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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-000206-38 | EudraCT Number | ||
| 54767414MMY3012 | Other Identifier | Janssen Research & Development, LLC |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dara SC | Experimental | 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. |
|
| Dara IV | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dara SC | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate (ORR) | 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. | Up to 1 year 8 months |
| Maximum Trough Concentration (Ctrough) of Daratumumab | Maximum Ctrough was defined as the serum predose concentration of daratumumab on Cycle 3 Day 1. | Predose on Cycle 3 Day 1 (each cycle of 28 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Treatment-emergent Infusion-related Reactions (IRR) | Percentage of participants with treatment-emergent infusion-related reactions were reported. | Up to 3 years |
| Progression Free Survival (PFS) |
Not provided
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:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dana Farber Cancer Institute | Boston | Massachusetts | 02215-5418 | United States | ||
| Levine Cancer Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39971605 | Derived | LaRoche JK, Lanier J, Alvarenga R, Collins M, Costelloe T, Chiau A, Whetherly H, De Soete W, Faludi J, Rens K. Climate footprint of industry-sponsored in-human clinical trials: life cycle assessments of clinical trials spanning multiple phases and disease areas. BMJ Open. 2025 Feb 19;15(2):e085364. doi: 10.1136/bmjopen-2024-085364. | |
| 37022569 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Daratumumab IV | Participants received daratumumab intravenous infusion (Dara IV) 16 milligrams per kilogram (mg/kg) once weekly in Cycle 1 and 2, every 2 weeks in Cycle 3 to 6, every 4 weeks thereafter until disease progression, unacceptable toxicity, withdrawal of consent, the investigator decides to stop treatment, or the start of subsequent anticancer therapy. The duration for each cycle was 28 days. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 1, 2020 | Nov 2, 2023 |
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| Dara IV | Drug | 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. |
|
|
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.
| Up to 3 years |
| Percentage of Participants With Very Good Partial Response (VGPR) or Better | 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. | Up to 3 years |
| Percentage of Participants With Complete Response (Including sCR) or Better | 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. | Up to 3 years |
| Time to Next Therapy | Time to next therapy was defined as the time from randomization to the start of the first subsequent anti-cancer therapy. | Up to 3 years |
| Overall Survival (OS) | OS was defined as the time from the date of randomization to the date of the participant's death due to any cause. | Up to 3 years |
| Patient-Reported Satisfaction With Therapy as Assessed With Cancer Therapy Satisfaction Questionnaire (CTSQ) | 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. | 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) |
| Duration of Response | 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. | Up to 3 years |
| Time to Partial Response (PR) or Better | Time to PR or better was defined as the time from randomization until onset of first response of PR or better. | Up to 3 years |
| Time to Very Good Partial Response (VGPR) or Better | Time to VGPR or better was defined as the time from randomization until onset of first VGPR or better. | Up to 3 years |
| Time to Complete Response (CR) or Better | Time to CR or better was defined as the time from randomization until onset of first CR or better. | Up to 3 years |
| Charlotte |
| North Carolina |
| 28204 |
| United States |
| Royal Prince Alfred Hospital | Camperdown | 2050 | Australia |
| St Vincents 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 | 14784-400 | Brazil |
| Centro de Pesquisa e Ensino em Oncologia de Santa Catarina CEPEN | Florianópolis | 88034-000 | Brazil |
| Fundacao Doutor Amaral Carvalho | Jaú | 17210 080 | Brazil |
| Instituto Joinvilense de Hematologia e Oncologia Ltda Centro de Hematologia e Oncologia | Joinville | 89201-260 | Brazil |
| Associacao Hospitalar Beneficente Sao Vicente de Paulo - Hospital Sao Vicente de Paulo | Passo Fundo | 99010-090 | Brazil |
| Hospital das Clinicas de Porto Alegre | Porto Alegre | 90035-903 | Brazil |
| Instituto de Educacao, Pesquisa e Gestao em Saude | Rio de Janeiro | 22775-001 | Brazil |
| CEHON | Salvador | 45995-000 | Brazil |
| Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto Hospital de Base | São José do Rio Preto | 15090-000 | Brazil |
| Clinica Sao Germano | São Paulo | 01455 010 | Brazil |
| Hospital Das Clinicas Da Faculdade De Medicina Da USP | São Paulo | 05403-010 | Brazil |
| Tom Baker Cancer Centre | Calgary | Alberta | T2N 4N2 | Canada |
| Cross Cancer Institute | Edmonton | Alberta | T6G 1Z2 | Canada |
| The Gordon & Leslie Diamond Health Care Center | Vancouver | British Columbia | V5Z 1M9 | Canada |
| QEII Health Sciences Centre | Halifax | Nova Scotia | B3H 1V7 | Canada |
| Victoria Hospital | London | Ontario | N6A 5W9 | Canada |
| Princess Margaret Hospital | Toronto | Ontario | M5G 1X6 | Canada |
| CHU de Quebec L Hotel Dieu de Quebec | Québec | Quebec | G1R 2J6 | Canada |
| Fakultni nemocnice Brno | Brno | 625 00 | Czechia |
| Fakultni nemocnice Hradec Kralove | Hradec Králové | 500 05 | Czechia |
| Fakultni nemocnice Olomouc | Olomouc | 779 00 | Czechia |
| Fakultni Nemocnice Ostrava | Ostrava | 70852 | Czechia |
| Fakultni nemocnice Plzen, Hemato-onkologicke oddeleni | Pilsen | 323 00 | Czechia |
| Fakultni nemocnice Kralovske Vinohrady | Prague | 100 34 | Czechia |
| Vseobecna fakultni nemocnice v Praze - I. interni klinika - klinika hematologie | Prague | 128 08 | Czechia |
| CHU Caen - Côte de Nacre | Caen | 14033 | France |
| Hopital Claude Huriez | Lille | 59000 | France |
| CHU de Nantes hotel Dieu | Nantes | 44093 | France |
| CHU de Boreaux | Pessac | 33604 | France |
| Centre hospitalier Lyon-Sud | Pierre-Bénite | 69495 | France |
| CHU Poitiers - Hopital la Miletrie | Poitiers | 86021 | France |
| CHU Nancy Brabois | Vandœuvre-lès-Nancy | 54511 | France |
| Alexandra General Hospital of Athens | Athens Attica | 115 28 | Greece |
| Hillel Yaffe Medical Center - Oncology | Hadera | 38100 | Israel |
| Rambam Med.Center - Hematology Institute | Haifa | 31096 | Israel |
| Carmel Medical Center | Haifa | 3436212 | 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 | Milan | 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 | 814-0180 | Japan |
| Chugoku Central Hospital | Fukuyama | 720-0001 | Japan |
| Ogaki Municipal Hospital | Gifu | 503-8502 | Japan |
| Gunma University Hospital | Gunma | 371-0034 | Japan |
| Kobe City Medical Center General Hospital | Kobe | 650 0047 | Japan |
| University Hospital Kyoto Prefectural University of Medicine | Kyoto | 602-8566 | Japan |
| Matsuyama Red Cross Hospital | Matsuyama | 790-8524 | Japan |
| Japanese Red Cross Nagoya Daini Hospital | Nagoya | 466-8650 | Japan |
| Nagoya City University Hospital | Nagoya | 467 8602 | Japan |
| Niigata Cancer Center Hospital | Niigata | 951-8566 | Japan |
| Iwate Medical University Hospital | Numakunai | 020-8505 | Japan |
| National Hospital Organization Okayama Medical Center | Okayama | 701-1192 | Japan |
| Osaka University Hospital | Osaka | 565-0871 | Japan |
| National Hospital Organization Sendai Medical Center | Sendai | 983-8520 | Japan |
| National Hospital Organization Shibukawa Medical Center | Shibukawa | 377-0280 | Japan |
| Japanese Red Cross Medical Center | Shibuya City | 150-8935 | Japan |
| Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny im Ks B Markiewicza | Brzozów | 36-200 | Poland |
| Szpital Uniwersytecki nr 2 im. Jana Biziela w Bydgoszczy | Bydgoszcz | 85-168 | Poland |
| Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespol Szpitali Miejskich | Chorzów | 41-500 | Poland |
| Szpitale Pomorskie Sp z o o | Gdynia | 81 519 | Poland |
| Szpital Uniwersytecki w Krakowie | Krakow | 31 501 | Poland |
| Wojewodzki Szpital Specjalistyczny w Legnicy | Legnica | 59-220 | Poland |
| Samodzielny Publiczny Szpital Kliniczny nr 1 w Lublinie | Lublin | 20-081 | Poland |
| Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego im Karola Marcinkowskiego | Poznan | 60 569 | Poland |
| Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy | Warsaw | 02-781 | Poland |
| Emergency Hospital of Dzerzhinsk | Dzerzhinsk | 606019 | Russia |
| S.P. Botkin Moscow City Clinical Hospital | Moscow | 125284 | Russia |
| City Clinical Hospital # 40 | Moscow | 129301 | Russia |
| Nizhniy Novgorod Region Clinical Hospital | Nizny Novgorod | 603126 | Russia |
| Penza Regional Oncology Dispensary | Penza | 440071 | Russia |
| Ryazan Regional Clinical Hospital | Ryazan | 390039 | Russia |
| Saint Petersburg City Hospital #15 | Saint Petersburg | 123182 | Russia |
| Clinical Research Institute of Hematology and Transfusiology | Saint Petersburg | 191024 | Russia |
| Samara Region Clinical Hospital | Samara | 443095 | Russia |
| Oncology Dispensary of Komi Republic | Syktyvkar | 167904 | Russia |
| Ekaterinburg City Clinical Hospital # 7 | Yekaterinburg | 620137 | Russia |
