A Study of Bortezomib, Lenalidomide and Dexamethasone (VRd) followed by Cilta-cel, a CAR-T Therapy Directed Against BCMA versus VRd followed by Lenalidomide and Dexamethasone (Rd) Therapy in Participants with Newly Diagnosed Multiple Myeloma for Whom A...

Last Updated   November 5, 2022 - 00:00

Want to learn how to participate in this trial?

OVERVIEW

  • Gender
    all
  • Age
    - years
  • Phase
    phase 3
    The drug or treatment is given to large groups of people to confirm its effectiveness, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
  • Sites
    160 sites
  • Status
    Recruiting

SUMMARY

The purpose of this study is to compare the efficacy of Bortezomib, Lenalidomide and Dexamethasone (VRd) induction followed by a single administration of ciltacabtagene autoleucel (cilta-cel) versus VRd induction followed by Lenalidomide and Dexamethasone (Rd) maintenance in newly diagnosed multiple myeloma participants for whom ASCT is not planned as initial therapy in terms of Progression Free Survival (PFS).

CONDITIONS

  • Multiple Myeloma

ELIGIBILITY

Inclusion Criteria:

  • • Documented diagnosis of multiple myeloma (MM) according to International Myeloma Working Group (IMWG) diagnostic criteria
  • • Measurable disease at screening as defined by any of the following: Serum monoclonal paraprotein (M-protein) level greater than or equal to (>=)1.0 gram per deciliter (g/dL) or urine M-protein level >=200 milligram (mg)/24 hours; or Light chain MM in whom only measurable disease is by serum free light chain (FLC) levels: Serum immunoglobin (Ig) free light chain >=10 milligrams per deciliter (mg/dL) and abnormal serum Ig kappa/lambda FLC ratio
  • • Eastern Cooperative Oncology Group Performance Status grade of 0 or 1
  • • Not considered for high-dose chemotherapy with Autologous Stem Cell Transplant (ASCT) due to: Ineligible due to advanced age; or Ineligible due to presence of comorbid condition(s) likely to have a negative impact on tolerability of high-dose chemotherapy with ASCT; or Deferral of high-dose chemotherapy with ASCT as initial treatment
  • • A woman of childbearing potential (WOCBP) must have 2 negative highly sensitive serum or urine pregnancy tests (beta-human chorionic gonadotropin) prior to starting Bortezomib, Lenalidomide and Dexamethasone (VRd) and must agree to further testing during the study.
  • • Clinical laboratory values meeting the following criteria during the screening phase: hemoglobin greater than or equal to (>=) 8.0 g/dL (>=5 millimoles per liter [mmol/L]), recombinant human erythropoietin use is permitted; platelets >=75 *10^9/L; absolute lymphocyte count >=0.3 *10^9/L; absolute neutrophil count (ANC) >=1.0 ×10^9/L (prior growth factor support is permitted but must be without support in the 7 days prior to the laboratory test); aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than or equal to (<=) 3.0 * upper limit of normal (ULN); estimated glomerular filtration rate >=40 milliliter per minute/1.73 meter square (mL/min/1.73 m^2) based upon modified diet in renal disease formula (MDRD-4) calculation or a 24-hour urine collection; total bilirubin <=2.0 * ULN; except in participants with congenital hyperbilirubinemia, such as Gilbert syndrome (in which case direct bilirubin <=2.0 * ULN is required)

Exclusion Criteria:

  • • Frailty index of >=2 according to Myeloma Geriatric Assessment score
  • • Peripheral neuropathy or neuropathic pain Grade 2 or higher, as defined by the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5
  • • Known active, or prior history of central nervous system (CNS) involvement or clinical signs of meningeal involvement of MM
  • • Stroke or seizure within 6 months of signing Informed Consent Form (ICF)
  • • Seropositive for human immunodeficiency virus (HIV)
  • • Vaccinated with live, attenuated vaccine within 4 weeks prior to first dose of VRd
  • • Participant must not require continuous supplemental oxygen
  • • Hepatitis B infection
  • • Hepatitis C infection
  • • Prior treatment with chimeric antigen receptor T (CAR-T) therapy directed at any target
  • • Any therapy that is targeted to B-cell maturation antigen (BCMA)

