Multiple Myeloma Clinical Trial

A Study Comparing JNJ-68284528, a CAR-T Therapy Directed Against B-cell Maturation Antigen (BCMA), Versus Pomalidomide, Bortezomib and Dexamethasone (PVd) or Daratumumab, Pomalidomide and Dexamethasone (DPd) in Participants With Relapsed and Lenalidomide-Refractory Multiple Myeloma

Summary

The purpose of this study is to compare the efficacy of JNJ-68284528 (ciltacabtagene autoleucel [cilta-cel]) with standard therapy, either Pomalidomide, Bortezomib and Dexamethasone (PVd) or Daratumumab, Pomalidomide and Dexamethasone (DPd).

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Full Description

Multiple myeloma is a malignant plasma cell disorder diagnosed annually in approximately 86,000 participants worldwide. JNJ-68284528 (cilta-cel) 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 (cilta-cel) 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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Measurable disease at screening as defined by any of the following: (a) Serum monoclonal paraprotein (M-protein) level greater than or equal to (>=) 0.5 gram per deciliter (g/dL) or urine M-protein level >=200 milligram (mg)/24 hours; or (b) Light chain multiple myeloma without measurable M-protein in the serum or the urine: Serum free light chain >=10 mg/dL and abnormal serum free light chain ratio
Have received 1 to 3 prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory drug (IMiD)
Have documented evidence of PD by International Myeloma Working Group (IMWG) criteria based on investigator's determination on or within 6 months of their last regimen
Be refractory to lenalidomide per IMWG consensus guidelines (failure to achieve minimal response or progression on or within 60 days of completing lenalidomide therapy). Progression on or within 60 days of the last dose of lenalidomide given as maintenance will meet this criterion. For participants with more than 1 prior line of therapy, there is no requirement to be lenalidomide refractory to the most recent line of prior therapy. However, participants must be refractory to lenalidomide in at least one prior line

Have clinical laboratory values meeting the following criteria during the Screening Phase (re testing is allowed but the below criteria must be met in the latest test prior to randomization):

Hemoglobin >=8 gram per deciliter (g/dL) (without prior RBC transfusion within 7 days before the laboratory test; recombinant human erythropoietin use is permitted);
Absolute neutrophil count (ANC) >=1 * 10^9 per liter (L) (without recombinant human granulocyte colony-stimulating factor [G-CSF] within 7 days and without pegylated G-CSF within 14 days of the laboratory test);
Platelet count >=75 * 10^9/L (without prior platelet transfusion within 7 days before the laboratory test) in participants in whom less than (<) 50 percent (%) of bone marrow nucleated cells are plasma cells; platelet count >=50 * 10^9/L (without prior platelet transfusion within 7 days before the laboratory test) in participants in whom >=50% of bone marrow nucleated cells are plasma cells;
Lymphocyte count >=0.3 * 10^9/L;
Aspartate aminotransferase (AST) less than or equal to (<=)3 * upper limit of normal (ULN);
Alanine aminotransferase (ALT) <=3 * ULN;
Total bilirubin <=2.0 * ULN; except in participants with congenital bilirubinemia, such as Gilbert syndrome (in which case direct bilirubin <=1.5 * ULN is required);
Estimated glomerular filtration rate >=40 milliliter per minute (mL/min) per 1.73 meter square (m^2) (to be calculated using the Modification of Diet in Renal Disease [MDRD] formula)

Exclusion Criteria:

Prior treatment with chimeric antigen receptor T-cell (CAR-T) therapy directed at any target
Any previous therapy that is targeted to B-cell maturation antigen (BCMA)
Ongoing toxicity from previous anticancer therapy that has not resolved to baseline levels or to Grade 1 or less; except for alopecia
Participants with Grade 1 peripheral neuropathy with pain or Grade 2 or higher peripheral neuropathy will not be permitted to receive pomalidomide, bortezomib, and dexamethasone (PVd) as standard therapy or bridging therapy; however, participants may receive daratumumab, pomalidomide, and dexamethasone (DPd) as standard therapy or bridging therapy
Received a cumulative dose of corticosteroids equivalent to >=70 mg of prednisone within the 7 days prior to randomization
Monoclonal antibody treatment within 21 days
Cytotoxic therapy within 14 days
Proteasome inhibitor therapy within 14 days
Immunomodulatory drug (IMiD) therapy within 7 days

