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 (KarMMa-9)

May 1, 2024 updated by: Celgene

A Randomized, Open-Label, Phase 3 Trial to Compare the Efficacy and Safety of Idecabtagene Vicleucel With Lenalidomide Maintenance Versus Lenalidomide Maintenance Therapy Alone in Adult Participants With Newly Diagnosed Multiple Myeloma Who Have Suboptimal Response After Autologous Stem Cell Transplantation (KarMMa-9)

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

618

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: BMS Study Connect Contact Center www.BMSStudyConnect.com
  • Phone Number: 855-907-3286
  • Email: Clinical.Trials@bms.com

Study Contact Backup

  • Name: First line of the email MUST contain the NCT# and Site #.

Study Locations

  • Australia
    • New South Wales
      • Camperdown, New South Wales, Australia, 2050
        • Recruiting
        • Royal Prince Alfred Hospital
        • Contact:
          • Phoebe Ho, Site 0007
          • Phone Number: 61295158031
    • Queensland
      • Brisbane, Queensland, Australia, 4029
        • Not yet recruiting
        • Local Institution - 0005
        • Contact:
          • Site 0005
    • Victoria
      • Melbourne, Victoria, Australia, 3000
        • Recruiting
        • Peter MacCallum Cancer Centre
        • Contact:
          • Simon Harrison, Site 0004
          • Phone Number: +61 3 8559 7835
      • Melbourne, Victoria, Australia, 3004
        • Recruiting
        • The Alfred Hospital
        • Contact:
          • Shafqat Inam, Site 0006
          • Phone Number: +61 3 9076 8297
      • Melbourne, Victoria, Australia, 3065
        • Recruiting
        • St Vincent's Hospital
        • Contact:
          • Hang Quach, Site 0008
          • Phone Number: +61 3 9231 3189
    • Western Australia
      • Murdoch, Western Australia, Australia, 6150
        • Recruiting
        • Fiona Stanley Hospital
        • Contact:
          • Stephanie Lam, Site 0011
          • Phone Number: +61 8 6152 6540
  • Austria
      • Salzburg, Austria, 5020
        • Recruiting
        • Uniklinikum Salzburg
        • Contact:
          • Richard Greil, Site 0089
          • Phone Number: 00435725525800
      • Wien, Austria, 1090
        • Recruiting
        • Medizinische Universität Wien
        • Contact:
          • Maria-Theresa Krauth, Site 0090
          • Phone Number: 004314040044100
  • Belgium
    • Bruxelles-Capitale, Région De
      • Anderlecht, Bruxelles-Capitale, Région De, Belgium, 1070
        • Recruiting
        • Institut Jules Bordet
        • Contact:
          • Marie Vercruyssen, Site 0083
          • Phone Number: 02 5413847
      • Brussels, Bruxelles-Capitale, Région De, Belgium, 1090
        • Recruiting
        • UZ Brussel
        • Contact:
          • Ann De Becker, Site 0084
          • Phone Number: 0000000000
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 1Z2
        • Not yet recruiting
        • Local Institution - 0133
        • Contact:
          • Site 0133
    • Ontario
      • Hamilton, Ontario, Canada, L8V5C2
        • Recruiting
        • Hamilton Health Sciences-Juravinski Cancer Centre
        • Contact:
          • Amaris Balitsky, Site 0001
          • Phone Number: 905-387-9495ext62491
    • Quebec
      • Montreal, Quebec, Canada, H1T 2M4
        • Not yet recruiting
        • Local Institution - 0134
        • Contact:
          • Site 0134
  • Czechia
      • Praha 2, Czechia, 12808
        • Not yet recruiting
        • Local Institution - 0033
        • Contact:
          • Site 0033
    • Brno-město
      • Brno, Brno-město, Czechia, 625 00
        • Not yet recruiting
        • Local Institution - 0036
        • Contact:
          • Site 0036
    • Hradec Králové
      • Hradec Kralove, Hradec Králové, Czechia, 500 05
        • Not yet recruiting
        • Local Institution - 0034
        • Contact:
          • Site 0034
    • Olomoucký Kraj
      • Olomouc, Olomoucký Kraj, Czechia, 779 00
        • Not yet recruiting
        • Local Institution - 0035
        • Contact:
          • Site 0035
  • Denmark
    • Syddanmark
      • Odense, Syddanmark, Denmark, 5000
        • Not yet recruiting
        • Local Institution - 0070
        • Contact:
          • Site 0070
  • France
      • Paris, France, 75010
        • Recruiting
        • Hôpital Saint-Louis
        • Contact:
          • Bertrand Arnulf, Site 0082
          • Phone Number: 33142499472
      • Toulouse, France, 31100
        • Recruiting
        • Institut Universitaire du Cancer Toulouse - Oncopole - CHU de TOULOUSE
        • Contact:
          • Aurore Perrot, Site 0092
          • Phone Number: 0531156184
    • Aquitaine
      • Pessac, Aquitaine, France, 33600
        • Recruiting
        • CHU Bordeaux Haut-Leveque
        • Contact:
