Clinical trial NCT06045806: 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
Official title: 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)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Multiple Myeloma
Keywords: CAR-T
Lead sponsor: Celgene
Sponsor class: INDUSTRY
Collaborators: name: Bristol-Myers Squibb
name: 2seventy bio
First posted: 2023-09-21
Enrollment: 618
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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.

Primary outcomes:
measure: Progression Free Survival (PFS)
timeFrame: Up to approximately 50 months after the first participant is randomized
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: Up to approximately 60 months after the last participant is randomized
measure: Percentage of Participants with Sustained Minimal Residual Disease Negative (MRDneg) Complete Response (CR) for 12 months
timeFrame: From randomization up to 60 months from randomization
measure: Percentage of Participants with Minimal Residual Disease Negative (MRDneg) Complete Response (CR)
timeFrame: From randomization up to 15 months from randomization
measure: Event-Free Survival (EFS)
timeFrame: Up to approximately 60 months after the last participant is randomized
measure: Duration of Response (DOR)
timeFrame: Up to approximately 60 months after the last participant is randomized
measure: Percentage of Participants with Complete Response (CR)
timeFrame: Up to approximately 60 months after the last participant is randomized
measure: Time to Progression (TTP)
timeFrame: Up to approximately 60 months after the last participant is randomized
measure: Progression post-next line of treatment (PFS2)
timeFrame: Up to approximately 60 months after the last participant is randomized
measure: Time to Next Treatment (TTNT)
timeFrame: Up to approximately 60 months after the last participant is randomized
measure: Number of Participants Experiencing Adverse Events (AEs)
timeFrame: Up to approximately 60 months after the last participant is randomized
measure: Number of Participants Experiencing Adverse Events of Special Interest (AESI)
timeFrame: Up to approximately 60 months after the last participant is randomized
measure: Maximum Observed Plasma Concentration (Cmax)
timeFrame: Up to approximately 60 months after the last participant is randomized
measure: Time of Maximum Observed Plasma Concentration (Tmax)
timeFrame: Up to approximately 60 months after the last participant is randomized
measure: Area Under the Curve (AUC) from time zero to 28 days post infusion (AUC [0- 28D])
timeFrame: Up to 28 days post infusion
measure: Time of Last Measurable Observed Plasma Concentration (Tlast)
timeFrame: Up to approximately 60 months after the last participant is randomized
measure: Time-to-Definitive Deterioration
timeFrame: Up to approximately 50 months after the first participant is randomized
measure: Mean Change from Baseline in EORTC QLQ-C30 Selected Subscales
timeFrame: Up to approximately 50 months after the first participant is randomized
measure: Mean Change from Baseline in EORTC QLQ-MY20 Selected Subscales
timeFrame: Up to approximately 50 months after the first participant is randomized
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Local Institution - 0131
state: California
city: Orange
country: United States
facility: Local Institution - 0126
state: California
city: Sacramento
country: United States
facility: Local Institution - 0113
state: California
city: Denver
country: United States
facility: Colorado Blood Cancer Institute
state: Colorado
city: New Haven
country: United States
facility: Yale University School of Medicine
state: Connecticut
city: Orlando
country: United States
facility: AdventHealth Orlando
state: Florida
city: Atlanta
country: United States
facility: Local Institution - 0121
state: Georgia
city: Atlanta
country: United States
facility: Local Institution - 0104
state: Georgia
city: Boston
country: United States
facility: Local Institution - 0151
state: Massachusetts
city: Southfield
country: United States
facility: Ascension Providence Hospital
state: Michigan
city: Minneapolis
country: United States
facility: M Health Fairview Clinics and Surgery Center
state: Minnesota
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: New York
country: United States
facility: Columbia University Irving Medical Center
state: New York
city: Charlotte
country: United States
facility: Novant Health Cancer Institute - Elizabeth
state: North Carolina
city: Columbus
country: United States
facility: The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive Cancer Center
state: Ohio
city: Philadelphia
country: United States
facility: Local Institution - 0132
state: Pennsylvania
city: Austin
country: United States
facility: Local Institution - 0124
state: Texas
city: Houston
country: United States
facility: Local Institution - 0109
state: Texas
city: Houston
country: United States
facility: University of Texas MD Anderson Cancer Center
state: Texas
city: Camperdown
country: Australia
facility: Local Institution - 0007
state: New South Wales
city: Brisbane
country: Australia
facility: Local Institution - 0005
state: Queensland
city: Melbourne
country: Australia
facility: Local Institution - 0004
state: Victoria
city: Melbourne
country: Australia
facility: Local Institution - 0006
state: Victoria
city: Melbourne
country: Australia
facility: Local Institution - 0008
state: Victoria
city: Murdoch
country: Australia
facility: Local Institution - 0011
state: Western Australia
city: Salzburg
country: Austria
facility: Local Institution - 0089
city: Wien
country: Austria
facility: Local Institution - 0090
city: Anderlecht
country: Belgium
facility: Local Institution - 0083
state: Bruxelles-Capitale, Région De
city: Brussels
country: Belgium
