Resumen

Elegibilidad

Detalles del diseño

Brazos e Intervenciones

Medidas de resultado

Sitios del ensayo

Fuente: NCT06399393

Reclutando

KarMMa-9: 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

Intervencionista

Fase 3

Boston Medical Center

Patrocinador: Bristol Myers Squibb

Última actualización: 3 de mayo de 2024
Aviso: La información proviene de registros públicos y puede no reflejar cambios en tiempo real en el centro local.

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).

Categoría de tratamiento

Quimioterapia, Terapia celular

Erforderliche Mutationen

Ninguna

Ensayo iniciado

16 de octubre de 2023

Última actualización por el patrocinador

3 de mayo de 2024

Finalización estimada

27 de marzo de 2031

Contacto del estudio

Nombre:BMS Study Connect Contact Center www.BMSStudyConnect.com

Correo electrónico:Clinical.Trials@bms.com

Teléfono:855-907-3286

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

Elegibilidad

Criterios de inclusión

* 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.

Criterios de exclusión

* 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.

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Detalles del diseño

AsignaciónRandomized

Modelo de intervenciónParallel Assignment

EnmascaramientoNone (Open Label)

Número a inscribir618

Brazos e Intervenciones

Brazos

Intervenciones

Tipo: Experimental

Descripción:

Intervenciones:

Cyclophosphamide
Fludarabine
Lenalidomide
idecabtagene vicleucel

Medidas de resultado

Medidas de resultado primarias

Progression Free Survival (PFS)Up to approximately 49 months after the first participant is randomized

PFS as assessed by Independent Review Committee (IRC)

Medidas de resultado secundarias

Overall Survival (OS)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 monthsFrom randomization up to 27 months from randomization

Percentage of Participants with Minimal Residual Disease Negative (MRDneg) Complete Response (CR)From randomization up to 15 months from randomization

Event-Free Survival (EFS)Up to approximately 60 months after the last participant is randomized

Duration of Response (DOR)Up to approximately 60 months after the last participant is randomized

Percentage of Participants with Complete Response (CR)Up to approximately 60 months after the last participant is randomized

CR as assessed by IRC

Time to Progression (TTP)Up to approximately 60 months after the last participant is randomized

Progression as assessed by IRC

Progression post-next line of treatment (PFS2)Up to approximately 60 months after the last participant is randomized

Time to Next Treatment (TTNT)Up to approximately 60 months after the last participant is randomized

Number of Participants Experiencing Adverse Events (AEs)Up to approximately 60 months after the last participant is randomized

Number of Participants Experiencing Adverse Events of Special Interest (AESI)Up to approximately 60 months after the last participant is randomized

Maximum Observed Plasma Concentration (Cmax)Up to approximately 60 months after the last participant is randomized

Time of Maximum Observed Plasma Concentration (Tmax)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])Up to 28 days post infusion

Time of Last Measurable Observed Plasma Concentration (Tlast)Up to approximately 60 months after the last participant is randomized

Time-to-Definitive DeteriorationUp 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

Mean Change from Baseline in EORTC QLQ-C30 Selected SubscalesUp 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

Mean Change from Baseline in EORTC QLQ-MY20 Selected SubscalesUp 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

