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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05050097




Registration number
NCT05050097
Ethics application status
Date submitted
10/09/2021
Date registered
20/09/2021

Titles & IDs
Public title
A Study of Talquetamab With Other Anticancer Therapies in Participants With Multiple Myeloma
Scientific title
A Multi-arm Phase 1b Study of Talquetamab With Other Anticancer Therapies in Participants With Multiple Myeloma
Secondary ID [1] 0 0
2020-004502-55
Secondary ID [2] 0 0
CR108946
Universal Trial Number (UTN)
Trial acronym
MonumenTAL-2
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 - Talquetamab
Treatment: Drugs - Carfilzomib
Treatment: Drugs - Daratumumab SC
Treatment: Drugs - Lenalidomide
Treatment: Drugs - Pomalidomide

Experimental: Treatment Regimen A: Talquetamab + Carfilzomib - Participants assigned to Treatment regimen A will receive talquetamab subcutaneously (SC) in combination with carfilzomib as an intravenous (IV) infusion.

Experimental: Treatment Regimen B: Talquetamab + Daratumumab + Carfilzomib - Participants assigned to Treatment regimen B will receive talquetamab SC in combination with daratumumab SC and carfilzomib as an IV infusion.

Experimental: Treatment Regimen C: Talquetamab + Lenalidomide - Participants assigned to Treatment regimen C will receive talquetamab SC in combination with lenalidomide orally.

Experimental: Treatment Regimen D: Talquetamab + Daratumumab + Lenalidomide - Participants assigned to Treatment regimen D will receive talquetamab SC in combination with daratumumab SC and lenalidomide orally.

Experimental: Treatment Regimen E: Talquetamab + Pomalidomide - Participants assigned to Treatment regimen E will receive talquetamab SC in combination with pomalidomide orally.


Treatment: Drugs: Talquetamab
Talquetamab will be administered subcutaneously.

Treatment: Drugs: Carfilzomib
Carfilzomib will be administered as an IV infusion.

Treatment: Drugs: Daratumumab SC
Daratumumab will be administered subcutaneously.

Treatment: Drugs: Lenalidomide
Lenalidomide will be self-administered orally.

Treatment: Drugs: Pomalidomide
Pomalidomide will be self-administered orally.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability
Timepoint [1] 0 0
Up to 1 year and 10 months
Primary outcome [2] 0 0
Number of Participants with AEs by Severity
Timepoint [2] 0 0
Up to 1 year and 10 months
Primary outcome [3] 0 0
Number of Participants with Clinically Significant Abnormalities in Laboratory Parameters
Timepoint [3] 0 0
Up to 1 year and 6 months
Primary outcome [4] 0 0
Number of Participants with Dose Limiting Toxicity (DLT)
Timepoint [4] 0 0
Up to 49 days
Secondary outcome [1] 0 0
Overall Response Rate (ORR)
Timepoint [1] 0 0
Up to 1 year and 10 months
Secondary outcome [2] 0 0
Very Good Partial Response (VGPR) or Better Response Rate
Timepoint [2] 0 0
Up to 1 year and 10 months
Secondary outcome [3] 0 0
Complete Response (CR) or Better Response Rate
Timepoint [3] 0 0
Up to 1 year and 10 months
Secondary outcome [4] 0 0
Stringent Complete Response (sCR)
Timepoint [4] 0 0
Up to 1 year and 10 months
Secondary outcome [5] 0 0
Duration of Response
Timepoint [5] 0 0
Up to 1 year and 10 months
Secondary outcome [6] 0 0
Time to Response
Timepoint [6] 0 0
Up to 1 year and 10 months
Secondary outcome [7] 0 0
Serum Concentration of Talquetamab
Timepoint [7] 0 0
Up to 1 year and 10 months
Secondary outcome [8] 0 0
Serum Concentration of Daratumumab
Timepoint [8] 0 0
Up to 1 year and 10 months
Secondary outcome [9] 0 0
Number of Participants with Anti-Drug Antibodies to Talquetamab
Timepoint [9] 0 0
Up to 1 year and 10 months
Secondary outcome [10] 0 0
Number of Participants with Anti-Drug Antibodies to Daratumumab
Timepoint [10] 0 0
Up to 1 year and 10 months
Secondary outcome [11] 0 0
Number of Participants with Anti-Drug Antibodies to Recombinant Human Hyaluronidase PH20 Enzyme (rHuPH20)
Timepoint [11] 0 0
Up to 1 year and 10 months