          • Cyrille Hulin, Site 0047
          • Phone Number: 33557656511
    • Bouches-du-Rhône
      • Marseille, Bouches-du-Rhône, France, 13273
        • Recruiting
        • Institut Paoli-Calmettes
        • Contact:
          • Gabriel Brisou, Site 0045
          • Phone Number: +33647880806
    • Nord
      • Lille, Nord, France, 59000
        • Recruiting
        • Hopital Claude Huriez - CHU de Lille
        • Contact:
          • Salomon Manier, Site 0030
          • Phone Number: 33320444292
    • Pays-de-la-Loire
      • Nantes, Pays-de-la-Loire, France, 44000
        • Recruiting
        • Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu
        • Contact:
          • Cyrille Touzeau, Site 0042
          • Phone Number: 33240083271
    • Rhône
      • Pierre-Bénite, Rhône, France, 69310
        • Recruiting
        • Centre Hospitalier Lyon Sud
        • Contact:
          • Lionel Karlin, Site 0046
          • Phone Number: 33478864309
    • Val-de-Marne
      • Créteil, Val-de-Marne, France, 94010
        • Recruiting
        • Henri Mondor Hospital
        • Contact:
          • Karim BELHADJ-MERZOUG, Site 0068
          • Phone Number: +33149812163
      • Villejuif, Val-de-Marne, France, 94805
        • Recruiting
        • Gustave Roussy
        • Contact:
          • Alina Danu, Site 0028
          • Phone Number: 33142114229
    • Vienne
      • Poitiers, Vienne, France, 86021
        • Not yet recruiting
        • Local Institution - 0029
        • Contact:
          • Site 0029
    • Île-de-France
      • Paris, Île-de-France, France, 75571
        • Recruiting
        • Hôpital Saint Antoine
        • Contact:
          • Mohamad Mohty, Site 0031
          • Phone Number: 33149282620
  • Germany
      • Essen, Germany, 45122
        • Not yet recruiting
        • Local Institution - 0115
        • Contact:
          • Site 0115
      • Hamburg, Germany, 20246
        • Not yet recruiting
        • Local Institution - 0076
        • Contact:
          • Site 0076
      • Wuerzburg, Germany, 97080
        • Not yet recruiting
        • Local Institution - 0074
        • Contact:
          • Site 0074
    • Baden-Württemberg
      • Heidelberg, Baden-Württemberg, Germany, 69120
        • Not yet recruiting
        • Local Institution - 0072
        • Contact:
          • Site 0072
      • Ulm, Baden-Württemberg, Germany, 89081
        • Not yet recruiting
        • Local Institution - 0078
        • Contact:
          • Site 0078
    • Bayern
      • Nuremberg, Bayern, Germany, 90419
        • Not yet recruiting
        • Local Institution - 0077
        • Contact:
          • Site 0077
    • Nordrhein-Westfalen
      • Köln, Nordrhein-Westfalen, Germany, 50937
        • Not yet recruiting
        • Local Institution - 0073
        • Contact:
          • Site 0073
    • Sachsen
      • Dresden, Sachsen, Germany, 01307
        • Not yet recruiting
        • Local Institution - 0079
        • Contact:
          • Site 0079
      • Leipzig, Sachsen, Germany, 04103
        • Not yet recruiting
        • Local Institution - 0087
        • Contact:
          • Site 0087
    • Schleswig-Holstein
      • Kiel, Schleswig-Holstein, Germany, 24105
        • Not yet recruiting
        • Local Institution - 0075
        • Contact:
          • Site 0075
  • Greece
    • Achaḯa
      • Patras, Achaḯa, Greece, 26504
        • Recruiting
        • University Hospital of Patras
        • Contact:
          • Alexandros Spyridonidis, Site 0063
          • Phone Number: 306977448977
    • Attikí
      • Athens, Attikí, Greece, 106 76
        • Recruiting
        • Evangelismos General Hospital of Athens
        • Contact:
          • Ioannis Baltadakis, Site 0061
          • Phone Number: +306974359426
      • Chaidari, Attikí, Greece, 12462
        • Recruiting
        • Attikon General University Hospital
        • Contact:
          • Evangelos Terpos, Site 0062
          • Phone Number: 00306937437111
    • Thessaloníki
      • Thessaloniki, Thessaloníki, Greece, 570 10
        • Recruiting
        • G. Papanikolaou General Hospital
        • Contact:
          • Ioanna Sakellari, Site 0060
          • Phone Number: 302313307550
  • Israel
      • Haifa, Israel, 31096
        • Recruiting
        • Rambam Health Care Campus
        • Contact:
          • Ofrat Beyar Katz, Site 0056
          • Phone Number: 0544980188
      • Jerusalem, Israel, 9112001
        • Recruiting
        • Hadassah Medical Center
        • Contact:
          • Eyal Lebel, Site 0059
          • Phone Number: 972-50-5172304
    • HaDarom
      • Be'er Sheva, HaDarom, Israel, 8410101
        • Not yet recruiting
        • Local Institution - 0055
        • Contact:
          • Site 0055
    • HaMerkaz
      • Petah-Tikva, HaMerkaz, Israel, 4910021
