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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

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
64407564MMY2008
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
Assessment method [1] 0 0
An AE is any untoward medical occurrence in a participant administered a pharmaceutical (investigational or non-investigational) product. It does not necessarily have a causal relationship with the investigational product. The severity of AEs has 5 grades based on NCI-CTCAE version 5.0 criteria: Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe; Grade 4: Life-threatening consequences; Grade 5: Death.
Timepoint [1] 0 0
Up to 3 years and 5 months
Secondary outcome [1] 0 0
Percentage of Participants With Overall Response (OR)
Assessment method [1] 0 0
The percentage of participants who have a partial response (PR) or better response according to the International Myeloma Working Group (IMWG) response criteria will be reported.
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
Assessment method [2] 0 0
The percentage of participants who achieve a VGPR or better response according to the IMWG response criteria will be reported.
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)
Assessment method [3] 0 0
The percentage of participants with best overall response of CR or sCR will be reported according to IMWG criteria.
Timepoint [3] 0 0
Up to 3 years and 5 months
Secondary outcome [4] 0 0
Duration of Response (DOR)
Assessment method [4] 0 0
DOR is defined as the time from the date of initial documentation of a response (PR or better) to the date of first documented evidence of progressive disease (PD) (defined in the IMWG response criteria) or death due to any cause, whichever occur first.
Timepoint [4] 0 0
Up to 3 years and 5 months
Secondary outcome [5] 0 0
Time to Response (TTR)
Assessment method [5] 0 0
TTR is defined as the time between date of the first study treatment and the first efficacy evaluation that the participant met all criteria for PR or better.
Timepoint [5] 0 0
Upto 3 years and 5 months
Secondary outcome [6] 0 0
Progression Free Survival (PFS)
Assessment method [6] 0 0
PFS is defined as the time from the date of the first study treatment to the date of first documented disease progression (defined in the IMWG response criteria), or death due to any cause, whichever occurs first.
Timepoint [6] 0 0
Up to 3 years and 5 months
Secondary outcome [7] 0 0
Overall Survival
Assessment method [7] 0 0
Overall Survival is measured from the date of the first study treatment to the date of the participant's death.
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
Assessment method [8] 0 0
The percentage of participants who achieve MRD-negativity at a threshold of 10\^-5 at any timepoint after the date of the first study treatment and before disease progression or start of any subsequent antimyeloma therapy will be reported.
Timepoint [8] 0 0
Up to 3 years and 5 months
Secondary outcome [9] 0 0
Percentage of Participants with Sustained MRD-Negativity
Assessment method [9] 0 0
The percentage of participants who sustained MRD-negative status, as determined by next generation sequencing (NGS) with sensitivity of 10\^-5, for at least 6 months without examination showing MRD-positive or PD in between will be reported.
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
31/08/2026
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
Iowa
Country [2] 0 0
United States of America
State/province [2] 0 0
Kentucky
Country [3] 0 0
United States of America
State/province [3] 0 0
Michigan
Country [4] 0 0
United States of America
State/province [4] 0 0
New York
Country [5] 0 0
United States of America
State/province [5] 0 0
Pennsylvania
Country [6] 0 0
United States of America
State/province [6] 0 0
Wisconsin

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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
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
Email 0 0
Participate-In-This-Study@its.jnj.com
Contact person for scientific queries

Data sharing statement


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/NCT06550895