Multiple Myeloma Clinical Trial

A Study of Subcutaneous Versus (vs.) Intravenous Administration of Daratumumab in Participants With Relapsed or Refractory Multiple Myeloma

Summary

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).

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Full 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.

View Eligibility Criteria

Eligibility Criteria

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 is for people with:

Multiple Myeloma

Phase:

Phase 3

Estimated Enrollment:

522

Study ID:

NCT03277105

Recruitment Status:

Active, not recruiting

Sponsor:

Janssen Research & Development, LLC

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There are 145 Locations for this study

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Dana-Farber Cancer Institute
Boston Massachusetts, 02215, United States
Levine Cancer Institute
Charlotte North Carolina, 28204, United States
Royal Prince Alfred Hospital
Camperdown , 2050, Australia
St. Vincent's Hospital Melbourne
Fitzroy , 3065, Australia
Alfred Health
Melbourne , 3004, Australia
Fiona Stanley Hospital
Murdoch , 6150, Australia
Sir Charles Gairdner Hospital
Nedlands , 6009, Australia
Calvary Mater Newcastle Hospital
Waratah , 2298, Australia
The Queen Elizabeth Hospital
Woodville South , 5011, Australia
Princess Alexandra Hospital
Woolloongabba , 4102, Australia
Fundacao Pio XII
Barretos , 14784, Brazil
Centro de Pesquisas Oncológicas - CEPON
Florianópolis , 88034, Brazil
Fundacao Amaral Carvalho
Jaú , 17210, Brazil
Instituto Joinvilensse de Hematologia e Oncologia
Joinville , 89201, Brazil
Associacao Hospitalar Beneficente Sao Vicente de Paulo - Hospital Sao Vicente de Paulo
Passo Fundo , 99010, Brazil
Hospital das Clinicas de Porto Alegre
Porto Alegre , 90035, Brazil
Instituto de Educacao, Pesquisa e Gestao em Saude Instituto Americas (COI)
Rio de Janeiro , 22793, Brazil
CEHON
Salvador , 45995, Brazil
Fundação Faculdade Regional de Medicina de São José do Rio Preto - Hospital de Base
São José do Rio Preto , 15090, Brazil
Clinica Sao Germano
São Paulo , 01455, Brazil
Hospital Das Clinicas Da Faculdade De Medicina Da USP
São Paulo , 05403, Brazil
Tom Baker Cancer Centre
Calgary Alberta, T2N 4, Canada
Cross Cancer Institute
Edmonton Alberta, T6G 1, Canada
The Gordon & Leslie Diamond Health Care Center
Vancouver British Columbia, V5Z 1, Canada
QEII Health Sciences Centre
Halifax Nova Scotia, B3H 1, Canada
Victoria Hospital
London Ontario, N6A 5, Canada
Princess Margaret Hospital
Toronto Ontario, M5G 1, Canada
CHU de Québec -L'Hôtel-Dieu de Québec
Québec Quebec, G1R 2, Canada
Fakultni nemocnice Brno
Brno , 625 0, Czechia
Fakultni nemocnice Hradec Kralove
Hradec Kralove , 500 0, Czechia
Fakultní nemocnice Olomouc
Olomouc , 779 0, Czechia
Fakultni nemocnice Ostrava
Ostrava , 70852, Czechia
Fakultni nemocnice Plzen, Hemato-onkologicke oddeleni
Plzen , 323 0, Czechia
Fakultni nemocnice Kralovske Vinohrady
Praha 10 , 100 3, Czechia
Vseobecna fakultni nemocnice v Praze - I. interni klinika - klinika hematologie
Praha 2 , 128 0, Czechia
CHU Caen - Côte de Nacre
Caen , 14033, France
Hopital Claude Huriez
Lille Cedex , 59000, France
CHU de Nantes hôtel-Dieu
Nantes Cedex 1 , 44093, France
CHU de Boreaux
Pessac , 33604, France
Centre hospitalier Lyon-Sud
Pierre-Bénite , 69495, France
CHU Poitiers - Hôpital la Milétrie
Poitiers , 86021, France
CHU Nancy Brabois
Vandoeuvre Les Nancy , 54511, France
Alexandra General Hospital of Athens
Athens Attica , 115 2, Greece
Hillel Yaffe Medical Center - Oncology
Hadera , 38100, Israel
Rambam Med.Center - Hematology Institute
Haifa , 31096, Israel
Carmel Medical Center
Haifa , 34362, Israel
Hadassah Medical Center
Jerusalem , 91120, Israel
Rabin Medical Center, Beilinson Campus
Petah Tikva , 49100, Israel
Sheba Medical Center Tel Hashomer
Ramat Gan , 52621, Israel
Tel Aviv Sourasky Medical Center
Tel Aviv , 64239, Israel
Policlinico Sant'Orsola Malpighi
Bologna , 40138, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori
Milano , 20133, Italy
Ospedale Villa Sofia-Cervello
Palermo , 90146, Italy
Fondazione IRCCS Policlinico San Matteo
Pavia , 27100, Italy
Azienda USL di Piacenza
Piacenza , 29121, Italy
Università di Roma La Sapienza
Roma , 00161, Italy
Policlinico Universitario Agostino Gemelli
Roma , 00168, Italy
A.O.U. Città della Salute e della Scienza
Torino , 10126, Italy
Fukuoka University Hospital
Fukuoka , 814-0, Japan
Chugoku Central Hospital
Fukuyama , 720-0, Japan
Ogaki Municipal Hospital
Gifu , 503-8, Japan
Gunma University Hospital
Gunma , 371-0, Japan
Kobe City Medical Center General Hospital
Hyogo , 650-0, Japan
Iwate Medical University Hospital
Iwate , 020-8, Japan
University Hospital Kyoto Perfectural University of Medicine
Kyoto , 602-8, Japan
Matsuyama Red Cross Hospital
Matsuyama , 790-8, Japan
Japanese Red Cross Nagoya Daini Hospital
Nagoya , 466-8, Japan
Nagoya City University Hospital
Nagoya , 467-8, Japan
Niigata Cancer Center Hospital
Niigata , 951-8, Japan
National Hospital Organization Okayama Medical Center
Okayama , 701-1, Japan
Osaka University Hospital
Osaka , 565-0, Japan
National Hospital Organization Sendai Medical Center
Sendai-City , 983-8, Japan
National Hospital Organization Shibukawa Medical Center
Shibukawa , 377-0, Japan
Japanese Red Cross Medical Center
Shibuya , 150-8, Japan
Pusan National University Hospital
Busan , 49241, Korea, Republic of
National Cancer Center
Goyang-Si , 10408, Korea, Republic of
Gachon University Gil Medical Center
Incheon , 21565, Korea, Republic of
Severance Hospital
Seoul , 03722, Korea, Republic of
Asan Medical Center
Seoul , 05505, Korea, Republic of
Samsung Medical Center
Seoul , 06351, Korea, Republic of
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul , 06591, Korea, Republic of
Ulsan University Hospital
Ulsan , 44033, Korea, Republic of
Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny im. Ks. B. Markiewicza
Brzozow , 36-20, Poland
Szpital Uniwersytecki nr 2 im. Jana Biziela w Bydgoszczy
Bydgoszcz , 85-16, Poland
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespol Szpitali Miejskich
Chorzów , 41-50, Poland
Szpitale Pomorskie Sp. z o.o.
Gdynia , 81-51, Poland
Szpital Uniwersytecki w Krakowie
Krakow , 31-50, Poland
Wojewodzki Szpital Specjalistyczny w Legnicy
Legnica , 59-22, Poland
Samodzielny Publiczny Szpital Kliniczny nr 1 w Lublinie
Lublin , 20-08, Poland
Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego
Poznan , 60-56, Poland
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy
Warszawa , 02-78, Poland
Emergency Hospital of Dzerzhinsk
Dzerzhinsk , 60601, Russian Federation
Ekaterinburg City Clinical Hospital # 7
Ekaterinburg , 62013, Russian Federation
S.P. Botkin Moscow City Clinical Hospital
Moscow , 12528, Russian Federation
City Clinical Hospital # 40
Moscow , 12930, Russian Federation
Nizhniy Novgorod Region Clinical Hospital
Nizny Novgorod , 60312, Russian Federation
Penza Regional Oncology Dispensary
Penza , 44007, Russian Federation
Ryazan Regional Clinical Hospital
Ryazan , 39003, Russian Federation
Saint Petersburg City Hospital #15
Saint-Petersburg , 12318, Russian Federation
Samara Region Clinical Hospital
Samara , 44309, Russian Federation
Clinical Research Institute of Hematology and Transfusiology
St-Petersburg , 19102, Russian Federation
Oncology Dispensary of Komi Republic
Syktyvkar , 16790, Russian Federation
Hosp. Univ. Germans Trias I Pujol
Badalona , 08916, Spain
Hosp. Clinic I Provincial de Barcelona
Barcelona , 08036, Spain
Hosp. Univ. Dr. Josep Trueta
Girona , 17007, Spain
Hosp. Univ. Virgen de Las Nieves
Granada , 18014, Spain
Hosp. Univ. de Canarias
La Laguna , 38320, Spain
Hosp. de Leon
Leon , 24080, Spain
Hosp. Gral. Univ. Gregorio Marañon
Madrid , 28007, Spain
Hosp. Univ. Infanta Leonor
Madrid , 28031, Spain
Hosp. Univ. 12 de Octubre
Madrid , 28041, Spain
Clinica Univ. de Navarra
Pamplona , 31008, Spain
Hosp. Quiron Madrid Pozuelo
Pozuelo de Alarcon , 28223, Spain
Hosp. Clinico Univ. de Salamanca
Salamanca , 37007, Spain
Hosp. Univ. Dr. Peset
Valencia , 46017, Spain
Falu Lasarett
Falun , 79182, Sweden
Helsingborgs lasarett
Helsingborg , 25187, Sweden
Karolinska University Hospital, Huddinge
Huddinge , 141 8, Sweden
Skanes universitetssjukhus
Lund , 222 4, Sweden
Norrlands University Hospital
Umea , 907 4, Sweden
Akademiska Sjukhuset
Uppsala , SE-75, Sweden
Chang-Hua Christian Hospital
Changhua , 50006, Taiwan
China Medical University Hospital
Taichung City , 40447, Taiwan
Taichung Veterans General Hospital
Taichung, , 40705, Taiwan
National Cheng Kung University Hospital
Tainan , 704, Taiwan
National Taiwan University Hospital
Taipei , 10048, Taiwan
Chang Gung Memorial Hospital
Taoyuan , 33305, Taiwan
Communal Nonprofit Enterprise 'Cherkasy Regional Oncology Dispensary Of Cherkasy Regional Council'
Cherkasy , 18009, Ukraine
Dnepropetrovsk City Clinical Hospital #4, Regional Hematology Center
Dnepropetrovsk , 49102, Ukraine
Ivano-Frankivsk Regional Clinical Hospital
Ivano-Frankivsk , 76008, Ukraine
SI Grigoriev Institute for Medical Radiology National Academy of Medical Science of Ukraine
Kharkiv , 61024, Ukraine
National Cancer Institute, Dept. of chemotherapy of hemoblastosis
Kiev , 03022, Ukraine
Kiev Marrow Transplantation Center, Bone Marrow Transplantation Department
Kiev , 03115, Ukraine
State Institution 'National Scientific Center for Radiation Medicine of NAMS of Ukraine'
Kiev , 03115, Ukraine
Institute of Blood Pathology and Transfusion Medicine of AMS of Ukraine
Lviv , 79044, Ukraine
Mykolaiv Regional Clinical Hospital
Mykolaiv , 54000, Ukraine
Ukrainian Medical Stomatological Academy, Poltava Regional Clinical Hospital
Poltava , 36011, Ukraine
Blackpool Victoria Hospital
Blackpool , FY3 8, United Kingdom
Royal Bournemouth Hospital
Bournemouth , BH7 7, United Kingdom
Leicester Royal Infirmary - Haematology
Leicester , LE1 5, United Kingdom
St Bartholomew's Hospital
London , EC1A , United Kingdom
Guy's & St Thomas Hospital
London , SE1 9, United Kingdom
Christie Hospital NHS Trust
Manchester , M20 9, United Kingdom
Nottingham City Hospital
Nottingham , NG5 1, United Kingdom
Royal Marsden Hospital
Surrey , SM2 5, United Kingdom
New Cross Hospital
Wolverhampton , WV10 , United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Multiple Myeloma

Phase:

Phase 3

Estimated Enrollment:

522

Study ID:

NCT03277105

Recruitment Status:

Active, not recruiting

Sponsor:


Janssen Research & Development, LLC

How clear is this clinincal trial information?

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