        • Not yet recruiting
        • Local Institution - 0058
        • Contact:
          • Site 0058
      • Ramat Gan, HaMerkaz, Israel, 5266202
        • Recruiting
        • Sheba Medical Center
        • Contact:
          • Hila Magen, Site 0057
          • Phone Number: 972504065462
    • Tell Abīb
      • Tel Aviv, Tell Abīb, Israel, 6423906
        • Recruiting
        • Sourasky Medical Center
        • Contact:
          • Ron Ram, Site 0088
          • Phone Number: 97236974138
  • Italy
      • Bologna, Italy, 40138
        • Recruiting
        • IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola
        • Contact:
          • Michele Cavo, Site 0065
          • Phone Number: 390516363680
      • Roma, Italy, 00161
        • Recruiting
        • AOU Policlinico Umberto I
        • Contact:
          • Alice Di Rocco, Site 0066
          • Phone Number: 393391240756
    • Milano
      • Rozzano, Milano, Italy, 20089
        • Recruiting
        • Humanitas
        • Contact:
          • Armando Santoro, Site 0064
          • Phone Number: 390282244080
    • Piemonte
      • Torino, Piemonte, Italy, 10126
        • Not yet recruiting
        • Local Institution - 0067
        • Contact:
          • Site 0067
  • Japan
      • Chiba, Japan, 260-8677
        • Recruiting
        • Chiba University Hospital
        • Contact:
          • Emiko Sakaida, Site 0049
          • Phone Number: +81432227171
      • Fukuoka, Japan, 812-8582
        • Not yet recruiting
        • Local Institution - 0054
        • Contact:
          • Site 0054
      • Okayama, Japan, 700-8558
        • Recruiting
        • Okayama University Hospital
        • Contact:
          • Nobuharu Fujii, Site 0053
          • Phone Number: 81862357224
      • Shimotsuke, Japan, 329-0498
        • Not yet recruiting
        • Local Institution - 0071
        • Contact:
          • Site 0071
      • Tokyo, Japan, 150-8935
        • Not yet recruiting
        • Local Institution - 0050
        • Contact:
          • Site 0050
    • Aichi
      • Nagoya, Aichi, Japan, 467-8602
        • Recruiting
        • Nagoya City University Hospital
        • Contact:
          • Shinsuke Iida, Site 0052
          • Phone Number: 81528515511
    • Hokkaido
      • Sapporo, Hokkaido, Japan, 060-8648
        • Recruiting
        • Hokkaido University Hospital
        • Contact:
          • Hideki Goto, Site 0048
          • Phone Number: 81117067214
    • Hyogo
      • Nishinomiya, Hyogo, Japan, 663-8501
        • Recruiting
        • Hyogo Medical University Hospital
        • Contact:
          • Satoshi Yoshihara, Site 0086
          • Phone Number: +81-90-2102-4734
    • Ishikawa
      • Kanazawa, Ishikawa, Japan, 920-8641
        • Recruiting
        • Kanazawa University Hospital
        • Contact:
          • Takeshi Yoroidaka, Site 0051
          • Phone Number: 0762652000
    • Kanagawa
      • Isehara, Kanagawa, Japan, 259-1193
        • Recruiting
        • Tokai University Hospital
        • Contact:
          • Yoshiaki Ogawa, Site 0085
          • Phone Number: 81463931121
  • Korea, Republic of
    • Jeonranamdo
      • Hwasun Gun, Jeonranamdo, Korea, Republic of, 58128
        • Not yet recruiting
        • Local Institution - 0041
        • Contact:
          • Site 0041
    • Seoul-teukbyeolsi [Seoul]
      • Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of, 03080
        • Not yet recruiting
        • Local Institution - 0039
        • Contact:
          • Site 0039
      • Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of, 05505
        • Not yet recruiting
        • Local Institution - 0040
        • Contact:
          • Site 0040
      • Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of, 06351
        • Not yet recruiting
        • Local Institution - 0038
        • Contact:
          • Site 0038
      • Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of, 06591
        • Not yet recruiting
        • Local Institution - 0043
        • Contact:
          • Site 0043
  • Norway
      • Oslo, Norway, 0372
        • Recruiting
        • Oslo Universitetssykehus Rikshospitalet
        • Contact:
          • Ingerid Abrahamsen, Site 0069
          • Phone Number: +4723070460
  • Poland
      • Gdańsk, Poland, 80-952
        • Recruiting
        • Uniwersyteckie Centrum Kliniczne
        • Contact:
          • Jan Zaucha, Site 0026
          • Phone Number: +48509219986
      • Poznań, Poland, 60-569
        • Recruiting
        • Uniwersytecki Szpital Kliniczny w Poznaniu
        • Contact:
          • Dominik Dytfeld, Site 0024
          • Phone Number: 602464708
    • Lubelskie
      • Lublin, Lubelskie, Poland, 20-090
        • Recruiting
        • Centrum Onkologii Ziemi Lubelskiej
        • Contact:
