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

Last updated: May 1, 2024
Sponsor: Celgene
Overall Status: Active - Recruiting

Phase

3

Condition

Cancer/tumors

Multiple Myeloma

Bone Neoplasm

Treatment

Lenalidomide

Fludarabine

idecabtagene vicleucel

Clinical Study ID

NCT06399393
CA089-1043
2022-501346-30
U1111-1280-9736
  • Ages > 18
  • All Genders

Study 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).

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

Total Participants: 618
Treatment Group(s): 4
Primary Treatment: Lenalidomide
Phase: 3
Study Start date:
October 16, 2023
Estimated Completion Date:
July 04, 2032

Connect with a study center

  • Royal Prince Alfred Hospital

    Camperdown, New South Wales 2050
    Australia

    Active - Recruiting

  • Local Institution - 0005

    Brisbane, Queensland 4029
    Australia

    Site Not Available

  • Peter MacCallum Cancer Centre

    Melbourne, Victoria 3000
    Australia

    Active - Recruiting

  • St Vincent's Hospital

    Melbourne, Victoria 3065
    Australia

    Active - Recruiting

  • The Alfred Hospital

    Melbourne, Victoria 3004
    Australia

    Active - Recruiting

  • Fiona Stanley Hospital

    Murdoch, Western Australia 6150
    Australia

    Active - Recruiting

  • Uniklinikum Salzburg

    Salzburg, 5020
    Austria

    Active - Recruiting

  • Medizinische Universität Wien

    Wien, 1090
    Austria

    Active - Recruiting

  • Institut Jules Bordet

    Anderlecht, Bruxelles-Capitale, Région De 1070
    Belgium

    Active - Recruiting

  • UZ Brussel

    Brussels, Bruxelles-Capitale, Région De 1090
    Belgium

    Active - Recruiting

  • Local Institution - 0133

    Edmonton, Alberta T6G 1Z2
    Canada

    Site Not Available

  • Hamilton Health Sciences-Juravinski Cancer Centre

    Hamilton, Ontario L8V5C2
    Canada

    Active - Recruiting

  • Local Institution - 0134

    Montreal, Quebec H1T 2M4
    Canada

    Site Not Available

  • Local Institution - 0036

    Brno, Brno-město 625 00
    Czechia

    Site Not Available

  • Local Institution - 0034

    Hradec Kralove, Hradec Králové 500 05
    Czechia

    Site Not Available

  • Local Institution - 0035

    Olomouc, Olomoucký Kraj 779 00
    Czechia

    Site Not Available

  • Local Institution - 0033

    Praha 2, 12808
    Czechia

    Site Not Available

  • Local Institution - 0070

    Odense, Syddanmark 5000
    Denmark

    Site Not Available

  • CHU Bordeaux Haut-Leveque

    Pessac, Aquitaine 33600
    France

    Active - Recruiting

  • Institut Paoli-Calmettes

    Marseille, Bouches-du-Rhône 13273
    France

    Active - Recruiting

  • Hopital Claude Huriez - CHU de Lille

    Lille, Nord 59000
    France

    Active - Recruiting

  • Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu

    Nantes, Pays-de-la-Loire 44000
    France

    Active - Recruiting

  • Centre Hospitalier Lyon Sud

    Pierre-Bénite, Rhône 69310
    France

    Active - Recruiting

  • Henri Mondor Hospital

    Créteil, Val-de-Marne 94010
    France

    Active - Recruiting

  • Gustave Roussy

    Villejuif, Val-de-Marne 94805
    France

    Active - Recruiting

  • Local Institution - 0029

    Poitiers, Vienne 86021
    France

    Site Not Available

  • Hôpital Saint Antoine

    Paris, Île-de-France 75571
    France

    Active - Recruiting

  • Hôpital Saint-Louis

    Paris, 75010
    France

    Active - Recruiting

  • Institut Universitaire du Cancer Toulouse - Oncopole - CHU de TOULOUSE

    Toulouse, 31100
    France

    Active - Recruiting

  • Local Institution - 0072

    Heidelberg, Baden-Württemberg 69120
    Germany

    Site Not Available

  • Local Institution - 0078

    Ulm, Baden-Württemberg 89081
    Germany

    Site Not Available

  • Local Institution - 0077

    Nuremberg, Bayern 90419
    Germany

    Site Not Available

  • Local Institution - 0073

    Köln, Nordrhein-Westfalen 50937
    Germany

    Site Not Available

  • Local Institution - 0079

    Dresden, Sachsen 01307
    Germany

    Site Not Available

  • Local Institution - 0087

    Leipzig, Sachsen 04103
    Germany

    Site Not Available

  • Local Institution - 0075

    Kiel, Schleswig-Holstein 24105
    Germany

    Site Not Available

  • Local Institution - 0115

