NCT03277105CompletedPhase 3
A Study of Subcutaneous Versus (vs.) Intravenous Administration of Daratumumab in Participants With Relapsed or Refractory Multiple Myeloma
A Phase 3 Randomized, Multicenter Study of Subcutaneous vs. Intravenous Administration of Daratumumab in Subjects With Relapsed or Refractory Multiple Myeloma
Source: ClinicalTrials.gov · Last updated 29 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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).
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 522 (actual)
- First submitted
- 7 Sept 2017
- Start date
- 27 Oct 2017
- Primary completion date
- 27 Jun 2019
- Lead sponsor
- Janssen Research & Development, LLC
- Diseases
- Multiple myeloma
- NCT number
- NCT03277105
- EudraCT number
- 2017-000206-38
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 522
- From 27 Oct 2017 to the primary completion date, 27 Jun 2019
- 146 sites in 18 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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)
Other illness
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (146)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Royal Prince Alfred Hospital Coordinator of this site? Confirm its status | Camperdown | Australia | Unknown status |
| St Vincents Hospital Melbourne Coordinator of this site? Confirm its status | Fitzroy | Australia | Unknown status |
| Alfred Health Coordinator of this site? Confirm its status | Melbourne | Australia | Unknown status |
| Fiona Stanley Hospital Coordinator of this site? Confirm its status | Murdoch | Australia | Unknown status |
| Sir Charles Gairdner Hospital Coordinator of this site? Confirm its status | Nedlands | Australia | Unknown status |
| Calvary Mater Newcastle Hospital Coordinator of this site? Confirm its status | Waratah | Australia | Unknown status |
| The Queen Elizabeth Hospital Coordinator of this site? Confirm its status | Woodville South | Australia | Unknown status |
| Princess Alexandra Hospital Coordinator of this site? Confirm its status | Woolloongabba | Australia | Unknown status |
| Fundacao Pio XII Coordinator of this site? Confirm its status | Barretos | Brazil | Unknown status |
| Centro de Pesquisa e Ensino em Oncologia de Santa Catarina - CEPEN Coordinator of this site? Confirm its status | Florianópolis | Brazil | Unknown status |
| Fundacao Doutor Amaral Carvalho Coordinator of this site? Confirm its status | Jaú | Brazil | Unknown status |
| Instituto Joinvilense de Hematologia e Oncologia Ltda Centro de Hematologia e Oncologia Coordinator of this site? Confirm its status | Joinville | Brazil | Unknown status |
| Associacao Hospitalar Beneficente Sao Vicente de Paulo - Hospital Sao Vicente de Paulo Coordinator of this site? Confirm its status | Passo Fundo | Brazil | Unknown status |
| Hospital das Clinicas de Porto Alegre Coordinator of this site? Confirm its status | Porto Alegre | Brazil | Unknown status |
| Instituto de Educacao Pesquisa e Gestao em Saude Coordinator of this site? Confirm its status | Rio de Janeiro | Brazil | Unknown status |
| CEHON Coordinator of this site? Confirm its status | Salvador | Brazil | Unknown status |
| Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto Hospital de Base Coordinator of this site? Confirm its status | São José do Rio Preto | Brazil | Unknown status |
| Hospital das Clinicas da Faculdade de Medicina da USP Coordinator of this site? Confirm its status | São Paulo | Brazil | Unknown status |
| Clinica Sao Germano Coordinator of this site? Confirm its status | São Paulo | Brazil | Unknown status |
| Tom Baker Cancer Centre Coordinator of this site? Confirm its status | Calgary | Canada | Unknown status |
| Cross Cancer Institute Coordinator of this site? Confirm its status | Edmonton | Canada | Unknown status |
| QEII Health Sciences Centre Coordinator of this site? Confirm its status | Halifax | Canada | Unknown status |
| Victoria Hospital Coordinator of this site? Confirm its status | London | Canada | Unknown status |
| CHU de Quebec - L'Hôtel-Dieu de Québec Coordinator of this site? Confirm its status | Québec | Canada | Unknown status |
| Princess Margaret Hospital Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
| The Gordon & Leslie Diamond Health Care Center Coordinator of this site? Confirm its status | Vancouver | Canada | Unknown status |
| Fakultni nemocnice Brno Coordinator of this site? Confirm its status | Brno | Czechia | Unknown status |
| Fakultni nemocnice Hradec Kralove Coordinator of this site? Confirm its status | Hradec Králové | Czechia | Unknown status |
| Fakultni nemocnice Olomouc Coordinator of this site? Confirm its status | Olomouc | Czechia | Unknown status |
