Übersicht

Eignung

Details zum Design

Arme & Interventionen

Ergebnismessungen

Studienzentren

Quelle: NCT06399393

Rekrutiert

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

Interventionsstudie

Phase 3

Boston Medical Center

Sponsor: Bristol Myers Squibb

Zuletzt aktualisiert: 3. Mai 2024
Hinweis - Die Informationen stammen aus öffentlichen Registern und spiegeln möglicherweise nicht die Echtzeitänderungen am lokalen Studienzentrum wider.

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).

Behandlungskategorie

Chemotherapie, Zelltherapie

Erforderliche Mutationen

Keine

Studie gestartet

16. Oktober 2023

Zuletzt vom Sponsor aktualisiert

3. Mai 2024

Voraussichtlicher Abschluss

27. März 2031

Studienkontakt

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

E-Mail:Clinical.Trials@bms.com

Telefon:855-907-3286

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

Eignung

Einschlusskriterien

* 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.

Ausschlusskriterien

* 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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Design-Details

ZuteilungRandomized

InterventionsmodellParallel Assignment

MaskierungNone (Open Label)

Anzahl der Teilnehmer618

Arme & Interventionen

Arme

Interventionen

Typ: Experimental

Beschreibung:

Interventionen:

Cyclophosphamide
Fludarabine
Lenalidomide
idecabtagene vicleucel

Ergebnismessungen

Primäre Ergebnismessungen

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

PFS as assessed by Independent Review Committee (IRC)

Sekundäre Ergebnismessungen

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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Studienzentren

Diese Studie hat 115 Studienzentren

Boston Medical Center

Boston, Massachusetts, US

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Saint Louis, Missouri, 63110 US

Washington University School of Medicine

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Tampa, Florida, 33612 US

Moffitt Cancer Center

Rekrutierend

Madrid, Madrid, 28041 ES

Hospital Universitario 12 de Octubre

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Boston, Massachusetts, 02114 US

Mass General Hospital

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Houston, Texas, 77030 US

University of Texas MD Anderson Cancer Center

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Atlanta, Georgia, 30342 US

Northside Hospital

Rekrutierend

Philadelphia, Pennsylvania, 19104 US

Hospital of the University of Pennsylvania

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Jacksonville, Florida, 32224 US

Mayo Clinic in Florida

Rekrutierend

Okayama, 700-8558 JP

Okayama University Hospital

Rekrutierend

Sapporo, Hokkaido, 060-8648 JP

Hokkaido University Hospital

Rekrutierend

Kanazawa, Ishikawa, 920-8641 JP

Kanazawa University Hospital

Rekrutierend

Melbourne, Victoria, 3000 AU

Peter MacCallum Cancer Centre

Rekrutierend

Camperdown, New South Wales, 2050 AU

Royal Prince Alfred Hospital

Rekrutierend

Melbourne, Victoria, 3004 AU

The Alfred Hospital

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Denver, Colorado, 80218 US

Colorado Blood Cancer Institute

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Atlanta, Georgia, 30322 US

Winship Cancer Institute, Emory University

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Houston, Texas, 77030 US

Houston Methodist Hospital

Rekrutierend

Murdoch, Western Australia, 6150 AU

Fiona Stanley Hospital

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Gilbert, Arizona, 85234 US

Banner MD Anderson Cancer Center

Rekrutierend

Haifa, 31096 IL

Rambam Health Care Campus

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New Haven, Connecticut, 06510 US

Yale University School of Medicine

Rekrutierend

Paris, 75010 FR

Hôpital Saint-Louis

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Cleveland, Ohio, 44106 US

University Hospitals Cleveland Medical Center

Rekrutierend

Melbourne, Victoria, 3065 AU

St Vincent's Hospital

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New York, New York, 10032 US

Columbia University Irving Medical Center

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Pamplona, Navarra, 31008 ES

Clínica Universidad de Navarra

Rekrutierend

Chiba, 260-8677 JP

Chiba University Hospital

Rekrutierend

Marseille, Bouches-du-Rhône, 13273 FR

Institut Paoli-Calmettes

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Jerusalem, 9112001 IL

Hadassah Medical Center

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Orlando, Florida, 32804 US

AdventHealth Orlando

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Isehara, Kanagawa, 259-1193 JP

