Daratumumab Retreatment in Participants With Multiple Myeloma Who Have Been Previously Treated With Daratumumab
Study Details
Study Description
Brief Summary
The purpose of this study is to compare the efficacy (rate of very good partial response [VGPR] or better as best response as defined by the International Myeloma Working Group [IMWG] criteria) of daratumumab subcutaneous (Dara-SC) in combination with carfilzomib and dexamethasone (Kd) with the efficacy of Kd in participants with relapsed refractory multiple myeloma who were previously exposed to daratumumab to evaluate daratumumab retreatment.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Detailed Description
For relapsed or refractory multiple myeloma, the treatment is determined on an individual basis. Common standard of care regimens use either a proteasome inhibitor (PI) or an immunomodulatory agent (IMiD) in combination with dexamethasone with or without a monoclonal antibody (mAb) such as daratumumab. After relapse from PIs or IMiDs, patients are often retreated with drugs that have same mechanism of action to which they have been sensitive. The disease becomes refractory and all effective treatment options are exhausted. Daratumumab is a human IgG1 mAb that binds with high affinity to unique epitope on cluster of differentiation 38 (CD38) and attacks tumor cells that overexpress CD38. Study is to determine the efficacy of Dara-SC in combination with carfilzomib and dexamethasone (DKd) in adult participants with relapsed refractory MM who had 1 to 3 prior line(s) of treatment including a line containing daratumumab to evaluate daratumumab retreatment. The MM treatment is determined on an individual basis where patient's age, prior therapy, bone marrow function, co-morbidities, patient preference and time to relapse are considered. Common standard of care regimens use either PI or an IMiD in combination with dexamethasone with or without a mAb. It is a targeted immunotherapy that attacks tumor cells that overexpress CD38, a transmembrane glycoprotein, in a variety of hematological malignancies including multiple myeloma. The study will be conducted in 3 phases: Screening (28 days), Treatment, and Follow-Up. Assessments like chest X-ray, spirometry test, electrocardiogram (ECG), will be performed during Screening phase. During the Treatment Phase, participants will be randomized to receive Kd or DKd. Efficacy assessments like bone marrow examination will be performed. Follow-up will continue until the end of study.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Arm A: Carfilzomib+Dexamethasone (Kd) Participants will receive carfilzomib 20 milligram per square meter (mg/m^2) intravenously (IV) on Day 1 of Cycle 1 and then 70 mg/m^2 on Days 8 and 15 of Cycle 1 and thereafter on Days 1, 8, 15 of Cycle 2 onwards. Participants will receive dexamethasone 20 mg on Cycle 1 Day 1, a second dose of 20 milligram (mg) will be given on Cycle 1 Day 2 and 40 mg IV or orally on Days 8, 15, 22 for Cycle 1. Patients will then receive dexamethasone 40mg on days 1, 8, 15 and 22 for cycles 2-9, then on Days 1, 8, 15 for Cycle 10 onwards, until death, intolerable toxicity, start of a new treatment for multiple myeloma, withdrawal of consent, or end of the study. The total duration of each cycle is 28 Days. |
Drug: Carfilzomib 20 mg/m^2
Carfilzomib 20 mg/m^2 will be administered intravenously (IV).
Drug: Carfilzomib 70 mg/m^2
Carfilzomib 70 mg/m^2 will be administered IV.
Drug: Dexamethasone 40 mg
Dexamethasone 40 mg will be administered as IV infusion or orally.
Drug: Dexamethasone 20 mg
Dexamethasone 20 mg will be administered as IV infusion or orally.