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Sitios del ensayo

Este estudio tiene 115 sitios de ensayo

Boston Medical Center

Boston, Massachusetts, US

Aún no recluta

Saint Louis, Missouri, 63110 US

Washington University School of Medicine

Aún no recluta

Tampa, Florida, 33612 US

Moffitt Cancer Center

Reclutando

Madrid, Madrid, 28041 ES

Hospital Universitario 12 de Octubre

Aún no recluta

Boston, Massachusetts, 02114 US

Mass General Hospital

Aún no recluta

Houston, Texas, 77030 US

University of Texas MD Anderson Cancer Center

Aún no recluta

Atlanta, Georgia, 30342 US

Northside Hospital

Reclutando

Philadelphia, Pennsylvania, 19104 US

Hospital of the University of Pennsylvania

Aún no recluta

Jacksonville, Florida, 32224 US

Mayo Clinic in Florida

Reclutando

Okayama, 700-8558 JP

Okayama University Hospital

Reclutando

Sapporo, Hokkaido, 060-8648 JP

Hokkaido University Hospital

Reclutando

Kanazawa, Ishikawa, 920-8641 JP

Kanazawa University Hospital

Reclutando

Melbourne, Victoria, 3000 AU

Peter MacCallum Cancer Centre

Reclutando

Camperdown, New South Wales, 2050 AU

Royal Prince Alfred Hospital

Reclutando

Melbourne, Victoria, 3004 AU

The Alfred Hospital

Reclutando

Denver, Colorado, 80218 US

Colorado Blood Cancer Institute

Aún no recluta

Atlanta, Georgia, 30322 US

Winship Cancer Institute, Emory University

Aún no recluta

Houston, Texas, 77030 US

Houston Methodist Hospital

Reclutando

Murdoch, Western Australia, 6150 AU

Fiona Stanley Hospital

Aún no recluta

Gilbert, Arizona, 85234 US

Banner MD Anderson Cancer Center

Reclutando

Haifa, 31096 IL

Rambam Health Care Campus

Aún no recluta

New Haven, Connecticut, 06510 US

Yale University School of Medicine

Reclutando

Paris, 75010 FR

Hôpital Saint-Louis

Aún no recluta

Cleveland, Ohio, 44106 US

University Hospitals Cleveland Medical Center

Reclutando

Melbourne, Victoria, 3065 AU

St Vincent's Hospital

Aún no recluta

New York, New York, 10032 US

Columbia University Irving Medical Center

Reclutando

Pamplona, Navarra, 31008 ES

Clínica Universidad de Navarra

Reclutando

Chiba, 260-8677 JP

Chiba University Hospital

Reclutando

Marseille, Bouches-du-Rhône, 13273 FR

Institut Paoli-Calmettes

Reclutando

Jerusalem, 9112001 IL

Hadassah Medical Center

Aún no recluta

Orlando, Florida, 32804 US

AdventHealth Orlando

Reclutando

Isehara, Kanagawa, 259-1193 JP

Tokai University Hospital

Reclutando

Wien, 1090 AT

Medizinische Universität Wien

Reclutando

Austin, Texas, 78704 US

St. David's South Austin Medical Center

Aún no recluta

Southfield, Michigan, 48075 US

Ascension Providence Hospital

Reclutando

Gdańsk, 80-952 PL

Uniwersyteckie Centrum Kliniczne

Reclutando

Nagoya, Aichi, 467-8602 JP

Nagoya City University Hospital

Reclutando

Roma, 00161 IT

AOU Policlinico Umberto I

Reclutando

Pierre-Bénite, Rhône, 69310 FR

Centre Hospitalier Lyon Sud

Reclutando

Bucharest, 022328 RO

Institutul Clinic Fundeni

Reclutando

Brussels, Bruxelles-Capitale, Région De, 1090 BE

UZ Brussel

Reclutando

Salzburg, 5020 AT

Uniklinikum Salzburg

Reclutando

Patras, Achaḯa, 26504 GR

University Hospital of Patras

Reclutando

Thessaloniki, Thessaloníki, 570 10 GR

G. Papanikolaou General Hospital

Reclutando

Salamanca, Salamanca, 37007 ES

Hospital Universitario de Salamanca

Aún no recluta

Rochester, Minnesota, 55905 US

Mayo Clinic in Rochester, Minnesota

Aún no recluta

Scottsdale, Arizona, 85259 US

Mayo Clinic in Arizona - Scottsdale

Reclutando

Chaidari, Attikí, 12462 GR

Attikon General University Hospital

Reclutando

Tel Aviv, Tell Abīb, 6423906 IL

Sourasky Medical Center

Reclutando

Barcelona, Barcelona, 8036 ES

Hospital Clínic de Barcelona

Reclutando

Athens, Attikí, 106 76 GR

Evangelismos General Hospital of Athens

Reclutando

Hamilton, Ontario, L8V5C2 CA

Hamilton Health Sciences-Juravinski Cancer Centre

Reclutando

València, València, 46026 ES

Hospital Universitario y Politécnico La Fe

Reclutando

Lille, Nord, 59000 FR

Hopital Claude Huriez - CHU de Lille

Aún no recluta

Sacramento, California, 95817 US

University of California Davis (UC Davis) Comprehensive Cancer Center

Reclutando

Anderlecht, Bruxelles-Capitale, Région De, 1070 BE

Institut Jules Bordet

Aún no recluta

Orange, California, 92868 US

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

Reclutando

Milano, Lombardia, 20089 IT

IRCCS Istituto Clinico Humanitas

Aún no recluta

Edmonton, Alberta, T6G 1Z2 CA

