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   April 24, 2024 - 21:08

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OVERVIEW

  • Gender
    all
  • Age
    18+ 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
    136 sites
  • Status
    Recruiting

SUMMARY

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.

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, Israel, Ireland, Hungary, Greece, Germany, France, Finland, Denmark, Czechia, Canada, Brazil, Belgium, Austria, Australia, Argentina
Country (26) City or Province (136) Status
United States Baltimore, MD University Of Maryland Medical Center
RECRUITING
United States Boston, MA Beth Israel Deaconess Medical Center
RECRUITING
United States Charlotte, NC Levine Cancer Institute
RECRUITING
United States Charlottesville, VA University of Virginia
RECRUITING
United States Detroit, MI Barbara Ann Karmanos Cancer Institute
RECRUITING
United States Detroit, MI Henry Ford Cancer Institute
RECRUITING
United States Iowa City, IA University of Iowa Hospitals & Clinics
RECRUITING
United States Lexington, KY University of Kentucky
COMPLETED
United States Louisville, KY Norton Cancer Institute
RECRUITING
United States Miami, FL University of Miami Health System
RECRUITING
United States Milwaukee, WI Medical College Of Wisconsin
RECRUITING
United States New Haven, CT Yale Cancer Center
RECRUITING
United States New York, NY Columbia University Medical Center
RECRUITING
United States New York, NY Memorial Sloan-Kettering Cancer Center
RECRUITING
United States New York, NY New York Presbyterian-Weill Cornell Medical College
RECRUITING
United States Orlando, FL AdventHealth Cancer Institute
RECRUITING
United States Philadelphia, PA Thomas Jefferson University
RECRUITING
United States Pittsburgh, PA University of Pittsburgh Medical Center
RECRUITING
United States San Francisco, CA UCSF
COMPLETED
United Kingdom Birmingham, WMD University Hospitals Birmingham NHS Trust,
ACTIVE_NOT_RECRUITING
United Kingdom Bristol Bristol Royal Infirmary
ACTIVE_NOT_RECRUITING
United Kingdom Leeds,, WYK Leeds Teaching Hospitals NHS Trust
ACTIVE_NOT_RECRUITING
United Kingdom London King s College Hospital
ACTIVE_NOT_RECRUITING
United Kingdom London University College Hospital
ACTIVE_NOT_RECRUITING
United Kingdom Manchester Manchester Royal Infirmary
ACTIVE_NOT_RECRUITING
United Kingdom Surrey The Royal Marsden NHS Trust Sutton
ACTIVE_NOT_RECRUITING
Switzerland Basel, BS Universitatsspital Basel
RECRUITING
Switzerland Bern INSELSPITAL Universitatsspital Bern
RECRUITING
Switzerland St. Gallen, SG Kantonsspital St.Gallen
RECRUITING
Sweden Goteborg Sahlgrenska University Hospital
COMPLETED
Sweden Linköping Universitetssjukhuset
RECRUITING
Sweden Lund Skane University Hospital
RECRUITING
Spain Barcelona, BA Hosp. Univ. Vall D Hebron
ACTIVE_NOT_RECRUITING
Spain Barcelona, BA Hosp. de La Santa Creu I Sant Pau
ACTIVE_NOT_RECRUITING
Spain L'Hospitalet de Llobregat, BA Instituto Catalan Deoncologia Hospital Duran I Reynals
ACTIVE_NOT_RECRUITING
Spain Madrid, MD Hosp. Gral. Univ. Gregorio Maranon
ACTIVE_NOT_RECRUITING
Spain Madrid, MD Hosp. Univ. 12 de Octubre
ACTIVE_NOT_RECRUITING
Spain Murcia, MU Hosp. Univ. Virgen de La Arrixaca
ACTIVE_NOT_RECRUITING
Spain Pamplona Clinica Univ. de Navarra
ACTIVE_NOT_RECRUITING
Spain Salamanca, SL Hosp. Clinico Univ. de Salamanca
ACTIVE_NOT_RECRUITING
Spain Santander, CT Hosp. Univ. Marques de Valdecilla
