Multiple Myeloma Clinical Trial

A Study to Compare the Efficacy and Safety of Idecabtagene Vicleucel With Lenalidomide Maintenance Therapy Versus Lenalidomide Maintenance Therapy Alone in Adult Participants With Newly Diagnosed Multiple Myeloma Who Have Suboptimal Response After Autologous Stem Cell Transplantation

Summary

The purpose of this study is to compare the efficacy, safety, and tolerability of ide-cel with lenalidomide (LEN) maintenance to that of LEN maintenance alone in adult participants with Newly Diagnosed Multiple Myeloma (NDMM) who have achieved a suboptimal response post autologous stem cell transplantation (ASCT).

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria

Participants aged ≥18 with Newly Diagnosed Multiple Myeloma (NDMM) who has received treatment-for-multiple-myeloma-induction-therapy/" >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 is for people with:

Multiple Myeloma

Phase:

Phase 3

Estimated Enrollment:

618

Study ID:

NCT06045806

Recruitment Status:

Recruiting

Sponsor:

Bristol-Myers Squibb

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There are 115 Locations for this study

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Banner MD Anderson Cancer Center
Gilbert Arizona, 85234, United States More Info
Rajneesh Nath, Site 0096
Contact
480-256-3223
Mayo Clinic in Arizona - Scottsdale
Scottsdale Arizona, 85259, United States More Info
Peter Bergsagel, Site 0097
Contact
480-342-4800
UCLA Hematology/Oncology - Westwood (Building 200 Suite 120)
Los Angeles California, 90095, United States More Info
Sarah Larson, Site 0131
Contact
310-829-5471
University of California, Irvine (UCI) Health - UC Irvine Medical Center
Orange California, 92868, United States More Info
Stefan Ciurea, Site 0126
Contact
714-509-2290
University of California Davis (UC Davis) Comprehensive Cancer Center
Sacramento California, 95817, United States More Info
Aaron Rosenberg, Site 0113
Contact
916-734-3771
Colorado Blood Cancer Institute
Denver Colorado, 80218, United States More Info
Tara Gregory, Site 0101
Contact
720-754-4800
Yale University School of Medicine
New Haven Connecticut, 06510, United States More Info
Noffar Bar, Site 0111
Contact
000-000-0000
Mayo Clinic in Florida
Jacksonville Florida, 32224, United States More Info
Sikander Ailawadhi, Site 0098
Contact
904-953-2000
AdventHealth Orlando
Orlando Florida, 32804, United States More Info
Rushang Patel, Site 0127
Contact
407-303-2070
Moffitt Cancer Center
Tampa Florida, 33612, United States More Info
Omar Castaneda Puglianini, Site 0129
Contact
813-745-0365
Winship Cancer Institute, Emory University
Atlanta Georgia, 30322, United States More Info
Nisha Joseph, Site 0121
Contact
502-608-5503
Northside Hospital
Atlanta Georgia, 30342, United States More Info
Scott Solomon, Site 0104
Contact
404-255-1930
Massachusetts General Hospital
Boston Massachusetts, 02114, United States More Info
Diana Cirstea, Site 0102
Contact
617-724-4000
Boston Medical Center
Boston Massachusetts, 02118, United States
Local Institution - 0123
Ann Arbor Michigan, 48109, United States More Info
Site 0123
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Ascension Providence Hospital
Southfield Michigan, 48075, United States More Info
Howard Terebelo, Site 0105
Contact
248-552-0620
Local Institution - 0119
Minneapolis Minnesota, 55455, United States More Info
Site 0119
Contact
Mayo Clinic in Rochester, Minnesota
Rochester Minnesota, 55905, United States More Info
Shaji Kumar, Site 0100
Contact
507-202-8384
Washington University School of Medicine
Saint Louis Missouri, 63110, United States More Info
RAVI VIJ, Site 0103
Contact
314-409-4144
Washington University School of Medicine
Saint Louis Missouri, 63110, United States More Info
Michael Slade, Site 0120
Contact
314-454-8304
Columbia University Irving Medical Center
New York New York, 10032, United States More Info
Ran Reshef, Site 0117
Contact
212-342-0530
Novant Health Cancer Institute - Elizabeth
Charlotte North Carolina, 28204, United States More Info
Raymond Thertulien, Site 0135
Contact
646-708-2544
Wake Forest Baptist Health
Winston-Salem North Carolina, 27157, United States
