Phase
Condition
Cancer/tumors
Multiple Myeloma
Bone Neoplasm
Treatment
Lenalidomide
Fludarabine
idecabtagene vicleucel
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria
Participants aged ≥18 with Newly Diagnosed Multiple Myeloma (NDMM) who has received induction therapy followed by high-dose chemotherapy and autologous stem cell transplantation (ASCT), without subsequent consolidation or maintenance. EXCEPTION: Participant received ≤ 7 days of lenalidomide (LEN) maintenance therapy and the investigator documents that there is no impact to the overall benefit/risk assessment due to the temporary interruption of LEN.
Participant must have received 4 to 6 cycles of induction therapy, which must contain at a minimum an immunomodulatory drugs (IMiD) and a proteasome inhibitor (PI) (with or without anti-CD38 monoclonal antibody) and must have had a single ASCT 80 to 120 days prior to consent. Note: Participant must not have confirmed progression since commencing induction.
Participant must have documented response of PR or VGPR at time of consent.
Participant must have Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1 (participants with ECOG 2 due to pain because of underlying myeloma-associated bone lesions are eligible per investigator's discretion).
Participant must have recovered to ≤ Grade 1 for any nonhematologic toxicities due to prior treatments, excluding alopecia and Grade 2 neuropathy.
Exclusion Criteria
Participant with known central nervous system involvement with myeloma.
Participant has non-secretory MM.
Participant has systemic and uncontrolled fungal, bacterial, viral, or other infection.
Participant has history of primary immunodeficiency.
Participant has previous history of an allogeneic hematopoietic stem cell transplantation or treatment with any gene therapy-based therapeutic for cancer or investigational cellular therapy for cancer or B-cell maturation antigen targeted therapy.
Other protocol-defined Inclusion/Exclusion criteria apply.
Study Design
Connect with a study center
Royal Prince Alfred Hospital
Camperdown, New South Wales 2050
AustraliaActive - Recruiting
Local Institution - 0005
Brisbane, Queensland 4029
AustraliaSite Not Available
Peter MacCallum Cancer Centre
Melbourne, Victoria 3000
AustraliaActive - Recruiting
St Vincent's Hospital
Melbourne, Victoria 3065
AustraliaActive - Recruiting
The Alfred Hospital
Melbourne, Victoria 3004
AustraliaActive - Recruiting
Fiona Stanley Hospital
Murdoch, Western Australia 6150
AustraliaActive - Recruiting
Uniklinikum Salzburg
Salzburg, 5020
AustriaActive - Recruiting
Medizinische Universität Wien
Wien, 1090
AustriaActive - Recruiting
Institut Jules Bordet
Anderlecht, Bruxelles-Capitale, Région De 1070
BelgiumActive - Recruiting
UZ Brussel
Brussels, Bruxelles-Capitale, Région De 1090
BelgiumActive - Recruiting
Local Institution - 0133
Edmonton, Alberta T6G 1Z2
CanadaSite Not Available
Hamilton Health Sciences-Juravinski Cancer Centre
Hamilton, Ontario L8V5C2
CanadaActive - Recruiting
Local Institution - 0134
Montreal, Quebec H1T 2M4
CanadaSite Not Available
Local Institution - 0036
Brno, Brno-město 625 00
CzechiaSite Not Available
Local Institution - 0034
Hradec Kralove, Hradec Králové 500 05
CzechiaSite Not Available
Local Institution - 0035
Olomouc, Olomoucký Kraj 779 00
CzechiaSite Not Available
Local Institution - 0033
Praha 2, 12808
CzechiaSite Not Available
Local Institution - 0070
Odense, Syddanmark 5000
DenmarkSite Not Available
CHU Bordeaux Haut-Leveque
Pessac, Aquitaine 33600
FranceActive - Recruiting
Institut Paoli-Calmettes
Marseille, Bouches-du-Rhône 13273
FranceActive - Recruiting
Hopital Claude Huriez - CHU de Lille
Lille, Nord 59000
FranceActive - Recruiting
Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu
Nantes, Pays-de-la-Loire 44000
FranceActive - Recruiting
Centre Hospitalier Lyon Sud
Pierre-Bénite, Rhône 69310
FranceActive - Recruiting
Henri Mondor Hospital
Créteil, Val-de-Marne 94010
FranceActive - Recruiting
Gustave Roussy
Villejuif, Val-de-Marne 94805
