants still receiving treatment with Dara-IV at the time of Protocol Amendment 4 the duration of infusion may be shortened to a 90-minute infusion or participants will have the option to switch to Dara 1800 mg subcutaneous (SC) on Day 1 of any cycle, at the discretion of the investigator.
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Participants will receive a fixed dose of Dara SC as 1800 mg daratumumab with rHuPH20 2000 U/mL, once weekly in Cycle 1 and 2, every 2 weeks in Cycle 3 to 6, every 4 weeks in Cycle 7 and thereafter until disease progression, unacceptable toxicity or the end of study.
Participants will receive Dara IV 16 mg/kg once weekly in Cycle 1 and 2, every 2 weeks in Cycle 3 to 6, every 4 weeks in Cycle 7 and thereafter until disease progression, unacceptable toxicity or the end of study.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Maximum Trough Concentration (Ctrough) of Daratumumab
Time Frame: Predose on Cycle 3 Day 1 (each cycle of 28 days)
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Maximum Ctrough was defined as the serum predose concentration of daratumumab on Cycle 3 Day 1.
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Predose on Cycle 3 Day 1 (each cycle of 28 days)
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Overall Response Rate (ORR)
Time Frame: Up to 1 year 8 months
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ORR was defined as the percentage of participants who achieved partial response (PR) or better according to International Myeloma Working Group (IMWG) criteria, during or after study treatment.
IMWG criteria for PR: greater than or equal to (>=) 50 percent (%) reduction of serum M-protein and reduction in 24-hour urinary M-protein by >=90% or to less than (<) 200 milligrams (mg)/24 hours, If the serum and urine M-proteins are not measurable, a decrease of >=50% in the difference between involved and uninvolved free light chain (FLC) levels were required in place of the M-protein criteria, If serum and urine M-protein are not measurable, and serum free light assay was also not measurable, >=50% reduction in bone marrow plasma cells (PCs) was required in place of M-protein, provided baseline bone marrow plasma cell percentage was >=30%.
In addition to the above criteria, if present at baseline, a >=50% reduction in the size of soft tissue plasmacytomas was also required.
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Up to 1 year 8 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Patient-Reported Satisfaction With Therapy as Assessed With Cancer Therapy Satisfaction Questionnaire (CTSQ)
Time Frame: Cycle 1 (Days 8,15 and 22), Cycle 2 (Days 1,8,15 and 22), Cycle 3,4,5,6,7,8,9,10,11,12,13,14,15,16,17,18,19,20,21 and 22 (Day 1)
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Modified-CTSQ contain 9 items (2 items for Thoughts about Cancer Therapy and 7 items in a defined domain of Satisfaction with Therapy) specific to satisfaction with therapy and for comparison of SC and IV administration.
Satisfaction with therapy was calculated based on 7-items using 5-point verbal rating scale, where 1= never and 5= always.
Scores were averaged and transformed to a 0-100 scale; higher scores represent better health.
At least 5 of the 7 items within the Satisfaction with Therapy domain had to be completed to calculate a domain score.
No domain score was calculated for Thoughts about Cancer Therapy.
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Cycle 1 (Days 8,15 and 22), Cycle 2 (Days 1,8,15 and 22), Cycle 3,4,5,6,7,8,9,10,11,12,13,14,15,16,17,18,19,20,21 and 22 (Day 1)
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Percentage of Participants With Treatment-emergent Infusion-related Reactions (IRR)
Time Frame: Up to 3 years
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Percentage of participants with treatment-emergent infusion-related reactions were reported.
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Up to 3 years
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Progression Free Survival (PFS)
Time Frame: Up to 3 years
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PFS was defined as time from date of randomization to either progression of disease (PD), death due to any cause, whichever occurs first.
IMWG criteria for PD: Increase of 25% from lowest response value in any one of the following: Serum M component (absolute increase must be >=0.5 gram per deciliter (g/dL), Urine M-component (absolute increase must be >=200 mg/24 hours), Participants without measurable serum and urine Mprotein levels: difference between involved and uninvolved free light chain (FLC) levels (absolute increase must be >10 milligrams per deciliter (mg/dL), participants without measurable serum and urine M-protein levels and without measurable disease by FLC levels, bone marrow PC% (absolute percentage must be >=10%), definite development of new bone lesions or soft tissue plasmacytomas or increase in size of bone lesions or tissue plasmacytomas and development of hypercalcemia (serum calcium >11.5 mg/dL) that can be attributed solely to PC proliferative disorder.