|
| Experimental: Arm B: Dara-SC in combination with Kd (DKd) Participants will receive daratumumab subcutaneous (Dara-SC) 1800 mg by SC injection on Days 1, 8, 15, 22 for Cycle 1 and 2, Days 1 and 15 for Cycle 3-6, Day 1 for Cycle 7 onwards. Participants will receive carfilzomib 20 mg/m^2 IV on Cycle 1 Day 1 and then 70 mg/m^2 on Day 8 and 15 of Cycle 1 and Days 1, 8 and 15 of Cycle 2. Participants will receive dexamethasone 20 mg on Cycle 1 Day 1, a second dose of 20 milligram (mg) will be given on Cycle 1 Day 2 and 40 mg IV or orally on Days 8, 15, 22 for Cycle 1. Patients will then receive dexamethasone 40mg on days 1, 8, 15 and 22 for cycles 2-9, then on Days 1, 8, 15 for Cycle 10 onwards, until death, intolerable toxicity, start of a new treatment for multiple myeloma, withdrawal of consent, or end of the study. The total duration of each cycle is 28 Days. |
Drug: Carfilzomib 20 mg/m^2
Carfilzomib 20 mg/m^2 will be administered intravenously (IV).
Drug: Carfilzomib 70 mg/m^2
Carfilzomib 70 mg/m^2 will be administered IV.
Drug: Dexamethasone 40 mg
Dexamethasone 40 mg will be administered as IV infusion or orally.
Drug: Dara-SC 1800 mg
Dara-SC 1800 mg will be administered by SC injection.
Drug: Dexamethasone 20 mg
Dexamethasone 20 mg will be administered as IV infusion or orally.
|
Outcome Measures
Primary Outcome Measures
- Percentage of Participants Achieving Very Good Partial Response (VGPR) or Better Response [Up to 6 years and 9 months]
Percentage of participants achieving VGPR or better response according IMWG criteria for VGPR will be reported. IMWG criteria for VGPR: Serum and urine M-component detectable by immunofixation but not on electrophoresis, or greater than or equal to (>=) 90 percent (%) reduction in serum M-protein plus urine M-protein less than (<) 100 milligram (mg)/24 hours.
Secondary Outcome Measures
- Overall Response Rate (ORR) [Up to 6 years and 9 months]
ORR is defined as percentage of participants who achieve partial response (PR) or better (including VGPR, CR, sCR) responses prior to subsequent anti-myeloma therapy. IMWG criteria for PR: >=50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by >=90% or to <200 mg/24 hours; If the serum and urine M-protein are not measurable, a decrease of >=50% in the difference between involved and uninvolved free light chain (FLC) levels is required in place of the M-protein criteria; If serum and urine M-protein are not measurable, and serum free light assay is also not measurable, >=50% reduction in bone marrow plasma cells (PCs) is required in place of M-protein, provided baseline bone marrow plasma cell percentage was >=30%; additionally, if present at baseline, a >=50% reduction in the size of soft tissue PCs is also required.
- Percentage of Participants Achieving Complete Response (CR) or Stringent Complete Response (sCR) [Up to 6 years and 9 months]
Complete response is based on serum M-Protein assessments. IMWG criteria for CR: Negative immunofixation on the serum and urine, and Disappearance of any soft tissue plasmacytomas (PCs), and <5% PCs in bone marrow. IMWG criteria for sCR defined as, CR plus normal free light chain (FLC) ratio, and Absence of clonal PCs by immunohistochemistry, immunofluorescence or 2- to 4- color flow cytometry.
- Progression Free Survival (PFS) [Up to 6 years and 9 months]
PFS is time from date of randomization to date of documented progressive disease (PD) on first line treatment given for multiple myeloma (MM) or death, whichever comes first. IMWG criteria for PD: >=25% from lowest response level in serum M-component (the absolute increase must be >=0.5 gram per deciliter [g/dL]) and/or in urine M-component (the absolute increase must be >=200 mg/24 hour); only in participants without measurable serum and urine M-protein levels: increase of >=25% in the difference between involved and uninvolved free light chain levels and the absolute increase must be >10 mg/dL. BMPC%: the absolute % must be >=10%; definite increase in size of existing bone lesions or soft tissue plasmacytomas; definite development of new bone lesions or soft tissue plasmacytomas; development of hypercalcemia (corrected serum calcium >11.5 milligrams per deciliter (mg/dL) or 2.65 millimoles per liter [mmol/L]) that can be attributed solely to PC proliferative disorder.
- Overall Survival (OS) [Up to 6 years and 9 months]
OS is defined as the time from the date of first dose of study drug to date of death due to any cause. If the participant is alive or the vital status is unknown, the participant will be censored at the date the participant will be last known to be alive.
- Percentage of Participants With Negative Minimal Residual Disease (MRD) [Up to 6 years and 9 months]
Percentage of participants who have achieved MRD negative status will be assessed.
- Time to Next Treatment [Up to 6 years and 9 months]
Time to next treatment is defined as the time from randomization to the start of the next-line treatment.
- Serum Concentrations of Daratumumab [Arm A: Cycle 1 (each cycle of 28 days) Day 1 (Cycle 1 Day 1), Cycle 3 Day 1; Arm B: Cycle 1 Day1, Cycle 3 Day 1, Cycle 7 Day 1 and Follow Up (post treatment Week 8)]
Serum concentrations of daratumumab will be assessed.
- Number of Participants with Anti-Daratumumab Antibodies [Arm A: Cycle 1 (each cycle of 28 days) Day 1 (Cycle 1 Day 1), Cycle 3 Day 1; Arm B: Cycle 1 Day1, Cycle 3 Day 1, Cycle 7 Day 1 and Follow Up (post treatment Week 8)]
Number of participants who test positive for anti-daratumumab antibodies will be reported.
- Number of Participants with Anti-recombinant Human Hyaluronidase (rHuPH20) Antibodies [Arm A: Cycle 1 (each cycle of 28 days) Day 1 (Cycle 1 Day 1), Cycle 3 Day 1; Arm B: Cycle 1 Day1, Cycle 3 Day 1, Cycle 7 Day 1 and Follow Up (post treatment Week 8)]
Number of participants who test positive for anti-rHuPH20 antibodies will be reported.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Evidence of a response (partial response or better based on investigator's determination of response by International Myeloma Working Group [IMWG] criteria) to daratumumab-containing therapy with response duration of at least 4 months
-
Participants must have progressed from or be refractory to their last line of treatment. Relapsed or refractory disease as defined as: a) Relapsed disease is defined as an initial response to previous treatment, followed by confirmed progressive disease (PD) by IMWG criteria greater than (>) 60 days after cessation of treatment. b) Refractory disease is defined as less than (<) 25 percent (%) reduction in M-protein or confirmed PD by IMWG criteria during previous treatment or >60 days after cessation of treatment
-
Received 1 to 3 prior line(s) of treatment of which one contained daratumumab, and completed daratumumab at least 3 months prior to randomization. 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 per day [mg/day] for 4 days) would not be considered prior lines of therapy
-
Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0, 1, or 2
-
Women of childbearing potential must have a negative urine or serum pregnancy test at screening within 14 days prior to randomization
Exclusion Criteria:
-
Previous treatment with daratumumab within the last 3 months prior to randomization
-
Discontinuation of daratumumab due to a daratumumab-related adverse event (AE)
-
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
-
Allergies, hypersensitivity, or intolerance to daratumumab, hyaluronidase, monoclonal antibodies (mAbs), human proteins, or their excipients, or known sensitivity to mammalian-derived products. Known history of allergy to Captisol (a cyclodextrin derivative used to solubilize carfilzomib)
-