| Pusan National University Hospital | Busan | 49241 | South Korea |
| National Cancer Center | Goyang-si | 10408 | South Korea |
| Gachon University Gil Medical Center | Incheon | 21565 | South Korea |
| Severance Hospital | Seoul | 03722 | South Korea |
| Asan Medical Center | Seoul | 05505 | South Korea |
| Samsung Medical Center | Seoul | 06351 | South Korea |
| The Catholic University of Korea Seoul St Marys Hospital | Seoul | 06591 | South Korea |
| Ulsan University Hospital | Ulsan | 44033 | South Korea |
| Hosp. Univ. Germans Trias I Pujol | Badalona | 08916 | Spain |
| Hosp Clinic de Barcelona | Barcelona | 08036 | Spain |
| Hosp. Univ. Dr. Josep Trueta | Girona | 17007 | Spain |
| Hosp. Univ. Virgen de Las Nieves | Granada | 18014 | Spain |
| Hosp. de Leon | León | 24008 | Spain |
| Hosp. Gral. Univ. Gregorio Maranon | 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 Alarcón | 28223 | Spain |
| Hosp Clinico Univ de Salamanca | Salamanca | 37007 | Spain |
| Hosp. Univ. de Canarias | San Cristóbal de La Laguna | 38320 | Spain |
| Hosp. Univ. Dr. Peset | Valencia | 46017 | Spain |
| Falu Lasarett | Falun | 79182 | Sweden |
| Helsingborgs lasarett | Helsingborg | 25187 | Sweden |
| Karolinska University Hospital Huddinge | Huddinge | 141 86 | Sweden |
| Skanes universitetssjukhus | Lund | 222 41 | Sweden |
| Norrlands University Hospital | Umeå | 907 46 | Sweden |
| Akademiska Sjukhuset | Uppsala | SE-751 85 | Sweden |
| Chang-Hua Christian Hospital | Changhua | 50006 | Taiwan |
| China Medical University Hospital | Taichung | 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 | Dnipro | 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 8NR | United Kingdom |
| Royal Bournemouth Hospital | Bournemouth | BH7 7DW | United Kingdom |
| Leicester Royal Infirmary - Haematology | Leicester | LE1 5WW | United Kingdom |
| St Bartholomew's Hospital | London | EC1A 7BE | United Kingdom |
| Guys St Thomas Hospital | London | SE1 9RT | United Kingdom |
| Christie Hospital NHS Trust | Manchester | M20 9BX | United Kingdom |
| Nottingham City Hospital | Nottingham | NG5 1PB | United Kingdom |
| Royal Marsden Hospital | Surrey | SM2 5PT | United Kingdom |
| New Cross Hospital | Wolverhampton | WV10 0QP | United Kingdom |
| Li X, Dosne AG, Perez Ruixo C, Perez Ruixo JJ. Pharmacodynamic-Mediated Drug Disposition (PDMDD) Model of Daratumumab Monotherapy in Patients with Multiple Myeloma. Clin Pharmacokinet. 2023 May;62(5):761-777. doi: 10.1007/s40262-023-01232-8. Epub 2023 Apr 6. |
| 35354247 | Derived | 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. |
| 33599794 | Derived | 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. |
| 32852632 | Derived | 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. |
| 32213342 | Derived | 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. |
| FG001 | Daratumumab SC | Participants received daratumumab 1800 mg subcutaneous injection (Dara SC) co-formulated with recombinant human hyaluronidase (rHuPH20) 2000 Units per milliliter (U/mL), once weekly in Cycle 1 and 2, every 2 weeks in Cycle 3 to 6, every 4 weeks thereafter until disease progression, unacceptable toxicity, withdrawal of consent, the investigator decides to stop treatment, or the start of subsequent anticancer therapy. The duration for each cycle was 28 days. |
| Treated (Safety Analysis Set) |
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| COMPLETED |
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| NOT COMPLETED |
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Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Daratumumab IV | Participants received daratumumab intravenous infusion (Dara IV) 16 milligrams per kilogram (mg/kg) once weekly in Cycle 1 and 2, every 2 weeks in Cycle 3 to 6, every 4 weeks thereafter until disease progression, unacceptable toxicity, withdrawal of consent, the investigator decides to stop treatment, or the start of subsequent anticancer therapy. The duration for each cycle was 28 days. |
| BG001 | Daratumumab SC | Participants received daratumumab 1800 mg subcutaneous injection (Dara SC) co-formulated with recombinant human hyaluronidase (rHuPH20) 2000 Units per milliliter (U/mL), once weekly in Cycle 1 and 2, every 2 weeks in Cycle 3 to 6, every 4 weeks thereafter until disease progression, unacceptable toxicity, withdrawal of consent, the investigator decides to stop treatment, or the start of subsequent anticancer therapy. The duration for each cycle was 28 days. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
| ||||||||||||||||