University Hospitals Cleveland Medical Center
Cleveland Ohio, 44106, United States More Info
Koen van Besien, Site 0116
Contact
216-844-0139
The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive Cancer Center
Columbus Ohio, 43210, United States More Info
Srinivas Devarakonda, Site 0106
Contact
570-423-0522
Hospital of the University of Pennsylvania
Philadelphia Pennsylvania, 19104, United States More Info
Adam Cohen, Site 0132
Contact
215-615-7362
St. David's South Austin Medical Center
Austin Texas, 78704, United States More Info
Aravind Ramakrishnan, Site 0124
Contact
512-952-1945
UT Southwestern Medical Center
Dallas Texas, 75390, United States More Info
Gurbakhash Kaur, Site 0114
Contact
214-648-5364
Houston Methodist Hospital
Houston Texas, 77030, United States More Info
Siddhartha Ganguly, Site 0109
Contact
713-441-9948
University of Texas MD Anderson Cancer Center
Houston Texas, 77030, United States More Info
Krina Patel, Site 0112
Contact
713-792-6662
Local Institution - 0136
Richmond Virginia, 23298, United States More Info
Site 0136
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Local Institution - 0007
Camperdown New South Wales, 2050, Australia More Info
Site 0007
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Local Institution - 0005
Brisbane Queensland, 4029, Australia More Info
Site 0005
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Peter MacCallum Cancer Centre
Melbourne Victoria, 3000, Australia More Info
Simon Harrison, Site 0004
Contact
+61 3 8559 7835
The Alfred Hospital
Melbourne Victoria, 3004, Australia More Info
Shafqat Inam, Site 0006
Contact
+61 3 9076 8297
St Vincent's Hospital
Melbourne Victoria, 3065, Australia More Info
Hang Quach, Site 0008
Contact
+61 3 9231 3189
Fiona Stanley Hospital
Murdoch Western Australia, 6150, Australia More Info
Stephanie Lam, Site 0011
Contact
+61 8 6152 6540
Local Institution - 0089
Salzburg , 5020, Austria More Info
Site 0089
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Medizinische Universität Wien
Wien , 1090, Austria More Info
Maria-Theresa Krauth, Site 0090
Contact
004314040044100
Institut Jules Bordet
Anderlecht Bruxelles-Capitale, Région De, 1070, Belgium More Info
Marie Vercruyssen, Site 0083
Contact
02 5413847
UZ Brussel
Brussels Bruxelles-Capitale, Région De, 1090, Belgium More Info
Ann De Becker, Site 0084
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0000000000
Local Institution - 0133
Edmonton Alberta, T6G 1, Canada More Info
Site 0133
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Hamilton Health Sciences-Juravinski Cancer Centre
Hamilton Ontario, L8V5C, Canada More Info
Amaris Balitsky, Site 0001
Contact
905-387-9495ext62491
Local Institution - 0134
Montreal Quebec, H1T 2, Canada More Info
Site 0134
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Local Institution - 0036
Brno Brno-město, 625 0, Czechia More Info
Site 0036
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Local Institution - 0034
Hradec Kralove Hradec Králové, 500 0, Czechia More Info
Site 0034
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Local Institution - 0035
Olomouc Olomoucký Kraj, 779 0, Czechia More Info
Site 0035
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Local Institution - 0033
Praha 2 , 12808, Czechia More Info
Site 0033
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Local Institution - 0070
Odense Syddanmark, 5000, Denmark More Info
Site 0070
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CHU Bordeaux Haut-Leveque
Pessac Aquitaine, 33600, France More Info
Cyrille Hulin, Site 0047
Contact
33557656511
Institut Paoli-Calmettes
Marseille Bouches-du-Rhône, 13273, France More Info
Gabriel Brisou, Site 0045
Contact
+33647880806
Hopital Claude Huriez - CHU de Lille
Lille Nord, 59000, France More Info
Salomon Manier, Site 0030
Contact
33320444292
Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu
Nantes Pays-de-la-Loire, 44000, France More Info
Cyrille Touzeau, Site 0042
Contact
33240083271
Centre Hospitalier Lyon Sud
Pierre-Bénite Rhône, 69310, France More Info
Lionel Karlin, Site 0046
Contact
33478864309
Henri Mondor Hospital
Créteil Val-de-Marne, 94010, France More Info
Karim BELHADJ-MERZOUG, Site 0068
