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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06045806




Registration number
NCT06045806
Ethics application status
Date submitted
13/09/2023
Date registered
21/09/2023
Date last updated
26/09/2024

Titles & IDs
Public title
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
Scientific 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)
Secondary ID [1] 0 0
2022-501346-30
Secondary ID [2] 0 0
CA089-1043
Universal Trial Number (UTN)
Trial acronym
KarMMa-9
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Multiple Myeloma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Other cancer types

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - idecabtagene vicleucel
Treatment: Drugs - Lenalidomide
Treatment: Drugs - Fludarabine
Treatment: Drugs - Cyclophosphamide

Experimental: Arm A -

Active comparator: Arm B -


Treatment: Other: idecabtagene vicleucel
Specified dose on specified days

Treatment: Drugs: Lenalidomide
Specified dose on specified days

Treatment: Drugs: Fludarabine
Specified dose on specified days

Treatment: Drugs: Cyclophosphamide
Specified dose on specified days
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression Free Survival (PFS)
Timepoint [1] 0 0
Up to approximately 49 months after the first participant is randomized
Secondary outcome [1] 0 0
Overall Survival (OS)
Timepoint [1] 0 0
Up to approximately 60 months after the last participant is randomized
Secondary outcome [2] 0 0
Percentage of Participants with Sustained Minimal Residual Disease Negative (MRDneg) Complete Response (CR) for 12 months
Timepoint [2] 0 0
From randomization up to 27 months from randomization
Secondary outcome [3] 0 0
Percentage of Participants with Minimal Residual Disease Negative (MRDneg) Complete Response (CR)
Timepoint [3] 0 0
From randomization up to 15 months from randomization
Secondary outcome [4] 0 0
Event-Free Survival (EFS)
Timepoint [4] 0 0
Up to approximately 60 months after the last participant is randomized
Secondary outcome [5] 0 0
Duration of Response (DOR)
Timepoint [5] 0 0
Up to approximately 60 months after the last participant is randomized
Secondary outcome [6] 0 0
Percentage of Participants with Complete Response (CR)
Timepoint [6] 0 0
Up to approximately 60 months after the last participant is randomized
Secondary outcome [7] 0 0
Time to Progression (TTP)
Timepoint [7] 0 0
Up to approximately 60 months after the last participant is randomized
Secondary outcome [8] 0 0
Progression post-next line of treatment (PFS2)
Timepoint [8] 0 0
Up to approximately 60 months after the last participant is randomized
Secondary outcome [9] 0 0
Time to Next Treatment (TTNT)
Timepoint [9] 0 0
Up to approximately 60 months after the last participant is randomized
Secondary outcome [10] 0 0
Number of Participants Experiencing Adverse Events (AEs)
Timepoint [10] 0 0
Up to approximately 60 months after the last participant is randomized
Secondary outcome [11] 0 0
Number of Participants Experiencing Adverse Events of Special Interest (AESI)
Timepoint [11] 0 0
Up to approximately 60 months after the last participant is randomized
Secondary outcome [12] 0 0
Maximum Observed Plasma Concentration (Cmax)
Timepoint [12] 0 0
Up to approximately 60 months after the last participant is randomized
Secondary outcome [13] 0 0
Time of Maximum Observed Plasma Concentration (Tmax)
Timepoint [13] 0 0
Up to approximately 60 months after the last participant is randomized
Secondary outcome [14] 0 0
Area Under the Curve (AUC) from time zero to 28 days post infusion (AUC [0- 28D])
Timepoint [14] 0 0
Up to 28 days post infusion
Secondary outcome [15] 0 0
Time of Last Measurable Observed Plasma Concentration (Tlast)
Timepoint [15] 0 0
Up to approximately 60 months after the last participant is randomized
Secondary outcome [16] 0 0
Time-to-Definitive Deterioration
Timepoint [16] 0 0
Up to approximately 49 months after the first participant is randomized
Secondary outcome [17] 0 0
Mean Change from Baseline in EORTC QLQ-C30 Selected Subscales
Timepoint [17] 0 0
Up to approximately 49 months after the first participant is randomized
Secondary outcome [18] 0 0
Mean Change from Baseline in EORTC QLQ-MY20 Selected Subscales
Timepoint [18] 0 0
Up to approximately 49 months after the first participant is randomized