Study is for people with:

Multiple Myeloma

Phase:

Phase 3

Estimated Enrollment:

419

Study ID:

NCT04181827

Recruitment Status:

Active, not recruiting

Sponsor:

Janssen Research & Development, LLC

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There are 88 Locations for this study

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University of Alabama at Birmingham
Birmingham Alabama, 35294, United States
Mayo Clinic Cancer Center-Scottsdale
Phoenix Arizona, 85054, United States
Stanford University Medical Center
Stanford California, 94305, United States
Colorado Blood Cancer Institute
Denver Colorado, 80218, United States
Yale New Haven Hospital
New Haven Connecticut, 06520, United States
University of Miami Leonard M. Miller School of Medicine - Sylvester Comprehensive Cancer Center
Miami Florida, 33136, United States
University of Iowa Hospitals & Clinics
Iowa City Iowa, 52242, United States
University of Kansas
Westwood Kansas, 66205, United States
University Of Maryland Medical Center
Baltimore Maryland, 21201, United States
Mayo Clinic - Rochester
Rochester Minnesota, 55905, United States
Washington University School of Medicine
Saint Louis Missouri, 63110, United States
Hackensack University Medical Center
Hackensack New Jersey, 07601, United States
Memorial Sloan-Kettering Cancer Center
New York New York, 10065, United States
University of Rochester Medical Center
Rochester New York, 14642, United States
Duke University Medical Center
Durham North Carolina, 27710, United States
The Ohio State University
Columbus Ohio, 43210, United States
Huntsman Cancer Institute
Salt Lake City Utah, 84112, United States
University of Wisconsin Carbone Cancer Center
Madison Wisconsin, 53792, United States
Medical College Of Wisconsin
Milwaukee Wisconsin, 53226, United States
Royal Adelaide Hospital
Adelaide , 5000, Australia
Royal Prince Alfred Hospital
Camperdown , 2050, Australia
Royal Brisbane and Womens Hospital
Herston , 4029, Australia
Alfred Health
Melbourne , 3004, Australia
Peter MacCallum Cancer Centre
Melbourne , 8006, Australia
Fiona Stanley Hospital
Murdoch , 6150, Australia
Universitair Ziekenhuis - Antwerpen
Antwerp , 2650, Belgium
UZ Gent
Gent , 9000, Belgium
UZ Leuven
Leuven , 3000, Belgium
Centre Hospitalier Universitaire de Liege Domaine Universitaire du Sart Tilman
Liege , B-400, Belgium
Rigshospitalet
Copenhagen , 2100, Denmark
CHRU de Lille - Hôpital Claude Huriez
LILLE Cedex , 59037, France
CHU de Montpellier, Hopital Saint-Eloi
Montpellier , 34295, France
C.H.U. Hotel Dieu - France
Nantes , 44093, France
Hopital Saint-Louis
Paris cedex 10 , 75475, France
Centre hospitalier Lyon-Sud
Pierre Benite cedex , 69495, France
CHU De Poitiers
Poitiers , 86021, France
Institut Universitaire du cancer de Toulouse-Oncopole
Toulouse cedex 9 , 31059, France
Universitatsklinikum Carl Gustvav Carus Dresden an der Technischen Universitat Dresden
Dresden , 01307, Germany
Universitaetsklinikum Hamburg Eppendorf
Hamburg , 20246, Germany
Universitaetsklinikum Koeln
Köln , 50924, Germany
Universitatsklinikum Leipzig
Leipzig , 04103, Germany
Klinikum der Eberhard-Karls-Universität/Abt. für innere Med. II/Hämatologie/Onkologie-Germany