Eligibility
Key inclusion criteria
* Have documented initial diagnosis of multiple myeloma according to International Myeloma Working Group (IMWG) diagnostic criteria
* Have measurable disease at screening as defined by at least 1 of the following: a. Serum monoclonal protein (M-protein) level greater than or equal to (>=) 1.0 gram per deciliter (g/dL); or b. Urine M-protein level >= 200 milligrams (mg)/24 hours; or c. Light chain multiple myeloma: Serum immunoglobulin (Ig) free light chain (FLC) >=10 milligrams per deciliter (mg/dL) and abnormal serum Ig kappa lambda FLC ratio
* Have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 at screening and immediately before the start of study treatment administration
* A woman of childbearing potential must have a negative highly sensitive serum beta human chorionic gonadotropin (beta-hCG) pregnancy test at screening and a negative urine or serum pregnancy test within 24 hours before the start of study treatment administration
* Be willing and able to adhere to the lifestyle restrictions specified in the protocol, including adherence to the applicable immunomodulatory drug (IMiD) global Pregnancy Prevention Plan (PPP) or local PPP/Risk Evaluation and Mitigation Strategy (REMS) program
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Live, attenuated vaccine within 4 weeks before the first dose of study treatment
* Received a cumulative dose of corticosteroids equivalent to >=140 mg of prednisone within the 14-day period before the start of study treatment administration
* Active central nervous system (CNS) involvement or exhibition of clinical signs of meningeal involvement of multiple myeloma. If either is suspected, brain magnetic resonance imaging (MRI) and lumbar cytology are required
* Known to be seropositive for human immunodeficiency virus
* History of stroke or seizure within 6 months prior to the first dose of study treatment

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
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
22/09/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
23/09/2025
Actual
Sample size
Target
Accrual to date
Final
166
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
St Vincents Hospital Melbourne - Fitzroy
Recruitment hospital [2] 0 0
Alfred Health - Melbourne
Recruitment hospital [3] 0 0
Gold Coast University Hospital - Southport
Recruitment hospital [4] 0 0
Wollongong Hospital - Wollongong
Recruitment postcode(s) [1] 0 0
3065 - Fitzroy
Recruitment postcode(s) [2] 0 0
3004 - Melbourne
Recruitment postcode(s) [3] 0 0
4215 - Southport
Recruitment postcode(s) [4] 0 0
2500 - Wollongong
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Georgia
Country [5] 0 0
United States of America
State/province [5] 0 0
Indiana
Country [6] 0 0
United States of America
State/province [6] 0 0
New Jersey
Country [7] 0 0
United States of America
State/province [7] 0 0
New York
Country [8] 0 0
United States of America
State/province [8] 0 0
North Carolina
Country [9] 0 0
United States of America
State/province [9] 0 0
Pennsylvania
Country [10] 0 0
United States of America
State/province [10] 0 0
Tennessee
Country [11] 0 0
United States of America
State/province [11] 0 0
Wisconsin
Country [12] 0 0
Belgium
State/province [12] 0 0
Brussel
Country [13] 0 0
Belgium
State/province [13] 0 0
Edegem
Country [14] 0 0
Belgium
State/province [14] 0 0
Gent
Country [15] 0 0
Belgium
State/province [15] 0 0
Leuven
Country [16] 0 0
France
State/province [16] 0 0
Nantes Cedex 1
Country [17] 0 0
France
State/province [17] 0 0
Pessac cedex
Country [18] 0 0
France
State/province [18] 0 0
Rennes
Country [19] 0 0
France
State/province [19] 0 0
TOULOUSE Cedex 9
Country [20] 0 0
Netherlands
State/province [20] 0 0
Groningen
Country [21] 0 0
Netherlands
State/province [21] 0 0
Maastricht
Country [22] 0 0
Netherlands
State/province [22] 0 0
Utrecht
Country [23] 0 0
United Kingdom
State/province [23] 0 0
London
Country [24] 0 0
United Kingdom
State/province [24] 0 0
Manchester
Country [25] 0 0
United Kingdom
State/province [25] 0 0
Oxford
Country [26] 0 0
United Kingdom
State/province [26] 0 0
Surrey

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
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

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/NCT05050097