    Essen, 45122
    Germany

    Site Not Available

  • Local Institution - 0076

    Hamburg, 20246
    Germany

    Site Not Available

  • Local Institution - 0074

    Wuerzburg, 97080
    Germany

    Site Not Available

  • University Hospital of Patras

    Patras, Achaḯa 26504
    Greece

    Active - Recruiting

  • Evangelismos General Hospital of Athens

    Athens, Attikí 106 76
    Greece

    Active - Recruiting

  • Attikon General University Hospital

    Chaidari, Attikí 12462
    Greece

    Active - Recruiting

  • G. Papanikolaou General Hospital

    Thessaloniki, Thessaloníki 570 10
    Greece

    Active - Recruiting

  • Local Institution - 0055

    Be'er Sheva, HaDarom 8410101
    Israel

    Site Not Available

  • Local Institution - 0058

    Petah-Tikva, HaMerkaz 4910021
    Israel

    Site Not Available

  • Sheba Medical Center

    Ramat Gan, HaMerkaz 5266202
    Israel

    Active - Recruiting

  • Sourasky Medical Center

    Tel Aviv, Tell Abīb 6423906
    Israel

    Active - Recruiting

  • Rambam Health Care Campus

    Haifa, 31096
    Israel

    Active - Recruiting

  • Hadassah Medical Center

    Jerusalem, 9112001
    Israel

    Active - Recruiting

  • Humanitas

    Rozzano, Milano 20089
    Italy

    Active - Recruiting

  • Local Institution - 0067

    Torino, Piemonte 10126
    Italy

    Site Not Available

  • IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola

    Bologna, 40138
    Italy

    Active - Recruiting

  • AOU Policlinico Umberto I

    Roma, 00161
    Italy

    Active - Recruiting

  • Nagoya City University Hospital

    Nagoya, Aichi 467-8602
    Japan

    Active - Recruiting

  • Hokkaido University Hospital

    Sapporo, Hokkaido 060-8648
    Japan

    Active - Recruiting

  • Hyogo Medical University Hospital

    Nishinomiya, Hyogo 663-8501
    Japan

    Active - Recruiting

  • Kanazawa University Hospital

    Kanazawa, Ishikawa 920-8641
    Japan

    Active - Recruiting

  • Tokai University Hospital

    Isehara, Kanagawa 259-1193
    Japan

    Active - Recruiting

  • Chiba University Hospital

    Chiba, 260-8677
    Japan

    Active - Recruiting

  • Local Institution - 0054

    Fukuoka, 812-8582
    Japan

    Site Not Available

  • Okayama University Hospital

    Okayama, 700-8558
    Japan

    Active - Recruiting

  • Local Institution - 0071

    Shimotsuke, 329-0498
    Japan

    Site Not Available

  • Local Institution - 0050

    Tokyo, 150-8935
    Japan

    Site Not Available

  • Local Institution - 0041

    Hwasun Gun, Jeonranamdo 58128
    Korea, Republic of

    Site Not Available

  • Local Institution - 0038

    Seoul, Seoul-teukbyeolsi [Seoul] 06351
    Korea, Republic of

    Site Not Available

  • Local Institution - 0039

    Seoul, Seoul-teukbyeolsi [Seoul] 03080
    Korea, Republic of

    Site Not Available

  • Local Institution - 0040

    Seoul, Seoul-teukbyeolsi [Seoul] 05505
    Korea, Republic of

    Site Not Available

  • Local Institution - 0043

    Seoul, Seoul-teukbyeolsi [Seoul] 06591
    Korea, Republic of

    Site Not Available

  • Oslo Universitetssykehus Rikshospitalet

    Oslo, 0372
    Norway

    Active - Recruiting

  • Centrum Onkologii Ziemi Lubelskiej

    Lublin, Lubelskie 20-090
    Poland

    Active - Recruiting

  • Instytut Hematologii i Transfuzjologii

    Warsaw, Mazowieckie 02-776
    Poland

    Active - Recruiting

  • Samodzielny Publiczny Centralny Szpital Kliniczny w Warszawie

    Warsaw, Mazowieckie 02-097
    Poland

    Active - Recruiting

  • Narodowy Instytut Onkologii - Oddzial w Gliwicach

    Gliwice, Śląskie 44-101
    Poland

    Active - Recruiting

  • Uniwersyteckie Centrum Kliniczne

    Gdańsk, 80-952
    Poland

    Active - Recruiting

  • Uniwersytecki Szpital Kliniczny w Poznaniu

    Poznań, 60-569
    Poland

    Active - Recruiting

  • Institutul Clinic Fundeni

    Bucharest, 022328
    Romania

    Active - Recruiting

  • Institut Català d'Oncologia (ICO) - Badalona

    Badalona, Barcelona [Barcelona] 08916
    Spain

    Active - Recruiting

  • Institut Català d'Oncologia - L'Hospitalet

    L'Hospitalet Del Llobregat, Barcelona [Barcelona] 08908
    Spain

    Active - Recruiting

  • Hospital Clínic de Barcelona