Tokai University Hospital

Rekrutierend

Wien, 1090 AT

Medizinische Universität Wien

Rekrutierend

Austin, Texas, 78704 US

St. David's South Austin Medical Center

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Southfield, Michigan, 48075 US

Ascension Providence Hospital

Rekrutierend

Gdańsk, 80-952 PL

Uniwersyteckie Centrum Kliniczne

Rekrutierend

Nagoya, Aichi, 467-8602 JP

Nagoya City University Hospital

Rekrutierend

Roma, 00161 IT

AOU Policlinico Umberto I

Rekrutierend

Pierre-Bénite, Rhône, 69310 FR

Centre Hospitalier Lyon Sud

Rekrutierend

Bucharest, 022328 RO

Institutul Clinic Fundeni

Rekrutierend

Brussels, Bruxelles-Capitale, Région De, 1090 BE

UZ Brussel

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Salzburg, 5020 AT

Uniklinikum Salzburg

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Patras, Achaḯa, 26504 GR

University Hospital of Patras

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Thessaloniki, Thessaloníki, 570 10 GR

G. Papanikolaou General Hospital

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Salamanca, Salamanca, 37007 ES

Hospital Universitario de Salamanca

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Rochester, Minnesota, 55905 US

Mayo Clinic in Rochester, Minnesota

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Scottsdale, Arizona, 85259 US

Mayo Clinic in Arizona - Scottsdale

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Chaidari, Attikí, 12462 GR

Attikon General University Hospital

Rekrutierend

Tel Aviv, Tell Abīb, 6423906 IL

Sourasky Medical Center

Rekrutierend

Barcelona, Barcelona, 8036 ES

Hospital Clínic de Barcelona

Rekrutierend

Athens, Attikí, 106 76 GR

Evangelismos General Hospital of Athens

Rekrutierend

Hamilton, Ontario, L8V5C2 CA

Hamilton Health Sciences-Juravinski Cancer Centre

Rekrutierend

València, València, 46026 ES

Hospital Universitario y Politécnico La Fe

Rekrutierend

Lille, Nord, 59000 FR

Hopital Claude Huriez - CHU de Lille

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Sacramento, California, 95817 US

University of California Davis (UC Davis) Comprehensive Cancer Center

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Anderlecht, Bruxelles-Capitale, Région De, 1070 BE

Institut Jules Bordet

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Orange, California, 92868 US

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

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Milano, Lombardia, 20089 IT

IRCCS Istituto Clinico Humanitas

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Edmonton, Alberta, T6G 1Z2 CA

Local Institution - 0133

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Charlotte, North Carolina, 28204 US

Novant Health Cancer Institute - Elizabeth

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Badalona, Barcelona, 17007 ES

ICO Institut Català d'Oncologia

Rekrutiert noch nicht

Los Angeles, California, 90095 US

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

Rekrutierend

Villejuif, Val-de-Marne, 94805 FR

Gustave Roussy

Rekrutierend

Pessac, Aquitaine, 33600 FR

CHU Bordeaux Haut-Leveque

Rekrutierend

Paris, Île-de-France, 75571 FR

Hôpital Saint Antoine

Rekrutierend

Bologna, 40138 IT

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

Rekrutierend

Nishinomiya, Hyogo, 663-8501 JP

Hyogo Medical University Hospital

Rekrutiert noch nicht

Columbus, Ohio, 43210 US

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

Rekrutierend

Toulouse, 31100 FR

Institut Universitaire du Cancer Toulouse - Oncopole - CHU de TOULOUSE

Rekrutiert noch nicht

Dallas, Texas, 75390-88520 US

UT Southwestern Medical Center

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Brisbane, Queensland, 4029 AU

Local Institution - 0005

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Brno, Brno-město, 625 00 CZ

Local Institution - 0036

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Hradec Kralove, Hradec Králové, 500 05 CZ

Local Institution - 0034

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Olomouc, Olomoucký Kraj, 779 00 CZ