DETAILS

Multiple myeloma (MM) is a malignant plasma cell disorder characterized by the production of monoclonal immunoglobulin (Ig) proteins or protein fragments (M proteins) that have lost their function. JNJ-68284528 (ciltacabtagene autoleucel [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 of this study is that in participants with newly diagnosed MM, treatment with VRd induction followed by a single administration of cilta-cel will significantly improve progression free survival compared to Bortezomib, Lenalidomide and Dexamethasone (VRd) induction followed by Rd maintenance. The study will screen participants with newly diagnosed MM who are not planned to receive autologous stem cell transplant (ASCT) as initial therapy. This study will be conducted in 4 phases: Screening (up to 28 days), Pre-randomization Treatment, Treatment, and Follow-up. Assessments like patient-reported outcome(s) (PROs), electrocardiogram (ECG), vital signs and pharmacokinetics will be performed during the study. Safety evaluations will include review of adverse events, laboratory test results, vital sign measurements, physical examination findings, assessment of cardiac function, Immune-Effector Cell-Associated Encephalopathy (ICE) and handwriting assessments (only for Arm B) and Eastern Cooperative Oncology Group (ECOG) performance status. Safety data will be periodically reviewed by an Independent Data Monitoring Committee (IDMC). The duration of the study is approximately 12 years 5 months.

