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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT06208150




Registration number
NCT06208150
Ethics application status
Date submitted
5/01/2024
Date registered
17/01/2024
Date last updated
22/05/2024

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. Vincent's Hospital - Darlinghurst
Recruitment hospital [4] 0 0
St. Vincent's Hospital Melbourne - Fitzroy
Recruitment hospital [5] 0 0
Gold Coast University Hospital - Southport
Recruitment hospital [6] 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
2500 - Wollongong
Recruitment outside Australia
Country [1] 0 0
Argentina
State/province [1] 0 0
Buenos Aires
Country [2] 0 0
Argentina
State/province [2] 0 0
Ciudad Autonoma de Buenos Aires
Country [3] 0 0
Belgium
State/province [3] 0 0
Charleroi
Country [4] 0 0
Belgium
State/province [4] 0 0
Genk
Country [5] 0 0
Belgium
State/province [5] 0 0
Gent
Country [6] 0 0
Belgium
State/province [6] 0 0
Sint-Niklaas
Country [7] 0 0
Brazil
State/province [7] 0 0
Brasilia
Country [8] 0 0
Brazil
State/province [8] 0 0
Caxias do Sul
Country [9] 0 0
Brazil
State/province [9] 0 0
Curitiba
Country [10] 0 0
Brazil
State/province [10] 0 0
Porto Alegre
Country [11] 0 0
Brazil
State/province [11] 0 0
Recife
Country [12] 0 0
Brazil
State/province [12] 0 0
Sao Jose do Rio Preto
Country [13] 0 0
Brazil
State/province [13] 0 0
Sao Paulo
Country [14] 0 0
Canada
State/province [14] 0 0
Ontario
Country [15] 0 0
Canada
State/province [15] 0 0
Quebec
Country [16] 0 0
China
State/province [16] 0 0
Beijing
Country [17] 0 0
China
State/province [17] 0 0
Guangzhou
Country [18] 0 0
China
State/province [18] 0 0
Hangzhou
Country [19] 0 0
China
State/province [19] 0 0
Nanchang
Country [20] 0 0
China
State/province [20] 0 0
Shanghai
Country [21] 0 0
China
State/province [21] 0 0
Wenzhou
Country [22] 0 0
China
State/province [22] 0 0
Wuhan
Country [23] 0 0
Czechia
State/province [23] 0 0
Brno - Bohunice
Country [24] 0 0
Czechia
State/province [24] 0 0
Hradec Kralove
Country [25] 0 0
Czechia
State/province [25] 0 0
Olomouc
Country [26] 0 0
Czechia
State/province [26] 0 0
Ostrava
Country [27] 0 0
Denmark
State/province [27] 0 0
Aarhus
Country [28] 0 0
Denmark
State/province [28] 0 0
Odense C
Country [29] 0 0
Denmark
State/province [29] 0 0
Vejle
Country [30] 0 0
France
State/province [30] 0 0
Lille
Country [31] 0 0
France
State/province [31] 0 0
Limoges
Country [32] 0 0
France
State/province [32] 0 0
Marseille
Country [33] 0 0
France
State/province [33] 0 0
Nantes
Country [34] 0 0
France
State/province [34] 0 0
Paris
Country [35] 0 0
France
State/province [35] 0 0
Pessac Cedex
Country [36] 0 0
France
State/province [36] 0 0
Pierre-Benite
Country [37] 0 0
France
State/province [37] 0 0
Toulouse Cedex 9
Country [38] 0 0
France
State/province [38] 0 0
TOURS Cedex 01
Country [39] 0 0
Germany
State/province [39] 0 0
Augsburg
Country [40] 0 0
Germany
State/province [40] 0 0
Halle (Saale)
Country [41] 0 0
Germany
State/province [41] 0 0
Heidelberg
Country [42] 0 0
Germany
State/province [42] 0 0
München
Country [43] 0 0
Germany
State/province [43] 0 0
Tuebingen
Country [44] 0 0
Germany
State/province [44] 0 0
Würzburg
Country [45] 0 0
Greece
State/province [45] 0 0
Athens
Country [46] 0 0
Greece
State/province [46] 0 0
Thessaloniki
Country [47] 0 0
India
State/province [47] 0 0
Gurgaon
Country [48] 0 0
India
State/province [48] 0 0
Pune
Country [49] 0 0
Israel
State/province [49] 0 0
Be'er Ya'akov
Country [50] 0 0
Israel
State/province [50] 0 0
Haifa
Country [51] 0 0