| Fakultni nemocnice Ostrava Coordinator of this site? Confirm its status | Ostrava | Czechia | Unknown status |
| Fakultni nemocnice Plzen, Hemato-onkologicke oddeleni Coordinator of this site? Confirm its status | Pilsen | Czechia | Unknown status |
| Fakultni nemocnice Kralovske Vinohrady Coordinator of this site? Confirm its status | Prague | Czechia | Unknown status |
| Vseobecna fakultni nemocnice v Praze - I. interni klinika - klinika hematologie Coordinator of this site? Confirm its status | Prague | Czechia | Unknown status |
| Hosp. Univ. Germans Trias I Pujol Coordinator of this site? Confirm its status | Badalona | Spain | Unknown status |
| Hosp Clinic de Barcelona Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| Hosp. Univ. Dr. Josep Trueta Coordinator of this site? Confirm its status | Girona | Spain | Unknown status |
| Hosp. Univ. Virgen de Las Nieves Coordinator of this site? Confirm its status | Granada | Spain | Unknown status |
| Hosp. de Leon Coordinator of this site? Confirm its status | León | Spain | Unknown status |
| Hosp. Gral. Univ. Gregorio Maranon Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Hosp. Univ. 12 de Octubre Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Hosp. Univ. Infanta Leonor Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Clinica Univ. de Navarra Coordinator of this site? Confirm its status | Pamplona | Spain | Unknown status |
| Hosp. Quiron Madrid Pozuelo Coordinator of this site? Confirm its status | Pozuelo de Alarcón | Spain | Unknown status |
| Hosp Clinico Univ de Salamanca Coordinator of this site? Confirm its status | Salamanca | Spain | Unknown status |
| Hosp. Univ. de Canarias Coordinator of this site? Confirm its status | San Cristóbal de La Laguna | Spain | Unknown status |
| Hosp. Univ. Dr. Peset Coordinator of this site? Confirm its status | Valencia | Spain | Unknown status |
| CHU Caen - Côte de Nacre Coordinator of this site? Confirm its status | Caen | France | Unknown status |
| Hopital Claude Huriez Coordinator of this site? Confirm its status | Lille | France | Unknown status |
| CHU de Nantes - Hôtel Dieu Coordinator of this site? Confirm its status | Nantes | France | Unknown status |
| CHU de Boreaux Coordinator of this site? Confirm its status | Pessac | France | Unknown status |
| Centre Hospitalier Lyon-Sud Coordinator of this site? Confirm its status | Pierre-Bénite | France | Unknown status |
| CHU Poitiers - Hôpital la Milétrie Coordinator of this site? Confirm its status | Poitiers | France | Unknown status |
| CHU Nancy-Brabois Coordinator of this site? Confirm its status | Vandœuvre-lès-Nancy | France | Unknown status |
| Blackpool Victoria Hospital Coordinator of this site? Confirm its status | Blackpool | United Kingdom | Unknown status |
| Royal Bournemouth Hospital Coordinator of this site? Confirm its status | Bournemouth | United Kingdom | Unknown status |
| Leicester Royal Infirmary - Haematology Coordinator of this site? Confirm its status | Leicester | United Kingdom | Unknown status |
| St. Bartholomew's Hospital Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Guys & St Thomas Hospital Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Christie Hospital NHS Trust Coordinator of this site? Confirm its status | Manchester | United Kingdom | Unknown status |
| Nottingham City Hospital Coordinator of this site? Confirm its status | Nottingham | United Kingdom | Unknown status |
| Royal Marsden Hospital Coordinator of this site? Confirm its status | Surrey | United Kingdom | Unknown status |
| New Cross Hospital Coordinator of this site? Confirm its status | Wolverhampton | United Kingdom | Unknown status |
| Alexandra General Hospital of Athens Coordinator of this site? Confirm its status | Athens Attica | Greece | Unknown status |
| Hillel Yaffe Medical Center - Oncology Coordinator of this site? Confirm its status | Hadera | Israel | Unknown status |
| Carmel Medical Center Coordinator of this site? Confirm its status | Haifa | Israel | Unknown status |
| Rambam Med.Center - Hematology Institute Coordinator of this site? Confirm its status | Haifa | Israel | Unknown status |
| Hadassah medical Center Coordinator of this site? Confirm its status | Jerusalem | Israel | Unknown status |
| Rabin Medical Center-Beilinson Campus Coordinator of this site? Confirm its status | Petah Tikva | Israel | Unknown status |
| Sheba Medical Center, Tel Hashomer Coordinator of this site? Confirm its status | Ramat Gan | Israel | Unknown status |
| Tel-Aviv Sourasky Medical Center Coordinator of this site? Confirm its status | Tel Aviv | Israel | Unknown status |
| Policlinico Sant'Orsola-Malpighi Coordinator of this site? Confirm its status | Bologna | Italy | Unknown status |
| Fondazione IRCCS - Istituto Nazionale dei Tumori Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
| Ospedale Villa Sofia-Cervello Coordinator of this site? Confirm its status | Palermo | Italy | Unknown status |
| Fondazione IRCCS Policlinico San Matteo Coordinator of this site? Confirm its status | Pavia | Italy | Unknown status |
| Azienda USL di Piacenza Coordinator of this site? Confirm its status | Piacenza | Italy | Unknown status |
| Policlinico Universitario Agostino Gemelli Coordinator of this site? Confirm its status | Roma | Italy | Unknown status |
| Università di Roma La Sapienza Coordinator of this site? Confirm its status | Roma | Italy | Unknown status |
| A.O.U. Città della Salute e della Scienza Coordinator of this site? Confirm its status | Torino | Italy | Unknown status |
| Fukuoka University Hospital Coordinator of this site? Confirm its status | Fukuoka | Japan | Unknown status |
| Chugoku Central Hospital Coordinator of this site? Confirm its status | Fukuyama | Japan | Unknown status |
| Ogaki Municipal Hospital Coordinator of this site? Confirm its status | Gifu | Japan | Unknown status |
| Gunma University Hospital Coordinator of this site? Confirm its status | Gunma | Japan | Unknown status |
| Kobe City Medical Center General Hospital Coordinator of this site? Confirm its status | Kobe | Japan | Unknown status |
| University Hospital Kyoto Prefectural University of Medicine Coordinator of this site? Confirm its status | Kyoto | Japan | Unknown status |
| Matsuyama Red Cross Hospital Coordinator of this site? Confirm its status | Matsuyama | Japan | Unknown status |
| Nagoya City University Hospital Coordinator of this site? Confirm its status | Nagoya | Japan | Unknown status |
| Japanese Red Cross Nagoya Daini Hospital Coordinator of this site? Confirm its status | Nagoya | Japan | Unknown status |
| Niigata Cancer Center Hospital Coordinator of this site? Confirm its status | Niigata | Japan | Unknown status |
| Iwate Medical University Hospital Coordinator of this site? Confirm its status | Numakunai | Japan | Unknown status |
| National Hospital Organization Okayama Medical Center Coordinator of this site? Confirm its status | Okayama | Japan | Unknown status |
| Osaka University Hospital Coordinator of this site? Confirm its status | Osaka | Japan | Unknown status |
| National Hospital Organization Sendai Medical Center Coordinator of this site? Confirm its status | Sendai | Japan | Unknown status |
| National Hospital Organization Shibukawa Medical Center Coordinator of this site? Confirm its status | Shibukawa | Japan | Unknown status |
| Japanese Red Cross Medical Center Coordinator of this site? Confirm its status | Shibuya City | Japan | Unknown status |
| Pusan National University Hospital Coordinator of this site? Confirm its status | Busan | South Korea | Unknown status |
| National Cancer Center Coordinator of this site? Confirm its status | Goyang-si | South Korea | Unknown status |
| Gachon University Gil Medical Center Coordinator of this site? Confirm its status | Incheon | South Korea | Unknown status |
| Asan Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Samsung Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| The Catholic University of Korea Seoul St Marys Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Severance hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Ulsan University Hospital Coordinator of this site? Confirm its status | Ulsan | South Korea | Unknown status |
| Szpital Specjalistyczny W Brzozowie Podkarpacki Osrodek Onkologiczny Im.Ks.B.Markiewicza Coordinator of this site? Confirm its status | Brzozów | Poland | Unknown status |
| Szpital Uniwersytecki nr 2 im. Jana Biziela w Bydgoszczy Coordinator of this site? Confirm its status | Bydgoszcz | Poland | Unknown status |
| Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespol Szpitali Miejskich Coordinator of this site? Confirm its status | Chorzów | Poland | Unknown status |
| Szpitale Pomorskie Sp z o o Coordinator of this site? Confirm its status | Gdynia | Poland | Unknown status |
| Szpital Uniwersytecki w Krakowie Coordinator of this site? Confirm its status | Krakow | Poland | Unknown status |
| Wojewodzki Szpital Specjalistyczny w Legnicy Coordinator of this site? Confirm its status | Legnica | Poland | Unknown status |
| Samodzielny Publiczny Szpital Kliniczny nr 1 w Lublinie Coordinator of this site? Confirm its status | Lublin | Poland | Unknown status |
| Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego Coordinator of this site? Confirm its status | Poznan | Poland | Unknown status |
| Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy Coordinator of this site? Confirm its status | Warsaw | Poland | Unknown status |
| Emergency Hospital of Dzerzhinsk Coordinator of this site? Confirm its status | Dzerzhinsk | Russia | Unknown status |
| City Clinical Hospital # 40 Coordinator of this site? Confirm its status | Moscow | Russia | Unknown status |
| S.P. Botkin Moscow City Clinical Hospital Coordinator of this site? Confirm its status | Moscow | Russia | Unknown status |
| Nizhniy Novgorod Region Clinical Hospital Coordinator of this site? Confirm its status | Nizny Novgorod | Russia | Unknown status |
| Penza Regional Oncology Dispensary Coordinator of this site? Confirm its status | Penza | Russia | Unknown status |
| Ryazan Regional Clinical Hospital Coordinator of this site? Confirm its status | Ryazan | Russia | Unknown status |
| Saint Petersburg City Hospital #15 Coordinator of this site? Confirm its status | Saint Petersburg | Russia | Unknown status |
| Clinical Research Institute of Hematology and Transfusiology Coordinator of this site? Confirm its status | Saint Petersburg | Russia | Unknown status |
| Samara Region Clinical Hospital Coordinator of this site? Confirm its status | Samara | Russia | Unknown status |
| Oncology Dispensary of Komi Republic Coordinator of this site? Confirm its status | Syktyvkar | Russia | Unknown status |
| Ekaterinburg City Clinical Hospital # 7 Coordinator of this site? Confirm its status | Yekaterinburg | Russia | Unknown status |
| Falu Lasarett Coordinator of this site? Confirm its status | Falun | Sweden | Unknown status |
| Helsingborgs lasarett Coordinator of this site? Confirm its status | Helsingborg | Sweden | Unknown status |
| Karolinska University Hospital, Huddinge Coordinator of this site? Confirm its status | Huddinge | Sweden | Unknown status |
| Skanes universitetssjukhus Coordinator of this site? Confirm its status | Lund | Sweden | Unknown status |
| Norrlands University Hospital Coordinator of this site? Confirm its status | Umeå | Sweden | Unknown status |
| Akademiska sjukhuset Coordinator of this site? Confirm its status | Uppsala | Sweden | Unknown status |
| Chang-Hua Christian Hospital Coordinator of this site? Confirm its status | Changhua | Taiwan | Unknown status |
| Taichung Veterans General Hospital Coordinator of this site? Confirm its status | Taichung | Taiwan | Unknown status |
| China Medical University Hospital Coordinator of this site? Confirm its status | Taichung | Taiwan | Unknown status |
| National Cheng Kung University Hospital Coordinator of this site? Confirm its status | Tainan | Taiwan | Unknown status |
| National Taiwan University Hospital Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
| Chang Gung Memorial Hospital Coordinator of this site? Confirm its status | Taoyuan | Taiwan | Unknown status |
| Communal Nonprofit Enterprise 'Cherkasy Regional Oncology Dispensary Of Cherkasy Regional Council' Coordinator of this site? Confirm its status | Cherkasy | Ukraine | Unknown status |
| Dnepropetrovsk City Clinical Hospital #4, Regional Hematology Center Coordinator of this site? Confirm its status | Dnipro | Ukraine | Unknown status |
| Ivano-Frankivsk Regional Clinical Hospital Coordinator of this site? Confirm its status | Ivano-Frankivsk | Ukraine | Unknown status |
| SI Grigoriev Institute for Medical Radiology National Academy of Medical Science of Ukraine Coordinator of this site? Confirm its status | Kharkiv | Ukraine | Unknown status |
| State Institution 'National Scientific Center for Radiation Medicine of NAMS of Ukraine' Coordinator of this site? Confirm its status | Kiev | Ukraine | Unknown status |
| Kiev Marrow Transplantation Center, Bone Marrow Transplantation Department Coordinator of this site? Confirm its status | Kiev | Ukraine | Unknown status |
| National Cancer Institute, Dept. of chemotherapy of hemoblastosis Coordinator of this site? Confirm its status | Kiev | Ukraine | Unknown status |
| Institute of Blood Pathology and Transfusion Medicine of AMS of Ukraine Coordinator of this site? Confirm its status | Lviv | Ukraine | Unknown status |
| Mykolaiv Regional Clinical Hospital Coordinator of this site? Confirm its status | Mykolaiv | Ukraine | Unknown status |
| Ukrainian Medical Stomatological Academy, Poltava Regional Clinical Hospital Coordinator of this site? Confirm its status | Poltava | Ukraine | Unknown status |
| Dana-Farber Cancer Institute Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| Levine Cancer Institute Coordinator of this site? Confirm its status | Charlotte | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.