LOCATIONS

Locations in:
United States, United Kingdom, Switzerland, Sweden, Spain, South Korea, Portugal, Poland, Norway, Netherlands, Japan, Italy, Israel, Ireland, Hungary, Greece, Germany, France, Finland, Denmark, Czechia, Canada, Brazil, Belgium, Austria, Australia, Argentina
Country (27) City or Province (160) Status
United States Baltimore, MD University Of Maryland Medical Center
Not yet recruiting
United States Boston, MA Dana Farber Cancer Institute
Withdrawn
United States Boston, MA Harvard Medical School-Beth Israel Deaconess Medical Center
Not yet recruiting
United States Boston, MA Massachusetts General Hospital
Withdrawn
United States Chapel Hill, NC University of North Carolina
Withdrawn
United States Charlotte, NC Levine Cancer Institute
Recruiting
United States Charlottesville, VA University of Virginia
Not yet recruiting
United States Dallas, TX University of Texas Southwestern Medical Center
Withdrawn
United States Detroit, MI Barbara Ann Karmanos Cancer Institute
Not yet recruiting
United States Detroit, MI Henry Ford Cancer Institute
Not yet recruiting
United States Iowa City, IA University of Iowa Hospitals & Clinics
Recruiting
United States Lexington, KY University of Kentucky
Recruiting
United States Lousville, KY Norton Cancer Institute
Recruiting
United States Melrose Park, IL Loyola University Medical Center
Not yet recruiting
United States Miami, FL University of Miami Health System
Not yet recruiting
United States Milwaukee, WI Medical College Of Wisconsin
Not yet recruiting
United States New Haven, CT Yale Cancer Center
Not yet recruiting
United States New York, NY Columbia University Medical Center
Recruiting
United States New York, NY Memorial Sloan-Kettering Cancer Center
Not yet recruiting
United States New York, NY New York Presbyterian-Weill Cornell Medical College
Not yet recruiting
United States Orlando, FL AdventHealth Cancer Institute
Not yet recruiting
United States Philadelphia, PA Thomas Jefferson University
Not yet recruiting
United States Pittsburgh, PA University of Pittsburgh Medical Center
Recruiting
United States Rochester, MN Mayo Clinic - Rochester
Withdrawn
United States San Francisco, CA UCSF
Not yet recruiting
United States Stanford, CA Stanford University Medical Center
Withdrawn
United States Westwood, KS University of Kansas Medical Center
Withdrawn
United Kingdom Birmingham, WMD University Hospitals Birmingham NHS Trust,
Recruiting
United Kingdom Bristol Bristol Royal Infirmary
Recruiting
United Kingdom Leeds,, WYK Leeds Teaching Hospitals NHS Trust
Recruiting
United Kingdom London King's College Hospital
Recruiting
United Kingdom London University College Hospital
Recruiting
United Kingdom Manchester Manchester Royal Infirmary
Recruiting
United Kingdom Surrey The Royal Marsden NHS Trust Sutton
Recruiting
Switzerland Basel, BS Universitatsspital Basel
Not yet recruiting
Switzerland Bern INSELSPITAL, Universitätsspital Bern
Recruiting
Switzerland Genève, GE Hôpitaux Universitaires de Genève - HUG
Withdrawn
Switzerland St. Gallen, SG Kantonsspital St.Gallen
Not yet recruiting
Switzerland Zürich, ZH UniversitaetsSpital Zuerich
Not yet recruiting
Sweden Göteborg Sahlgrenska University Hospital
Recruiting
Sweden LINKÖPING UNIVERSITETSSJUKHUSET
Recruiting
Sweden Lund Skane University Hospital
Recruiting
Sweden Stockholm Haematology Centre, R 51
Withdrawn
Sweden Uppsala Akademiska Sjukhuset
Withdrawn
Spain Barcelona, BA HOSP. DE LA SANTA CREU I SANT PAU
Recruiting
Spain Barcelona, BA HOSP. UNIV. VALL D HEBRON
Recruiting
Spain L'Hospitalet de Llobregat, BA INSTITUTO CATALAN DEONCOLOGIA HOSPITAL DURAN I REYNALS
Recruiting
Spain Madrid, MD HOSP. GRAL. UNIV. GREGORIO MARAÑON
Recruiting
Spain Madrid, MD HOSP. UNIV. 12 DE OCTUBRE
Recruiting
Spain Murcia, MU HOSP. UNIV. VIRGEN DE LA ARRIXACA
Recruiting
Spain Pamplona CLINICA UNIV. DE NAVARRA
Recruiting