          • Wojciech Legiec, Site 0027
          • Phone Number: 48502074194
    • Mazowieckie
      • Warsaw, Mazowieckie, Poland, 02-097
        • Recruiting
        • Samodzielny Publiczny Centralny Szpital Kliniczny w Warszawie
        • Contact:
          • Grzegorz Basak, Site 0095
          • Phone Number: +48(22)5992898
      • Warsaw, Mazowieckie, Poland, 02-776
        • Recruiting
        • Instytut Hematologii I Transfuzjologii
        • Contact:
          • Ewa Lech-Maranda, Site 0023
          • Phone Number: 48223496176
    • Śląskie
      • Gliwice, Śląskie, Poland, 44-101
        • Recruiting
        • Narodowy Instytut Onkologii - Oddzial w Gliwicach
        • Contact:
          • Sebastian Giebel, Site 0022
          • Phone Number: 48322788523
  • Romania
      • Bucharest, Romania, 022328
        • Recruiting
        • Institutul Clinic Fundeni
        • Contact:
          • Alina Tanase, Site 0091
          • Phone Number: 40784219942
  • Spain
      • Madrid, Spain, 28041
        • Recruiting
        • Hospital Universitario 12 de Octubre
        • Contact:
          • Joaquin Martinez Lopez, Site 0021
          • Phone Number: 34913908525
      • Salamanca, Spain, 37007
        • Recruiting
        • Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca
        • Contact:
          • Maria Victoria Mateos Manteca, Site 0013
          • Phone Number: 34923291100
      • València, Spain, 46026
        • Recruiting
        • Hospital Universitari i Politecnic La Fe
        • Contact:
          • Javier DE LA RUBIA COMOS, Site 0014
          • Phone Number: +34661028232
    • Barcelona [Barcelona]
      • Badalona, Barcelona [Barcelona], Spain, 08916
        • Recruiting
        • Institut Català d'Oncologia (ICO) - Badalona
        • Contact:
          • Albert Oriol Rocafiguera, Site 0020
          • Phone Number: 34934978987
      • L'Hospitalet Del Llobregat, Barcelona [Barcelona], Spain, 08908
        • Recruiting
        • Institut Català d'Oncologia - L'Hospitalet
        • Contact:
          • Ana Maria Sureda Balari, Site 0017
          • Phone Number: 34932607750
    • Catalunya [Cataluña]
      • Barcelona, Catalunya [Cataluña], Spain, 08036
        • Recruiting
        • Hospital Clinic De Barcelona
        • Contact:
          • Carlos Fernández de Larrea Rodríguez, Site 0016
          • Phone Number: +34932275428
    • Navarra
      • Pamplona, Navarra, Spain, 31008
        • Recruiting
        • Clinica Universidad de Navarra
        • Contact:
          • Paula Rodriguez Otero, Site 0012
          • Phone Number: 0034948255400-5813
  • United Kingdom
      • Glasgow, United Kingdom, G12 0YN
        • Not yet recruiting
        • Local Institution - 0081
        • Contact:
          • Site 0081
    • England
      • Birmingham, England, United Kingdom, B15 2TH
        • Not yet recruiting
        • Local Institution - 0093
        • Contact:
          • Site 0093
    • London, City Of
      • London, London, City Of, United Kingdom, SE5 9RS
        • Not yet recruiting
        • Local Institution - 0080
        • Contact:
          • Site 0080
      • London, London, City Of, United Kingdom, W12 0HS
        • Not yet recruiting
        • Local Institution - 0094
        • Contact:
          • Site 0094
  • United States
    • Arizona
      • Gilbert, Arizona, United States, 85234
        • Not yet recruiting
        • Banner MD Anderson Cancer Center
        • Contact:
          • Rajneesh Nath, Site 0096
          • Phone Number: 480-256-3223
      • Scottsdale, Arizona, United States, 85259
        • Not yet recruiting
        • Mayo Clinic in Arizona - Scottsdale
        • Contact:
          • Peter Bergsagel, Site 0097
          • Phone Number: 480-342-4800
    • California
      • Los Angeles, California, United States, 90095
        • Not yet recruiting
        • UCLA Hematology/Oncology - Westwood (Building 200 Suite 120)
        • Contact:
          • Sarah Larson, Site 0131
          • Phone Number: 310-829-5471
      • Orange, California, United States, 92868
        • Not yet recruiting
        • University of California, Irvine (UCI) Health - UC Irvine Medical Center
        • Contact:
          • Stefan Ciurea, Site 0126
          • Phone Number: 714-509-2290
      • Sacramento, California, United States, 95817
        • Not yet recruiting
        • University of California Davis (UC Davis) Comprehensive Cancer Center
        • Contact:
          • Aaron Rosenberg, Site 0113
          • Phone Number: 916-734-3771
    • Colorado
      • Denver, Colorado, United States, 80218
        • Recruiting
        • Colorado Blood Cancer Institute
        • Contact:
          • Tara Gregory, Site 0101
          • Phone Number: 720-754-4800
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Not yet recruiting
