The purpose of this study is to compare the efficacy of JNJ-68284528 with standard therapy, either Pomalidomide, Bortezomib and Dexamethasone (PVd) or Daratumumab, Pomalidomide and Dexamethasone (DPd).
Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
No |
Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies. |
Interventional |
Eligible Ages | 18 Years and Over |
Gender | All |
Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries. |
NCT04181827 |
Phase
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use. |
Phase 3 |
Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
Janssen Research & Development, LLC |
Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
Janssen Research & Development, LLC Clinical Trial |
Principal Investigator Affiliation | Janssen Research & Development, LLC |
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Industry |
Overall Status | Recruiting |
Countries | Australia, Austria, Belgium, Denmark, France, Germany, Greece, Israel, Italy, Japan, Korea, Republic of, Netherlands, Poland, Spain, Sweden, United Kingdom, United States |
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Multiple Myeloma |
Study Website: | View Trial Website |
Multiple myeloma is a malignant plasma cell disorder diagnosed annually in approximately 86,000 participants worldwide. JNJ-68284528 is an autologous chimeric antigen receptor T-cell (CAR-T) therapy that targets B-cell maturation antigen (BCMA), a molecule expressed on the surface of mature B lymphocytes and malignant plasma cells. The primary hypothesis for this study is that JNJ-68284528 will significantly improve progression free survival (PFS) compared with standard therapy (PVd or DPd), in participants who have previously received 1 to 3 prior line(s) of therapy, that included a proteasome inhibitor (PI) and an immunomodulatory drug (IMiD) and who are refractory to lenalidomide. This study will be conducted in 3 phases: Screening (up to 28 days before randomization), Treatment, and Follow-Up. Assessment like patient-reported outcome(s) (PROs) assessments, electrocardiogram (ECG), vital signs, pharmacokinetic will be performed during the study. Safety evaluations will include review of adverse events, laboratory test results, vital sign measurements, physical examination findings, and assessments of cardiac function, Immune Effector Cell-associated Encephalopathy (only for Arm B) and Eastern Cooperative Oncology Group performance status. Safety data will be periodically reviewed by an Independent Data Monitoring Committee (IDMC). The duration of the study is approximately 6 years.
Experimental: Arm A: PVd or DPd (Standard Therapy)
Participants will receive either PVd or DPd as a standard therapy. In PVd treatment, participants will receive oral pomalidomide 4 mg on Days 1 to 14 in each cycle; bortezomib 1.3 mg/meter square (m^2) SC on Days 1, 4, 8 and 11 (Cycles 1 to 8) and on Days 1 and 8 (Cycle 9 onwards) and oral dexamethasone 20 mg on Days 1, 2, 4, 5, 8, 9, 11 and 12 (Cycles 1 to 8) and Days 1, 2, 8 and 9 (Cycle 9 onwards). Each cycle will consist of 21 days. In DPd treatment, participants will receive daratumumab SC 1800 mg weekly on Days 1, 8, 15, and 22 (Cycles 1 and 2), every 2 weeks on Days 1 and 15 (Cycles 3 to 6) and every 4 weeks on Day 1 (Cycle 7 onwards); oral pomalidomide 4 mg on Days 1 to 21 (Cycle 1 onwards); dexamethasone 40 mg oral or IV weekly on Days 1, 8, 15, and 22 (Cycle 1 onwards). Each cycle will consist of 28 days. Participants will continue to receive PVd or DPd until confirmed PD, death, intolerable toxicity, withdrawal of consent, or end of the study, whichever occurs earlier.
Experimental: Arm B: JNJ-68284528
Participants will receive one cycle of bridging therapy (PVd or DPd) and additional cycles of bridging therapy may be considered based on participant's clinical status and timing of availability of JNJ-68284528 along with conditioning regimen (cyclophosphamide 300 milligram [mg]/m^2 intravenous [IV] and fludarabine 30 mg/m^2 IV daily, for 3 days), and JNJ-68284528 infusion 0.75 * 10^6 chimeric antigen receptor (CAR)-positive viable T cells/ kilogram (kg).
Drug: - JNJ-68284528
JNJ-68284528 infusion will be administered at a target dose of 0.75 * 10^6 CAR-positive viable T cells/kilogram (kg).
Drug: - Pomalidomide
Pomalidomide 4 mg will be administered orally.
Drug: - Bortezomib
Bortezomib 1.3 milligram per meter square (mg/m^2) will be administered subcutaneously (SC).
Drug: - Dexamethasone
Dexamethasone 20 mg/day (10mg/day for participants >75 years of age) (on bortezomib treatment days and the days following bortezomib treatment) will be administered orally in PVd treatment; and orally or intravenous (IV) at 40 mg weekly (20mg weekly for participants >75 years of age) in DPd treatment.
Drug: - Daratumumab
Daratumumab 1800 mg will be administered SC.