Spain Salamanca, SL HOSP. CLINICO UNIV. DE SALAMANCA
Recruiting
Spain Santander, CT HOSP. UNIV. MARQUES DE VALDECILLA
Recruiting
Spain Sevilla HOSP. VIRGEN DEL ROCIO
Recruiting
Spain Valencia, VC HOSP. UNIV. I POLITECNI LA FE
Recruiting
South Korea Jeollanam-do, 46 Chonnam National University Hwasun Hospital
Recruiting
South Korea Seoul Asan Medical Center
Recruiting
South Korea Seoul Samsung Medical Center
Recruiting
South Korea Seoul Seoul National University Hospital
Recruiting
South Korea Seoul Severance Hospital, Yonsei University Health System
Recruiting
South Korea Seoul The Catholic University of Korea, Seoul St. Mary's Hospital
Recruiting
Portugal Lisboa Hospital De Santa Maria
Not yet recruiting
Portugal Lisboa Instituto Portugues de Oncologia
Not yet recruiting
Portugal Porto Instituto Portugues de Oncologia
Not yet recruiting
Poland Gdansk Uniwersyteckie Centrum Kliniczne
Recruiting
Poland Gliwice Narodowy Instytut Onkologii im.Marii Sklodowskiej Curie Panstwowy Instytut BadawczyOddz. w Gliwicach
Recruiting
Poland Lublin Centrum Onkologii Ziemi Lubelskiej im. św. Jana z Dukli
Recruiting
Poland Poznań Szpital Kliniczny im. H. Swiecickiego Uniwersytetu Medycznego im. K. Marcinkowskiego w Poznaniu
Recruiting
Poland Warszawa Instytut Hematologii i Transfuzjologii
Recruiting
Poland Wroclaw Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu
Not yet recruiting
Norway Oslo, OL Oslo universitetssykehus HF, Rikshospitalet
Recruiting
Netherlands AMSTERDAM VU Medisch Centrum
Not yet recruiting
Netherlands Groningen, GR University Medical Center Groningen
Recruiting
Netherlands Nijmegen, GE UMC Radboud
Recruiting
Netherlands Rotterdam Erasmus MC
Recruiting
Japan Fukuoka Kyushu University Hospital
Recruiting
Japan Kanazawa Kanazawa University Hospital
Recruiting
Japan Kyoto University Hospital Kyoto Perfectural University of Medicine
Recruiting
Japan Nagoya Nagoya City University Hospital
Recruiting
Japan Okayama, 33 Okayama University Hospital
Recruiting
Japan Sapporo, 01 Hokkaido University Hospital
Recruiting
Japan Sendai, 04 Tohoku University Hospital
Recruiting
Japan Shibuya, 13 Japanese Red Cross Medical Center
Recruiting
Italy Ancona A.O. Universitaria Ospedali Riuniti di Ancona
Not yet recruiting
Italy Bergamo Azienda Ospedaliera Papa Giovanni XXIII
Not yet recruiting
Italy Bologna Policlinico Sant'Orsola Malpighi
Not yet recruiting
Italy Genova IRCCS Azienda Ospedaliera San Martino - IST
Not yet recruiting
Italy Milano ASST Grande Ospedale Metropolitano Niguarda
Not yet recruiting
Italy Milano Fondazione IRCCS Istituto Nazionale dei Tumori
Not yet recruiting
Italy Palermo Casa di Cura La Maddalena
Not yet recruiting
Italy Reggio Calabria Grande Ospedale Metropolitano 'Bianchi-Melacrino-Morelli' Reggio Calabria
Not yet recruiting
Italy Roma AOU Policlinico Umberto I
Not yet recruiting
Italy Verona Azienda Ospedaliera Universitaria Integrata Verona
Not yet recruiting
Israel Jerusalem Hadassah University Hospita - Ein Kerem
Recruiting
Israel Ramat Gan Sheba Medical Center Tel Hashomer
Recruiting
Israel Tel Aviv Tel Aviv Sourasky Medical Center
Recruiting
Ireland Dublin St James's Hospital
Not yet recruiting
Hungary Budapest Dél-pesti Centrumkórház - Országos Hematológiai és Infektológiai Intézet, Szent László Telephely
Not yet recruiting
Hungary Debrecen Debreceni Egyetem Klinikai Kozpont
Not yet recruiting
Greece Athens Attikon University General Hospital of Attica
Recruiting
Greece Thessaloniki G.Papanikolaou
Recruiting
Germany Berlin, BE Charité - Universitätsmedizin Berlin, Campus Benjamin Franklin
Not yet recruiting
Germany Dresden, SN Universitaetsklinikum Carl Gustav Carus TU Dresden
Recruiting
Germany Freiburg, BW Universitatsklinikum Freiburg
Not yet recruiting
Germany Hamburg, HH Universitaetsklinikum Hamburg Eppendorf
Not yet recruiting
Germany Hannover Medizinische Hochschule Hannover
Withdrawn
Germany Heidelberg, BW Universitaetsklinikum Heidelberg
