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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05257083




Registration number
NCT05257083
Ethics application status
Date submitted
16/02/2022
Date registered
25/02/2022

Titles & IDs
Public title
A Study of Daratumumab, Bortezomib, Lenalidomide and Dexamethasone (DVRd) Followed by Ciltacabtagene Autoleucel Versus Daratumumab, Bortezomib, Lenalidomide and Dexamethasone (DVRd) Followed by Autologous Stem Cell Transplant (ASCT) in Participants With Newly Diagnosed Multiple Myeloma
Scientific title
A Phase 3 Randomized Study Comparing Daratumumab, Bortezomib, Lenalidomide and Dexamethasone (DVRd) Followed by Ciltacabtagene Autoleucel Versus Daratumumab, Bortezomib, Lenalidomide and Dexamethasone (DVRd) Followed by Autologous Stem Cell Transplant (ASCT) in Participants With Newly Diagnosed Multiple Myeloma Who Are Transplant Eligible
Secondary ID [1] 0 0
2021-003284-10
Secondary ID [2] 0 0
EMN28/68284528MMY3005
Universal Trial Number (UTN)
Trial acronym
CARTITUDE-6
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: Drugs - Daratumumab
Treatment: Drugs - Bortezomib
Treatment: Drugs - Lenalidomide
Treatment: Drugs - Dexamethasone
Treatment: Drugs - Cilta-cel
Treatment: Drugs - Cyclophosphamide
Treatment: Drugs - Fludarabine

Active comparator: Arm A: DVRd + ASCT+DVRd (Standard Therapy) - Participants will receive daratumumab, bortezomib, lenalidomide and dexamethasone (DVRd) for 4 induction cycles. Followed by ASCT and 2 cycles of DVRd consolidation, and lenalidomide maintenance therapy for 2 years

Daratumumab subcutaneously (SC), 1800 mg on days 1, 8, 15 and 22 of cycle 1 and 2, on days 1 and 15 of cycle 3-6.

Bortezomib SC 1.3 mg/m\^2 on days 1, 4, 8, and 11 of each cycle 1-6. Lenalidomide orally, 25 mg on days 1 to 21 of each cycle 1-6. Dexamethasone orally, 40 mg once a week on days 1, 8, 15 and 22 of each cycle 1-6.

Each cycle will consist 28 days.

Lenalidomide maintenance orally 10 to 15 mg on days 1 to 28 (continuously) until confirmed progressive disease or unacceptable toxicity or for a maximum of 2 years

Experimental: Arm B: DVRd followed by Ciltacabtagene Autoleucel - Participants will receive daratumumab, bortezomib, lenalidomide and dexamethasone (DVRd) for 6 induction cycles.

Participants will receive a conditioning regimen (cyclophosphamide 300 mg/m\^2 intravenous \[IV\] and fludarabine 30 mg/m\^2 IV daily for 3 days) and Cilta-cel infusion 0.75\*10\^6 chimeric antigen receptor (CAR)-positive viable T cells/kilogram (kg), followed by lenalidomide post CAR-T cell therapy for 2 years

Daratumumab subcutaneously (SC), 1800 mg on days 1, 8, 15 and 22 of cycle 1 and 2, on days 1 and 15 of cycle 3-6.

Bortezomib SC 1.3 mg/m\^2 on days 1, 4, 8, and 11 of each cycle 1-6.

Lenalidomide orally, 25 mg on days 1 to 21 of each cycle 1-6.

Dexamethasone orally, 40 mg once a week on days 1, 8, 15 and 22 of each cycle 1-6.

Each cycle will consist of 28 days.

Lenalidomide maintenance orally 10 to 15 mg on days 1 to 28 (continuously) until confirmed progressive disease or unacceptable toxicity or for a maximum of 2 years


Treatment: Drugs: Daratumumab
Daratumumab will be administered SC.

Treatment: Drugs: Bortezomib
Bortezomib will be administered SC.

Treatment: Drugs: Lenalidomide
Lenalidomide will be administered orally.

Treatment: Drugs: Dexamethasone
Dexamethasone will be administered orally.

Treatment: Drugs: Cilta-cel
Cilta-cel will be administered intravenously

Treatment: Drugs: Cyclophosphamide
Cyclophosphamide will be administered intravenously.

Treatment: Drugs: Fludarabine
Fludarabine will be administered intravenously.
Intervention code [1] 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 10 years ( or 300 PFS events)
Primary outcome [2] 0 0
Sustained MRD-negative CR
Timepoint [2] 0 0
up to 24 months
Secondary outcome [1] 0 0
Overall Response (OR)
Timepoint [1] 0 0
up to 17 years
Secondary outcome [2] 0 0
Complete Response (CR) or better status
Timepoint [2] 0 0
up to 17 years
Secondary outcome [3] 0 0
Overall Minimal Residual Disease (MRD) -negative CR
Timepoint [3] 0 0
up to 17 years
Secondary outcome [4] 0 0
Time to subsequent antimyeloma therapy
Timepoint [4] 0 0
up to 17 years
Secondary outcome [5] 0 0
Progression Free Survival on Next-line Therapy (PFS2)
Timepoint [5] 0 0
up to 17 years
Secondary outcome [6] 0 0
Overall Survival (OS)
Timepoint [6] 0 0
up to 17 years
Secondary outcome [7] 0 0
Change from Baseline in Health-Related Quality of Life (HRQoL) as Assessed by European Organization for Research and Treatment of Cancer Quality-of-life Questionnaire Core 30 (EORTC-QLQ-C30) Scale Score
Timepoint [7] 0 0
up to 17 years
Secondary outcome [8] 0 0
Change from Baseline in Health-Related Quality of Life as Assessed by MySIm-Q Scale Score
Timepoint [8] 0 0
up to 17 years
Secondary outcome [9] 0 0
Change from Baseline in Health-Related Quality of Life as Assessed by European Quality of Life - 5 Dimensions-5 Levels (EQ-5D-5L) Scale Scor
Timepoint [9] 0 0
up to 17 years
Secondary outcome [10] 0 0
Change from Baseline in Health-Related Quality of Life as Assessed by Patient Global Impression of Symptom Severity (PGIS) Scale Score
Timepoint [10] 0 0
up to 17 years
Secondary outcome [11] 0 0
Patient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Timepoint [11] 0 0
up to 280 days

Eligibility
Key inclusion criteria
* Participants with documented NDMM according to IMWG diagnostic criteria, for whom high-dose therapy and ASCT are part of the intended initial treatment plan.
* Measurable disease, as assessed by central laboratory, at screening as defined by any of the following:

1. Serum monoclonal paraprotein (M-protein) level =1.0 g/dL or urine M-protein level =200 mg/24 hours; or
2. Light chain MM without measurable disease in serum or urine: serum Ig free-light chain (FLC) =10 mg/dL and abnormal serum Ig kappa lambda FLC ratio.
* ECOG performance status of grade 0 or 1
* Clinical laboratory values within prespecified range.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Prior treatment with CAR-T therapy directed at any target.
* Any prior BCMA target therapy.
* Any prior therapy for MM or smoldering myeloma other than a short course of corticosteroids
* Received a strong cytochrome P450 (CYP)3A4 inducer within 5 half-lives prior to randomization
* Received or plans to receive any live, attenuated vaccine (except for COVID-19 vaccines) within 4 weeks prior to randomization.
* Known active, or prior history of central nervous system (CNS) involvement or clinical signs of meningeal involvement of MM
* Stroke or seizure within 6 months of signing Informed Consent Form (ICF)

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
10/10/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/08/2040
Actual
Sample size
Target
750
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [2] 0 0
Princess Alexandra Hospital - Brisbane
Recruitment hospital [3] 0 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [4] 0 0
Royal Brisbane and Womens Hospital - Herston
Recruitment hospital [5] 0 0
Alfred Health - Melbourne
Recruitment hospital [6] 0 0
Austin Hospital - Melbourne
Recruitment hospital [7] 0 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment hospital [8] 0 0
St. Vincent's Hospital - Melbourne
Recruitment hospital [9] 0 0
Fiona Stanley Hospital - Murdoch
Recruitment hospital [10] 0 0
Calvary Mater Newcastle Hospital - Waratah
Recruitment hospital [11] 0 0
Westmead Hospital - Westmead
Recruitment postcode(s) [1] 0 0
- Adelaide
Recruitment postcode(s) [2] 0 0
- Brisbane
Recruitment postcode(s) [3] 0 0
- Camperdown
Recruitment postcode(s) [4] 0 0
- Herston
Recruitment postcode(s) [5] 0 0
- Melbourne
Recruitment postcode(s) [6] 0 0
- Murdoch
Recruitment postcode(s) [7] 0 0
- Waratah
Recruitment postcode(s) [8] 0 0
- Westmead
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arkansas
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United States of America
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California
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Florida
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Georgia
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Illinois
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Iowa
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Kansas
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Maryland
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Massachusetts
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Michigan
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Minnesota
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New York
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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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Washington
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Wisconsin
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Belgium
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Antwerpen
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Belgium
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Gent
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Belgium
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Leuven
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Calgary
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Edmonton
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Hamilton
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Montréal
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Ottawa
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Québec
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Canada
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Toronto
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Canada
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Vancouver
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Czechia
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Brno
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Czechia
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Králová
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Ostrava
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Plzen
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Toulouse
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Cologne
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Dresden
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Hamburg
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Heidelberg
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Germany
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Leipzig
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Germany
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Tübingen
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Würzburg
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Ramat Gan
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Ancona
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Tohoku
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Netherlands
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Amsterdam
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Groningen
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Nijmegen
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Rotterdam
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Utrecht
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Norway
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Oslo
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Spain
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Badalona
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Barcelona
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Madrid
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Pamplona
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Spain
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Salamanca
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Spain
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Santiago De Compostela
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Spain
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Sevilla
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Spain
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Valencia
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Sweden
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Göteborg
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Sweden
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Linköping
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Sweden
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Lund
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Sweden
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Uppsala
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Switzerland
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Basel
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Switzerland
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Bern
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Switzerland
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Lausanne
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Switzerland
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Zürich
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United Kingdom
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Birmingham
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United Kingdom
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Cardiff
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United Kingdom
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Leeds

Funding & Sponsors
Primary sponsor type
Other
Name
Stichting European Myeloma Network
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Janssen Research & Development, LLC
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Giulia Gazzera
Address 0 0
Country 0 0
Phone 0 0
+39 377 390 9394
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05257083