Contact
+33149812163
Gustave Roussy
Villejuif Val-de-Marne, 94805, France More Info
Alina Danu, Site 0028
Contact
33142114229
Local Institution - 0029
Poitiers Vienne, 86021, France More Info
Site 0029
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Hôpital Saint-Louis
Paris , 75010, France More Info
Bertrand Arnulf, Site 0082
Contact
33142499472
Institut Universitaire du Cancer Toulouse - Oncopole - CHU de TOULOUSE
Toulouse , 31100, France More Info
Aurore Perrot, Site 0092
Contact
0531156184
Hôpital Saint Antoine
Paris Île-de-France, 75571, France More Info
Mohamad Mohty, Site 0031
Contact
33149282620
Local Institution - 0072
Heidelberg Baden-Württemberg, 69120, Germany More Info
Site 0072
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Local Institution - 0078
Ulm Baden-Württemberg, 89081, Germany More Info
Site 0078
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Local Institution - 0077
Nuremberg Bayern, 90419, Germany More Info
Site 0077
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Local Institution - 0073
Köln Nordrhein-Westfalen, 50937, Germany More Info
Site 0073
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Local Institution - 0079
Dresden Sachsen, 01307, Germany More Info
Site 0079
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Local Institution - 0087
Leipzig Sachsen, 04103, Germany More Info
Site 0087
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Local Institution - 0075
Kiel Schleswig-Holstein, 24105, Germany More Info
Site 0075
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Local Institution - 0115
Essen , 45122, Germany More Info
Site 0115
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Local Institution - 0076
Hamburg , 20246, Germany More Info
Site 0076
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Local Institution - 0074
Wuerzburg , 97080, Germany More Info
Site 0074
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University Hospital of Patras
Patras Achaḯa, 26504, Greece More Info
Alexandros Spyridonidis, Site 0063
Contact
306977448977
Evangelismos General Hospital of Athens
Athens Attikí, 106 7, Greece More Info
Ioannis Baltadakis, Site 0061
Contact
+306974359426
Attikon General University Hospital
Chaidari Attikí, 12462, Greece More Info
Evangelos Terpos, Site 0062
Contact
00306937437111
G. Papanikolaou General Hospital
Thessaloniki Thessaloníki, 570 1, Greece More Info
Ioanna Sakellari, Site 0060
Contact
302313307550
Local Institution - 0055
Be'er Sheva HaDarom, 84101, Israel More Info
Site 0055
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Local Institution - 0058
Petah-Tikva HaMerkaz, 49100, Israel More Info
Site 0058
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Sheba Medical Center
Ramat Gan HaMerkaz, 52662, Israel More Info
Hila Magen, Site 0057
Contact
972504065462
Local Institution - 0088
Tel Aviv Tell Abīb, 64239, Israel More Info
Site 0088
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Rambam Health Care Campus
Haifa , 31096, Israel More Info
Ofrat Beyar Katz, Site 0056
Contact
0544980188
Hadassah Medical Center
Jerusalem , 91120, Israel More Info
Eyal Lebel, Site 0059
Contact
972-50-5172304
Humanitas
Rozzano Milano, 20089, Italy More Info
Armando Santoro, Site 0064
Contact
390282244080
Local Institution - 0067
Torino Piemonte, 10126, Italy More Info
Site 0067
Contact
IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola
Bologna , 40138, Italy More Info
Michele Cavo, Site 0065
Contact
390516363680
AOU Policlinico Umberto I
Roma , 00161, Italy More Info
Alice Di Rocco, Site 0066
Contact
393391240756
Local Institution - 0052
Nagoya Aichi, 467-8, Japan More Info
Site 0052
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Hokkaido University Hospital
Sapporo Hokkaido, 060-8, Japan More Info
Hideki Goto, Site 0048
Contact
81117067214
Hyogo Medical University Hospital
Nishinomiya Hyogo, 663-8, Japan More Info
Satoshi Yoshihara, Site 0086
Contact
+81-90-2102-4734
Kanazawa University Hospital
Kanazawa Ishikawa, 920-8, Japan More Info
Takeshi Yoroidaka, Site 0051
Contact
0762652000
Tokai University Hospital
Isehara Kanagawa, 259-1, Japan More Info
Yoshiaki Ogawa, Site 0085
Contact
81463931121
Chiba University Hospital
Chiba , 260-8, Japan More Info
Emiko Sakaida, Site 0049
Contact
+81432227171
Local Institution - 0054
Fukuoka , 812-8, Japan More Info
Site 0054
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Okayama University Hospital
Okayama , 700-8, Japan More Info
Nobuharu Fujii, Site 0053
Contact
81862357224
Local Institution - 0071
Shimotsuke , 329-0, Japan More Info
Site 0071
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Local Institution - 0050
Tokyo , 150-8, Japan More Info
Site 0050
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Local Institution - 0041
Hwasun Gun Jeonranamdo, 58128, Korea, Republic of More Info
Site 0041
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Local Institution - 0039
Seoul Seoul-teukbyeolsi [Seoul], 03080, Korea, Republic of More Info
Site 0039
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Local Institution - 0040
Seoul Seoul-teukbyeolsi [Seoul], 05505, Korea, Republic of More Info
Site 0040
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Local Institution - 0038
Seoul Seoul-teukbyeolsi [Seoul], 06351, Korea, Republic of More Info
Site 0038
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Local Institution - 0043
Seoul Seoul-teukbyeolsi [Seoul], 06591, Korea, Republic of More Info
Site 0043
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Oslo Universitetssykehus Rikshospitalet
Oslo , 0372, Norway More Info
Ingerid Abrahamsen, Site 0069
Contact
+4723070460
Centrum Onkologii Ziemi Lubelskiej
Lublin Lubelskie, 20-09, Poland More Info
Wojciech Legiec, Site 0027
Contact
48502074194
Local Institution - 0095
Warsaw Mazowieckie, 02-09, Poland More Info
Site 0095
Contact
Uniwersyteckie Centrum Kliniczne
Gdańsk , 80-95, Poland More Info
Jan Zaucha, Site 0026
Contact
+48509219986
Uniwersytecki Szpital Kliniczny w Poznaniu
Poznań , 60-56, Poland More Info
Dominik Dytfeld, Site 0024
Contact
602464708
Instytut Hematologii i Transfuzjologii
Warsaw , 02-77, Poland More Info
Ewa Lech-Maranda, Site 0023
Contact
48223496176
Narodowy Instytut Onkologii - Oddzial w Gliwicach
Gliwice Śląskie, 44-10, Poland More Info
Sebastian Giebel, Site 0022
Contact
48322788523
Institutul Clinic Fundeni
Bucharest , 02232, Romania More Info
Alina Tanase, Site 0091
Contact
40784219942
Institut Català d'Oncologia (ICO) - Badalona
Badalona Barcelona [Barcelona], 08916, Spain More Info
Albert Oriol Rocafiguera, Site 0020
Contact
34934978987
Institut Català d'Oncologia - L'Hospitalet
L'Hospitalet Del Llobregat Barcelona [Barcelona], 08908, Spain More Info
Ana Maria Sureda Balari, Site 0017
Contact
34932607750
Hospital Clínic de Barcelona
Barcelona Catalunya [Cataluña], 08036, Spain More Info
Carlos Fernández de Larrea Rodríguez, Site 0016
Contact
+34932275428
Clinica Universidad de Navarra
Pamplona Navarra, 31008, Spain More Info
Paula Rodriguez Otero, Site 0012
Contact
0034948255400-5813
Hospital Universitario 12 de Octubre
Madrid , 28041, Spain More Info
Joaquin Martinez Lopez, Site 0021
Contact
34913908525
Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca
Salamanca , 37007, Spain More Info
Maria Victoria Mateos Manteca, Site 0013
Contact
34923291100
Hospital Universitari i Politecnic La Fe
València , 46026, Spain More Info
Javier DE LA RUBIA COMOS, Site 0014
Contact
+34661028232
Local Institution - 0093
Birmingham England, B15 2, United Kingdom More Info
Site 0093
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Local Institution - 0080
London London, City Of, SE5 9, United Kingdom More Info
Site 0080
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Local Institution - 0094
London London, City Of, W12 0, United Kingdom More Info
Site 0094
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Local Institution - 0081
Glasgow , G12 0, United Kingdom More Info
Site 0081
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How clear is this clinincal trial information?

Study is for people with:

Multiple Myeloma

Phase:

Phase 3

Estimated Enrollment:

618

Study ID:

NCT06045806

Recruitment Status:

Recruiting

Sponsor:


Bristol-Myers Squibb

How clear is this clinincal trial information?

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