FranceActive - Recruiting
Local Institution - 0029
Poitiers, Vienne 86021
FranceSite Not Available
Hôpital Saint Antoine
Paris, Île-de-France 75571
FranceActive - Recruiting
Hôpital Saint-Louis
Paris, 75010
FranceActive - Recruiting
Institut Universitaire du Cancer Toulouse - Oncopole - CHU de TOULOUSE
Toulouse, 31100
FranceActive - Recruiting
Local Institution - 0072
Heidelberg, Baden-Württemberg 69120
GermanySite Not Available
Local Institution - 0078
Ulm, Baden-Württemberg 89081
GermanySite Not Available
Local Institution - 0077
Nuremberg, Bayern 90419
GermanySite Not Available
Local Institution - 0073
Köln, Nordrhein-Westfalen 50937
GermanySite Not Available
Local Institution - 0079
Dresden, Sachsen 01307
GermanySite Not Available
Local Institution - 0087
Leipzig, Sachsen 04103
GermanySite Not Available
Local Institution - 0075
Kiel, Schleswig-Holstein 24105
GermanySite Not Available
Local Institution - 0115
Essen, 45122
GermanySite Not Available
Local Institution - 0076
Hamburg, 20246
GermanySite Not Available
Local Institution - 0074
Wuerzburg, 97080
GermanySite Not Available
University Hospital of Patras
Patras, Achaḯa 26504
GreeceActive - Recruiting
Evangelismos General Hospital of Athens
Athens, Attikí 106 76
GreeceActive - Recruiting
Attikon General University Hospital
Chaidari, Attikí 12462
GreeceActive - Recruiting
G. Papanikolaou General Hospital
Thessaloniki, Thessaloníki 570 10
GreeceActive - Recruiting
Local Institution - 0055
Be'er Sheva, HaDarom 8410101
IsraelSite Not Available
Local Institution - 0058
Petah-Tikva, HaMerkaz 4910021
IsraelSite Not Available
Sheba Medical Center
Ramat Gan, HaMerkaz 5266202
IsraelActive - Recruiting
Sourasky Medical Center
Tel Aviv, Tell Abīb 6423906
IsraelActive - Recruiting
Rambam Health Care Campus
Haifa, 31096
IsraelActive - Recruiting
Hadassah Medical Center
Jerusalem, 9112001
IsraelActive - Recruiting
Humanitas
Rozzano, Milano 20089
ItalyActive - Recruiting
Local Institution - 0067
Torino, Piemonte 10126
ItalySite Not Available
IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola
Bologna, 40138
ItalyActive - Recruiting
AOU Policlinico Umberto I
Roma, 00161
ItalyActive - Recruiting
Nagoya City University Hospital
Nagoya, Aichi 467-8602
JapanActive - Recruiting
Hokkaido University Hospital
Sapporo, Hokkaido 060-8648
JapanActive - Recruiting
Hyogo Medical University Hospital
Nishinomiya, Hyogo 663-8501
JapanActive - Recruiting
Kanazawa University Hospital
Kanazawa, Ishikawa 920-8641
JapanActive - Recruiting
Tokai University Hospital
Isehara, Kanagawa 259-1193
JapanActive - Recruiting
Chiba University Hospital
Chiba, 260-8677
JapanActive - Recruiting
Local Institution - 0054
Fukuoka, 812-8582
JapanSite Not Available
Okayama University Hospital
Okayama, 700-8558
JapanActive - Recruiting
Local Institution - 0071
Shimotsuke, 329-0498
JapanSite Not Available
Local Institution - 0050
Tokyo, 150-8935
JapanSite Not Available
Local Institution - 0041
Hwasun Gun, Jeonranamdo 58128
Korea, Republic ofSite Not Available
Local Institution - 0038
Seoul, Seoul-teukbyeolsi [Seoul] 06351
Korea, Republic ofSite Not Available
Local Institution - 0039
Seoul, Seoul-teukbyeolsi [Seoul] 03080
Korea, Republic ofSite Not Available
Local Institution - 0040
Seoul, Seoul-teukbyeolsi [Seoul] 05505
Korea, Republic ofSite Not Available
Local Institution - 0043
Seoul, Seoul-teukbyeolsi [Seoul] 06591
Korea, Republic ofSite Not Available
Oslo Universitetssykehus Rikshospitalet
Oslo, 0372
NorwayActive - Recruiting
Centrum Onkologii Ziemi Lubelskiej
Lublin, Lubelskie 20-090
PolandActive - Recruiting
Instytut Hematologii i Transfuzjologii
Warsaw, Mazowieckie 02-776
PolandActive - Recruiting
Samodzielny Publiczny Centralny Szpital Kliniczny w Warszawie
Warsaw, Mazowieckie 02-097
PolandActive - Recruiting
Narodowy Instytut Onkologii - Oddzial w Gliwicach
Gliwice, Śląskie 44-101
PolandActive - Recruiting
Uniwersyteckie Centrum Kliniczne
Gdańsk, 80-952
PolandActive - Recruiting
Uniwersytecki Szpital Kliniczny w Poznaniu
