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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
Date last updated
4/05/2025
Titles & IDs
Public title
A Study of Talquetamab With Other Anticancer Therapies in Participants With Multiple Myeloma
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Scientific title
A Multi-arm Phase 1b Study of Talquetamab With Other Anticancer Therapies in Participants With Multiple Myeloma
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Secondary ID [1]
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64407564MMY1004
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Secondary ID [2]
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CR108946
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Universal Trial Number (UTN)
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Trial acronym
MonumenTAL-2
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Multiple Myeloma
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Condition category
Condition code
Cancer
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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
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.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability
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Assessment method [1]
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An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.
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Timepoint [1]
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Up to 1 year and 10 months
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Primary outcome [2]
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Number of Participants with AEs by Severity
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Assessment method [2]
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Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Severity scale ranges from Grade 1 (Mild) to Grade 5 (Death). Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening, and Grade 5= Death related to AE.
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Timepoint [2]
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Up to 1 year and 10 months
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Primary outcome [3]
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Number of Participants with Clinically Significant Abnormalities in Laboratory Parameters
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Assessment method [3]
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Number of participants with clinically significant abnormalities in laboratory parameters such as hematology and serum chemistry will be reported.
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Timepoint [3]
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Up to 1 year and 6 months
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Primary outcome [4]
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Number of Participants with Dose Limiting Toxicity (DLT)
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Assessment method [4]
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Number of participants with DLT will be reported. The DLTs are specific adverse events and are defined as any of the following: high grade non-hematologic toxicity of grade 3 or higher, clinical laboratory abnormalities, or hematologic toxicity.
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Timepoint [4]
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Up to 49 days
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Secondary outcome [1]
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Overall Response Rate (ORR)
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Assessment method [1]
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ORR is defined as the percentage of participants who achieve partial response (PR) or better according to the International Myeloma Working Group (IMWG) 2016 criteria. Response to treatment will be evaluated by the investigator based on IMWG criteria.
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Timepoint [1]
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Up to 1 year and 10 months
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Secondary outcome [2]
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Very Good Partial Response (VGPR) or Better Response Rate
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Assessment method [2]
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VGPR or better response rate is defined as the percentage of participants who achieve a VGPR or better response (stringent complete response \[sCR\] + complete response \[CR\] +VGPR) according to the IMWG 2016 criteria.
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Timepoint [2]
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Up to 1 year and 10 months
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Secondary outcome [3]
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Complete Response (CR) or Better Response Rate
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Assessment method [3]
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CR or better response rate is defined as the percentage of participants who achieve a CR or better response (sCR+CR) according to the IMWG 2016 criteria.
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Timepoint [3]
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Up to 1 year and 10 months
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Secondary outcome [4]
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Stringent Complete Response (sCR)
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Assessment method [4]
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sCR rate is defined as the percentage of participants who achieve an sCR according to the IMWG 2016 criteria.
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Timepoint [4]
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Up to 1 year and 10 months
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Secondary outcome [5]
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Duration of Response
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Assessment method [5]
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Duration of response is defined as time from the date of initial documentation of a response (PR or better) to the date of first documented evidence of progressive disease, as defined in the IMWG 2016 criteria, or death due to disease progression, whichever occurs first.
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Timepoint [5]
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Up to 1 year and 10 months
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Secondary outcome [6]
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Time to Response
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Assessment method [6]
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Time to response is defined as the time between date of first dose of study treatment and the first efficacy evaluation at which the participant has met all criteria for PR or better.
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Timepoint [6]
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Up to 1 year and 10 months
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Secondary outcome [7]
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Serum Concentration of Talquetamab
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Assessment method [7]
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Serum samples will be analyzed to determine concentrations of talquetamab.
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Timepoint [7]
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Up to 1 year and 10 months
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Secondary outcome [8]
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Serum Concentration of Daratumumab
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Assessment method [8]
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Serum samples will be analyzed to determine concentrations of daratumumab for treatment regimens B and D.
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Timepoint [8]
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Up to 1 year and 10 months
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Secondary outcome [9]
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Number of Participants with Anti-Drug Antibodies to Talquetamab
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Assessment method [9]
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Number of participants with anti-drug antibodies to talquetamab will be reported.
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Timepoint [9]
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Up to 1 year and 10 months
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Secondary outcome [10]
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Number of Participants with Anti-Drug Antibodies to Daratumumab
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Assessment method [10]
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Number of participants with anti-drug antibodies to daratumumab will be reported for treatment regimens B and D.
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Timepoint [10]
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Up to 1 year and 10 months
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Secondary outcome [11]
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Number of Participants with Anti-Drug Antibodies to Recombinant Human Hyaluronidase PH20 Enzyme (rHuPH20)
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Assessment method [11]
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Number of participants with anti-drug antibodies to rHuPH20 will be reported.
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Timepoint [11]
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Up to 1 year and 10 months
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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
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Minimum age
18
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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
* 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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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 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not 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
22/09/2021
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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
7/04/2027
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Actual
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Sample size
Target
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Accrual to date
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Final
166
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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St Vincents Hospital Melbourne - Fitzroy
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Recruitment hospital [2]
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Alfred Health - Melbourne
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Recruitment hospital [3]
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Gold Coast University Hospital - Southport
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Recruitment hospital [4]
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Wollongong Hospital - Wollongong
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Recruitment postcode(s) [1]
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3065 - Fitzroy
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Recruitment postcode(s) [2]
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3004 - Melbourne
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Recruitment postcode(s) [3]
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4215 - Southport
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Recruitment postcode(s) [4]
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2500 - Wollongong
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Recruitment outside Australia
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United States of America
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Alabama
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California
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Colorado
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Georgia
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United States of America
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Indiana
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New Jersey
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United States of America
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New York
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North Carolina
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Pennsylvania
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Tennessee
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Wisconsin
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Belgium
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Brussel
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Belgium
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Edegem
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Belgium
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Gent
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Belgium
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Leuven
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France
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Nantes Cedex 1
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France
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Pessac cedex
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France
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Rennes
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France
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TOULOUSE Cedex 9
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Groningen
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Maastricht
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Netherlands
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Utrecht
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United Kingdom
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London
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United Kingdom
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Manchester
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United Kingdom
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Oxford
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United Kingdom
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State/province [26]
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Surrey
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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 characterize the safety and tolerability of talquetamab when administered in different combination regimens and to identify the safe dose(s) of talquetamab combination regimens.
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Trial website
https://clinicaltrials.gov/study/NCT05050097
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Janssen Research & Development, LLC Clinical Trial
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Address
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Janssen Research & Development, LLC
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Study Contact
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Address
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Phone
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844-434-4210
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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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
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When will data be available (start and end dates)?
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Available to whom?
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Available for what types of analyses?
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How or where can data be obtained?
IPD available at link: https://www.janssen.com/clinical-trials/transparency
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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
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