facility: Local Institution - 0084
state: Bruxelles-Capitale, Région De
city: Brussels
country: Belgium
facility: Local Institution - 0144
state: Bruxelles-Capitale, Région De
city: Edmonton
country: Canada
facility: Local Institution - 0133
state: Alberta
city: Hamilton
country: Canada
facility: Local Institution - 0001
state: Ontario
city: Montreal
country: Canada
facility: Local Institution - 0134
state: Quebec
city: Odense
country: Denmark
facility: Local Institution - 0070
state: Syddanmark
city: Pessac
country: France
facility: Local Institution - 0047
state: Aquitaine
city: Marseille
country: France
facility: Institut Paoli-Calmettes
state: Bouches-du-Rhône
city: Lille
country: France
facility: Hopital Claude Huriez - CHU de Lille
state: Nord
city: Nantes
country: France
facility: Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu
state: Pays-de-la-Loire
city: Pierre-Bénite
country: France
facility: Local Institution - 0046
state: Rhône
city: Créteil
country: France
facility: Henri Mondor Hospital
state: Val-de-Marne
city: Villejuif
country: France
facility: Local Institution - 0028
state: Val-de-Marne
city: Poitiers
country: France
facility: Local Institution - 0029
state: Vienne
city: Paris
country: France
facility: Local Institution - 0082
city: Toulouse
country: France
facility: Institut Universitaire du Cancer Toulouse - Oncopole - CHU de TOULOUSE
city: Paris
country: France
facility: Local Institution - 0031
state: Île-de-France
city: Heidelberg
country: Germany
facility: Local Institution - 0072
state: Baden-Württemberg
city: Ulm
country: Germany
facility: Local Institution - 0078
state: Baden-Württemberg
city: Nuremberg
country: Germany
facility: Local Institution - 0077
state: Bayern
city: Köln
country: Germany
facility: Local Institution - 0073
state: Nordrhein-Westfalen
city: Leipzig
country: Germany
facility: Local Institution - 0087
state: Sachsen
city: Dresden
country: Germany
facility: Local Institution - 0079
city: Essen
country: Germany
facility: Local Institution - 0115
city: Hamburg
country: Germany
facility: Local Institution - 0076
city: Wuerzburg
country: Germany
facility: Local Institution - 0074
city: Patras
country: Greece
facility: Local Institution - 0063
state: Achaḯa
city: Athens
country: Greece
facility: Local Institution - 0061
state: Attikí
city: Chaidari
country: Greece
facility: Local Institution - 0062
state: Attikí
city: Thessaloniki
country: Greece
facility: Local Institution - 0060
state: Thessaloníki
city: Be'er Sheva
country: Israel
facility: Local Institution - 0055
state: HaDarom
city: Petah-Tikva
country: Israel
facility: Local Institution - 0058
state: HaMerkaz
city: Ramat Gan
country: Israel
facility: Local Institution - 0057
state: HaMerkaz
city: Tel Aviv
country: Israel
facility: Local Institution - 0088
state: Tell Abīb
city: Haifa
country: Israel
facility: Local Institution - 0056
city: Jerusalem
country: Israel
facility: Local Institution - 0059
city: Rozzano
country: Italy
facility: Local Institution - 0064
state: Milano
city: Bologna
country: Italy
facility: Local Institution - 0065
city: Roma
country: Italy
facility: Local Institution - 0066
city: Nagoya
country: Japan
facility: Nagoya City University Hospital
state: Aichi
city: Sapporo
country: Japan
facility: Hokkaido University Hospital
state: Hokkaido
city: Nishinomiya
country: Japan
facility: Hyogo Medical University Hospital
state: Hyogo
city: Kanazawa
country: Japan
facility: Kanazawa University Hospital
state: Ishikawa
city: Isehara
country: Japan
facility: Local Institution - 0085
state: Kanagawa
city: Shibuya-ku
country: Japan
facility: Japanese Red Cross Medical Center
state: Tokyo
city: Chiba
country: Japan
facility: Chiba University Hospital
city: Fukuoka
country: Japan
facility: Kyushu University Hospital
city: Okayama
country: Japan
facility: Okayama University Hospital
city: Shimotsuke
country: Japan
facility: Local Institution - 0071
city: Hwasun
country: Korea, Republic of
facility: Chonnam National University Hwasun Hospital
state: Jeonranamdo
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: Local Institution - 0038
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: Local Institution - 0043
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
state: Seoul-teukbyeolsi
city: Oslo
country: Norway
facility: Local Institution - 0069
city: Lublin
country: Poland
facility: Local Institution - 0027
state: Lubelskie
city: Warsaw
country: Poland
facility: Local Institution - 0095
state: Mazowieckie
city: Warsaw
country: Poland
facility: Local Institution - 0023
state: Mazowieckie
city: Gdańsk
country: Poland
facility: Local Institution - 0026
city: Poznań
country: Poland
facility: Local Institution - 0024
city: Gliwice
country: Poland
facility: Local Institution - 0022
state: Śląskie
city: Bucharest
country: Romania
facility: Local Institution - 0091
city: Badalona
country: Spain
facility: Local Institution - 0020
state: Barcelona [Barcelona]
city: L'Hospitalet Del Llobregat
country: Spain
facility: Local Institution - 0017
state: Barcelona [Barcelona]
city: Barcelona
country: Spain
facility: Hospital Clínic de Barcelona
state: Catalunya [Cataluña]
city: Pamplona
country: Spain
facility: Local Institution - 0012
state: Navarra
city: Madrid
country: Spain
facility: Local Institution - 0021
city: Salamanca
country: Spain
facility: Local Institution - 0013
city: València
country: Spain
facility: Hospital Universitari i Politecnic La Fe
city: Birmingham
country: United Kingdom
facility: Local Institution - 0093
state: England
city: London
country: United Kingdom
facility: Local Institution - 0080
state: London, City Of
city: London
country: United Kingdom
facility: Local Institution - 0094
state: London, City Of
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: