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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06399393
Other study ID # CA089-1043
Secondary ID 2022-501346-30U1
Status Recruiting
Phase Phase 3
First received
Last updated
Start date October 16, 2023
Est. completion date July 4, 2032

Study information

Verified date May 2024
Source Celgene
Contact BMS Study Connect Contact Center www.BMSStudyConnect.com
Phone 855-907-3286
Email Clinical.Trials@bms.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


Recruitment information / eligibility

Status Recruiting
Enrollment 618
Est. completion date July 4, 2032
Est. primary completion date March 27, 2031
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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


Related Conditions & MeSH terms


Intervention

Biological:
idecabtagene vicleucel
Specified dose on specified days
Drug:
Lenalidomide
Specified dose on specified days
Fludarabine
Specified dose on specified days
Cyclophosphamide
Specified dose on specified days

Locations

Country Name City State
Australia Local Institution - 0005 Brisbane Queensland
Australia Royal Prince Alfred Hospital Camperdown New South Wales
Australia Peter MacCallum Cancer Centre Melbourne Victoria
Australia St Vincent's Hospital Melbourne Victoria
Australia The Alfred Hospital Melbourne Victoria
Australia Fiona Stanley Hospital Murdoch Western Australia
Austria Uniklinikum Salzburg Salzburg
Austria Medizinische Universität Wien Wien
Belgium Institut Jules Bordet Anderlecht Bruxelles-Capitale, Région De
Belgium UZ Brussel Brussels Bruxelles-Capitale, Région De
Canada Local Institution - 0133 Edmonton Alberta
Canada Hamilton Health Sciences-Juravinski Cancer Centre Hamilton Ontario
Canada Local Institution - 0134 Montreal Quebec
Czechia Local Institution - 0036 Brno Brno-mesto
Czechia Local Institution - 0034 Hradec Kralove Hradec Králové
Czechia Local Institution - 0035 Olomouc Olomoucký Kraj
Czechia Local Institution - 0033 Praha 2
Denmark Local Institution - 0070 Odense Syddanmark
France Henri Mondor Hospital Créteil Val-de-Marne
France Hopital Claude Huriez - CHU de Lille Lille Nord
France Institut Paoli-Calmettes Marseille Bouches-du-Rhône
France Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu Nantes Pays-de-la-Loire
France Hôpital Saint Antoine Paris Île-de-France
France Hôpital Saint-Louis Paris
France CHU Bordeaux Haut-Leveque Pessac Aquitaine
France Centre Hospitalier Lyon Sud Pierre-Bénite Rhône
France Local Institution - 0029 Poitiers Vienne
France Institut Universitaire du Cancer Toulouse - Oncopole - CHU de TOULOUSE Toulouse
France Gustave Roussy Villejuif Val-de-Marne
Germany Local Institution - 0079 Dresden Sachsen
Germany Local Institution - 0115 Essen
Germany Local Institution - 0076 Hamburg
Germany Local Institution - 0072 Heidelberg Baden-Württemberg
Germany Local Institution - 0075 Kiel Schleswig-Holstein
Germany Local Institution - 0073 Köln Nordrhein-Westfalen
Germany Local Institution - 0087 Leipzig Sachsen
Germany Local Institution - 0077 Nuremberg Bayern
Germany Local Institution - 0078 Ulm Baden-Württemberg
Germany Local Institution - 0074 Wuerzburg
Greece Evangelismos General Hospital of Athens Athens Attikí
Greece Attikon General University Hospital Chaidari Attikí
Greece University Hospital of Patras Patras Acha?a
Greece G. Papanikolaou General Hospital Thessaloniki Thessaloníki
Israel Local Institution - 0055 Be'er Sheva HaDarom
Israel Rambam Health Care Campus Haifa
Israel Hadassah Medical Center Jerusalem
Israel Local Institution - 0058 Petah-Tikva HaMerkaz
Israel Sheba Medical Center Ramat Gan HaMerkaz
Israel Sourasky Medical Center Tel Aviv Tell Abib
Italy IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola Bologna
Italy AOU Policlinico Umberto I Roma
Italy Humanitas Rozzano Milano
Italy Local Institution - 0067 Torino Piemonte
Japan Chiba University Hospital Chiba
Japan Local Institution - 0054 Fukuoka
Japan Tokai University Hospital Isehara Kanagawa
Japan Kanazawa University Hospital Kanazawa Ishikawa
Japan Nagoya City University Hospital Nagoya Aichi
Japan Hyogo Medical University Hospital Nishinomiya Hyogo
Japan Okayama University Hospital Okayama
Japan Hokkaido University Hospital Sapporo Hokkaido
Japan Local Institution - 0071 Shimotsuke
Japan Local Institution - 0050 Tokyo
Korea, Republic of Local Institution - 0041 Hwasun Gun Jeonranamdo
Korea, Republic of Local Institution - 0038 Seoul Seoul-teukbyeolsi [Seoul]
Korea, Republic of Local Institution - 0039 Seoul Seoul-teukbyeolsi [Seoul]
Korea, Republic of Local Institution - 0040 Seoul Seoul-teukbyeolsi [Seoul]
Korea, Republic of Local Institution - 0043 Seoul Seoul-teukbyeolsi [Seoul]
Norway Oslo Universitetssykehus Rikshospitalet Oslo
Poland Uniwersyteckie Centrum Kliniczne Gdansk
Poland Narodowy Instytut Onkologii - Oddzial w Gliwicach Gliwice Slaskie
Poland Centrum Onkologii Ziemi Lubelskiej Lublin Lubelskie
Poland Uniwersytecki Szpital Kliniczny w Poznaniu Poznan
Poland Instytut Hematologii i Transfuzjologii Warsaw Mazowieckie
Poland Samodzielny Publiczny Centralny Szpital Kliniczny w Warszawie Warsaw Mazowieckie
Romania Institutul Clinic Fundeni Bucharest
Spain Institut Català d'Oncologia (ICO) - Badalona Badalona Barcelona [Barcelona]
Spain Hospital Clínic de Barcelona Barcelona Catalunya [Cataluña]
Spain Institut Català d'Oncologia - L'Hospitalet L'Hospitalet Del Llobregat Barcelona [Barcelona]
Spain Hospital Universitario 12 de Octubre Madrid
Spain Clinica Universidad de Navarra Pamplona Navarra
Spain Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca Salamanca
Spain Hospital Universitari i Politecnic La Fe València
United Kingdom Local Institution - 0093 Birmingham England
United Kingdom Local Institution - 0081 Glasgow
United Kingdom Local Institution - 0080 London London, City Of
United Kingdom Local Institution - 0094 London London, City Of
United States Local Institution - 0123 Ann Arbor Michigan
United States Northside Hospital Atlanta Georgia
United States Winship Cancer Institute, Emory University Atlanta Georgia
United States St. David's South Austin Medical Center Austin Texas
United States Boston Medical Center Boston Massachusetts
United States Massachusetts General Hospital Boston Massachusetts
United States Novant Health Cancer Institute - Elizabeth Charlotte North Carolina
United States University Hospitals Cleveland Medical Center Cleveland Ohio
United States The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive Cancer Center Columbus Ohio
United States UT Southwestern Medical Center Dallas Texas
United States Colorado Blood Cancer Institute Denver Colorado
United States Banner MD Anderson Cancer Center Gilbert Arizona
United States Houston Methodist Hospital Houston Texas
United States University of Texas MD Anderson Cancer Center Houston Texas
United States Mayo Clinic in Florida Jacksonville Florida
United States UCLA Hematology/Oncology - Westwood (Building 200 Suite 120) Los Angeles California
United States Local Institution - 0119 Minneapolis Minnesota
United States Yale University School of Medicine New Haven Connecticut
United States Columbia University Irving Medical Center New York New York
United States University of California, Irvine (UCI) Health - UC Irvine Medical Center Orange California
United States AdventHealth Orlando Orlando Florida
United States Hospital of the University of Pennsylvania Philadelphia Pennsylvania
United States Local Institution - 0136 Richmond Virginia
United States Mayo Clinic in Rochester, Minnesota Rochester Minnesota
United States University of California Davis (UC Davis) Comprehensive Cancer Center Sacramento California
United States Washington University School of Medicine Saint Louis Missouri
United States Washington University School of Medicine Saint Louis Missouri
United States Mayo Clinic in Arizona - Scottsdale Scottsdale Arizona
United States Ascension Providence Hospital Southfield Michigan
United States Moffitt Cancer Center Tampa Florida
United States Wake Forest Baptist Health Winston-Salem North Carolina

