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ACTIVE NOT RECRUITING

NCT04181827

PHASE3

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

Sponsor: Janssen Research & Development, LLC

View on ClinicalTrials.gov

Summary

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

Official title: A Phase 3 Randomized Study Comparing JNJ-68284528, a Chimeric Antigen Receptor T Cell (CAR-T) Therapy Directed Against BCMA, Versus Pomalidomide, Bortezomib and Dexamethasone (PVd) or Daratumumab, Pomalidomide and Dexamethasone (DPd) in Subjects With Relapsed and Lenalidomide-Refractory Multiple Myeloma

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

419

Start Date

2020-06-12

Completion Date

2029-04-09

Last Updated

2026-03-16

Healthy Volunteers

Conditions

Multiple Myeloma

Interventions

DRUG

Cilta-cel

Cilta-cel 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.

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): 1. Hemoglobin \>=8 gram per deciliter (g/dL) (without prior RBC transfusion within 7 days before the laboratory test; recombinant human erythropoietin use is permitted); 2. 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); 3. 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; 4. Lymphocyte count \>=0.3 \* 10\^9/L; 5. Aspartate aminotransferase (AST) less than or equal to (\<=)3 \* upper limit of normal (ULN); 6. Alanine aminotransferase (ALT) \<=3 \* ULN; 7. 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); 8. 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

Locations (88)

University of Alabama at Birmingham

Birmingham, Alabama, United States

Mayo Clinic Cancer Center-Scottsdale

Phoenix, Arizona, United States

Stanford University Medical Center

Stanford, California, United States

Colorado Blood Cancer Institute

Denver, Colorado, United States

Yale New Haven Hospital

New Haven, Connecticut, United States

University Of Miami Leonard M Mille School Of Medicine SCCC

Miami, Florida, United States

University of Iowa Hospitals and Clinics

Iowa City, Iowa, United States

University of Kansas

Westwood, Kansas, United States

University Of Maryland Medical Center

Baltimore, Maryland, United States

Mayo Clinic - Rochester

Rochester, Minnesota, United States

Washington University School Of Medicine

St Louis, Missouri, United States

Hackensack University Medical Center

Hackensack, New Jersey, United States

Memorial Sloan-Kettering Cancer Center

New York, New York, United States

University of Rochester Medical Center

Rochester, New York, United States

Duke University Medical Center

Durham, North Carolina, United States

The Ohio State University

Columbus, Ohio, United States

Huntsman Cancer Institute

Salt Lake City, Utah, United States

Wisconsin Institutes for Medical Research

Madison, Wisconsin, United States

Medical College Of Wisconsin

Milwaukee, Wisconsin, United States

Royal Adelaide Hospital

Adelaide, Australia

Royal Prince Alfred Hospital

Camperdown, Australia

Royal Brisbane and Womens Hospital

Herston, Australia

Peter MacCallum Cancer Centre

Melbourne, Australia

Alfred Health

Melbourne, Australia

Fiona Stanley Hospital

Murdoch, Australia

Universitair Ziekenhuis - Antwerpen

Antwerp, Belgium

UZ Gent

Ghent, Belgium

UZ Leuven

Leuven, Belgium

Centre Hospitalier Universitaire de Liege Domaine Universitaire du Sart Tilman

Liège, Belgium

Rigshospitalet

Copenhagen, Denmark

CHRU de Lille Hopital Claude Huriez

Lille, France

Hospices Civils de Lyon HCL

Lyon, France

CHU de Montpellier Hopital Saint Eloi

Montpellier, France

C.H.U. Hotel Dieu - France

Nantes, France

Hopital Saint Louis

Paris, France

CHU De Poitiers

Poitiers, France

Institut Universitaire du cancer de Toulouse-Oncopole

Toulouse, France

Universitaetsklinikum Koeln

Cologne, Germany

Universitatsklinikum Carl Gustvav Carus Dresden an der Technischen Universitat Dresden

Dresden, Germany

Universitaetsklinikum Hamburg Eppendorf

Hamburg, Germany

Universitaetsklinikum Leipzig

Leipzig, Germany

Klinikum der Eberhard Karls Universitaet Abt fur innere Med II Haematologie Onkologie Germany

Tübingen, Germany

Universitatsklinikum Wurzburg

Würzburg, Germany

Attikon University General Hospital of Attica

Athens, Greece

Hadassah University Hospita Ein Kerem

Jerusalem, Israel

Sheba Medical Center

Ramat Gan, Israel

Sourasky Medical Center

Tel Aviv, Israel

Azienda Opedaliero-Universitaria Policlinico Sant'orsola Malpighi di Bologna

Bologna, Italy

IRCCS Ospedale San Raffaele HSR

Milan, Italy

Fondazione IRCCS Istituto Nazionale dei Tumori

Milan, Italy

Policlinico Universitario Agostino Gemelli

Roma, Italy

A.O.U. Citta della Salute e della Scienza di Torino - Presidio Molinette

Turin, Italy

Kyushu University Hospital

Fukuoka, Japan

Kanazawa University Hospital

Kanazawa, Japan

University Hospital Kyoto Prefectural University of Medicine

Kyoto, Japan

Nagoya City University Hospital

Nagoya, Japan

Okayama University Hospital

Okayama, Japan

Hokkaido University Hospital

Sapporo, Japan

Tohoku University Hospital

Sendai, Japan

Japanese Red Cross Medical Center

Shibuya City, Japan

VU Medisch Centrum

Amsterdam, Netherlands

University Medical Center Groningen

Groningen, Netherlands

Erasmus MC

Rotterdam, Netherlands

UMC Utrecht

Utrecht, Netherlands

Uniwersyteckie Centrum Kliniczne

Gdansk, Poland

Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut BadawczyOddz w Gliwicach

Gliwice, Poland

Uniwersytecki Szpital Kliniczny w Poznaniu

Poznan, Poland

Instytut Hematologii i Transfuzjologii

Warsaw, Poland

Seoul National University Hospital

Seoul, South Korea

Samsung Medical Center

Seoul, South Korea

The Catholic University of Korea Seoul St Marys Hospital

Seoul, South Korea

Inst. Cat. D'Oncologia-Badalona

Badalona, Spain

Hosp Clinic de Barcelona

Barcelona, Spain

Hosp. Gral. Univ. Gregorio Maranon

Madrid, Spain

Hosp. Univ. 12 de Octubre

Madrid, Spain

Clinica Univ. de Navarra

Pamplona, Spain

Hosp Clinico Univ de Salamanca

Salamanca, Spain

Hosp. Virgen Del Rocio

Seville, Spain

Skane University Hospital

Lund, Sweden

Karolinska Universitetssjukhuset Huddinge, Hematologiska Kliniken, Huddinge

Stockholm, Sweden

Akademiska Sjukhuset

Uppsala, Sweden

Queen Elizabeth Hospital

Birmingham, United Kingdom

Bristol Haematology and Oncology Centre

Bristol, United Kingdom

University Hospital Wales

Cardiff, United Kingdom

University College Hospital

London, United Kingdom

Kings College Hospital

London, United Kingdom

Christie Hospital

Manchester, United Kingdom

Freeman Hospital

Newcastle upon Tyne, United Kingdom

Clinical Research Directory

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

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (88)