Local Institution - 0035

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Praha 2, 12808 CZ

Local Institution - 0033

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Odense, Syddanmark, 5000 DK

Local Institution - 0070

Rekrutierend

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

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

Rekrutierend

Créteil, Val-de-Marne, 94010 FR

Henri Mondor Hospital

Rekrutiert noch nicht

Heidelberg, Baden-Württemberg, 69120 DE

Local Institution - 0072

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Ulm, Baden-Württemberg, 89081 DE

Local Institution - 0078

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Nuremberg, Bayern, 90419 DE

Local Institution - 0077

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Köln, Nordrhein-Westfalen, 50937 DE

Local Institution - 0073

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Dresden, Sachsen, 01307 DE

Local Institution - 0079

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Leipzig, Sachsen, 04103 DE

Local Institution - 0087

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Kiel, Schleswig-Holstein, 24105 DE

Local Institution - 0075

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Essen, 45122 DE

Local Institution - 0115

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Hamburg, 20246 DE

Local Institution - 0076

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Be'er Sheva, HaDarom, 8410101 IL

Local Institution - 0055

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Petah-Tikva, HaMerkaz, 4910021 IL

Local Institution - 0058

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Torino, Piemonte, 10126 IT

Local Institution - 0067

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Fukuoka, 812-8582 JP

Local Institution - 0054

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Shimotsuke, 329-0498 JP

Local Institution - 0071

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Tokyo, 150-8935 JP

Local Institution - 0050

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Hwasun Gun, Jeonranamdo, 58128 KR

Local Institution - 0041

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Seoul, Seoul-teukbyeolsi [Seoul], 03080 KR

Local Institution - 0039

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Seoul, Seoul-teukbyeolsi [Seoul], 05505 KR

Local Institution - 0040

Rekrutiert noch nicht

Seoul, Seoul-teukbyeolsi [Seoul], 06351 KR

Local Institution - 0038

Rekrutiert noch nicht

Seoul, Seoul-teukbyeolsi [Seoul], 06591 KR

Local Institution - 0043

Rekrutiert noch nicht

Birmingham, West Midlands, B15 2GW GB

Queen Elizabeth Hospital Birmingham

Rekrutiert noch nicht

London, Greater London, SE5 9RS GB

King's College Hospital

Rekrutiert noch nicht

London, Greater London, W12 0HS GB

Hammersmith Hospital

Rekrutiert noch nicht

Glasgow, Scotland, G12 0YN GB

Beatson West of Scotland Cancer Centre

Rekrutierend

Oslo, 0372 NO

Oslo Universitetssykehus Rikshospitalet

Rekrutiert noch nicht

Montreal, Quebec, H1T 2M4 CA

Local Institution - 0134

Rekrutiert noch nicht

Richmond, Virginia, 23298 US

Local Institution - 0136

Rekrutiert noch nicht

Minneapolis, Minnesota, 55455 US

Local Institution - 0119

Rekrutierend

L'Hospitalet de Llobregat, Barcelona, 8908 ES

ICO Institut Català d'Oncologia

Rekrutiert noch nicht

Ann Arbor, Michigan, 48109 US

Local Institution - 0123

Rekrutierend

Ramat Gan, HaMerkaz, 5266202 IL

Sheba Medical Center

Rekrutierend

Lublin, Lubelskie, 20-090 PL

Centrum Onkologii Ziemi Lubelskiej

Rekrutierend

Poznań, 60-569 PL

Uniwersytecki Szpital Kliniczny w Poznaniu

Rekrutierend

Gliwice, Śląskie, 44-101 PL

Narodowy Instytut Onkologii - Oddzial w Gliwicach

Rekrutiert noch nicht

Poitiers, Vienne, 86021 FR

Local Institution - 0029

Rekrutiert noch nicht

Wuerzburg, 97080 DE

Local Institution - 0074

Rekrutierend

Warsaw, Mazowieckie, 02-776 PL

Instytut Hematologii i Transfuzjologii

Rekrutierend

Warsaw, Mazowieckie, 02-097 PL

Samodzielny Publiczny Centralny Szpital Kliniczny w Warszawie

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