Phase
Condition
Cancer/tumors
Bone Neoplasm
Leukemia
Treatment
Cyclophosphamide
Cilta-cel
Lenalidomide
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Documented diagnosis of multiple myeloma (MM) according to International MyelomaWorking Group (IMWG) diagnostic criteria
Measurable disease at screening as defined by any of the following: Serum monoclonalparaprotein (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 inwhom only measurable disease is by serum free light chain (FLC) levels: Serumimmunoglobin (Ig) free light chain >=10 milligrams per deciliter (mg/dL) andabnormal 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 ofcomorbid condition(s) likely to have a negative impact on tolerability of high-dosechemotherapy with ASCT; or Deferral of high-dose chemotherapy with ASCT as initialtreatment
A woman of childbearing potential (WOCBP) must have 2 negative highly sensitiveserum or urine pregnancy tests (beta-human chorionic gonadotropin) prior to startingBortezomib, Lenalidomide and Dexamethasone (VRd) and must agree to further testingduring the study.
Clinical laboratory values meeting the following criteria during the screeningphase: 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 supportin the 7 days prior to the laboratory test); aspartate aminotransferase (AST) andalanine aminotransferase (ALT) less than or equal to (<=) 3.0 * upper limit ofnormal (ULN); estimated glomerular filtration rate >=40 milliliter per minute/1.73meter 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
Exclusion Criteria:
Frailty index of >=2 according to Myeloma Geriatric Assessment score
Peripheral neuropathy or neuropathic pain Grade 2 or higher, as defined by theNational Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE)Version 5
Known active, or prior history of central nervous system (CNS) involvement orclinical 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 anytarget
Any therapy that is targeted to B-cell maturation antigen (BCMA)
Study Design
Study Description
Connect with a study center
Hospital Aleman
Buenos Aires, C1118AAT
ArgentinaSite Not Available
Hospital Italiano de Buenos Aires
Buenos Aires, C1199ABD
ArgentinaSite Not Available
Hospital Privado Centro Medico de Cordoba
Cordoba, X5016KEH
ArgentinaSite Not Available
Hospital Privado Universitario De Cordoba
Cordoba, 5016
ArgentinaSite Not Available
Hospital Universitario Austral
Pilar, 1629
ArgentinaSite Not Available
Royal Prince Alfred Hospital
Camperdown, 2050
AustraliaSite Not Available
St Vincents Hospital Melbourne
Fitzroy, 3065
AustraliaSite Not Available
St. Vincent's Hospital Melbourne
Fitzroy, 3065
AustraliaSite Not Available
Austin Health
Heidelberg, 3084
AustraliaSite Not Available
Royal Brisbane and Womens Hospital
Herston, 4029
AustraliaSite Not Available
Alfred Health
Melbourne, 3004
AustraliaSite Not Available
Peter MacCallum Cancer Centre
Melbourne, 8006
AustraliaSite Not Available
Fiona Stanley Hospital
Murdoch, 6150
AustraliaSite Not Available
Calvary Mater Newcastle Hospital
Waratah, 2298
AustraliaSite Not Available
Western Sydney Local Health District
Westmead, 2145
AustraliaSite Not Available
Medizinische Universität Graz, LKH-Univ.Klinikum Graz, Klinische Abteilung für Hämatologie
Graz, 8036
AustriaSite Not Available
Medizinische Universitatsklinik Innsbruck
Innsbruck, 6020
AustriaSite Not Available
Krankenhaus der Elisabethinen Linz
Linz, 4020
AustriaSite Not Available
LKH - Universitätsklinikum der PMU Salzburg
Salzburg, 5020
AustriaSite Not Available
Medical University of Vienna Universitatsklinik fur Innere Medizin I
Vienna, 1090
AustriaSite Not Available
Medical University of Vienna,Universitätsklinik für Innere Medizin I
Vienna, 1090
AustriaSite Not Available
Universitair Ziekenhuis - Antwerpen