Israel
State/province [51] 0 0
Petah-Tikva
Country [52] 0 0
Israel
State/province [52] 0 0
Ramat Gan
Country [53] 0 0
Israel
State/province [53] 0 0
Tel Aviv-Yafo
Country [54] 0 0
Italy
State/province [54] 0 0
Alessandria
Country [55] 0 0
Italy
State/province [55] 0 0
Brindisi
Country [56] 0 0
Italy
State/province [56] 0 0
Legnano
Country [57] 0 0
Italy
State/province [57] 0 0
Milano
Country [58] 0 0
Italy
State/province [58] 0 0
Pavia
Country [59] 0 0
Italy
State/province [59] 0 0
Pescara
Country [60] 0 0
Italy
State/province [60] 0 0
Ravenna
Country [61] 0 0
Japan
State/province [61] 0 0
Bunkyo Ku
Country [62] 0 0
Japan
State/province [62] 0 0
Fukuoka
Country [63] 0 0
Japan
State/province [63] 0 0
Kanazawa
Country [64] 0 0
Japan
State/province [64] 0 0
Kyoto
Country [65] 0 0
Japan
State/province [65] 0 0
Nagasaki
Country [66] 0 0
Japan
State/province [66] 0 0
Niigata
Country [67] 0 0
Japan
State/province [67] 0 0
Nishinomiya-shi
Country [68] 0 0
Japan
State/province [68] 0 0
Osaka
Country [69] 0 0
Japan
State/province [69] 0 0
Shiwa-gun
Country [70] 0 0
Japan
State/province [70] 0 0
Suita-City
Country [71] 0 0
Japan
State/province [71] 0 0
Sunto-gun
Country [72] 0 0
Japan
State/province [72] 0 0
Tottori
Country [73] 0 0
Japan
State/province [73] 0 0
Yokohama City
Country [74] 0 0
Korea, Republic of
State/province [74] 0 0
Busan
Country [75] 0 0
Korea, Republic of
State/province [75] 0 0
Jeollanam-do
Country [76] 0 0
Korea, Republic of
State/province [76] 0 0
Seoul
Country [77] 0 0
Korea, Republic of
State/province [77] 0 0
Ulsan
Country [78] 0 0
Netherlands
State/province [78] 0 0
Almere
Country [79] 0 0
Netherlands
State/province [79] 0 0
Den Haag
Country [80] 0 0
Netherlands
State/province [80] 0 0
Eindhoven
Country [81] 0 0
Netherlands
State/province [81] 0 0
Nieuwegein
Country [82] 0 0
Netherlands
State/province [82] 0 0
Zwolle
Country [83] 0 0
Poland
State/province [83] 0 0
Biala Podlaska
Country [84] 0 0
Poland
State/province [84] 0 0
Brzozow
Country [85] 0 0
Poland
State/province [85] 0 0
Kielce
Country [86] 0 0
Poland
State/province [86] 0 0
Lublin
Country [87] 0 0
Poland
State/province [87] 0 0
Szczecin
Country [88] 0 0
Poland
State/province [88] 0 0
Wroclaw
Country [89] 0 0
Spain
State/province [89] 0 0
Asturias
Country [90] 0 0
Spain
State/province [90] 0 0
Burgos
Country [91] 0 0
Spain
State/province [91] 0 0
Cáceres
Country [92] 0 0
Spain
State/province [92] 0 0
Granada
Country [93] 0 0
Spain
State/province [93] 0 0
Lugo
Country [94] 0 0
Spain
State/province [94] 0 0
Madrid
Country [95] 0 0
Spain
State/province [95] 0 0
Palma de Mallorca
Country [96] 0 0
Spain
State/province [96] 0 0
Pamplona
Country [97] 0 0
Spain
State/province [97] 0 0
Salamanca
Country [98] 0 0
Spain
State/province [98] 0 0
San Sebastian
Country [99] 0 0
Spain
State/province [99] 0 0
Santiago de Compostela
Country [100] 0 0
Sweden
State/province [100] 0 0
Lund
Country [101] 0 0
Sweden
State/province [101] 0 0
Uppsala
Country [102] 0 0
Sweden
State/province [102] 0 0
Varberg
Country [103] 0 0
United Kingdom
State/province [103] 0 0
Cardiff
Country [104] 0 0
United Kingdom
State/province [104] 0 0
Dundee
Country [105] 0 0
United Kingdom
State/province [105] 0 0
Plymouth

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 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).
Trial website
https://clinicaltrials.gov/ct2/show/NCT06208150
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
Participate-In-This-Study@its.jnj.com
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT06208150