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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT06399393




Registration number
NCT06399393
Ethics application status
Date submitted
1/05/2024
Date registered
3/05/2024
Date last updated
3/05/2024

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
Other interventions - idecabtagene vicleucel
Treatment: Drugs - Lenalidomide
Treatment: Drugs - Fludarabine
Treatment: Drugs - Cyclophosphamide

Experimental: Arm A -

Active Comparator: Arm B -


Other interventions: 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
Other interventions
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
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,VIC,WA
Recruitment hospital [1] 0 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 0 0
Local Institution - 0005 - Brisbane
Recruitment hospital [3] 0 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment hospital [4] 0 0
The Alfred Hospital - Melbourne
Recruitment hospital [5] 0 0
St Vincent's Hospital - Melbourne
Recruitment hospital [6] 0 0
Fiona Stanley Hospital - Murdoch
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
4029 - Brisbane
Recruitment postcode(s) [3] 0 0
3000 - Melbourne
Recruitment postcode(s) [4] 0 0
3004 - Melbourne
Recruitment postcode(s) [5] 0 0
3065 - Melbourne
Recruitment postcode(s) [6] 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
Country [4] 0 0
United States of America
State/province [4] 0 0
Connecticut
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Georgia
Country [7] 0 0
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
United States of America
State/province [9] 0 0
Minnesota
Country [10] 0 0
United States of America
State/province [10] 0 0
Missouri
Country [11] 0 0
United States of America
State/province [11] 0 0
New York
Country [12] 0 0
United States of America
State/province [12] 0 0
North Carolina
Country [13] 0 0
United States of America
State/province [13] 0 0
Ohio
Country [14] 0 0
United States of America
State/province [14] 0 0
Pennsylvania
Country [15] 0 0
United States of America
State/province [15] 0 0
Texas
Country [16] 0 0
United States of America
State/province [16] 0 0
Virginia
Country [17] 0 0
Austria
State/province [17] 0 0
Salzburg
Country [18] 0 0
Austria
State/province [18] 0 0
Wien
Country [19] 0 0
Belgium
State/province [19] 0 0
Bruxelles-Capitale, Région De
Country [20] 0 0
Canada
State/province [20] 0 0
Alberta
Country [21] 0 0
Canada
State/province [21] 0 0
Ontario
Country [22] 0 0
Canada
State/province [22] 0 0
Quebec
Country [23] 0 0
Czechia
State/province [23] 0 0
Brno-mesto
Country [24] 0 0
Czechia
State/province [24] 0 0
Hradec Králové
Country [25] 0 0
Czechia
State/province [25] 0 0
Olomoucký Kraj
Country [26] 0 0
Czechia
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Praha 2
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Syddanmark
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Aquitaine
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France
State/province [29] 0 0
Bouches-du-Rhône
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France
State/province [30] 0 0
Nord
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France
State/province [31] 0 0
Pays-de-la-Loire
Country [32] 0 0
France
State/province [32] 0 0
Rhône
Country [33] 0 0
France
State/province [33] 0 0
Val-de-Marne
Country [34] 0 0
France
State/province [34] 0 0
Vienne
Country [35] 0 0
France
State/province [35] 0 0
Paris
Country [36] 0 0
France
State/province [36] 0 0
Toulouse
Country [37] 0 0
France
State/province [37] 0 0
Île-de-France
Country [38] 0 0
Germany
State/province [38] 0 0
Baden-Württemberg
Country [39] 0 0
Germany
State/province [39] 0 0
Bayern
Country [40] 0 0
Germany
State/province [40] 0 0
Nordrhein-Westfalen
Country [41] 0 0
Germany
State/province [41] 0 0
Sachsen
Country [42] 0 0
Germany
State/province [42] 0 0
Schleswig-Holstein
Country [43] 0 0
Germany
State/province [43] 0 0
Essen
Country [44] 0 0
Germany
State/province [44] 0 0
Hamburg
Country [45] 0 0
Germany
State/province [45] 0 0
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
Country [51] 0 0
Israel
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Tell Abib
Country [52] 0 0
Israel
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Haifa
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Israel
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Jerusalem
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Italy
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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
State/province [57] 0 0
Roma
Country [58] 0 0
Japan
State/province [58] 0 0
Aichi
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Japan
State/province [59] 0 0
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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Japan
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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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Japan
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Tokyo
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Korea, Republic of
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Jeonranamdo
Country [69] 0 0
Korea, Republic of
State/province [69] 0 0
Seoul-teukbyeolsi [Seoul]
Country [70] 0 0
Norway
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Oslo
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Poland
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Lubelskie
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Poland
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Mazowieckie
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Gdansk
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Poland
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Poznan
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Poland
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Slaskie
Country [76] 0 0
Romania
State/province [76] 0 0
Bucharest
Country [77] 0 0
Spain
State/province [77] 0 0
Barcelona [Barcelona]
Country [78] 0 0
Spain
State/province [78] 0 0
Catalunya [Cataluña]
Country [79] 0 0
Spain
State/province [79] 0 0
Navarra
Country [80] 0 0
Spain
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Madrid
Country [81] 0 0
Spain
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Salamanca
Country [82] 0 0
Spain
State/province [82] 0 0
València
Country [83] 0 0
United Kingdom
State/province [83] 0 0
England
Country [84] 0 0
United Kingdom
State/province [84] 0 0
London, City Of
Country [85] 0 0
United Kingdom
State/province [85] 0 0
Glasgow

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/ct2/show/NCT06399393
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 Study Connect Contact Center www.BMSStudyConnect.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/ct2/show/NCT06399393