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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record athttps://clinicaltrials.gov/study/NCT06208150
Registration number
NCT06208150
Ethics application status
Date submitted
5/01/2024
Date registered
17/01/2024
Date last updated
20/06/2024
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
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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
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Secondary ID [1]00
64407564MMY3009
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Secondary ID [2]00
64407564MMY3009
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Universal Trial Number (UTN)
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Trial acronym
MonumenTAL-6
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Relapsed or Refractory Multiple Myeloma00
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Condition category
Condition code
Cancer0000
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Other cancer types
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Talquetamab 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 Treatment: Drugs: Pomalidomide Treatment: Drugs: Teclistamab Treatment: Drugs: Elotuzumab Treatment: Drugs: Dexamethasone Treatment: Drugs: Bortezomib
Treatment: Drugs - Pomalidomide
Treatment: Drugs - Teclistamab
Treatment: Drugs - Elotuzumab
Treatment: Drugs - Dexamethasone
Treatment: Drugs - Bortezomib
Talquetamab will be administered as a SC injection.
Pomalidomide will be administered orally.
Teclistamab will be administered as a SC injection.
Elotuzumab will be administered intravenously.
Dexamethasone will be administered either orally or intravenously.
Bortezomib will be administered as a SC injection.
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Intervention code [1]00
Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]00
Progression Free Survival (PFS)
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Timepoint [1]00
Up to 6 years 5 months
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Secondary outcome [1]00
Overall Response Rate (ORR)
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Timepoint [1]00
Up to 6 years 5 months
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Secondary outcome [2]00
Complete Response (CR) or Better Rate
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Timepoint [2]00
Up to 6 years 5 months
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Secondary outcome [3]00
Very Good Partial Response (VGPR) or Better Rate
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Timepoint [3]00
Up to 6 years 5 months
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Secondary outcome [4]00
Minimal Residual Disease (MRD)-negative CR Rate
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Timepoint [4]00
Up to 6 years 5 months
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Secondary outcome [5]00
Overall Survival (OS)
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Timepoint [5]00
Up to 6 years 5 months
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Secondary outcome [6]00
Progression Free Survival on Next-line Therapy (PFS2)
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Timepoint [6]00
Up to 6 years 5 months
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Secondary outcome [7]00
Time to Next Treatment (TTNT)
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Timepoint [7]00
Up to 6 years 5 months
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Secondary outcome [8]00
Serum Concentration of Talquetamab and Teclistamab
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Timepoint [8]00
Up to 6 years 5 months
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Secondary outcome [9]00
Number of Participants with Anti-drug Antibodies (ADAs) to Talquetamab and Teclistamab
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Timepoint [9]00
Up to 6 years 5 months
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Secondary outcome [10]00
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)
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Timepoint [10]00
Up to 6 years 5 months
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Secondary outcome [11]00
Time to Sustained Worsening in Symptoms, Functioning, and Health-related Quality of Life (HRQoL) as Assessed by EORTC-QLQ-C30
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Timepoint [11]00
Up to 6 years 5 months
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Secondary outcome [12]00
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)
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Timepoint [12]00
Up to 6 years 5 months
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Secondary outcome [13]00
Time to Sustained Worsening in Symptoms, Functioning, and Health-related Quality of Life (HRQoL) as Assessed by Patient Global Impression -Severity (PGI-S)
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Timepoint [13]00
Up to 6 years 5 months
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Secondary outcome [14]00
Time to Sustained Worsening in Symptoms, Functioning, and Health-related Quality of Life (HRQoL) as Assessed by Epstein Taste Survey
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Timepoint [14]00
Up to 6 years 5 months
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Secondary outcome [15]00
Change from Baseline in Symptoms, Functioning, and Health-related Quality of Life (HRQoL) as Assessed by MySIm-Q
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Timepoint [15]00
Up to 6 years 5 months
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Secondary outcome [16]00
Change from Baseline in Symptoms, Functioning, and Health-related Quality of Life (HRQoL) as Assessed by EORTC-QLQ-C30
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Timepoint [16]00
Up to 6 years 5 months
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Secondary outcome [17]00
Change from Baseline in Symptoms, Functioning, and Health-related Quality of Life (HRQoL) as Assessed by EQ-5D-5L
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Timepoint [17]00
Up to 6 years 5 months
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Secondary outcome [18]00
Change from Baseline in Symptoms, Functioning, and Health-related Quality of Life (HRQoL) as Assessed by PGI-S
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Timepoint [18]00
Up to 6 years 5 months
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Secondary outcome [19]00
Change from Baseline in Symptoms, Functioning, and Health-related Quality of Life (HRQoL) as Assessed by Epstein Taste Survey
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Timepoint [19]00
Up to 6 years 5 months
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Secondary outcome [20]00
Percentage of Participants With Meaningful Improvement in HRQoL as Assessed by EORTC-QLQ-C30
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Timepoint [20]00
Up to 6 years 5 months
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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
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Minimum age
18Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealmentprocedures)
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Methods used to generate the sequence in which subjects will be randomised (sequencegeneration)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
22/01/2024
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
30/06/2030
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Actual
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Sample size
Target
795
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]00
Royal Adelaide Hospital - Adelaide
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Recruitment hospital [2]00
Box Hill Hospital - Box Hill
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Recruitment hospital [3]00
St. Vincent's Hospital - Darlinghurst
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Recruitment hospital [4]00
St Vincents Hospital Melbourne - Fitzroy
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Recruitment hospital [5]00
Gold Coast University Hospital - Southport
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Recruitment hospital [6]00
Perth Blood Institute - West Perth
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Recruitment hospital [7]00
Wollongong Hospital - Wollongong
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Recruitment postcode(s) [1]00
5000 - Adelaide
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Recruitment postcode(s) [2]00
3128 - Box Hill
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Recruitment postcode(s) [3]00
2010 - Darlinghurst
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Recruitment postcode(s) [4]00
3065 - Fitzroy
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Recruitment postcode(s) [5]00
4215 - Southport
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Recruitment postcode(s) [6]00
6005 - West Perth
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Recruitment postcode(s) [7]00
2500 - Wollongong
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Recruitment outside Australia
Country [1]00
Argentina
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Buenos Aires
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Argentina
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Ciudad Autonoma de Buenos Aires
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Belgium
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Charleroi
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Belgium
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Genk
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Belgium
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Gent
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Belgium
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Sint-Niklaas
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Brazil
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Brasilia
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Brazil
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Caxias do Sul
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Brazil
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Curitiba
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Brazil
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Porto Alegre
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Brazil
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Recife
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Brazil
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Rio de Janeiro
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Brazil
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Sao Jose do Rio Preto
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Brazil
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Sao Paulo
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Ontario
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Canada
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Quebec
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China
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Beijing
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China
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Changzhou
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China
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Guangzhou
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China
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Hangzhou
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China
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Nanchang
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China
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Shanghai
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China
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Shenzhen
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China
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Tianjin
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China
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Wenzhou
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China
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Wuhan
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Czechia
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Brno - Bohunice
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Czechia
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Hradec Kralove
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Czechia
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Czechia
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Ostrava
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Aarhus
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Denmark
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Odense C
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Denmark
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Vejle
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France
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Lille
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France
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Limoges
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France
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Marseille
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France
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Nantes
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France
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Paris
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France
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Pessac Cedex
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France
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Pierre-Benite
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France
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Strasbourg
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France
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Toulouse Cedex 9
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France
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TOURS Cedex 01
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Germany
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Augsburg
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Germany
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Halle (Saale)
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Germany
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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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Germany
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Würzburg
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Greece
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Athens
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Greece
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Thessaloniki
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Gurgaon
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India
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Pune
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Israel
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Be'er Ya'akov
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Israel
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Haifa
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Israel
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Petah-Tikva
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Israel
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Ramat Gan
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Israel
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Tel Aviv-Yafo
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Italy
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Alessandria
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Italy
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Brindisi
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Italy
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Catania
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Italy
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Genova
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Italy
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Legnano
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Italy
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Milano
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Italy
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Pavia
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Italy
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Pescara
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Italy
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Ravenna
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Italy
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Torino
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Italy
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Verona
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Bunkyo Ku
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Japan
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f*ckuoka
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Japan
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Kanazawa
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Japan
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Kyoto
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Japan
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Nagasaki
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Japan
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Niigata
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Japan
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Nishinomiya-shi
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Japan
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Osaka
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Japan
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Sapporo
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Japan
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Shibuya-ku
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Japan
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Shiwa-gun
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Japan
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Suita-City
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Japan
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Sunto-gun
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Japan
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Tokyo
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Japan
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Tottori
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Japan
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Yokohama City
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Korea, Republic of
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Busan
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Korea, Republic of
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Jeollanam-do
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Korea, Republic of
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Seoul
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Korea, Republic of
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Ulsan
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Netherlands
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Almere
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Netherlands
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Den Haag
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Netherlands
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Eindhoven
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Netherlands
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Netherlands
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Zwolle
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Poland
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Biala Podlaska
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Poland
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Brzozow
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Poland
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Kielce
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Poland
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Lublin
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Poland
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Szczecin
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Poland
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Wroclaw
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Spain
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Asturias
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Spain
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Barcelona
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Spain
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Burgos
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Spain
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Cáceres
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Spain
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Granada
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Spain
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Lugo
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Spain
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Madrid
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Spain
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Palma de Mallorca
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Spain
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Pamplona
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Spain
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Salamanca
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Spain
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San Sebastian
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Spain
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Santander
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Spain
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Santiago de Compostela
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Sweden
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Lund
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Sweden
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Uppsala
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Sweden
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Varberg
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Turkey
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Ankara
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Turkey
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Denizli
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Turkey
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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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Plymouth
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United Kingdom
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Portsmouth
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Janssen Research & Development, LLC
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study is to compare the effectiveness of either talquetamab plus pomalidomide (Tal-P) or talquetamab plus teclistamab (Tal-Tec) with elotuzumab, pomalidomide, and dexamethasone (EPd) or pomalidomide, bortezomib, and dexamethasone (PVd).
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Trial website
https://clinicaltrials.gov/study/NCT06208150
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name00
Janssen Research & Development, LLC Clinical Trial
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Address00
Janssen Research & Development, LLC
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Contact person for public queries
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Study Contact
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Phone00
844-434-4210
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[emailprotected]
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
For IPD and results data, please seehttps://clinicaltrials.gov/study/NCT06208150