    Barcelona, Catalunya [Cataluña] 08036
    Spain

    Active - Recruiting

  • Clinica Universidad de Navarra

    Pamplona, Navarra 31008
    Spain

    Active - Recruiting

  • Hospital Universitario 12 de Octubre

    Madrid, 28041
    Spain

    Active - Recruiting

  • Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca

    Salamanca, 37007
    Spain

    Active - Recruiting

  • Hospital Universitari i Politecnic La Fe

    València, 46026
    Spain

    Active - Recruiting

  • Local Institution - 0093

    Birmingham, England B15 2TH
    United Kingdom

    Site Not Available

  • Local Institution - 0080

    London, London, City Of SE5 9RS
    United Kingdom

    Site Not Available

  • Local Institution - 0094

    London, London, City Of W12 0HS
    United Kingdom

    Site Not Available

  • Local Institution - 0081

    Glasgow, G12 0YN
    United Kingdom

    Site Not Available

  • Banner MD Anderson Cancer Center

    Gilbert, Arizona 85234
    United States

    Site Not Available

  • Mayo Clinic in Arizona - Scottsdale

    Scottsdale, Arizona 85259
    United States

    Site Not Available

  • UCLA Hematology/Oncology - Westwood (Building 200 Suite 120)

    Los Angeles, California 90095
    United States

    Site Not Available

  • University of California, Irvine (UCI) Health - UC Irvine Medical Center

    Orange, California 92868
    United States

    Site Not Available

  • University of California Davis (UC Davis) Comprehensive Cancer Center

    Sacramento, California 95817
    United States

    Site Not Available

  • Colorado Blood Cancer Institute

    Denver, Colorado 80218
    United States

    Active - Recruiting

  • Yale University School of Medicine

    New Haven, Connecticut 06510
    United States

    Site Not Available

  • Mayo Clinic in Florida

    Jacksonville, Florida 32224
    United States

    Site Not Available

  • AdventHealth Orlando

    Orlando, Florida 32804
    United States

    Site Not Available

  • Moffitt Cancer Center

    Tampa, Florida 33612
    United States

    Site Not Available

  • Northside Hospital

    Atlanta, Georgia 30342
    United States

    Site Not Available

  • Winship Cancer Institute, Emory University

    Atlanta, Georgia 30322
    United States

    Site Not Available

  • Boston Medical Center

    Boston, Massachusetts 02118
    United States

    Site Not Available

  • Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Site Not Available

  • Local Institution - 0123

    Ann Arbor, Michigan 48109
    United States

    Site Not Available

  • Ascension Providence Hospital

    Southfield, Michigan 48075
    United States

    Site Not Available

  • Local Institution - 0119

    Minneapolis, Minnesota 55455
    United States

    Site Not Available

  • Mayo Clinic in Rochester, Minnesota

    Rochester, Minnesota 55905
    United States

    Site Not Available

  • Washington University School of Medicine

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • Columbia University Irving Medical Center

    New York, New York 10032
    United States

    Site Not Available

  • Novant Health Cancer Institute - Elizabeth

    Charlotte, North Carolina 28204
    United States

    Site Not Available

  • Wake Forest Baptist Health

    Winston-Salem, North Carolina 27157
    United States

    Site Not Available

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio 44106
    United States

    Site Not Available

  • The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive Cancer Center

    Columbus, Ohio 43210
    United States

    Site Not Available

  • Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania 19104
    United States

    Active - Recruiting

  • St. David's South Austin Medical Center

    Austin, Texas 78704
    United States

    Active - Recruiting

  • UT Southwestern Medical Center

    Dallas, Texas 75390-88520
    United States

    Site Not Available

  • Houston Methodist Hospital

    Houston, Texas 77030
    United States

    Site Not Available

  • University of Texas MD Anderson Cancer Center

    Houston, Texas 77030
    United States

    Site Not Available

  • Local Institution - 0136

    Richmond, Virginia 23298
    United States

    Site Not Available

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