ACTIVE_NOT_RECRUITING
Spain Sevilla Hosp. Virgen Del Rocio
ACTIVE_NOT_RECRUITING
Spain Valencia, VC Hosp. Univ. I Politecni La Fe
ACTIVE_NOT_RECRUITING
South Korea Jeollanam-do, 46 Chonnam National University Hwasun Hospital
ACTIVE_NOT_RECRUITING
South Korea Seoul Asan Medical Center
ACTIVE_NOT_RECRUITING
South Korea Seoul Samsung Medical Center
ACTIVE_NOT_RECRUITING
South Korea Seoul Seoul National University Hospital
ACTIVE_NOT_RECRUITING
South Korea Seoul Severance Hospital, Yonsei University Health System
ACTIVE_NOT_RECRUITING
South Korea Seoul The Catholic University of Korea Seoul St. Mary's Hospital
ACTIVE_NOT_RECRUITING
Portugal Lisboa Instituto Portugues de Oncologia
ACTIVE_NOT_RECRUITING
Portugal Porto Instituto Portugues de Oncologia
ACTIVE_NOT_RECRUITING
Poland Gdansk Uniwersyteckie Centrum Kliniczne
ACTIVE_NOT_RECRUITING
Poland Gliwice Narodowy Instytut Onkologii im.Marii Sklodowskiej Curie Panstwowy Instytut BadawczyOddz. w Gliwicach
ACTIVE_NOT_RECRUITING
Poland Lublin Centrum Onkologii Ziemi Lubelskiej im. sw. Jana z Dukli
ACTIVE_NOT_RECRUITING
Poland Poznan Uniwersytecki Szpital Kliniczny w Poznaniu
ACTIVE_NOT_RECRUITING
Poland Warszawa Instytut Hematologii i Transfuzjologii
ACTIVE_NOT_RECRUITING
Poland Wroclaw Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu
ACTIVE_NOT_RECRUITING
Norway Oslo, OL Oslo universitetssykehus HF, Rikshospitalet
ACTIVE_NOT_RECRUITING
Netherlands Amsterdam VU Medisch Centrum
COMPLETED
Netherlands Groningen, GR University Medical Center Groningen
ACTIVE_NOT_RECRUITING
Netherlands Nijmegen, GE UMC Radboud
ACTIVE_NOT_RECRUITING
Netherlands Rotterdam Erasmus MC
ACTIVE_NOT_RECRUITING
Japan Bunkyo Ku, 13 Juntendo University Hospital
ACTIVE_NOT_RECRUITING
Japan Fukuoka Kyushu University Hospital
ACTIVE_NOT_RECRUITING
Japan Hyôgo, 28 Hyogo Medical University Hospital
ACTIVE_NOT_RECRUITING
Japan Kanazawa Kanazawa University Hospital
ACTIVE_NOT_RECRUITING
Japan Kyoto University Hospital Kyoto Perfectural University of Medicine
ACTIVE_NOT_RECRUITING
Japan Nagoya Nagoya City University Hospital
COMPLETED
Japan Okayama, 33 Okayama University Hospital
ACTIVE_NOT_RECRUITING
Japan Sapporo, 01 Hokkaido University Hospital
ACTIVE_NOT_RECRUITING
Japan Sendai, 04 Tohoku University Hospital
ACTIVE_NOT_RECRUITING
Japan Shibuya, 13 Japanese Red Cross Medical Center
ACTIVE_NOT_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 Hospital
RECRUITING
Hungary Budapest Del Pesti Centrumkorhaz Orszagos Hematologiai es Infektologiai Intezet Szent Laszlo Telephely
RECRUITING
Hungary Debrecen Debreceni Egyetem Klinikai Kozpont
COMPLETED
Greece Athens Alexandra General Hospital of Athens
ACTIVE_NOT_RECRUITING
Greece Athens Attikon University General Hospital of Attica
ACTIVE_NOT_RECRUITING
Greece Thessaloniki G.Papanikolaou
ACTIVE_NOT_RECRUITING
Germany Berlin, BE Charité - Universitätsmedizin Berlin, Campus Benjamin Franklin
ACTIVE_NOT_RECRUITING
Germany Dresden, SN Universitaetsklinikum Carl Gustav Carus TU Dresden
ACTIVE_NOT_RECRUITING
Germany Freiburg, BW Universitatsklinikum Freiburg
ACTIVE_NOT_RECRUITING
Germany Hamburg, HH Universitaetsklinikum Hamburg Eppendorf
ACTIVE_NOT_RECRUITING
Germany Heidelberg, BW Universitaetsklinikum Heidelberg
ACTIVE_NOT_RECRUITING
Germany Leipzig Universitaetsklinikum Leipzig
ACTIVE_NOT_RECRUITING
Germany Mainz, RP Universitätsmedizin der Johannes Gutenberg-Universität Mainz
ACTIVE_NOT_RECRUITING