Not yet recruiting
Germany Leipzig Universitatsklinikum Leipzig
Recruiting
Germany Mainz, RP Universitätsmedizin der Johannes Gutenberg-Universität Mainz
Not yet recruiting
Germany Regensburg Universitaetsklinikum Regensburg
Not yet recruiting
Germany Tübingen, BW Klinikum der Eberhard-Karls-Universität/Abt. für innere Med. II/Hämatologie/Onkologie-Germany
Recruiting
Germany Würzburg Universitätsklinikum Würzburg
Recruiting
France Lille Cedex Centre Hospitalier Régional Universitaire de Lille, Hôpital Claude Huriez
Not yet recruiting
France Nantes C.H.U. Hotel Dieu - France
Not yet recruiting
France Paris cedex 10 Hopital Saint-Louis
Not yet recruiting
France Poitiers CHU Poitiers - Hôpital la Milétrie
Not yet recruiting
France Toulouse cedex 9 Institut Universitaire du cancer de Toulouse-Oncopole
Not yet recruiting
Finland Helsinki Helsinki University Hospital
Recruiting
Finland Oulu Oulu University Hospital
Recruiting
Finland Turku Turku University Hospital
Recruiting
Denmark Aarhus C Aarhus University Hospital
Not yet recruiting
Denmark Copenhagen Rigshospitalet
Recruiting
Denmark Odense C Odense Universitetshospital
Not yet recruiting
Czechia Brno Fakultni nemocnice Brno
Recruiting
Czechia Hradec Kralove Fakultni nemocnice Hradec Kralove
Recruiting
Czechia Ostrava Fakultni nemocnice Ostrava
Recruiting
Czechia Plzen-Lochotin Fakultni nemocnice Plzen
Withdrawn
Czechia Praha 2 Vseobecna fakultni nemocnice v Praze
Not yet recruiting
Canada Calgary, AB Tom Baker Cancer Centre
Recruiting
Canada Hamilton, ON Juravinski Cancer Centre
Recruiting
Canada Montréal, QC Hopital Maisonneuve-Rosemont
Recruiting
Canada Toronto, ON Princess Margaret Cancer Centre University Health Network
Recruiting
Canada Vancouver, BC Vancouver General Hospital
Recruiting
Brazil Salvador Hospital Sao Rafael
Recruiting
Brazil Sao Paulo, SP Fundação Antônio Prudente - A.C. Camargo Cancer Center
Recruiting
Brazil São Paulo, SP Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein
Recruiting
Belgium Antwerp Universitair Ziekenhuis - Antwerpen
Recruiting
Belgium Brugge AZ St.-Jan Brugge-Oostende AV
Recruiting
Belgium Brussel, BRU Cliniques Universitaires St-Luc
Not yet recruiting
Belgium Gent UZ Gent
Recruiting
Belgium Leuven UZ Leuven
Completed
Belgium Liege, WLG Centre Hospitalier Universitaire de Liege Domaine Universitaire du Sart Tilman
Recruiting
Austria Graz Medizinische Universität Graz, LKH-Univ.Klinikum Graz, Klinische Abteilung für Hämatologie
Not yet recruiting
Austria Innsbruck Medizinische Universitatsklinik Innsbruck
Not yet recruiting
Austria Linz Krankenhaus der Elisabethinen Linz
Not yet recruiting
Austria Salzburg, SAL LKH - Universitätsklinikum der PMU Salzburg
Recruiting
Austria Vienna Medical University of Vienna,Universitätsklinik für Innere Medizin I
Not yet recruiting
Australia Camperdown, NSW Royal Prince Alfred Hospital
Recruiting
Australia Fitzroy, VIC St. Vincent's Hospital Melbourne
Recruiting
Australia Heidelberg, VIC AUSTIN HEALTH
Recruiting
Australia Herston, QLD Royal Brisbane and Womens Hospital
Recruiting
Australia Melbourne, VIC Alfred Health
Recruiting
Australia Melbourne, VIC Peter MacCallum Cancer Centre
Recruiting
Australia Murdoch, WA Fiona Stanley Hospital
Recruiting
Australia Waratah, NSW Calvary Mater Newcastle Hospital
Recruiting
Australia Westmead, NSW Western Sydney Local Health District
Recruiting
Argentina Buenos Aires, B Hospital Aleman
Recruiting
Argentina Buenos Aires, B Hospital Italiano de Buenos Aires
Recruiting
Argentina Cordoba Hospital Privado Centro Medico de Cordoba
Recruiting
Argentina Pilar Hospital Universitario Austral
Not yet recruiting
x
50

Indicates 50+ sites in this region: click to zoom in.

10

Indicates 10+ sites in this region: click to zoom in.

5

Indicates < 10 sites in this region: click to zoom in.

Corresponds to individual site.

View Map Legend