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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/NCT04722146
Registration number
NCT04722146
Ethics application status
Date submitted
20/01/2021
Date registered
25/01/2021
Date last updated
24/05/2024
Titles & IDs
Public title
A Study of Teclistamab With Other Anticancer Therapies in Participants With Multiple Myeloma
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Scientific title
A Multi-arm Phase 1b Study of Teclistamab With Other Anticancer Therapies in Participants With Multiple Myeloma
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Secondary ID [1]
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2020-004404-33
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Secondary ID [2]
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CR108927
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Universal Trial Number (UTN)
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Trial acronym
MajesTEC-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 - Teclistamab
Treatment: Drugs - Daratumumab
Treatment: Drugs - Pomalidomide
Treatment: Drugs - Lenalidomide
Treatment: Drugs - Bortezomib
Treatment: Drugs - Nirogacestat
Experimental: Treatment Regimen A: Teclistamab + Daratumumab + Pomalidomide - Participants will receive teclistamab plus daratumumab plus pomalidomide.
Experimental: Treatment Regimen B: Teclistamab + Daratumumab + Lenalidomide + Bortezomib (21-day Cycles) - Participants will receive teclistamab plus daratumumab plus lenalidomide plus bortezomib in 21-day cycles.
Experimental: Treatment Regimen C: Teclistamab + Nirogacestat - Participants will receive teclistamab plus nirogacestat.
Experimental: Treatment Regimen D: Teclistamab + Lenalidomide - Participants will receive teclistamab plus lenalidomide.
Experimental: Treatment Regimen E: Teclistamab + Daratumumab + Lenalidomide - Participants will receive teclistamab plus daratumumab plus lenalidomide.
Experimental: Treatment Regimen F: Teclistamab + Daratumumab + Lenalidomide + Bortezomib (28-day Cycles) - Participants will receive teclistamab plus daratumumab plus lenalidomide plus bortezomib in 28-day cycles.
Treatment: Drugs: Teclistamab
Participants will receive teclistamab.
Treatment: Drugs: Daratumumab
Participants will receive daratumumab.
Treatment: Drugs: Pomalidomide
Participants will receive pomalidomide.
Treatment: Drugs: Lenalidomide
Participants will receive lenalidomide.
Treatment: Drugs: Bortezomib
Participants will receive bortezomib.
Treatment: Drugs: Nirogacestat
Participants will receive nirogacestat.
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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 Incidence of Adverse Events (AEs)
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Assessment method [1]
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An AE can be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non-investigational) product, whether or not related to that medicinal (investigational or non-investigational) product.
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Timepoint [1]
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Up to 2 year and 5 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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Number of participants with AEs by severity will be reported.
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Timepoint [2]
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Up to 2 year and 5 months
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Primary outcome [3]
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Number of Participants with Abnormalities in Laboratory Values
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Assessment method [3]
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Number of participants with abnormalities in laboratory values (such as serum chemistry, hematology) will be reported.
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Timepoint [3]
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Up to 2 year and 5 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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The Dose Limiting Toxicities (DLTs) are based on drug related adverse events and defined as any of the following events: hematological / non hematological toxicity of Grade 3 or higher.
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Timepoint [4]
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Up to Cycle 2 Day 21 (each cycle is of 28 days for Treatment Regimen A and 21 days for Treatment Regimen B)
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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 proportion of participants who achieve partial response (PR) or better according to the international myeloma working group (IMWG) 2016 criteria.
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Timepoint [1]
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Up to 2 year and 5 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 proportion 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 2 year and 5 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 proportion 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 2 year and 5 months
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Secondary outcome [4]
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Stringent Complete Response (sCR) Rate
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Assessment method [4]
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sCR rate is defined as the proportion of participants who achieve an sCR according to the IMWG 2016 criteria.
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Timepoint [4]
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Up to 2 year and 5 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 date of initial documentation of a response (PR or better) to date of first documented evidence of progressive disease (PD), per IMWG criteria.
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Timepoint [5]
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Up to 2 year and 5 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 2 year and 5 months
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Secondary outcome [7]
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Serum Concentrations of Teclistamab
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Assessment method [7]
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Serum concentrations of teclistamab will be reported.
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Timepoint [7]
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Up to 2 year and 5 months
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Secondary outcome [8]
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Serum Concentrations of Daratumumab
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Assessment method [8]
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Serum concentrations of daratumumab will be reported.
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Timepoint [8]
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Up to 2 year and 5 months
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Secondary outcome [9]
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Serum Concentrations of Nirogacestat
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Assessment method [9]
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Serum concentration of nirogacestat will be reported.
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Timepoint [9]
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Up to 2 year and 5 months
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Secondary outcome [10]
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Number of Participants with Presence of Anti-Drug Antibodies to Teclistamab
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Assessment method [10]
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Number of participants with anti-drug antibodies to teclistamab will be reported for all treatment regimens.
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Timepoint [10]
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Up to 2 year and 5 months
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Secondary outcome [11]
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Number of Participants with Presence of Anti-Drug Antibodies to Daratumumab
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Assessment method [11]
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Number of participants with anti-drug antibodies to daratumumab will be reported for Treatment Regimen A, B, E and F.
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Timepoint [11]
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Up to 2 year and 5 months
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Secondary outcome [12]
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Number of Participants with Presence of Anti-Drug Antibodies to Recombinant Human Hyaluronidase PH20 Enzyme (rHuPH20)
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Assessment method [12]
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Number of participants with anti-drug antibodies to rHuPH20 will be reported for Treatment Regimen A, B, E and F.
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Timepoint [12]
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Up to 2 year and 5 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
- Meet treatment regimen-specific requirements as follows: Treatment Regimen A
(teclistamab [tec]-daratumumab [dara]-pomalidomide [pom]) only: Participant has
relapsed or refractory multiple myeloma and has received 1 to 3 prior lines of
therapy, including exposure to a proteasome inhibitor (PI) and lenalidomide; Treatment
Regimen B (tec-dara-lenalidomide [len]-bortezomib [bor]) only: Participant has newly
diagnosed or relapsed/refractory multiple myeloma and is naive to treatment with
lenalidomide; Treatment Regimen C (tec-nirogacestat [niro]) only: Participant has
relapsed or refractory multiple myeloma and has 1) received 3 or more prior lines of
therapy or 2) is double refractory to a PI and an immunomodulatory drug (IMiD) and
triple exposed to a PI, an IMiD, and an anti-cluster of differentiation (CD)38
monoclonal antibody (mAb); Treatment Regimen D (tec-len) only: Participant has
multiple myeloma and has received greater than or equal to (>=) 2 prior lines of
therapy, including exposure to a PI, an IMiD, and an anti-CD38 mAb; Treatment Regimen
E (tec-dara-len) only: Participant has newly diagnosed multiple myeloma or if
previously treated has received 1 to 3 prior lines of therapy, including exposure to a
PI and an IMiD; Treatment Regimen F (tec-dara-len-bor) only: Participant has newly
diagnosed multiple myeloma
- Have measurable disease at screening as defined by at least one of the following:
serum M-protein level >= 1.0 gram/deciliter (g/dL); or urine M-protein level >= 200
milligrams (mg)/24 hours; or light chain multiple myeloma: serum immunoglobulin (Ig)
free light chain (FLC) >= 10 milligram/deciliter (mg/dL) and abnormal serum Ig kappa
lambda FLC ratio
- A woman of childbearing potential must have a negative serum (beta human chorionic
gonadotropin [hCG]) pregnancy test at screening and a negative urine or serum
pregnancy test within 24 hours before the start of study treatment administration and
must agree to further serum or urine pregnancy tests during the study
- A woman must agree not to donate eggs (ova, oocytes) for the purposes of assisted
reproduction during the study and for at least 100 days after the last dose of study
treatment
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Minimum age
18
Years
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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
- Prior treatment with any therapy that targets B-cell maturation antigen (BCMA): This
exclusion does not apply to Treatment Regimen C
- Live, attenuated vaccine within 30 days 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
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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
Other
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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
12/03/2021
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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
24/02/2025
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Actual
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Sample size
Target
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Accrual to date
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Final
140
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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St. Vincent's 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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Calvary Mater Newcastle Hospital - Waratah
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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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2298 - Waratah
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Recruitment outside Australia
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United States of America
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State/province [1]
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Alabama
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United States of America
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California
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United States of America
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Colorado
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Georgia
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Indiana
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Missouri
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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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Washington
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Wisconsin
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Country [14]
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Belgium
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State/province [14]
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Edegem
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Belgium
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State/province [15]
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Gent
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France
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State/province [16]
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Lyon Cedex 8
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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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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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State/province [23]
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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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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 teclistamab when
administered in different combination regimen and to identify the optimal dose(s) of
teclistamab combination regimens.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04722146
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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 and Development, LLC Clinical Trial
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Address
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Janssen Research and Development LLC
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Fax
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Email
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Contact person for public queries
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04722146
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