Germany München Klinikum Großhadern der Ludwig-Maximilians-Universität
ACTIVE_NOT_RECRUITING
Germany Regensburg Universitaetsklinikum Regensburg
ACTIVE_NOT_RECRUITING
Germany Tubingen, BW Klinikum der Eberhard Karls Universitaet Abt fur innere Med II Haematologie Onkologie Germany
ACTIVE_NOT_RECRUITING
Germany Wuerzburg Universitatsklinikum Wurzburg
ACTIVE_NOT_RECRUITING
France Lille Cedex Centre Hospitalier Régional Universitaire de Lille, Hôpital Claude Huriez
ACTIVE_NOT_RECRUITING
France Nantes C.H.U. Hotel Dieu - France
COMPLETED
France Paris cedex 10 Hopital Saint Louis
ACTIVE_NOT_RECRUITING
France Poitiers CHU Poitiers - Hopital la Miletrie
ACTIVE_NOT_RECRUITING
France Toulouse cedex 9 Institut Universitaire du cancer de Toulouse-Oncopole
ACTIVE_NOT_RECRUITING
Finland Helsinki Helsinki University Hospital
ACTIVE_NOT_RECRUITING
Finland Oulu Oulu University Hospital
ACTIVE_NOT_RECRUITING
Finland Turku Turku University Hospital
ACTIVE_NOT_RECRUITING
Denmark Aarhus C Aarhus University Hospital
RECRUITING
Denmark Copenhagen Rigshospitalet
RECRUITING
Denmark Odense C Odense Universitetshospital
RECRUITING
Czechia Brno Fakultni nemocnice Brno
RECRUITING
Czechia Hradec Kralove Fakultni nemocnice Hradec Kralove
RECRUITING
Czechia Ostrava - Poruba Fakultni nemocnice Ostrava
RECRUITING
Czechia Praha 2 Vseobecna fakultni nemocnice v Praze
RECRUITING
Canada Calgary, AB Tom Baker Cancer Centre
ACTIVE_NOT_RECRUITING
Canada Hamilton, ON Juravinski Cancer Centre
ACTIVE_NOT_RECRUITING
Canada Montréal, QC Hopital Maisonneuve-Rosemont
ACTIVE_NOT_RECRUITING
Canada Toronto, ON Princess Margaret Cancer Centre University Health Network
ACTIVE_NOT_RECRUITING
Canada Vancouver, BC Vancouver General Hospital
ACTIVE_NOT_RECRUITING
Brazil Salvador, BA Hospital Sao Rafael
ACTIVE_NOT_RECRUITING
Brazil Sao Paulo, SP Fundacao Antonio Prudente A C Camargo Cancer Center
ACTIVE_NOT_RECRUITING
Brazil São Paulo, SP Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein
ACTIVE_NOT_RECRUITING
Belgium Antwerp Universitair Ziekenhuis - Antwerpen
ACTIVE_NOT_RECRUITING
Belgium Brugge AZ St.-Jan Brugge-Oostende AV
ACTIVE_NOT_RECRUITING
Belgium Gent UZ Gent
COMPLETED
Belgium Leuven UZ Leuven
COMPLETED
Belgium Liege Centre Hospitalier Universitaire de Liege Domaine Universitaire du Sart Tilman
COMPLETED
Austria Graz Medizinische Universität Graz, LKH-Univ.Klinikum Graz, Klinische Abteilung für Hämatologie
COMPLETED
Austria Linz Krankenhaus der Elisabethinen Linz
ACTIVE_NOT_RECRUITING
Austria Salzburg, SAL LKH - Universitätsklinikum der PMU Salzburg
ACTIVE_NOT_RECRUITING
Austria Vienna Medical University of Vienna,Universitätsklinik für Innere Medizin I
ACTIVE_NOT_RECRUITING
Australia Camperdown, NSW Royal Prince Alfred Hospital
ACTIVE_NOT_RECRUITING
Australia Fitzroy, VIC St. Vincent's Hospital Melbourne
ACTIVE_NOT_RECRUITING
Australia Heidelberg, VIC Austin Health
ACTIVE_NOT_RECRUITING
Australia Herston, QLD Royal Brisbane and Womens Hospital
ACTIVE_NOT_RECRUITING
Australia Melbourne, VIC Alfred Health
ACTIVE_NOT_RECRUITING
Australia Melbourne, VIC Peter MacCallum Cancer Centre
ACTIVE_NOT_RECRUITING
Australia Murdoch, WA Fiona Stanley Hospital
ACTIVE_NOT_RECRUITING
Australia Waratah, NSW Calvary Mater Newcastle Hospital
ACTIVE_NOT_RECRUITING
Australia Westmead, NSW Western Sydney Local Health District
ACTIVE_NOT_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
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