Poznań, 60-569
PolandActive - Recruiting
Institutul Clinic Fundeni
Bucharest, 022328
RomaniaActive - Recruiting
Institut Català d'Oncologia (ICO) - Badalona
Badalona, Barcelona [Barcelona] 08916
SpainActive - Recruiting
Institut Català d'Oncologia - L'Hospitalet
L'Hospitalet Del Llobregat, Barcelona [Barcelona] 08908
SpainActive - Recruiting
Hospital Clínic de Barcelona
Barcelona, Catalunya [Cataluña] 08036
SpainActive - Recruiting
Clinica Universidad de Navarra
Pamplona, Navarra 31008
SpainActive - Recruiting
Hospital Universitario 12 de Octubre
Madrid, 28041
SpainActive - Recruiting
Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca
Salamanca, 37007
SpainActive - Recruiting
Hospital Universitari i Politecnic La Fe
València, 46026
SpainActive - Recruiting
Local Institution - 0093
Birmingham, England B15 2TH
United KingdomSite Not Available
Local Institution - 0080
London, London, City Of SE5 9RS
United KingdomSite Not Available
Local Institution - 0094
London, London, City Of W12 0HS
United KingdomSite Not Available
Local Institution - 0081
Glasgow, G12 0YN
United KingdomSite Not Available
Banner MD Anderson Cancer Center
Gilbert, Arizona 85234
United StatesSite Not Available
Mayo Clinic in Arizona - Scottsdale
Scottsdale, Arizona 85259
United StatesSite Not Available
UCLA Hematology/Oncology - Westwood (Building 200 Suite 120)
Los Angeles, California 90095
United StatesSite Not Available
University of California, Irvine (UCI) Health - UC Irvine Medical Center
Orange, California 92868
United StatesSite Not Available
University of California Davis (UC Davis) Comprehensive Cancer Center
Sacramento, California 95817
United StatesSite Not Available
Colorado Blood Cancer Institute
Denver, Colorado 80218
United StatesActive - Recruiting
Yale University School of Medicine
New Haven, Connecticut 06510
United StatesSite Not Available
Mayo Clinic in Florida
Jacksonville, Florida 32224
United StatesSite Not Available
AdventHealth Orlando
Orlando, Florida 32804
United StatesSite Not Available
Moffitt Cancer Center
Tampa, Florida 33612
United StatesSite Not Available
Northside Hospital
Atlanta, Georgia 30342
United StatesSite Not Available
Winship Cancer Institute, Emory University
Atlanta, Georgia 30322
United StatesSite Not Available
Boston Medical Center
Boston, Massachusetts 02118
United StatesSite Not Available
Massachusetts General Hospital
Boston, Massachusetts 02114
United StatesSite Not Available
Local Institution - 0123
Ann Arbor, Michigan 48109
United StatesSite Not Available
Ascension Providence Hospital
Southfield, Michigan 48075
United StatesSite Not Available
Local Institution - 0119
Minneapolis, Minnesota 55455
United StatesSite Not Available
Mayo Clinic in Rochester, Minnesota
Rochester, Minnesota 55905
United StatesSite Not Available
Washington University School of Medicine
Saint Louis, Missouri 63110
United StatesSite Not Available
Columbia University Irving Medical Center
New York, New York 10032
United StatesSite Not Available
Novant Health Cancer Institute - Elizabeth
Charlotte, North Carolina 28204
United StatesSite Not Available
Wake Forest Baptist Health
Winston-Salem, North Carolina 27157
United StatesSite Not Available
University Hospitals Cleveland Medical Center
Cleveland, Ohio 44106
United StatesSite Not Available
The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive Cancer Center
Columbus, Ohio 43210
United StatesSite Not Available
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania 19104
United StatesActive - Recruiting
St. David's South Austin Medical Center
Austin, Texas 78704
United StatesActive - Recruiting
UT Southwestern Medical Center
Dallas, Texas 75390-88520
United StatesSite Not Available
Houston Methodist Hospital
Houston, Texas 77030
United StatesSite Not Available
University of Texas MD Anderson Cancer Center
Houston, Texas 77030
United StatesSite Not Available
Local Institution - 0136
Richmond, Virginia 23298
United StatesSite Not Available

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