Antwerp, 2650
BelgiumSite Not Available
AZ St.-Jan Brugge-Oostende AV
Brugge, 8000
BelgiumSite Not Available
Cliniques Universitaires St-Luc
Brussel, 1200
BelgiumSite Not Available
UZ Gent
Gent, 9000
BelgiumSite Not Available
UZ Leuven
Leuven, 3000
BelgiumSite Not Available
Centre Hospitalier Universitaire de Liege Domaine Universitaire du Sart Tilman
Liege, B-4000
BelgiumSite Not Available
Hospital Sao Rafael
Salvador, 41253-190
BrazilSite Not Available
Fundacao Antonio Prudente - A.C. Camargo Cancer Center
Sao Paulo, 01509900
BrazilActive - Recruiting
Fundacao Antonio Prudente A C Camargo Cancer Center
Sao Paulo, 01509 900
BrazilSite Not Available
Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein
Sao Paulo, 05652 900
BrazilSite Not Available
Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein
São Paulo, 05652-900
BrazilSite Not Available
Arthur J E Child Comprehensive Cancer Centre
Calgary, Alberta T2N 5G2
CanadaSite Not Available
Arthur J. E. Child Comprehensive Cancer Centre
Calgary, Alberta T2N 5G2
CanadaSite Not Available
Tom Baker Cancer Centre
Calgary, Alberta T2N 4N2
CanadaSite Not Available
Vancouver General Hospital
Vancouver, British Columbia V5Z 1M9
CanadaSite Not Available
Juravinski Cancer Centre
Hamilton, Ontario L8V5C2
CanadaSite Not Available
Princess Margaret Cancer Centre University Health Network
Toronto, Ontario M5G2M9
CanadaSite Not Available
Hopital Maisonneuve Rosemont
Montreal, Quebec H1T 2M4
CanadaSite Not Available
Hopital Maisonneuve-Rosemont
Montréal, Quebec H1T 2M4
CanadaSite Not Available
Fakultni nemocnice Brno
Brno, 625 00
CzechiaSite Not Available
Fakultni nemocnice Hradec Kralove
Hradec Kralove, 500 05
CzechiaSite Not Available
Fakultni nemocnice Ostrava
Ostrava, 70852
CzechiaSite Not Available
Fakultni Nemocnice Ostrava
Ostrava - Poruba, 708 52
CzechiaSite Not Available
Fakultni nemocnice Plzen
Plzen-Lochotin, 304 60
CzechiaSite Not Available
Vseobecna fakultni nemocnice v Praze
Praha 2, 128 08
CzechiaSite Not Available
Aarhus University Hospital
Aarhus C, 8000
DenmarkSite Not Available
Rigshospitalet
Copenhagen, 2100
DenmarkSite Not Available
Odense Universitetshospital
Odense C, 5000
DenmarkSite Not Available
Helsinki University Hospital
Helsinki, 00029 HUS
FinlandSite Not Available
Oulu University Hospital
Oulu, 90220
FinlandSite Not Available
Turku University Hospital
Turku, 20520
FinlandSite Not Available
Centre Hospitalier Régional Universitaire de Lille, Hôpital Claude Huriez
Lille Cedex, 59000
FranceSite Not Available
C.H.U. Hotel Dieu - France
Nantes, 44093
FranceSite Not Available
Hopital Saint Louis
Paris cedex 10, 75475
FranceSite Not Available
Hopital Saint-Louis
Paris cedex 10, 75475
FranceActive - Recruiting
CHU Poitiers - Hopital la Miletrie
Poitiers, 86021
FranceSite Not Available
CHU Poitiers - Hôpital la Milétrie
Poitiers, 86021
FranceSite Not Available
Institut Universitaire du cancer de Toulouse-Oncopole
Toulouse cedex 9, 31059
FranceSite Not Available
Charité - Universitätsmedizin Berlin, Campus Benjamin Franklin
Berlin, 12203
GermanySite Not Available
Universitaetsklinikum Carl Gustav Carus TU Dresden
Dresden, 01307
GermanySite Not Available
Universitatsklinikum Freiburg
Freiburg, 79106
GermanySite Not Available
Universitaetsklinikum Hamburg Eppendorf
Hamburg, 20246
GermanySite Not Available
Medizinische Hochschule Hannover
Hannover, 30625
GermanySite Not Available
Universitaetsklinikum Heidelberg
Heidelberg, 69120
GermanySite Not Available
Universitaetsklinikum Leipzig
Leipzig, 04103
GermanySite Not Available
Universitatsklinikum Leipzig
Leipzig, 04103
GermanyActive - Recruiting
Universitatsmedizin der Johannes Gutenberg Universitat Mainz
Mainz, 55131
GermanySite Not Available
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