Participant is: a) Known to be seropositive for human immunodeficiency virus (HIV) with one or more of the following: not receiving highly active antiretroviral therapy (ART), had a change in ART within 6 months of the start of screening, receiving ART that may interfere with study treatment, cluster of differentiation (CD)4 count <350 (unit: cells per cubic millimeter of blood) at screening, acquired immunodeficiency syndrome (AIDS)-defining opportunistic infection within 6 months of start of screening, and not agreeing to start ART and be on ART >4 weeks plus having HIV viral load <400 copies/milliliters (mL) at end of 4-week period (to ensure ART is tolerated and HIV controlled. b) Seropositive for hepatitis B (defined by a positive test for hepatitis B surface antigen [HBsAg]). Participants with resolved infection (example: participants who are HBsAg negative but positive for antibodies to hepatitis B core antigen [anti-HBc] and/or antibodies to hepatitis B surface antigen [anti-HBs]) must be screened using real-time polymerase chain reaction (PCR) measurement of hepatitis B virus (HBV) deoxyribonucleic acid (DNA) levels. Those who are PCR positive will be excluded. c) Known to be seropositive for hepatitis C (except in the setting of a sustained virologic response [SVR], defined as aviremia at least 12 weeks after completion of antiviral therapy)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Banner MD Anderson Cancer Center | Gilbert | Arizona | United States | 85234 |
| 2 | Oncology Institute of Hope and Innovation | Tucson | Arizona | United States | 85745 |
| 3 | American Institute of Research (AIR) | Whittier | California | United States | 90603 |
| 4 | Fort Wayne Medical Oncology and Hematology, Inc. | Fort Wayne | Indiana | United States | 46804 |
| 5 | Karmanos Cancer Institute - Wayne State University | Detroit | Michigan | United States | 48201 |
| 6 | Mayo Clinic - Rochester | Rochester | Minnesota | United States | 55905 |
| 7 | Washington University School of Medicine | Saint Louis | Missouri | United States | 63110-1032 |
| 8 | Columbia University Medical Center | New York | New York | United States | 10032 |
| 9 | Weill Medical College of Cornell University | New York | New York | United States | 10065 |
| 10 | Cleveland Clinic Main Campus | Cleveland | Ohio | United States | 44195 |
| 11 | Baylor Scott and White Health | Dallas | Texas | United States | 75246 |
| 12 | Millennium Oncology | Houston | Texas | United States | 77090 |
| 13 | Medical College Of Wisconsin | Milwaukee | Wisconsin | United States | 53226 |
| 14 | ZNA Stuivenberg | Antwerpen | Belgium | 2060 | |
| 15 | UZ Gent | Gent | Belgium | 9000 | |
| 16 | Universidade Estadual de Campinas (UNICAMP) - Centro De Hematologia e Hemoterapia | Campinas | Brazil | 13083-878 | |
| 17 | Hospital Erasto Gaertner- Liga Paranaense de Combate ao Câncer | Curitiba | Brazil | 81520-060 | |
| 18 | Hospital Das Clinicas Da Universidade Federal De Goias | Goiânia | Brazil | ||
| 19 | Liga Norte Riograndense Contra O Cancer | Natal | Brazil | 59062-000 | |
| 20 | Santa Casa Porto Alegre | Porto Alegre | Brazil | 90050-170 | |
| 21 | Centro Gaucho Integrado De Oncologia | Porto Alegre | Brazil | 90110-270 | |
| 22 | INCA - Instituto Nacional Do Cancer | Rio De Janeiro | Brazil | 20230-130 | |
| 23 | Instituto COI de Educacao e Pesquisa | Rio De Janeiro | Brazil | 22793-080 | |
| 24 | Hospital Sao Rafael | Salvador | Brazil | 41253-190 | |
| 25 | CEHON | Salvador | Brazil | 45995-000 | |
| 26 | Instituto de Ensino E Pesquisa Sao Lucas | Sao Paulo | Brazil | 01236-030 | |
| 27 | Ac Camargo Cancer Center | Sao Paulo | Brazil | 01509-010 | |
| 28 | IBCC Instituto Brasileiro de Controle do Cancer | Sao Paulo | Brazil | 03102-002 | |