Local Institution - 0133

Aún no recluta

Charlotte, North Carolina, 28204 US

Novant Health Cancer Institute - Elizabeth

Reclutando

Badalona, Barcelona, 17007 ES

ICO Institut Català d'Oncologia

Aún no recluta

Los Angeles, California, 90095 US

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

Reclutando

Villejuif, Val-de-Marne, 94805 FR

Gustave Roussy

Reclutando

Pessac, Aquitaine, 33600 FR

CHU Bordeaux Haut-Leveque

Reclutando

Paris, Île-de-France, 75571 FR

Hôpital Saint Antoine

Reclutando

Bologna, 40138 IT

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

Reclutando

Nishinomiya, Hyogo, 663-8501 JP

Hyogo Medical University Hospital

Aún no recluta

Columbus, Ohio, 43210 US

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

Reclutando

Toulouse, 31100 FR

Institut Universitaire du Cancer Toulouse - Oncopole - CHU de TOULOUSE

Aún no recluta

Dallas, Texas, 75390-88520 US

UT Southwestern Medical Center

Aún no recluta

Brisbane, Queensland, 4029 AU

Local Institution - 0005

Aún no recluta

Brno, Brno-město, 625 00 CZ

Local Institution - 0036

Aún no recluta

Hradec Kralove, Hradec Králové, 500 05 CZ

Local Institution - 0034

Aún no recluta

Olomouc, Olomoucký Kraj, 779 00 CZ

Local Institution - 0035

Aún no recluta

Praha 2, 12808 CZ

Local Institution - 0033

Aún no recluta

Odense, Syddanmark, 5000 DK

Local Institution - 0070

Reclutando

Nantes, Pays-de-la-Loire, 44000 FR

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

Reclutando

Créteil, Val-de-Marne, 94010 FR

Henri Mondor Hospital

Aún no recluta

Heidelberg, Baden-Württemberg, 69120 DE

Local Institution - 0072

Aún no recluta

Ulm, Baden-Württemberg, 89081 DE

Local Institution - 0078

Aún no recluta

Nuremberg, Bayern, 90419 DE

Local Institution - 0077

Aún no recluta

Köln, Nordrhein-Westfalen, 50937 DE

Local Institution - 0073

Aún no recluta

Dresden, Sachsen, 01307 DE

Local Institution - 0079

Aún no recluta

Leipzig, Sachsen, 04103 DE

Local Institution - 0087

Aún no recluta

Kiel, Schleswig-Holstein, 24105 DE

Local Institution - 0075

Aún no recluta

Essen, 45122 DE

Local Institution - 0115

Aún no recluta

Hamburg, 20246 DE

Local Institution - 0076

Aún no recluta

Be'er Sheva, HaDarom, 8410101 IL

Local Institution - 0055

Aún no recluta

Petah-Tikva, HaMerkaz, 4910021 IL

Local Institution - 0058

Aún no recluta

Torino, Piemonte, 10126 IT

Local Institution - 0067

Aún no recluta

Fukuoka, 812-8582 JP

Local Institution - 0054

Aún no recluta

Shimotsuke, 329-0498 JP

Local Institution - 0071

Aún no recluta

Tokyo, 150-8935 JP

Local Institution - 0050

Aún no recluta

Hwasun Gun, Jeonranamdo, 58128 KR

Local Institution - 0041

Aún no recluta

Seoul, Seoul-teukbyeolsi [Seoul], 03080 KR

Local Institution - 0039

Aún no recluta

Seoul, Seoul-teukbyeolsi [Seoul], 05505 KR

Local Institution - 0040

Aún no recluta

Seoul, Seoul-teukbyeolsi [Seoul], 06351 KR

Local Institution - 0038

Aún no recluta

Seoul, Seoul-teukbyeolsi [Seoul], 06591 KR

Local Institution - 0043

Aún no recluta

Birmingham, West Midlands, B15 2GW GB

Queen Elizabeth Hospital Birmingham

Aún no recluta

London, Greater London, SE5 9RS GB

King's College Hospital

Aún no recluta

London, Greater London, W12 0HS GB

Hammersmith Hospital

Aún no recluta

Glasgow, Scotland, G12 0YN GB

Beatson West of Scotland Cancer Centre

Reclutando

Oslo, 0372 NO

Oslo Universitetssykehus Rikshospitalet

Aún no recluta

Montreal, Quebec, H1T 2M4 CA

Local Institution - 0134

Aún no recluta

Richmond, Virginia, 23298 US

Local Institution - 0136

Aún no recluta

Minneapolis, Minnesota, 55455 US

Local Institution - 0119

Reclutando

L'Hospitalet de Llobregat, Barcelona, 8908 ES

ICO Institut Català d'Oncologia

Aún no recluta

Ann Arbor, Michigan, 48109 US

Local Institution - 0123

Reclutando

Ramat Gan, HaMerkaz, 5266202 IL

Sheba Medical Center

Reclutando

Lublin, Lubelskie, 20-090 PL

Centrum Onkologii Ziemi Lubelskiej

Reclutando

Poznań, 60-569 PL

Uniwersytecki Szpital Kliniczny w Poznaniu

Reclutando

Gliwice, Śląskie, 44-101 PL

Narodowy Instytut Onkologii - Oddzial w Gliwicach

Aún no recluta

Poitiers, Vienne, 86021 FR

Local Institution - 0029

Aún no recluta

Wuerzburg, 97080 DE

Local Institution - 0074

Reclutando

Warsaw, Mazowieckie, 02-776 PL

Instytut Hematologii i Transfuzjologii

Reclutando

Warsaw, Mazowieckie, 02-097 PL

Samodzielny Publiczny Centralny Szpital Kliniczny w Warszawie

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