Mainz, 55131
GermanySite Not Available
Klinikum Großhadern der Ludwig-Maximilians-Universität
München, 81377
GermanySite Not Available
Universitaetsklinikum Regensburg
Regensburg, 93053
GermanySite Not Available
Klinikum der Eberhard Karls Universitaet Abt fur innere Med II Haematologie Onkologie Germany
Tubingen, 72076
GermanySite Not Available
Klinikum der Eberhard-Karls-Universität/Abt. für innere Med. II/Hämatologie/Onkologie-Germany
Tübingen, 72076
GermanySite Not Available
Universitatsklinikum Wurzburg
Wuerzburg, 97080
GermanySite Not Available
Universitatsklinikum Wurzburg
Würzburg, 97080
GermanySite Not Available
Universitätsklinikum Würzburg
Würzburg, 97080
GermanyActive - Recruiting
Alexandra General Hospital of Athens
Athens, 11528
GreeceSite Not Available
Attikon University General Hospital of Attica
Athens, 12462
GreeceSite Not Available
G.Papanikolaou
Thessaloniki, 57010
GreeceSite Not Available
Del Pesti Centrumkorhaz Orszagos Hematologiai es Infektologiai Intezet Szent Laszlo Telephely
Budapest, 1097
HungarySite Not Available
Dél-pesti Centrumkórház - Országos Hematológiai és Infektológiai Intézet, Szent László Telephely
Budapest, 1097
HungaryActive - Recruiting
Debreceni Egyetem Klinikai Kozpont
Debrecen, 4032
HungarySite Not Available
St James Hospital
Dublin, D08 NHY1
IrelandSite Not Available
Rambam Medical Center
Haifa, 3109601
IsraelSite Not Available
Hadassah University Hospita - Ein Kerem
Jerusalem, P.O.B. 12000
IsraelActive - Recruiting
Hadassah University Hospita Ein Kerem
Jerusalem, P.O.B. 12000
IsraelSite Not Available
Sheba Medical Center Tel Hashomer
Ramat Gan, 52621
IsraelSite Not Available
Tel Aviv Sourasky Medical Center
Tel Aviv, 64239
IsraelSite Not Available
A.O. Universitaria Ospedali Riuniti di Ancona
Ancona, 60020
ItalySite Not Available
Azienda Ospedaliera Papa Giovanni XXIII
Bergamo, 24127
ItalySite Not Available
Policlinico Sant'Orsola Malpighi
Bologna, 40138
ItalySite Not Available
IRCCS Azienda Ospedaliera San Martino - IST
Genova, 16132
ItalySite Not Available
Fondazione IRCCS Istituto Nazionale dei Tumori
Milano, 20133
ItalySite Not Available
Casa di Cura La Maddalena
Palermo, 90146
ItalySite Not Available
Grande Ospedale Metropolitano 'Bianchi-Melacrino-Morelli' Reggio Calabria
Reggio Calabria, 89133
ItalySite Not Available
AOU Policlinico Umberto I
Roma, 00161
ItalySite Not Available
Azienda Ospedaliera Universitaria Integrata Verona
Verona, 37134
ItalySite Not Available
Juntendo University Hospital
Bunkyo Ku, 113 8431
JapanSite Not Available
Juntendo University Hospital
Bunkyo-Ku, 113-8431
JapanSite Not Available
Kyushu University Hospital
Fukuoka, 812 8582
JapanSite Not Available
Hyogo Medical University Hospital
Hyôgo, 663-8501
JapanSite Not Available
Kanazawa University Hospital
Kanazawa, 920 8641
JapanSite Not Available
University Hospital Kyoto Perfectural University of Medicine
Kyoto, 602-8566
JapanSite Not Available
University Hospital Kyoto Prefectural University of Medicine
Kyoto, 602-8566
JapanSite Not Available
Nagoya City University Hospital
Nagoya, 467 8602
JapanSite Not Available
Okayama University Hospital
Okayama, 700 8558
JapanSite Not Available
Hokkaido University Hospital
Sapporo, 060-8648
JapanSite Not Available
Tohoku University Hospital
Sendai, 980 8574
JapanSite Not Available
Japanese Red Cross Medical Center
Shibuya, 150-8935
JapanSite Not Available
Chonnam National University Hwasun Hospital
Hwasun Gun, 58128
Korea, Republic ofSite Not Available
Chonnam National University Hwasun Hospital
Jeollanam-do, 58128
Korea, Republic ofSite Not Available
Asan Medical Center
Seoul, 05505
Korea, Republic ofSite Not Available
Samsung Medical Center
Seoul, 06351
Korea, Republic ofSite Not Available