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
Status
Recruiting
Address
University of Alabama at Birmingham
Birmingham, Alabama, 35294
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Mayo Clinic Cancer Center-Scottsdale
Phoenix, Arizona, 85054
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Recruiting
Address
Stanford University Medical Center
Stanford, California, 94305-5623
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Recruiting
Address
Colorado Blood Cancer Institute
Denver, Colorado, 80218
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Recruiting
Address
Yale New Haven Hospital
New Haven, Connecticut, 06520
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Recruiting
Address
University of Miami Leonard M. Miller School of Medicine - Sylvester Comprehensive Cancer Center
Miami, Florida, 33136-1002
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Address
Emory University
Atlanta, Georgia, 30322
Status
Withdrawn
Address
Northside Hospital Cancer Institute
Atlanta, Georgia, 30342
Status
Recruiting
Address
University of Iowa Hospitals & Clinics
Iowa City, Iowa, 52242
Status
Recruiting
Address
University of Kansas
Westwood, Kansas, 66205
Status
Not yet recruiting
Address
University Of Maryland Medical Center
Baltimore, Maryland, 21201
Status
Not yet recruiting
Address
University of Michigan Health System
Ann Arbor, Michigan, 48109
Status
Withdrawn
Address
University Of Minnesota
Minneapolis, Minnesota, 55455
Status
Not yet recruiting
Address
Mayo Clinic - Rochester
Rochester, Minnesota, 55905
Status
Recruiting
Address
Washington University School of Medicine
Saint Louis, Missouri, 63110
Status
Recruiting
Address
Hackensack University Medical Center
Hackensack, New Jersey, 07601
Status
Recruiting
Address
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065
Status
Recruiting
Address
University of Rochester Medical Center
Rochester, New York, 14642
Status
Not yet recruiting
Address
Duke University Medical Center
Durham, North Carolina, 27710
Status
Withdrawn
Address
Cleveland Clinic
Cleveland, Ohio, 44195
Status
Recruiting
Address
The Ohio State University
Columbus, Ohio, 43210
Status
Not yet recruiting
Address
Sarah Cannon Research Institute
Nashville, Tennessee, 37203
Status
Recruiting
Address
Huntsman Cancer Institute
Salt Lake City, Utah, 84112
Status
Not yet recruiting
Address
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, 53792
Status
Recruiting
Address
Medical College Of Wisconsin
Milwaukee, Wisconsin, 53226
Status
Recruiting
Address
Royal Adelaide Hospital
Adelaide, , 5000
Status
Recruiting
Address
Royal Prince Alfred Hospital
Camperdown, , 2050
Status
Recruiting
Address
Royal Brisbane and Womens Hospital
Herston, , 4029
Status
Recruiting
Address
Alfred Health
Melbourne, , 3004
Status
Recruiting
Address
Peter MacCallum Cancer Centre
Melbourne, , 8006
Status
Recruiting
Address
Fiona Stanley Hospital
Murdoch, , 6150
Status
Not yet recruiting
Address
Calvary Mater Newcastle Hospital
Waratah, , 2298
Status
Not yet recruiting
Address
Western Sydney Local Health District
Westmead, , 2145
Status
Not yet recruiting
Address
Medical University of Vienna,Universitätsklinik für Innere Medizin I
Vienna, , 1090
Status
Recruiting
Address
Universitair Ziekenhuis - Antwerpen
Antwerp, , 2650
Status
Withdrawn
Address
Institut Jules Bordet
Brussel, , 1000
Status
Recruiting
Address
Centre Hospitalier Universitaire de Liege Domaine Universitaire du Sart Tilman
Liege, , B-4000
Status
Recruiting
Address
Rigshospitalet
Copenhagen, , 2100
Status
Recruiting
Address
CHRU de Lille - Hôpital Claude Huriez
LILLE Cedex, , 59037
Status
Not yet recruiting
Address
CHU de Montpellier, Hopital Saint-Eloi
Montpellier, , 34295
Status
Recruiting
Address
C.H.U. Hotel Dieu - France
Nantes, , 44093
Status
Not yet recruiting
Address
Hopital Saint-Louis
Paris cedex 10, , 75475
Status
Withdrawn
Address
CHU de Bordeaux - Hôpital Haut-Lévêque
Pessac cedex, , 33604
Status
Recruiting
Address
Centre hospitalier Lyon-Sud
Pierre Benite cedex, , 69495
Status
Recruiting
Address
CHU De Poitiers
Poitiers, , 86021
Status
Not yet recruiting
Address
Institut Universitaire du cancer de Toulouse-Oncopole
Toulouse cedex 9, , 31059
Status
Recruiting
Address
Universitatsklinikum Carl Gustvav Carus Dresden an der Technischen Universitat Dresden
Dresden, , 01307
Status
Not yet recruiting
Address
Universitaetsklinikum Hamburg Eppendorf
Hamburg, , 20246
Status
Not yet recruiting
Address
Universitaetsklinikum Heidelberg
Heidelberg, , 69120
Status
Not yet recruiting
Address
Universitaetsklinikum Koeln
Köln, , 50924
Status
Not yet recruiting
Address
Universitatsklinikum Leipzig
Leipzig, , 04103
Status
Not yet recruiting
Address
Klinikum der Eberhard-Karls-Universität/Abt. für innere Med. II/Hämatologie/Onkologie-Germany
Tübingen, , 72076
Status
Not yet recruiting
Address
Universitätsklinikum Würzburg
Würzburg, , 97080
Status
Not yet recruiting
Address
Attikon University General Hospital of Attica
Athens, , 12462
Status
Not yet recruiting
Address
Hadassah University Hospita - Ein Kerem
Jerusalem, , P.O.B. 12000
Status
Recruiting
Address
Sheba Medical Center
Ramat Gan, , 74047
Status
Recruiting
Address
Sourasky Medical Center
Tel-Aviv, , 64239
Status
Recruiting
Address
Policlinico Sant'Orsola Malpighi
Bologna, , 40138
Status
Not yet recruiting
Address
Ospedale San Raffaele HSR Istituto Scientifico Universitario San Raffaele
Milano, , 20132
Status
Recruiting
Address
Fondazione IRCCS Istituto Nazionale dei Tumori
Milano, , 20133
Status
Recruiting
Address
Policlinico Universitario Agostino Gemelli
Roma, , 00168
Status
Recruiting
Address
A.O.U. Citta della Salute e della Scienza di Torino - Presidio Molinette
Turin, , 10126
Status
Recruiting
Address
Kyushu University Hospital
Fukuoka, , 812-8582
Status
Recruiting
Address
Kanazawa University Hospital
Kanazawa, , 920-8641
Status
Recruiting
Address
University Hospital Kyoto Perfectural University of Medicine
Kyoto, , 602-8566
Status
Recruiting
Address
Nagoya City University Hospital
Nagoya, , 467-8602
Status
Recruiting
Address
Okayama University Hospital
Okayama, , 700-8558
Status
Recruiting
Address
Hokkaido University Hospital
Sapporo, , 060-8648
Status
Recruiting
Address
Tohoku University Hospital
Sendai, , 980-8574
Status
Recruiting
Address
Japanese Red Cross Medical Center
Shibuya, , 150-8935
Status
Recruiting
Address
Samsung Medical Center
Seoul, , 06351
Status
Recruiting
Address
The Catholic University of Korea Seoul St. Mary's Hospital
Seoul, , 06591
Status
Recruiting
Address
Seoul National University Hospital
Seoul, , 3080
Status
Recruiting
Address
VU Medisch Centrum
Amsterdam, , 1081 HV
Status
Recruiting
Address
University Medical Center Groningen
Groningen, , 9713 GZ
Status
Recruiting
Address
Erasmus MC
Rotterdam, , 3015 CN
Status
Recruiting
Address
UMC Utrecht
Utrecht, , 3584 CX
Status
Recruiting
Address
Uniwersyteckie Centrum Kliniczne
Gdansk, , 80-952
Status
Recruiting
Address
Narodowy Instytut Onkologii im.Marii Sklodowskiej Curie Panstwowy Instytut BadawczyOddz. w Gliwicach
Gliwice, , 44102
Status
Recruiting
Address
Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego
Poznan, , 60-569
Status
Recruiting
Address
Instytut Hematologii i Transfuzjologii
Warszawa, , 02-776
Status
Recruiting
Address
Inst. Cat. D'Oncologia-Badalona
Badalona, , 08916
Status
Recruiting
Address
Hosp. Clinic I Provincial de Barcelona
Barcelona, , 08036
Status
Not yet recruiting
Address
Hosp. Gral. Univ. Gregorio Marañon
Madrid, , 28007
Status
Recruiting
Address
Hosp. Univ. 12 de Octubre
Madrid, , 28041
Status
Recruiting
Address
Clinica Univ. de Navarra
Pamplona, , 31008
Status
Recruiting
Address
Hosp. Clinico Univ. de Salamanca
Salamanca, , 37007
Status
Not yet recruiting
Address
Hosp. Virgen Del Rocio
Sevilla, , 41013
Status
Recruiting
Address
Skane University Hospital
Lund, , 221 85
Status
Recruiting
Address
Karolinska Universitetssjukhuset Huddinge, Hematologiska Kliniken, Huddinge
Stockholm, , 141 86
Status
Recruiting
Address
Akademiska Sjukhuset
Uppsala, , 751 85
Status
Not yet recruiting
Address
Queen Elizabeth Hospital
Birmingham, , B15 2TH
Status
Recruiting
Address
Bristol Royal Infirmary
Bristol, , BS2 8BJ
Status
Not yet recruiting
Address
University Hospital Wales
Cardiff, , CF14 4XW
Status
Recruiting
Address
University College Hospital
London, , NW1 2BU
Status
Not yet recruiting
Address
King's College Hospital
London, , SE5 9RS
Status
Not yet recruiting
Address
Christie Hospital
Manchester, , M20 4BX
Status
Recruiting
Address
Freeman Hospital
Newcastle Upon Tyne, , NE7 7DN