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Up to 3 years
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Percentage of Participants With Very Good Partial Response (VGPR) or Better
Time Frame: Up to 3 years
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VGPR or better was defined as the percentage of participants who achieved VGPR or better (VGPR, complete response (CR) or stringent complete response [sCR]), based on computerized algorithm as per IMWG criteria during or after the study treatment.
IMWG criteria for VGPR: Serum and urine M-component detectable by immunofixation but not on electrophoresis, or >=90 percent (%) reduction in serum M-protein plus urine M-protein <100 milligrams (mg)/24 hours, CR: Negative immunofixation on the serum and urine, disappearance of any soft tissue plasmacytomas and <5% plasma cells (PCs) in bone marrow.
sCR: CR plus normal FLC ratio, and absence of clonal PCs by immunohistochemistry (IHC), immunofluorescencea or 2- to 4 color flow cytometry.
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Up to 3 years
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Percentage of Participants With Complete Response (Including sCR) or Better
Time Frame: Up to 3 years
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CR or better was defined as percentage of participants with a CR or better (CR or stringent complete response [sCR]) based on computerized algorithm as per IMWG criteria.
IMWG criteria for CR- negative immunofixation on the serum and urine, and disappearance of any soft tissue plasmacytomas, and <5% PCs in bone marrow.
sCR: CR plus normal FLC ratio, and absence of clonal PCs by IHC, immunofluorescencea or 2- to 4 color flow cytometry.
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Up to 3 years
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Time to Next Therapy
Time Frame: Up to 3 years
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Time to next therapy was defined as the time from randomization to the start of the first subsequent anti-cancer therapy.
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Up to 3 years
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Overall Survival (OS)
Time Frame: Up to 3 years
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OS was defined as the time from the date of randomization to the date of the participant's death due to any cause.
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Up to 3 years
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Duration of Response
Time Frame: Up to 3 years
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Duration of response was defined as the duration from the date of initial documentation of a response (PR or better) to the date of first documented evidence of progressive disease according to the IMWG criteria.
PD was defined as an increase of 25 % from the lowest response value in one of the following: serum and urine M-component (absolute increase must be >= 0.5 g/dL and >=200 mg/24 hours respectively); Only in participants without measurable serum and urine M-protein levels the difference between involved and uninvolved FLC levels (absolute increase must be > 10 mg/dL); Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas; Development of hypercalcemia (corrected serum calcium >11.5 mg/dL) that can be attributed solely to PC proliferative disorder.
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Up to 3 years
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Time to Partial Response (PR) or Better
Time Frame: Up to 3 years
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Time to PR or better was defined as the time from randomization until onset of first response of PR or better.
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Up to 3 years
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Time to Very Good Partial Response (VGPR) or Better
Time Frame: Up to 3 years
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Time to VGPR or better was defined as the time from randomization until onset of first VGPR or better.
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Up to 3 years
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Time to Complete Response (CR) or Better
Time Frame: Up to 3 years
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Time to CR or better was defined as the time from randomization until onset of first CR or better.
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Up to 3 years
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Usmani SZ, Nahi H, Legiec W, Grosicki S, Vorobyev V, Spicka I, Hungria V, Korenkova S, Bahlis NJ, Flogegard M, Blade J, Moreau P, Kaiser M, Iida S, Laubach J, Magen H, Cavo M, Hulin C, White D, De Stefano V, Lantz K, O'Rourke L, Heuck C, Delioukina M, Qin X, Nnane I, Qi M, Mateos MV. Final analysis of the phase III non-inferiority COLUMBA study of subcutaneous versus intravenous daratumumab in patients with relapsed or refractory multiple myeloma. Haematologica. 2022 Oct 1;107(10):2408-2417. doi: 10.3324/haematol.2021.279459.
- Iida S, Ishikawa T, Min CK, Kim K, Yeh SP, Usmani SZ, Mateos MV, Nahi H, Heuck C, Qin X, Parasrampuria DA, Gries KS, Qi M, Bahlis N, Ito S. Subcutaneous daratumumab in Asian patients with heavily pretreated multiple myeloma: subgroup analyses of the noninferiority, phase 3 COLUMBA study. Ann Hematol. 2021 Apr;100(4):1065-1077. doi: 10.1007/s00277-021-04405-2. Epub 2021 Feb 18.