        • Yale University School of Medicine
        • Contact:
          • Noffar Bar, Site 0111
          • Phone Number: 000-000-0000
    • Florida
      • Jacksonville, Florida, United States, 32224
        • Not yet recruiting
        • Mayo Clinic in Florida
        • Contact:
          • Sikander Ailawadhi, Site 0098
          • Phone Number: 904-953-2000
      • Orlando, Florida, United States, 32804
        • Not yet recruiting
        • AdventHealth Orlando
        • Contact:
          • Rushang Patel, Site 0127
          • Phone Number: 407-303-2070
      • Tampa, Florida, United States, 33612
        • Not yet recruiting
        • Moffitt Cancer Center
        • Contact:
          • Omar Castaneda Puglianini, Site 0129
          • Phone Number: 813-745-0365
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Not yet recruiting
        • Northside Hospital
        • Contact:
          • Scott Solomon, Site 0104
          • Phone Number: 404-255-1930
      • Atlanta, Georgia, United States, 30322
        • Not yet recruiting
        • Winship Cancer Institute, Emory University
        • Contact:
          • Nisha Joseph, Site 0121
          • Phone Number: 502-608-5503
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Not yet recruiting
        • Massachusetts General Hospital
        • Contact:
          • Diana Cirstea, Site 0102
          • Phone Number: 617-724-4000
      • Boston, Massachusetts, United States, 02118
        • Withdrawn
        • Boston Medical Center
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Not yet recruiting
        • Local Institution - 0123
        • Contact:
          • Site 0123
      • Southfield, Michigan, United States, 48075
        • Not yet recruiting
        • Ascension Providence Hospital
        • Contact:
          • Howard Terebelo, Site 0105
          • Phone Number: 248-552-0620
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • Not yet recruiting
        • Local Institution - 0119
        • Contact:
          • Site 0119
      • Rochester, Minnesota, United States, 55905
        • Not yet recruiting
        • Mayo Clinic in Rochester, Minnesota
        • Contact:
          • Shaji Kumar, Site 0100
          • Phone Number: 507-202-8384
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Not yet recruiting
        • Washington University School of Medicine
        • Contact:
          • Michael Slade, Site 0120
          • Phone Number: 314-454-8304
    • New York
      • New York, New York, United States, 10032
        • Not yet recruiting
        • Columbia University Irving Medical Center
        • Contact:
          • Ran Reshef, Site 0117
          • Phone Number: 212-342-0530
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • Not yet recruiting
        • Novant Health Cancer Institute - Elizabeth
        • Contact:
          • Raymond Thertulien, Site 0135
          • Phone Number: 646-708-2544
      • Winston-Salem, North Carolina, United States, 27157
        • Withdrawn
        • Wake Forest Baptist Health
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • Not yet recruiting
        • University Hospitals Cleveland Medical Center
        • Contact:
          • Koen van Besien, Site 0116
          • Phone Number: 216-844-0139
      • Columbus, Ohio, United States, 43210
        • Not yet recruiting
        • The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive Cancer Center
        • Contact:
          • Srinivas Devarakonda, Site 0106
          • Phone Number: 570-423-0522
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Recruiting
        • Hospital of the University of Pennsylvania
        • Contact:
          • Adam Cohen, Site 0132
          • Phone Number: 215-615-7362
    • Texas
      • Austin, Texas, United States, 78704
        • Recruiting
        • St. David's South Austin Medical Center
        • Contact:
          • Aravind Ramakrishnan, Site 0124
          • Phone Number: 512-952-1945
      • Dallas, Texas, United States, 75390-88520
        • Not yet recruiting
        • UT Southwestern Medical Center
        • Contact:
          • Gurbakhash Kaur, Site 0114
          • Phone Number: 214-648-5364
      • Houston, Texas, United States, 77030
        • Not yet recruiting
        • Houston Methodist Hospital
        • Contact:
          • Siddhartha Ganguly, Site 0109
          • Phone Number: 713-441-9948
      • Houston, Texas, United States, 77030
        • Not yet recruiting
        • University of Texas MD Anderson Cancer Center
        • Contact:
          • Krina Patel, Site 0112
          • Phone Number: 713-792-6662
    • Virginia
      • Richmond, Virginia, United States, 23298
        • Not yet recruiting
        • Local Institution - 0136
        • Contact:
          • Site 0136

