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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06550895




Registration number
NCT06550895
Ethics application status
Date submitted
9/08/2024
Date registered
13/08/2024
Date last updated
24/10/2024

Titles & IDs
Public title
A Study of Ciltacabtagene Autoleucel and Talquetamab for the Treatment of Participants With High-Risk Multiple Myeloma
Scientific title
A Phase 2, Open-Label, Multicenter Study of Ciltacabtagene Autoleucel and Talquetamab for the Treatment of Participants With High-Risk Multiple Myeloma
Secondary ID [1] 0 0
2023-507989-76
Secondary ID [2] 0 0
64407564MMY2008
Universal Trial Number (UTN)
Trial acronym
MonumenTAL-8
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 - Cilta-cel
Treatment: Drugs - Talquetamab
Treatment: Drugs - Daratumumab
Treatment: Drugs - Lenalidomide
Treatment: Drugs - Dexamethasone

Experimental: Cohort 1: Cilta-cel + Talquetamab Consolidation Post Chimeric Antigen Receptor T cell (CAR-T)Therapy - Participants with relapsed and/or refractory multiple myeloma (RRMM) will be administered Cilta-cel followed by multiple cycles of talquetamab consolidation treatment and will be followed up until death, lost to follow-up, consent withdrawal, or study end, whichever occurs first.

Experimental: Cohort 2: Cilta-cel + Talquetamab Consolidation Post CAR-T Therapy - Participants with newly diagnosed multiple myeloma (NDMM) will undergo daratummab, lenalidomide and dexamthasone (DRd) induction therapy followed by cilta-cel therapy and multiple cycles of talquetamab consolidation treatment and will be followed up until death, lost to follow-up, consent withdrawal, or study end, whichever occurs first.

Experimental: Cohort 3: Tal Bridging Therapy Pre-CAR-T Therapy + Cilta-cel - Participants with RRMM will receive multiple cycles of talquetamab bridging therapy followed by cilta-cel therapy and will be followed up until death, lost to follow-up, consent withdrawal, or study end, whichever occurs first.


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

Treatment: Drugs: Talquetamab
Talquetamab will be administered subcutaneously.

Treatment: Drugs: Daratumumab
Daratumumab will be administered subcutaneously as a part of DRd induction therapy.

Treatment: Drugs: Lenalidomide
Lenalidomide will be administered orally as a part of DRd induction therapy.

Treatment: Drugs: Dexamethasone
Dexamethasone will be administered orally or intravenously as a part of DRd induction therapy.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With Adverse Events (AE) by Severity According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0
Timepoint [1] 0 0
Up to 3 years and 5 months
Secondary outcome [1] 0 0
Percentage of Participants With Overall Response (OR)
Timepoint [1] 0 0
Up to 3 years and 5 months
Secondary outcome [2] 0 0
Percentage of Participants with Very Good Partial Response (VGPR) or Better
Timepoint [2] 0 0
Up to 3 years and 5 months
Secondary outcome [3] 0 0
Percentage of Participants with Complete Response (CR) or Stringent Complete Response (sCR)
Timepoint [3] 0 0
Up to 3 years and 5 months
Secondary outcome [4] 0 0
Duration of Response (DOR)
Timepoint [4] 0 0
Up to 3 years and 5 months
Secondary outcome [5] 0 0
Time to Response (TTR)
Timepoint [5] 0 0
Upto 3 years and 5 months
Secondary outcome [6] 0 0
Progression Free Survival (PFS)
Timepoint [6] 0 0
Up to 3 years and 5 months
Secondary outcome [7] 0 0
Overall Survival
Timepoint [7] 0 0
Up to 3 years and 5 months
Secondary outcome [8] 0 0
Percentage of Participants with Minimal Residual Disease (MRD) Negativity
Timepoint [8] 0 0
Up to 3 years and 5 months
Secondary outcome [9] 0 0
Percentage of Participants with Sustained MRD-Negativity
Timepoint [9] 0 0
Up to 3 years and 5 months

Eligibility
Key inclusion criteria
* Documented diagnosis of MM according to the IMWG diagnostic criteria and is defined as a measurable disease at screening
* Cohorts 1 and 3: Received at least 3 prior lines of antimyeloma therapy and have undergone greater than or equal to (>=) 1 complete cycle of the therapy. Cohort 2: Be newly diagnosed MM and considered ineligible for high-dose chemotherapy with autologous stem cell transplant (ASCT)
* Cohorts 1 and 3: Documented evidence of progression of disease (PD) or failure to achieve a response to the last line of therapy
* Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
* Participant of childbearing potential (POCBP) must have a negative pregnancy test using a highly sensitive ß-human chorionic gonadotropin (hCG) serum pregnancy test at screening
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Cohorts 1 and 3: Prior treatment with chimeric antigen receptor T cell (CAR-T) therapy directed at any target or any prior B cell maturation antigen (BCMA)-directed therapy/prior G protein-coupled receptor family C Group 5 member D (GPRC5D)-directed therapy. Cohort 2: Received any prior therapy for MM or smoldering myeloma other than a short course of corticosteroids
* Cohorts 1 and 3: Received either of the following: An allogenic stem cell transplant within 6 months before apheresis/first dose of study drug and no immunosuppressive medications administered before the start of study treatment. And secondly, received an autologous stem cell transplant less than (<)12 weeks before apheresis/first dose of study treatment
* Cohort 2: Received a strong cytochrome P450 (CYP450) inducer within 5 half-lives prior to daratumumab, lenalidomide and dexamethasone (DRd) induction therapy
* Receive live, attenuated vaccine within 4 weeks of enrollment
* Toxicity from previous anticancer therapy not resolved to baseline levels or to Grade 1 or less except for alopecia or peripheral neuropathy

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Other
Other design features
Phase
Phase 2
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
16/09/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
15/02/2027
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 0 0
Austin Hospital - Heidelberg
Recruitment hospital [3] 0 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment hospital [4] 0 0
The Alfred Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
3084 - Heidelberg
Recruitment postcode(s) [3] 0 0
3000 - Melbourne
Recruitment postcode(s) [4] 0 0
3004 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Iowa
Country [3] 0 0
United States of America
State/province [3] 0 0
Kentucky
Country [4] 0 0
United States of America
State/province [4] 0 0
Michigan
Country [5] 0 0
United States of America
State/province [5] 0 0
New York
Country [6] 0 0
United States of America
State/province [6] 0 0
Pennsylvania
Country [7] 0 0
United States of America
State/province [7] 0 0
Wisconsin

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Janssen Research & Development, LLC
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to define the safety of Ciltacabtagene Autoleucel (Cilta-cel) and Talquetamab in participants with high-risk multiple myeloma (MM).
Trial website
https://clinicaltrials.gov/study/NCT06550895
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Janssen Research & Development, LLC Clinical trial
Address 0 0
Janssen Research & Development, LLC
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Study Contact
Address 0 0
Country 0 0
Phone 0 0
844-434-4210
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/NCT06550895