Sponsors (2)

Lead Sponsor Collaborator
Celgene Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Belgium,  Canada,  Czechia,  Denmark,  France,  Germany,  Greece,  Israel,  Italy,  Japan,  Korea, Republic of,  Norway,  Poland,  Romania,  Spain,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Progression Free Survival (PFS) PFS as assessed by Independent Review Committee (IRC) Up to approximately 49 months after the first participant is randomized
Secondary Overall Survival (OS) Up to approximately 60 months after the last participant is randomized
Secondary Percentage of Participants with Sustained Minimal Residual Disease Negative (MRDneg) Complete Response (CR) for 12 months From randomization up to 27 months from randomization
Secondary Percentage of Participants with Minimal Residual Disease Negative (MRDneg) Complete Response (CR) From randomization up to 15 months from randomization
Secondary Event-Free Survival (EFS) Up to approximately 60 months after the last participant is randomized
Secondary Duration of Response (DOR) Up to approximately 60 months after the last participant is randomized
Secondary Percentage of Participants with Complete Response (CR) CR as assessed by IRC Up to approximately 60 months after the last participant is randomized
Secondary Time to Progression (TTP) Progression as assessed by IRC Up to approximately 60 months after the last participant is randomized
Secondary Progression post-next line of treatment (PFS2) Up to approximately 60 months after the last participant is randomized
Secondary Time to Next Treatment (TTNT) Up to approximately 60 months after the last participant is randomized
Secondary Number of Participants Experiencing Adverse Events (AEs) Up to approximately 60 months after the last participant is randomized
Secondary Number of Participants Experiencing Adverse Events of Special Interest (AESI) Up to approximately 60 months after the last participant is randomized
Secondary Maximum Observed Plasma Concentration (Cmax) Up to approximately 60 months after the last participant is randomized
Secondary Time of Maximum Observed Plasma Concentration (Tmax) Up to approximately 60 months after the last participant is randomized
Secondary Area Under the Curve (AUC) from time zero to 28 days post infusion (AUC [0- 28D]) Up to 28 days post infusion
Secondary Time of Last Measurable Observed Plasma Concentration (Tlast) Up to approximately 60 months after the last participant is randomized
Secondary Time-to-Definitive Deterioration 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
Secondary Mean Change from Baseline in EORTC QLQ-C30 Selected Subscales 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
Secondary Mean Change from Baseline in EORTC QLQ-MY20 Selected Subscales 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
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