Tübingen , 72076, Germany
Universitätsklinikum Würzburg
Würzburg , 97080, Germany
Attikon University General Hospital of Attica
Athens , 12462, Greece
Hadassah University Hospita - Ein Kerem
Jerusalem , P.O.B, Israel
Sheba Medical Center
Ramat Gan , 74047, Israel
Sourasky Medical Center
Tel-Aviv , 64239, Israel
Azienda Opedaliero-Universitaria Policlinico Sant'orsola Malpighi di Bologna
Bologna , 40138, Italy
Ospedale San Raffaele HSR Istituto Scientifico Universitario San Raffaele
Milano , 20132, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori
Milano , 20133, Italy
Policlinico Universitario Agostino Gemelli
Roma , 00168, Italy
A.O.U. Citta della Salute e della Scienza di Torino - Presidio Molinette
Turin , 10126, Italy
Kyushu University Hospital
Fukuoka , 812-8, Japan
Kanazawa University Hospital
Kanazawa , 920-8, Japan
University Hospital Kyoto Perfectural University of Medicine
Kyoto , 602-8, Japan
Nagoya City University Hospital
Nagoya , 467-8, Japan
Okayama University Hospital
Okayama , 700-8, Japan
Hokkaido University Hospital
Sapporo , 060-8, Japan
Tohoku University Hospital
Sendai , 980-8, Japan
Japanese Red Cross Medical Center
Shibuya , 150-8, Japan
Seoul National University Hospital
Seoul , 03080, Korea, Republic of
Samsung Medical Center
Seoul , 06351, Korea, Republic of
The Catholic University of Korea Seoul St. Mary's Hospital
Seoul , 06591, Korea, Republic of
VU Medisch Centrum
Amsterdam , 1081 , Netherlands
University Medical Center Groningen
Groningen , 9713 , Netherlands
Erasmus MC
Rotterdam , 3015 , Netherlands
UMC Utrecht
Utrecht , 3584 , Netherlands
Uniwersyteckie Centrum Kliniczne
Gdansk , 80-21, Poland
Narodowy Instytut Onkologii im.Marii Sklodowskiej Curie Panstwowy Instytut BadawczyOddz. w Gliwicach
Gliwice , 44102, Poland
Szpital Kliniczny im. H. Swiecickiego Uniwersytetu Medycznego im. K. Marcinkowskiego w Poznaniu
Poznań , 60-35, Poland
Instytut Hematologii i Transfuzjologii
Warszawa , 02-77, Poland
Inst. Cat. D'Oncologia-Badalona
Badalona , 08916, Spain
Hosp. Clinic I Provincial De Barcelona
Barcelona , 08036, Spain
Hosp. Gral. Univ. Gregorio Marañon
Madrid , 28007, Spain
Hosp. Univ. 12 de Octubre
Madrid , 28041, Spain
Clinica Univ. de Navarra
Pamplona , 31008, Spain
Hosp. Clinico Univ. de Salamanca
Salamanca , 37007, Spain
Hosp. Virgen Del Rocio
Sevilla , 41013, Spain
Skane University Hospital
Lund , 221 8, Sweden
Karolinska Universitetssjukhuset Huddinge, Hematologiska Kliniken, Huddinge
Stockholm , 141 8, Sweden
Akademiska Sjukhuset
Uppsala , 751 8, Sweden
Queen Elizabeth Hospital
Birmingham , B15 2, United Kingdom
Bristol Royal Infirmary
Bristol , BS2 8, United Kingdom
University Hospital Wales
Cardiff , CF14 , United Kingdom
University College Hospital
London , NW1 2, United Kingdom
King's College Hospital
London , SE5 9, United Kingdom
Christie Hospital
Manchester , M20 4, United Kingdom
Freeman Hospital
Newcastle Upon Tyne , NE7 7, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Multiple Myeloma

Phase:

Phase 3

Estimated Enrollment:

419

Study ID:

NCT04181827

Recruitment Status:

Active, not recruiting

Sponsor:


Janssen Research & Development, LLC

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