- Usmani SZ, Mateos MV, Hungria V, Iida S, Bahlis NJ, Nahi H, Magen H, Cavo M, Hulin C, White D, De Stefano V, Fastenau J, Slavcev M, Heuck C, Qin X, Pei H, Masterson T, Lantz K, Gries KS. Greater treatment satisfaction in patients receiving daratumumab subcutaneous vs. intravenous for relapsed or refractory multiple myeloma: COLUMBA clinical trial results. J Cancer Res Clin Oncol. 2021 Feb;147(2):619-631. doi: 10.1007/s00432-020-03365-w. Epub 2020 Aug 27.
- Mateos MV, Nahi H, Legiec W, Grosicki S, Vorobyev V, Spicka I, Hungria V, Korenkova S, Bahlis N, Flogegard M, Blade J, Moreau P, Kaiser M, Iida S, Laubach J, Magen H, Cavo M, Hulin C, White D, De Stefano V, Clemens PL, Masterson T, Lantz K, O'Rourke L, Heuck C, Qin X, Parasrampuria DA, Yuan Z, Xu S, Qi M, Usmani SZ. Subcutaneous versus intravenous daratumumab in patients with relapsed or refractory multiple myeloma (COLUMBA): a multicentre, open-label, non-inferiority, randomised, phase 3 trial. Lancet Haematol. 2020 May;7(5):e370-e380. doi: 10.1016/S2352-3026(20)30070-3. Epub 2020 Mar 23. Erratum In: Lancet Haematol. 2020 Oct;7(10):e710.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 27, 2017
Primary Completion (Actual)
June 27, 2019
Study Completion (Actual)
January 12, 2024
Study Registration Dates
First Submitted
September 7, 2017
First Submitted That Met QC Criteria
September 7, 2017
First Posted (Actual)
September 8, 2017
Study Record Updates
Last Update Posted (Actual)
March 13, 2024
Last Update Submitted That Met QC Criteria
March 11, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Immunoproliferative Disorders
- Hematologic Diseases
- Hemorrhagic Disorders
- Hemostatic Disorders
- Paraproteinemias
- Blood Protein Disorders
- Multiple Myeloma
- Neoplasms, Plasma Cell
Other Study ID Numbers
- CR108342
- 2017-000206-38 (EudraCT Number)
- 54767414MMY3012 (Other Identifier: Janssen Research & Development, LLC)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Multiple Myeloma
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Lawson Health Research InstituteThe Ottawa Hospital; Hamilton Health Sciences Corporation; Dalhousie University; Niagara Health SystemActive, not recruitingMultiple Myeloma in Relapse | Multiple Myeloma With Failed Remission | Multiple Myeloma Stage I | Multiple Myeloma Progression | Multiple Myeloma Stage II | Multiple Myeloma Stage IIICanada
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National Cancer Institute (NCI)Active, not recruitingSmoldering Multiple Myeloma | Refractory Multiple Myeloma | DS Stage I Multiple Myeloma | DS Stage II Multiple Myeloma | DS Stage III Multiple MyelomaUnited States
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Fred Hutchinson Cancer Research Center/University...National Cancer Institute (NCI)CompletedStage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
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Case Comprehensive Cancer CenterNational Cancer Institute (NCI)TerminatedStage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
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Mayo ClinicCompletedMultiple Myeloma | Stage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
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National Cancer Institute (NCI)TerminatedStage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
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National Cancer Institute (NCI)CompletedStage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
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City of Hope Medical CenterCompletedStage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
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University of WashingtonNational Cancer Institute (NCI)TerminatedStage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
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Fred Hutchinson Cancer CenterNational Cancer Institute (NCI)CompletedStage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
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Janssen Pharmaceutical K.K.Completed
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Washington University School of MedicineJanssen, LPWithdrawn
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The First Affiliated Hospital of Soochow UniversityNot yet recruitingNewly Diagnosed Multiple Myeloma
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University of Alabama at BirminghamJanssen Scientific Affairs, LLCRecruitingMultiple MyelomaUnited States
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Innovent Biologics (Suzhou) Co. Ltd.CompletedHypercholesterolemiaChina
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Hangzhou Sumgen Biotech Co., Ltd.RecruitingSystemic Lupus Erythematosus (SLE)China