Seoul National University Hospital
Seoul, 03080
Korea, Republic ofSite Not Available
Severance Hospital Yonsei University Health System
Seoul, 03722
Korea, Republic ofSite Not Available
Severance Hospital, Yonsei University Health System
Seoul, 03722
Korea, Republic ofSite Not Available
The Catholic University of Korea Seoul St Marys Hospital
Seoul, 06591
Korea, Republic ofSite Not Available
The Catholic University of Korea Seoul St. Mary's Hospital
Seoul, 06591
Korea, Republic ofSite Not Available
VU Medisch Centrum
Amsterdam, 1081 HV
NetherlandsSite Not Available
University Medical Center Groningen
Groningen, 9713 GZ
NetherlandsSite Not Available
UMC Radboud
Nijmegen, 6500 HB
NetherlandsSite Not Available
Erasmus MC
Rotterdam, 3075 EA
NetherlandsSite Not Available
Oslo universitetssykehus HF, Rikshospitalet
Oslo, 0372
NorwaySite Not Available
Uniwersyteckie Centrum Kliniczne
Gdansk, 80 214
PolandSite Not Available
Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut BadawczyOddz w Gliwicach
Gliwice, 44102
PolandSite Not Available
Narodowy Instytut Onkologii im.Marii Sklodowskiej Curie Panstwowy Instytut BadawczyOddz. w Gliwicach
Gliwice, 44102
PolandSite Not Available
Centrum Onkologii Ziemi Lubelskiej im sw Jana z Dukli
Lublin, 20 090
PolandSite Not Available
Centrum Onkologii Ziemi Lubelskiej im. sw. Jana z Dukli
Lublin, 20-090
PolandSite Not Available
Centrum Onkologii Ziemi Lubelskiej im. św. Jana z Dukli
Lublin, 20-090
PolandActive - Recruiting
Uniwersytecki Szpital Kliniczny w Poznaniu
Poznan, 60-569
PolandSite Not Available
Szpital Kliniczny im. H. Swiecickiego Uniwersytetu Medycznego im. K. Marcinkowskiego w Poznaniu
Poznań, 60-569
PolandSite Not Available
Instytut Hematologii i Transfuzjologii
Warszawa, 02 776
PolandSite Not Available
Uniwersytecki Szpital Kliniczny im Jana Mikulicza Radeckiego we Wroclawiu
Wroclaw, 50 367
PolandSite Not Available
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu
Wroclaw, 52-007
PolandSite Not Available
Hospital De Santa Maria
Lisboa, 1649-035
PortugalSite Not Available
Instituto Portugues de Oncologia
Lisboa, 1099-023
PortugalSite Not Available
Instituto Portugues de Oncologia
Porto, 4200072
PortugalSite Not Available
Hosp Univ Vall D Hebron
Barcelona, 8035
SpainSite Not Available
Hosp. Univ. Vall D Hebron
Barcelona, 8035
SpainSite Not Available
Hosp. de La Santa Creu I Sant Pau
Barcelona, 08025
SpainSite Not Available
Hosp. de la Santa Creu i Sant Pau
Barcelona, 08041
SpainActive - Recruiting
Instituto Catalan Deoncologia Hospital Duran I Reynals
L'Hospitalet de Llobregat, 08908
SpainSite Not Available
Hosp. Gral. Univ. Gregorio Maranon
Madrid, 28007
SpainSite Not Available
Hosp. Gral. Univ. Gregorio Marañon
Madrid, 28007
SpainActive - Recruiting
Hosp. Univ. 12 de Octubre
Madrid, 28041
SpainSite Not Available
Hosp. Univ. Virgen de La Arrixaca
Murcia, 30120
SpainSite Not Available
Clinica Univ. de Navarra
Pamplona, 31008
SpainSite Not Available
Hosp Clinico Univ de Salamanca
Salamanca, 37007
SpainSite Not Available
Hosp. Clinico Univ. de Salamanca
Salamanca, 37007
SpainSite Not Available
Hosp. Univ. Marques de Valdecilla
Santander, 39008
SpainSite Not Available
Hosp. Virgen Del Rocio
Sevilla, 41013
SpainSite Not Available
Hosp. Univ. I Politecni La Fe
Valencia, 46026
SpainSite Not Available
Sahlgrenska University Hospital
Goteborg, 413 45
SwedenSite Not Available
Sahlgrenska University Hospital
Göteborg, 413 45
SwedenSite Not Available
Universitetssjukhuset
Linköping, 58185
SwedenSite Not Available
Skane University Hospital
Lund, 221 85
SwedenSite Not Available
Haematology Centre, R 51
Stockholm, SE-141 86
SwedenSite Not Available
Akademiska Sjukhuset
Uppsala, 751 85
SwedenSite Not Available
Universitatsspital Basel
Basel, 4031
SwitzerlandSite Not Available