| 29 | Hospital Beneficencia Portuguesa | São Paulo | Brazil | 01323-030 | |
| 30 | Clinica Sao Germano | São Paulo | Brazil | 01455-010 | |
| 31 | Tom Baker Cancer Centre | Calgary | Alberta | Canada | T2N 4N2 |
| 32 | Aarhus University Hospital | Aarhus N | Denmark | DK-8200 | |
| 33 | Regionshospitalet i Holstebro | Holstebro | Denmark | 7500 | |
| 34 | Haematological Research unit HFE-X OUH. | Odense | Denmark | 5000 | |
| 35 | Vejle Hospital | Vejle | Denmark | DK-7100 | |
| 36 | Hopital Claude Huriez | Lille | France | 59037 | |
| 37 | CHU de Montpellier, Hopital Saint-Eloi | Montpellier | France | 34295 | |
| 38 | Centre Hospitalier Emile Muller | Mulhouse | France | 68100 | |
| 39 | Hotel Dieu | Nantes | France | 44035 | |
| 40 | Hopitaux Universitaires Est Parisien Hopital Saint Antoine | Paris | France | 75012 | |
| 41 | Hopital de la Pitie Salpetriere | Paris | France | 75013 | |
| 42 | Hôpital Necker-Enfants Malades | Paris | France | 75743 | |
| 43 | Fentre F Magendie, Hôpital Haut Leveque, CHU Bordeaux | Pessac | France | 33600 | |
| 44 | Centre Hospitalier Lyon-Sud Service d'hematologie | Pierre Benite | France | 69310 | |
| 45 | CHU Poitiers - Hôpital la Milétrie | Poitiers | France | 86021 | |
| 46 | Chu Rennes - Hopital Pontchaillou | Rennes Cedex | France | 35033 | |
| 47 | Institut Claudius Regaud | Toulouse | France | 31052 | |
| 48 | CHU Bretonneau | Tours | France | 37044 | |
| 49 | CHU Nancy Brabois | Vandoeuvre Les Nancy | France | 54511 | |
| 50 | Universitätsklinik Carl Gustav Carus, Med. Klinik u. Poliklinik I | Dresden | Germany | 1307 | |
| 51 | Evangelisches Krankenhaus Essen-Werden | Essen | Germany | 45239 | |
| 52 | Universitatsklinikum Essen | Essen | Germany | D-45147 | |
| 53 | Universitätsklinik Hamburg-Eppendorf UKE | Hamburg | Germany | 20246 | |
| 54 | St. Barbara-Klinik Hamm GmbH | Hamm | Germany | 59075 | |
| 55 | Universitaetsklinikum Heidelberg | Heidelberg | Germany | 69120 | |
| 56 | Praxisklinik für Haematologie und Onkologie Koblenz | Koblenz | Germany | 56068 | |
| 57 | Universitaetsklinikum Koeln | Koeln | Germany | 50397 | |
| 58 | Universitätsmedizin der Johannes gutenberg-Universität; III. Med. Klinik - Germany | Mainz | Germany | 55101 | |
| 59 | Onkologische Schwerpunkt Praxis | Saarbrucken | Germany | ||
| 60 | Klinikum der Eberhard-Karls-Universität/Abt. für innere Med. II/Hämatologie/Onkologie-Germany | Tubingen | Germany | 72076 | |
| 61 | Schwarzwald-Baar Klinikum | Villingen-Schwenningen | Germany | 78052 | |
| 62 | Universitätsklinikum Würzburg Med. Klinik U. Poliklinik Ii | Würzburg | Germany | 97080 | |
| 63 | Alexandra General Hospital of Athens | Athens Attica | Greece | 115 28 | |
| 64 | University of Athens - Evaggelismos Hospital (Evangelismos Hospital) | Athens | Greece | 106 76 | |
| 65 | University Hospital Of Larissa | Larisa | Greece | 41110 | |
| 66 | University General Hospital of Rio | Patra | Greece | 26500 | |
| 67 | Anticancer Hospital of Thessaloniki 'Theageneio' | Thessaloniki | Greece | 546 39 | |
| 68 | Azienda Ospedaliera Papa Giovanni XXIII | Bergamo | Italy | 24127 | |
| 69 | Istituto di Ematologia Seràgnoli azienda ospedaliera univeristaria Policlinico S.Orsola-Malpighi | Bologna | Italy | 40138 | |
| 70 | Azienda Ospedaliera Universitaria Careggi | Firenze | Italy | 50139 | |
| 71 | IRCCS Azienda Ospedaliera San Martino - IST | Genova | Italy | 16132 | |
| 72 | San Martino Hospital | Genova | Italy | 16132 | |
| 73 | Asst Ovest Milanese - Ospedale Di Legnano | Legnano | Italy | 20025 | |
| 74 | Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori | Meldola | Italy | 47014 | |
| 75 | ASST Grande Ospedale Metropolitano Niguarda | Milano | Italy | 20162 | |
| 76 | Ospedale Maggiore della Carità | Novara | Italy | 28100 | |
| 77 | Casa di Cura La Maddalena | Palermo | Italy | 90146 | |
| 78 | Ospedale Villa Sofia-Cervello | Palermo | Italy | 90146 | |
| 79 | Fondazione IRCCS Policlinico San Matteo | Pavia | Italy | 27100 | |
| 80 | Universita Degli Studi di Roma 'Tor Vergata' | Roma | Italy | 00133 | |
| 81 | Sapienza University of Rome | Roma | Italy | 00161 | |
| 82 | ASL ROMA | Roma | Italy | 30 - 00153 | |
| 83 | Fondazione Policlinico Universitario A. Gemelli IRCCS | Rome | Italy | 00168 | |
| 84 | IRCCS Ospedale Casa Sollievo della Sofferenza | San Giovanni Rotondo | Italy | 71013 | |
| 85 | Azienda Ospedaliera Santa Maria | Terni | Italy | 5100 | |
| 86 | VUMC | Amsterdam | Netherlands | 1081 | |
| 87 | Albert Schweitzer ziekenhuis-lokatie Dordwijk | Dordrecht | Netherlands | 3318 AT | |
| 88 | Zuyderland Medical Center | Sittard | Netherlands | 6130 MB | |
| 89 | Szpital Uniwersytecki nr 2 im. Jana Biziela w Bydgoszczy | Bydgoszcz | Poland | 85-168 | |
| 90 | Szpital Wojewodzki w Opolu | Opole | Poland | 45-061 | |
| 91 | Szpital Magodent | Warszawa | Poland | 01-748 | |
| 92 | Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu | Wroclaw | Poland | 50-367 | |
| 93 | Emergency Hospital of Dzerzhinsk | Dzerzhinsk | Russian Federation | 606019 | |
| 94 | S.P. Botkin Moscow City Clinical Hospital | Moscow | Russian Federation | 125284 | |
| 95 | Nizhniy Novgorod Region Clinical Hospital | Nizhny Novgorod | Russian Federation | 603126 | |
| 96 | Ryazan Regional Clinical Hospital | Ryazan | Russian Federation | 390003 | |
| 97 | Samara Region Clinical Hospital | Samara | Russian Federation | 443095 | |
| 98 | Oncological dispensary #2 | Sochi | Russian Federation | 354057 | |
| 99 | Clinical Research Institute of Hematology and Transfusiology | St-Petersburg | Russian Federation | 191024 | |
| 100 | Oncology Dispensary of Komi Republic | Syktyvkar | Russian Federation | 167904 | |
| 101 | Hosp. Clinic I Provincial de Barcelona | Barcelona | Spain | 08036 | |
| 102 | Inst. Cat. Doncologia-H Duran I Reynals | Barcelona | Spain | 08908 | |
| 103 | Hosp. de Jerez de La Frontera | Jerez de la Frontera | Spain | 11407 | |
| 104 | Hosp. de Leon | Leon | Spain | 24080 | |
| 105 | Hosp. Univ. Ramon Y Cajal | Madrid | Spain | 28034 | |
| 106 | Hosp. Univ. 12 de Octubre | Madrid | Spain | 28041 | |
| 107 | Hosp. Univ. de La Paz | Madrid | Spain | 28046 | |
| 108 | Hosp. Costa Del Sol | Malaga | Spain | 29603 | |
| 109 | Hosp. Univ. Son Espases | Palma | Spain | 7120 | |
| 110 | Clinica Univ. de Navarra | Pamplona | Spain | 31008 | |
| 111 | Hosp. Clinico Univ. de Salamanca | Salamanca | Spain | 37007 | |
| 112 | Hosp. Univ. de Canarias | San Cristóbal de La Laguna | Spain | 38320 | |
| 113 | Hosp. Virgen Del Rocio | Sevilla | Spain | 41013 | |
| 114 | Hosp. Gral. Univ. de Toledo | Toledo | Spain | 45007 |
Sponsors and Collaborators
- Janssen Research & Development, LLC
Investigators
- Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CR108598
- 2018-004185-34
- 54767414MMY2065