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
OVERVIEW
-
Gender
all -
Age
years -
Phase
phase 3The 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
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
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
|
Indicates 50+ sites in this region: click to zoom in.
Indicates 10+ sites in this region: click to zoom in.
Indicates < 10 sites in this region: click to zoom in.
Corresponds to individual site.