Eligibility
Key inclusion 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
16/10/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
4/07/2032
Actual
Sample size
Target
618
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 0 0
Local Institution - 0141 - Liverpool
Recruitment hospital [3] 0 0
Royal Brisbane and Women's Hospital - Brisbane
Recruitment hospital [4] 0 0
Local Institution - 0140 - Adelaide
Recruitment hospital [5] 0 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment hospital [6] 0 0
The Alfred Hospital - Melbourne
Recruitment hospital [7] 0 0
St Vincent's Hospital - Melbourne
Recruitment hospital [8] 0 0
Fiona Stanley Hospital - Murdoch
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2170 - Liverpool
Recruitment postcode(s) [3] 0 0
4029 - Brisbane
Recruitment postcode(s) [4] 0 0
5000 - Adelaide
Recruitment postcode(s) [5] 0 0
3000 - Melbourne
Recruitment postcode(s) [6] 0 0
3004 - Melbourne
Recruitment postcode(s) [7] 0 0
3065 - Melbourne
Recruitment postcode(s) [8] 0 0
6150 - Murdoch
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
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State/province [4] 0 0
Connecticut
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United States of America
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Florida
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United States of America
State/province [6] 0 0
Georgia
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United States of America
State/province [7] 0 0
Massachusetts
Country [8] 0 0
United States of America
State/province [8] 0 0
Michigan
Country [9] 0 0
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State/province [9] 0 0
Minnesota
Country [10] 0 0
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Missouri
Country [11] 0 0
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State/province [11] 0 0
New York
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State/province [12] 0 0
North Carolina
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Ohio
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Pennsylvania
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Texas
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Virginia
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Austria
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Salzburg
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Austria
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Wien
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Bruxelles-Capitale, Région De
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Canada
State/province [20] 0 0
Alberta
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Canada
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Ontario
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Quebec
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Czechia
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Brno-mesto
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Czechia
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Hradec Králové
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Praha 2
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Syddanmark
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Aquitaine
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France
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Bouches-du-Rhône
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Nord
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Rhône
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France
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Vienne
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France
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Toulouse
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France
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Île-de-France
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Germany
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Baden-Württemberg
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Germany
State/province [39] 0 0
Bayern
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Germany
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Nordrhein-Westfalen
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Germany
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Sachsen
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Germany
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Schleswig-Holstein
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Germany
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Dresden
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Germany
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Essen
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Germany
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Hamburg
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Germany
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Wuerzburg
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Greece
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Acha?a
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Greece
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Attikí
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Greece
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Thessaloníki
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Israel
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HaDarom
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Israel
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HaMerkaz
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Israel
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Tell Abib
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Israel
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Haifa
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Israel
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Jerusalem
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Lombardia
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Milano
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Italy
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Piemonte
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Italy
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Bologna
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Italy
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Roma
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Japan
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Aichi
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Japan
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Hokkaido
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Japan
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Hyogo
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Japan
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Ishikawa
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Japan
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Kanagawa
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Tokyo
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Chiba
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Japan
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Fukuoka
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Japan
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Okayama
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Japan
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Shimotsuke
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Korea, Republic of
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Jeonranamdo
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Seoul Teugbyeolsi
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Oslo
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Lubelskie
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Mazowieckie
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Gdansk
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Poznan
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Slaskie
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Romania
State/province [79] 0 0
Bucharest
Country [80] 0 0
Spain
State/province [80] 0 0
Barcelona [Barcelona]
Country [81] 0 0
Spain
State/province [81] 0 0
Catalunya [Cataluña]
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Spain
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Navarra
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Spain
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Madrid
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Spain
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Salamanca
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Spain
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València
Country [86] 0 0
United Kingdom
State/province [86] 0 0
England
Country [87] 0 0
United Kingdom
State/province [87] 0 0
Glasgow City
Country [88] 0 0
United Kingdom
State/province [88] 0 0
Hampshire
Country [89] 0 0
United Kingdom
State/province [89] 0 0
London, City Of

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Celgene
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Bristol-Myers Squibb
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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).
Trial website
https://clinicaltrials.gov/study/NCT06045806
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bristol-Myers Squibb
Address 0 0
Bristol-Myers Squibb
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
Address 0 0
Country 0 0
Phone 0 0
855-907-3286
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06045806