| Stage of Disease (ISS) | Measure Description: The International Staging System (ISS) consists of following 3 stages - Stage I: serum beta2-microglobulin less than (<) 3.5 milligrams per liter (mg/L) and albumin greater than or equal to (>=) 3.5 grams (g) per 100 milliliter; Stage II: neither stage I nor stage III and Stage III: serum beta2-microglobulin >= 5.5 mg/L. | Count of Participants | Participants |
| |||||||||||||||
| Number of prior lines | Count of Participants | Participants |
| ||||||||||||||||
| Refractory status | Count of Participants | Participants |
| ||||||||||||||||
| Weight group | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Overall Response Rate (ORR) | 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. | Intent-to-treat (ITT) population included all the randomized participants. | Posted | Number | 95% Confidence Interval | Percentage of participants | Up to 1 year 8 months |
|
|
| ||||||||||||||||||||||||||||
| Primary | Maximum Trough Concentration (Ctrough) of Daratumumab | Maximum Ctrough was defined as the serum predose concentration of daratumumab on Cycle 3 Day 1. | Pharmacokinetics (PK) population included participants who received at least 1 administration of study drug and had at least 1 PK sample concentration value after the first dose administration. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure. | Posted | Mean | Standard Deviation | micrograms per milliliter (mcg/mL) | Predose on Cycle 3 Day 1 (each cycle of 28 days) |
| ||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Treatment-emergent Infusion-related Reactions (IRR) | Percentage of participants with treatment-emergent infusion-related reactions were reported. | Safety population included all randomized participants who received at least 1 dose of study drug. | Posted | Number | 95% Confidence Interval | Percentage of participants | Up to 3 years |
| ||||||||||||||||||||||||||||||
| Secondary | Progression Free Survival (PFS) | 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. | ITT population included all the randomized participants. | Posted | Median | 95% Confidence Interval | Months | Up to 3 years |
| ||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Very Good Partial Response (VGPR) or Better | 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. | ITT population included all the randomized participants. | Posted | Number | 95% Confidence Interval | Percentage of participants | Up to 3 years |
| ||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Complete Response (Including sCR) or Better | 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. | ITT population included all the randomized participants. | Posted | Number | 95% Confidence Interval | Percentage of participants | Up to 3 years |
| ||||||||||||||||||||||||||||||
| Secondary | Time to Next Therapy | Time to next therapy was defined as the time from randomization to the start of the first subsequent anti-cancer therapy. | ITT population included all the randomized participants. | Posted | Median | 95% Confidence Interval | Months | Up to 3 years |
|
| |||||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) | OS was defined as the time from the date of randomization to the date of the participant's death due to any cause. | ITT population included all the randomized participants. | Posted | Median | 95% Confidence Interval | Months | Up to 3 years |
|
| |||||||||||||||||||||||||||||
| Secondary | Patient-Reported Satisfaction With Therapy as Assessed With Cancer Therapy Satisfaction Questionnaire (CTSQ) | 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. | ITT population included all the randomized participants. Here, 'N' (number of participants analysed) signifies participants who were evaluable for this outcome measure and 'n' (number of participants analyzed) signifies the number of participants analyzed at a specified time point. | Posted | Mean | Standard Deviation | Units on a scale | 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) |
| ||||||||||||||||||||||||||||||
| Secondary | Duration of Response | 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. | Participants analyzed included responders (PR or better) in ITT analysis set. | Posted | Median | 95% Confidence Interval | Months | Up to 3 years |
| ||||||||||||||||||||||||||||||
| Secondary | Time to Partial Response (PR) or Better | Time to PR or better was defined as the time from randomization until onset of first response of PR or better. | Participants analyzed included responders (PR or better) in ITT analysis set. | Posted | Median | Full Range | Months | Up to 3 years |
|
| |||||||||||||||||||||||||||||
| Secondary | Time to Very Good Partial Response (VGPR) or Better | Time to VGPR or better was defined as the time from randomization until onset of first VGPR or better. | Participants analyzed included responders (VGPR or better) in ITT analysis set. Here, 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure. | Posted | Median | Full Range | Months | Up to 3 years |
| ||||||||||||||||||||||||||||||
| Secondary | Time to Complete Response (CR) or Better | Time to CR or better was defined as the time from randomization until onset of first CR or better. | Participants analyzed included responders (CR or better) in ITT analysis set. Here, 'N' (number of participants analysed) signifies participants who were evaluable for this outcome measure. | Posted | Median | Full Range | months | Up to 3 years |
|
Up to 3 years
Safety population included all randomized participants who received at least 1 dose of study drug.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Daratumumab IV | Participants received daratumumab intravenous infusion (Dara IV) 16 milligrams per kilogram (mg/kg) once weekly in Cycle 1 and 2, every 2 weeks in Cycle 3 to 6, every 4 weeks thereafter until disease progression, unacceptable toxicity, withdrawal of consent, the investigator decides to stop treatment, or the start of subsequent anticancer therapy. The duration for each cycle was 28 days. | 130 | 258 | 89 | 258 | 216 | 258 |
| EG001 | Daratumumab SC | Participants received daratumumab 1800 mg subcutaneous injection (Dara SC) co-formulated with recombinant human hyaluronidase (rHuPH20) 2000 Units per milliliter (U/mL), once weekly in Cycle 1 and 2, every 2 weeks in Cycle 3 to 6, every 4 weeks thereafter until disease progression, unacceptable toxicity, withdrawal of consent, the investigator decides to stop treatment, or the start of subsequent anticancer therapy. The duration for each cycle was 28 days. | 126 | 260 | 83 | 260 | 217 | 260 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Disseminated Intravascular Coagulation | Blood and lymphatic system disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Febrile Neutropenia | Blood and lymphatic system disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Hyperviscosity Syndrome | Blood and lymphatic system disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Acute Coronary Syndrome | Cardiac disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Angina Pectoris | Cardiac disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Atrial Fibrillation | Cardiac disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Atrioventricular Block | Cardiac disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Atrioventricular Block Complete | Cardiac disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Cardiac Failure | Cardiac disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Cardiac Failure Chronic | Cardiac disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Cardiopulmonary Failure | Cardiac disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Myocardial Infarction | Cardiac disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Myocardial Ischaemia | Cardiac disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Deafness Neurosensory | Ear and labyrinth disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Hypoacusis | Ear and labyrinth disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Gastrointestinal Haemorrhage | Gastrointestinal disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Gingival Bleeding | Gastrointestinal disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Inguinal Hernia | Gastrointestinal disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Oesophageal Varices Haemorrhage | Gastrointestinal disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Small Intestinal Obstruction | Gastrointestinal disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Subileus | Gastrointestinal disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Chest Discomfort | General disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Chest Pain | General disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| General Physical Health Deterioration | General disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Multiple Organ Dysfunction Syndrome | General disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Performance Status Decreased | General disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Acute Hepatitis B | Infections and infestations | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Bronchiolitis | Infections and infestations | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Campylobacter Gastroenteritis | Infections and infestations | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Corona Virus Infection | Infections and infestations | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Device Related Infection | Infections and infestations | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Escherichia Infection | Infections and infestations | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Furuncle | Infections and infestations | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Hepatitis B Reactivation | Infections and infestations | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Listeriosis | Infections and infestations | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Lower Respiratory Tract Infection | Infections and infestations | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Lung Infection | Infections and infestations | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Mastoiditis | Infections and infestations | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Meningitis Cryptococcal | Infections and infestations | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Meningitis Pneumococcal | Infections and infestations | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Neutropenic Sepsis | Infections and infestations | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Pneumocystis Jirovecii Pneumonia | Infections and infestations | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Respiratory Syncytial Virus Bronchitis | Infections and infestations | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Respiratory Tract Infection | Infections and infestations | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Rhinovirus Infection | Infections and infestations | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Septic Shock | Infections and infestations | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Staphylococcal Sepsis | Infections and infestations | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Femoral Neck Fracture | Injury, poisoning and procedural complications | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Femur Fracture | Injury, poisoning and procedural complications | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Humerus Fracture | Injury, poisoning and procedural complications | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Subdural Haematoma | Injury, poisoning and procedural complications | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Upper Limb Fracture | Injury, poisoning and procedural complications | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Blood Pressure Increased | Investigations | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| General Physical Condition Abnormal | Investigations | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Oxygen Saturation Decreased | Investigations | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Hypernatraemia | Metabolism and nutrition disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Bone Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Muscular Weakness | Musculoskeletal and connective tissue disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Myofascial Pain Syndrome | Musculoskeletal and connective tissue disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Neck Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Pain in Extremity | Musculoskeletal and connective tissue disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Pathological Fracture | Musculoskeletal and connective tissue disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Rhabdomyolysis | Musculoskeletal and connective tissue disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Spinal Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Trismus | Musculoskeletal and connective tissue disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Adenocarcinoma of Colon | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Colon Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Gastric Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Lung Neoplasm Malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Metastases to Liver | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Oesophageal Squamous Cell Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Plasmacytoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Prostate Cancer Recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Thyroid Neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Tumour Associated Fever | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Brain Oedema | Nervous system disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Cerebral Infarction | Nervous system disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Cerebrovascular Accident | Nervous system disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Cerebrovascular Insufficiency | Nervous system disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Iiird