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm A
Drug: Cyclophosphamide
Specified dose on specified days
Other Names:
  • CYTOXAN
  • ENDOXAN
Drug: Fludarabine
Specified dose on specified days
Other Names:
  • FLUDARA
  • BENDARBIN
Drug: Lenalidomide
Specified dose on specified days
Other Names:
  • Revlimid
  • LEN
Biological: idecabtagene vicleucel
Specified dose on specified days
Other Names:
  • ide-cel
  • BMS-986395
  • Abecma
  • bb2121
Active Comparator: Arm B
Drug: Lenalidomide
Specified dose on specified days
Other Names:
  • Revlimid
  • LEN

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression Free Survival (PFS)
Time Frame: Up to approximately 49 months after the first participant is randomized
PFS as assessed by Independent Review Committee (IRC)
Up to approximately 49 months after the first participant is randomized

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival (OS)
Time Frame: Up to approximately 60 months after the last participant is randomized
Up to approximately 60 months after the last participant is randomized
Percentage of Participants with Sustained Minimal Residual Disease Negative (MRDneg) Complete Response (CR) for 12 months
Time Frame: From randomization up to 27 months from randomization
From randomization up to 27 months from randomization
Percentage of Participants with Minimal Residual Disease Negative (MRDneg) Complete Response (CR)
Time Frame: From randomization up to 15 months from randomization
From randomization up to 15 months from randomization
Event-Free Survival (EFS)
Time Frame: Up to approximately 60 months after the last participant is randomized
Up to approximately 60 months after the last participant is randomized
Duration of Response (DOR)
Time Frame: Up to approximately 60 months after the last participant is randomized
Up to approximately 60 months after the last participant is randomized
Percentage of Participants with Complete Response (CR)
Time Frame: Up to approximately 60 months after the last participant is randomized
CR as assessed by IRC
Up to approximately 60 months after the last participant is randomized
Time to Progression (TTP)
Time Frame: Up to approximately 60 months after the last participant is randomized
Progression as assessed by IRC
Up to approximately 60 months after the last participant is randomized
Progression post-next line of treatment (PFS2)
Time Frame: Up to approximately 60 months after the last participant is randomized
Up to approximately 60 months after the last participant is randomized
Time to Next Treatment (TTNT)
Time Frame: Up to approximately 60 months after the last participant is randomized
Up to approximately 60 months after the last participant is randomized
Number of Participants Experiencing Adverse Events (AEs)
Time Frame: Up to approximately 60 months after the last participant is randomized
Up to approximately 60 months after the last participant is randomized
Number of Participants Experiencing Adverse Events of Special Interest (AESI)
Time Frame: Up to approximately 60 months after the last participant is randomized
Up to approximately 60 months after the last participant is randomized
Maximum Observed Plasma Concentration (Cmax)
Time Frame: Up to approximately 60 months after the last participant is randomized
Up to approximately 60 months after the last participant is randomized
Time of Maximum Observed Plasma Concentration (Tmax)
Time Frame: Up to approximately 60 months after the last participant is randomized
Up to approximately 60 months after the last participant is randomized
Area Under the Curve (AUC) from time zero to 28 days post infusion (AUC [0- 28D])
Time Frame: Up to 28 days post infusion
Up to 28 days post infusion
Time of Last Measurable Observed Plasma Concentration (Tlast)
Time Frame: Up to approximately 60 months after the last participant is randomized
Up to approximately 60 months after the last participant is randomized
Time-to-Definitive Deterioration
Time Frame: Up to approximately 49 months after the first participant is randomized
Time-to-definitive deterioration based on the European Organization for Research and Treatment of Cancer core quality of life questionnaire EORTC QLQ-C30 global health status/quality of life subscale
Up to approximately 49 months after the first participant is randomized
Mean Change from Baseline in EORTC QLQ-C30 Selected Subscales
Time Frame: Up to approximately 49 months after the first participant is randomized