Ente Ospedaliero Cantonale
Bellinzona, 6500
SwitzerlandSite Not Available
INSELSPITAL, Universitätsspital Bern
Bern, 3010
SwitzerlandActive - Recruiting
Inselspital Universitatsspital Bern
Bern, 3010
SwitzerlandSite Not Available
Hôpitaux Universitaires de Genève - HUG
Genève, 1205
SwitzerlandSite Not Available
Kantonsspital St Gallen
St. Gallen, 9007
SwitzerlandSite Not Available
Kantonsspital St.Gallen
St. Gallen, 9007
SwitzerlandActive - Recruiting
UniversitaetsSpital Zuerich
Zürich,
SwitzerlandSite Not Available
University Hospitals Birmingham NHS Trust,
Birmingham, B15 2TH
United KingdomSite Not Available
Bristol Royal Infirmary
Bristol, BS2 8BJ
United KingdomSite Not Available
Leeds Teaching Hospitals NHS Trust
Leeds, LS9 7TF
United KingdomSite Not Available
Leeds Teaching Hospitals NHS Trust
Leeds,, LS9 7TF
United KingdomSite Not Available
King s College Hospital
London, SE5 9RS
United KingdomSite Not Available
King's College Hospital
London, SE5 9RS
United KingdomSite Not Available
Kings College Hospital
London, SE5 9RS
United KingdomSite Not Available
University College Hospital
London, NW1 2BU
United KingdomSite Not Available
Manchester Royal Infirmary
Manchester, M13 9WL
United KingdomSite Not Available
The Royal Marsden NHS Trust Sutton
Surrey, SM2 5PT
United KingdomSite Not Available
UCSF
San Francisco, California 94143
United StatesSite Not Available
Stanford University Medical Center
Stanford, California 94305-5623
United StatesSite Not Available
Yale Cancer Center
New Haven, Connecticut 06510
United StatesSite Not Available
University of Miami Health System
Miami, Florida 33136
United StatesSite Not Available
AdventHealth Cancer Institute
Orlando, Florida 32832
United StatesSite Not Available
Loyola University Medical Center
Melrose Park, Illinois 60160
United StatesSite Not Available
University of Iowa Hospitals & Clinics
Iowa City, Iowa 52242
United StatesSite Not Available
University of Iowa Hospitals and Clinics
Iowa City, Iowa 52242
United StatesSite Not Available
University of Kansas Medical Center
Westwood, Kansas 66205
United StatesSite Not Available
University of Kentucky
Lexington, Kentucky 40536-0293
United StatesSite Not Available
Norton Cancer Institute
Louisville, Kentucky 40207
United StatesSite Not Available
University Of Maryland Medical Center
Baltimore, Maryland 21201-1595
United StatesSite Not Available
Beth Israel Deaconess Medical Center
Boston, Massachusetts 02215
United StatesSite Not Available
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan 48201
United StatesSite Not Available
Henry Ford Cancer Institute
Detroit, Michigan 48202-2608
United StatesSite Not Available
Mayo Clinic - Rochester
Rochester, Minnesota 55905
United StatesSite Not Available
Columbia University Medical Center
New York, New York 10032
United StatesSite Not Available
Memorial Sloan-Kettering Cancer Center
New York, New York 10065
United StatesSite Not Available
New York Presbyterian-Weill Cornell Medical College
New York, New York 10065
United StatesSite Not Available
University of North Carolina
Chapel Hill, North Carolina 27599
United StatesSite Not Available
Levine Cancer Institute
Charlotte, North Carolina 28204
United StatesSite Not Available
Thomas Jefferson University
Philadelphia, Pennsylvania 19107
United StatesSite Not Available
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania 15232
United StatesSite Not Available
University of Texas Southwestern Medical Center
Dallas, Texas 75390-8562
United StatesSite Not Available
University of Virginia
Charlottesville, Virginia 22903
United StatesSite Not Available
Medical College Of Wisconsin
Milwaukee, Wisconsin 53226
United StatesSite Not Available
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