Nerve Paralysis | Nervous system disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Monoparesis | Nervous system disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Peripheral Sensory Neuropathy | Nervous system disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Spinal Cord Compression | Nervous system disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Transient Ischaemic Attack | Nervous system disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Confusional State | Psychiatric disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Acute Kidney Injury | Renal and urinary disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Myeloma Cast Nephropathy | Renal and urinary disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Renal Failure | Renal and urinary disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Pelvic Pain | Reproductive system and breast disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Chronic Obstructive Pulmonary Disease | Respiratory, thoracic and mediastinal disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Lung Disorder | Respiratory, thoracic and mediastinal disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Pulmonary Oedema | Respiratory, thoracic and mediastinal disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Pulmonary Thrombosis | Respiratory, thoracic and mediastinal disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Respiratory Distress | Respiratory, thoracic and mediastinal disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Circulatory Collapse | Vascular disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Deep Vein Thrombosis | Vascular disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Chills | General disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Oedema Peripheral | General disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Bone Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Musculoskeletal Chest Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Musculoskeletal Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Pain in Extremity | Musculoskeletal and connective tissue disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Nasal Congestion | Respiratory, thoracic and mediastinal disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA Version 21.1 | Non-systematic Assessment |
|
If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Head | Janssen Research & Development, LLC | 844-434-4210 | ClinicalTrialDisclosure@its.jnj.com |
| Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 12, 2019 | Jun 19, 2020 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| BRAZIL |
|
| CANADA |
|
| CZECH REPUBLIC |
|
| FRANCE |
|
| GREECE |
|
| ISRAEL |
|
| ITALY |
|
| JAPAN |
|
| POLAND |
|
| RUSSIAN FEDERATION |
|
| SOUTH KOREA |
|
| SPAIN |
|
| SWEDEN |
|
| TAIWAN |
|
| UKRAINE |
|
| UNITED KINGDOM |
|
| UNITED STATES |
|
| Stage II |
|
| Stage III |
|
| Data missing or Unknown |
|
| Greater than (>) 4 Lines |
|
| IMiD only |
|
| None |
|
| PI only |
|
| >65 - 85 |
|
| >85 |
|
| Not Reported |
|
|
|
| Units | Counts |
|---|
| Participants |
|
|
| Daratumumab SC |
Participants received daratumumab 1800 mg subcutaneous injection (Dara SC) co-formulated with recombinant human hyaluronidase (rHuPH20) 2000 Units per milliliter (U/mL), once weekly in Cycle 1 and 2, every 2 weeks in Cycle 3 to 6, every 4 weeks thereafter until disease progression, unacceptable toxicity, withdrawal of consent, the investigator decides to stop treatment, or the start of subsequent anticancer therapy. The duration for each cycle was 28 days. |
|
|
|
|
|
|
| Counts |
|---|
| Participants |
|
|
| Participants |
|
|
| OG001 |
| Daratumumab SC |
Participants received daratumumab 1800 mg subcutaneous injection (Dara SC) co-formulated with recombinant human hyaluronidase (rHuPH20) 2000 Units per milliliter (U/mL), once weekly in Cycle 1 and 2, every 2 weeks in Cycle 3 to 6, every 4 weeks thereafter until disease progression, unacceptable toxicity, withdrawal of consent, the investigator decides to stop treatment, or the start of subsequent anticancer therapy. The duration for each cycle was 28 days. |
|
|
Participants received daratumumab 1800 mg subcutaneous injection (Dara SC) co-formulated with recombinant human hyaluronidase (rHuPH20) 2000 Units per milliliter (U/mL), once weekly in Cycle 1 and 2, every 2 weeks in Cycle 3 to 6, every 4 weeks thereafter until disease progression, unacceptable toxicity, withdrawal of consent, the investigator decides to stop treatment, or the start of subsequent anticancer therapy. The duration for each cycle was 28 days.
|
|
| Counts |
|---|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|