The following subscales on the European Organization for Research and Treatment of Cancer core quality of life questionnaire EORTC QLQ-C30 will be assessed:

  • Global health status/quality of life
  • Physical Functioning
  • Fatigue
  • Pain
Up to approximately 49 months after the first participant is randomized
Mean Change from Baseline in EORTC QLQ-MY20 Selected Subscales
Time Frame: Up to approximately 49 months after the first participant is randomized

The following subscales on the European Organization for Research and Treatment of Cancer core quality of life questionnaire EORTC QLQ-MY20 will be assessed:

  • Disease symptoms
  • Side-effects of treatment
Up to approximately 49 months after the first participant is randomized

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Celgene

Collaborators

Bristol-Myers Squibb

Investigators

  • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 16, 2023

Primary Completion (Estimated)

March 27, 2031

Study Completion (Estimated)

July 4, 2032

Study Registration Dates

First Submitted

May 1, 2024

First Submitted That Met QC Criteria

May 1, 2024

First Posted (Actual)

May 3, 2024

Study Record Updates

Last Update Posted (Actual)

May 3, 2024

Last Update Submitted That Met QC Criteria

May 1, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA089-1043
  • 2022-501346-30 (EudraCT Number)
  • U1111-1280-9736 (Other Identifier: WHO)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html

IPD Sharing Time Frame

See plan description

IPD Sharing Access Criteria

See plan description

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Multiple Myeloma

Clinical Trials on Cyclophosphamide

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in United Arab Emirates

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe