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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06208150




Registration number
NCT06208150
Ethics application status
Date submitted
5/01/2024
Date registered
17/01/2024

Titles & IDs
Public title
A Study Comparing Talquetamab Plus Pomalidomide, Talquetamab Plus Teclistamab, and Elotuzumab, Pomalidomide, and Dexamethasone or Pomalidomide, Bortezomib, and Dexamethasone in Participants With Relapsed or Refractory Myeloma Who Have Received an Anti-CD38 Antibody and Lenalidomide
Scientific title
A Phase 3 Randomized Study Comparing Talquetamab in Combination With Pomalidomide (Tal-P), Talquetamab in Combination With Teclistamab (Tal-Tec), and Investigator's Choice of Either Elotuzumab, Pomalidomide, and Dexamethasone (EPd) or Pomalidomide, Bortezomib, and Dexamethasone (PVd) in Participants With Relapsed or Refractory Myeloma Who Have Received 1 to 4 Prior Lines of Therapy Including an Anti-CD38 Antibody and Lenalidomide
Secondary ID [1] 0 0
64407564MMY3009
Secondary ID [2] 0 0
64407564MMY3009
Universal Trial Number (UTN)
Trial acronym
MonumenTAL-6
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Relapsed or Refractory 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 - Talquetamab
Treatment: Drugs - Pomalidomide
Treatment: Drugs - Teclistamab
Treatment: Drugs - Elotuzumab
Treatment: Drugs - Dexamethasone
Treatment: Drugs - Bortezomib

Experimental: Arm A: Talquetamab + Pomalidomide (Tal-P) - Participants will receive talquetamab as subcutaneous (SC) injections; pomalidomide will be self-administered as a single dose orally; dexamethasone may be given orally or intravenously as a pretreatment medication and study drug.

Experimental: Arm B: Talquetamab + Teclistamab (Tal-Tec) - Participants will receive teclistamab in combination with talquetamab both as SC injection; dexamethasone may be given orally or intravenously as a pretreatment medication and study drug.

Active comparator: Arm C: Elotuzumab+ Pomalidomide+Dexamethasone (EPd) or Pomalidomide+Bortezomib+Dexamethasone (PVd) - Participants will either receive elotuzumab intravenous (IV) injection in combination with pomalidomide and dexamethasone orally; or pomalidamide orally in combination with bortezomib SC injection and dexamethasone orally as per investigator choice. Dexamethasone will be administered as a pretreatment medication.


Treatment: Drugs: Talquetamab
Talquetamab will be administered as a SC injection.

Treatment: Drugs: Pomalidomide
Pomalidomide will be administered orally.

Treatment: Drugs: Teclistamab
Teclistamab will be administered as a SC injection.

Treatment: Drugs: Elotuzumab
Elotuzumab will be administered intravenously.

Treatment: Drugs: Dexamethasone
Dexamethasone will be administered either orally or intravenously.

Treatment: Drugs: Bortezomib
Bortezomib will be administered as a SC injection.
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 6 years 5 months
Secondary outcome [1] 0 0
Overall Response Rate (ORR)
Timepoint [1] 0 0
Up to 6 years 5 months
Secondary outcome [2] 0 0
Complete Response (CR) or Better Rate
Timepoint [2] 0 0
Up to 6 years 5 months
Secondary outcome [3] 0 0
Very Good Partial Response (VGPR) or Better Rate
Timepoint [3] 0 0
Up to 6 years 5 months
Secondary outcome [4] 0 0
Minimal Residual Disease (MRD)-negative CR Rate
Timepoint [4] 0 0
Up to 6 years 5 months
Secondary outcome [5] 0 0
Overall Survival (OS)
Timepoint [5] 0 0
Up to 6 years 5 months
Secondary outcome [6] 0 0
Progression Free Survival on Next-line Therapy (PFS2)
Timepoint [6] 0 0
Up to 6 years 5 months
Secondary outcome [7] 0 0
Time to Next Treatment (TTNT)
Timepoint [7] 0 0
Up to 6 years 5 months
Secondary outcome [8] 0 0
Serum Concentration of Talquetamab and Teclistamab
Timepoint [8] 0 0
Up to 6 years 5 months
Secondary outcome [9] 0 0
Number of Participants with Anti-drug Antibodies (ADAs) to Talquetamab and Teclistamab
Timepoint [9] 0 0
Up to 6 years 5 months
Secondary outcome [10] 0 0
Time to Sustained Worsening in Symptoms, Functioning, and Health-related Quality of Life (HRQoL) as Assessed by Multiple Myeloma Symptom and Impact Questionnaire (MySIm-Q)
Timepoint [10] 0 0
Up to 6 years 5 months
Secondary outcome [11] 0 0
Time to Sustained Worsening in Symptoms, Functioning, and Health-related Quality of Life (HRQoL) as Assessed by EORTC-QLQ-C30
Timepoint [11] 0 0
Up to 6 years 5 months
Secondary outcome [12] 0 0
Time to Sustained Worsening in Symptoms, Functioning, and Health-related Quality of Life (HRQoL) as Assessed by EuroQol Five Dimension Questionnaire 5-Level (EQ-5D-5L)
Timepoint [12] 0 0
Up to 6 years 5 months
Secondary outcome [13] 0 0
Time to Sustained Worsening in Symptoms, Functioning, and Health-related Quality of Life (HRQoL) as Assessed by Patient Global Impression -Severity (PGI-S)
Timepoint [13] 0 0
Up to 6 years 5 months
Secondary outcome [14] 0 0
Time to Sustained Worsening in Symptoms, Functioning, and Health-related Quality of Life (HRQoL) as Assessed by Epstein Taste Survey
Timepoint [14] 0 0
Up to 6 years 5 months
Secondary outcome [15] 0 0
Change from Baseline in Symptoms, Functioning, and Health-related Quality of Life (HRQoL) as Assessed by MySIm-Q
Timepoint [15] 0 0
Up to 6 years 5 months
Secondary outcome [16] 0 0
Change from Baseline in Symptoms, Functioning, and Health-related Quality of Life (HRQoL) as Assessed by EORTC-QLQ-C30
Timepoint [16] 0 0
Up to 6 years 5 months
Secondary outcome [17] 0 0
Change from Baseline in Symptoms, Functioning, and Health-related Quality of Life (HRQoL) as Assessed by EQ-5D-5L
Timepoint [17] 0 0
Up to 6 years 5 months
Secondary outcome [18] 0 0
Change from Baseline in Symptoms, Functioning, and Health-related Quality of Life (HRQoL) as Assessed by PGI-S
Timepoint [18] 0 0
Up to 6 years 5 months
Secondary outcome [19] 0 0
Change from Baseline in Symptoms, Functioning, and Health-related Quality of Life (HRQoL) as Assessed by Epstein Taste Survey
Timepoint [19] 0 0
Up to 6 years 5 months
Secondary outcome [20] 0 0
Percentage of Participants With Meaningful Improvement in HRQoL as Assessed by EORTC-QLQ-C30
Timepoint [20] 0 0
Up to 6 years 5 months

Eligibility
Key inclusion criteria
* Documented multiple myeloma as defined by the criteria below: (a) multiple myeloma diagnosis according to the international myeloma working group (IMWG) diagnostic criteria (b) measurable disease at screening as assessed by central laboratory, defined by any of the following: (i) serum M-protein level greater than or equal to (>=) 0.5 gram per deciliter (g/dL); or (ii) urine M-protein level >= 200 milligram (mg) per 24 hours; or (iii) light chain multiple myeloma without measurable M-protein in the serum or the urine: serum immunoglobulin (Ig) free light chain (FLC) >= 10 milligrams per deciliter (mg/dL) and abnormal serum Ig kappa lambda FLC ratio
* Relapsed or refractory disease as defined below: a) Relapsed disease is defined as an initial response to prior treatment, followed by confirmed progressive disease (PD) by IMWG criteria greater than (>) 60 days after cessation of treatment. b) Refractory disease is defined as less than (<) 25 percent (%) reduction in M-protein or confirmed PD by IMWG criteria during previous treatment or less than or equal to (<=) 60 days after cessation of treatment
* Documented evidence of PD or failure to achieve a minimal response to the last line of therapy based on investigator's determination of response by IMWG criteria on or after their last regimen
* Have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2 at screening and immediately prior to the start of administration of study treatment
* A participant must agree not to be pregnant, breastfeeding, or planning to become pregnant while enrolled in this study or within 6months after the last dose of study treatment
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Contraindications or life-threatening allergies, hypersensitivity, or intolerance to any study drug or its excipients
* Stroke, transient ischemic attack, or seizure within 6 months prior to signing informed consent form (ICF)
* Major surgery or had significant traumatic injury within 2 weeks prior to the start of administration of study treatment, or will not have fully recovered from surgery, or has major surgery planned during the time the participant is expected to be treated in the study or within 2 weeks after administration of the last dose of study treatment
* A maximum cumulative dose of corticosteroids of >=140 mg of prednisone or equivalent within 14-day period before the first dose of study drug
* Known active central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of multiple myeloma. If either is suspected, negative whole brain magnetic resonance imaging (MRI) and lumbar cytology are required

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
22/01/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/06/2030
Actual
Sample size
Target
795
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [2] 0 0
Box Hill Hospital - Box Hill
Recruitment hospital [3] 0 0
St Vincents Hospital - Darlinghurst
Recruitment hospital [4] 0 0
St Vincents Hospital Melbourne - Fitzroy
Recruitment hospital [5] 0 0
Gold Coast University Hospital - Southport
Recruitment hospital [6] 0 0
Perth Blood Institute - West Perth
Recruitment hospital [7] 0 0
Wollongong Hospital - Wollongong
Recruitment postcode(s) [1] 0 0
5000 - Adelaide
Recruitment postcode(s) [2] 0 0
3128 - Box Hill
Recruitment postcode(s) [3] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [4] 0 0
3065 - Fitzroy
Recruitment postcode(s) [5] 0 0
4215 - Southport
Recruitment postcode(s) [6] 0 0
6005 - West Perth
Recruitment postcode(s) [7] 0 0
2500 - Wollongong
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Connecticut
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United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
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Georgia
Country [4] 0 0
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Idaho
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Iowa
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Kentucky
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Michigan
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Washington
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Argentina
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Buenos Aires
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Ciudad Autonoma de Buenos Aires
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Austria
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Salzburg
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Austria
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Vienna
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Charleroi
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Genk
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Gent
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Belo Horizonte
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Brasilia
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Caxias do Sul
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Curitiba
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Porto Alegre
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Recife
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Aarhus
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Vejle
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Lille
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Limoges
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TOURS Cedex 01
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Augsburg
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Halle (Saale)
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Heidelberg
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Germany
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Magdeburg
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Germany
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München
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Germany
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Tuebingen
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Greece
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Thessaloniki
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Budapest
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Debrecen
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Riyadh
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Barcelona
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Burgos
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Lugo
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Pamplona
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Salamanca
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San Sebastian
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Santander
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Santiago de Compostela
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Sweden
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Lund
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Umea
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Uppsala
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Varberg
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Ankara
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Denizli
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Istanbul
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Turkey
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Samsun
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United Kingdom
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Cardiff
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United Kingdom
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Dundee
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United Kingdom
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London
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United Kingdom
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Nottingham
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United Kingdom
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Plymouth
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United Kingdom
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Portsmouth

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

Ethics approval
Ethics application status

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

Contacts
Principal investigator
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Janssen Research & Development, LLC Clinical Trial
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Janssen Research & Development, LLC
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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
Participate-In-This-Study@its.jnj.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson and Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) project site at yoda.yale.edu
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.janssen.com/clinical-trials/transparency


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/NCT06208150