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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/NCT03277105
Registration number
NCT03277105
Ethics application status
Date submitted
7/09/2017
Date registered
8/09/2017
Date last updated
13/03/2024
Titles & IDs
Public title
A Study of Subcutaneous Versus (vs.) Intravenous Administration of Daratumumab in Participants With Relapsed or Refractory Multiple Myeloma
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Scientific title
A Phase 3 Randomized, Multicenter Study of Subcutaneous vs. Intravenous Administration of Daratumumab in Subjects With Relapsed or Refractory Multiple Myeloma
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Secondary ID [1]
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2017-000206-38
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Secondary ID [2]
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CR108342
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Universal Trial Number (UTN)
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Trial acronym
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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 - Dara SC
Treatment: Drugs - Dara IV
Experimental: Dara SC - Participants will receive a fixed dose of daratumumab as 1800 milligram (mg) subcutaneously (Dara SC) co-formulated with recombinant human hyaluronidase (rHuPH20) 2000 Unit per milliliter (U/mL), once weekly in Cycle 1 and 2, every 2 weeks in Cycle 3 to 6, every 4 weeks in Cycle 7 and thereafter until disease progression, unacceptable toxicity or the end of study. The duration for each cycle is 4 weeks.
Active Comparator: Dara IV - Participants will receive daratumumab for intravenous infusion (Dara IV) 16 mg/kg once weekly in Cycle 1 and 2, every 2 weeks in Cycle 3 to 6, every 4 weeks on Day 1 in Cycle 7 and thereafter until disease progression, unacceptable toxicity or the end of study. The duration for each cycle is 4 weeks. For Participants still receiving treatment with Dara-IV at the time of Protocol Amendment 4 the duration of infusion may be shortened to a 90-minute infusion or participants will have the option to switch to Dara 1800 mg subcutaneous (SC) on Day 1 of any cycle, at the discretion of the investigator.
Treatment: Drugs: Dara SC
Participants will receive a fixed dose of Dara SC as 1800 mg daratumumab with rHuPH20 2000 U/mL, once weekly in Cycle 1 and 2, every 2 weeks in Cycle 3 to 6, every 4 weeks in Cycle 7 and thereafter until disease progression, unacceptable toxicity or the end of study.
Treatment: Drugs: Dara IV
Participants will receive Dara IV 16 mg/kg once weekly in Cycle 1 and 2, every 2 weeks in Cycle 3 to 6, every 4 weeks in Cycle 7 and thereafter until disease progression, unacceptable toxicity or the end of study.
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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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Overall Response Rate (ORR)
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Assessment method [1]
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ORR was defined as the percentage of participants who achieved partial response (PR) or better according to International Myeloma Working Group (IMWG) criteria, during or after study treatment. IMWG criteria for PR: greater than or equal to (>=) 50 percent (%) reduction of serum M-protein and reduction in 24-hour urinary M-protein by >=90% or to less than (<) 200 milligrams (mg)/24 hours, If the serum and urine M-proteins are not measurable, a decrease of >=50% in the difference between involved and uninvolved free light chain (FLC) levels were required in place of the M-protein criteria, If serum and urine M-protein are not measurable, and serum free light assay was also not measurable, >=50% reduction in bone marrow plasma cells (PCs) was required in place of M-protein, provided baseline bone marrow plasma cell percentage was >=30%. In addition to the above criteria, if present at baseline, a >=50% reduction in the size of soft tissue plasmacytomas was also required.
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Timepoint [1]
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Up to 1 year 8 months
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Primary outcome [2]
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Maximum Trough Concentration (Ctrough) of Daratumumab
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Assessment method [2]
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Maximum Ctrough was defined as the serum predose concentration of daratumumab on Cycle 3 Day 1.
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Timepoint [2]
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Predose on Cycle 3 Day 1 (each cycle of 28 days)
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Secondary outcome [1]
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Percentage of Participants With Treatment-emergent Infusion-related Reactions (IRR)
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Assessment method [1]
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Percentage of participants with treatment-emergent infusion-related reactions were reported.
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Timepoint [1]
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Up to 3 years
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Secondary outcome [2]
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Progression Free Survival (PFS)
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Assessment method [2]
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PFS was defined as time from date of randomization to either progression of disease (PD), death due to any cause, whichever occurs first. IMWG criteria for PD: Increase of 25% from lowest response value in any one of the following: Serum M component (absolute increase must be >=0.5 gram per deciliter (g/dL), Urine M-component (absolute increase must be >=200 mg/24 hours), Participants without measurable serum and urine Mprotein levels: difference between involved and uninvolved free light chain (FLC) levels (absolute increase must be >10 milligrams per deciliter (mg/dL), participants without measurable serum and urine M-protein levels and without measurable disease by FLC levels, bone marrow PC% (absolute percentage must be >=10%), definite development of new bone lesions or soft tissue plasmacytomas or increase in size of bone lesions or tissue plasmacytomas and development of hypercalcemia (serum calcium >11.5 mg/dL) that can be attributed solely to PC proliferative disorder.
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Timepoint [2]
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Up to 3 years
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Secondary outcome [3]
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Percentage of Participants With Very Good Partial Response (VGPR) or Better
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Assessment method [3]
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VGPR or better was defined as the percentage of participants who achieved VGPR or better (VGPR, complete response (CR) or stringent complete response [sCR]), based on computerized algorithm as per IMWG criteria during or after the study treatment. IMWG criteria for VGPR: Serum and urine M-component detectable by immunofixation but not on electrophoresis, or >=90 percent (%) reduction in serum M-protein plus urine M-protein <100 milligrams (mg)/24 hours, CR: Negative immunofixation on the serum and urine, disappearance of any soft tissue plasmacytomas and <5% plasma cells (PCs) in bone marrow. sCR: CR plus normal FLC ratio, and absence of clonal PCs by immunohistochemistry (IHC), immunofluorescencea or 2- to 4 color flow cytometry.
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Timepoint [3]
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Up to 3 years
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Secondary outcome [4]
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Percentage of Participants With Complete Response (Including sCR) or Better
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Assessment method [4]
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CR or better was defined as percentage of participants with a CR or better (CR or stringent complete response [sCR]) based on computerized algorithm as per IMWG criteria. IMWG criteria for CR- negative immunofixation on the serum and urine, and disappearance of any soft tissue plasmacytomas, and <5% PCs in bone marrow. sCR: CR plus normal FLC ratio, and absence of clonal PCs by IHC, immunofluorescencea or 2- to 4 color flow cytometry.
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Timepoint [4]
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Up to 3 years
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Secondary outcome [5]
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Time to Next Therapy
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Assessment method [5]
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Time to next therapy was defined as the time from randomization to the start of the first subsequent anti-cancer therapy.
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Timepoint [5]
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Up to 3 years
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Secondary outcome [6]
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Overall Survival (OS)
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Assessment method [6]
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OS was defined as the time from the date of randomization to the date of the participant's death due to any cause.
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Timepoint [6]
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Up to 3 years
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Secondary outcome [7]
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Patient-Reported Satisfaction With Therapy as Assessed With Cancer Therapy Satisfaction Questionnaire (CTSQ)
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Assessment method [7]
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Modified-CTSQ contain 9 items (2 items for Thoughts about Cancer Therapy and 7 items in a defined domain of Satisfaction with Therapy) specific to satisfaction with therapy and for comparison of SC and IV administration. Satisfaction with therapy was calculated based on 7-items using 5-point verbal rating scale, where 1= never and 5= always. Scores were averaged and transformed to a 0-100 scale; higher scores represent better health. At least 5 of the 7 items within the Satisfaction with Therapy domain had to be completed to calculate a domain score. No domain score was calculated for Thoughts about Cancer Therapy.
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Timepoint [7]
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Cycle 1 (Days 8,15 and 22), Cycle 2 (Days 1,8,15 and 22), Cycle 3,4,5,6,7,8,9,10,11,12,13,14,15,16,17,18,19,20,21 and 22 (Day 1)
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Secondary outcome [8]
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Duration of Response
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Assessment method [8]
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Duration of response was defined as the duration from the date of initial documentation of a response (PR or better) to the date of first documented evidence of progressive disease according to the IMWG criteria. PD was defined as an increase of 25 % from the lowest response value in one of the following: serum and urine M-component (absolute increase must be >= 0.5 g/dL and >=200 mg/24 hours respectively); Only in participants without measurable serum and urine M-protein levels the difference between involved and uninvolved FLC levels (absolute increase must be > 10 mg/dL); Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas; Development of hypercalcemia (corrected serum calcium >11.5 mg/dL) that can be attributed solely to PC proliferative disorder.
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Timepoint [8]
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Up to 3 years
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Secondary outcome [9]
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Time to Partial Response (PR) or Better
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Assessment method [9]
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Time to PR or better was defined as the time from randomization until onset of first response of PR or better.
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Timepoint [9]
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Up to 3 years
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Secondary outcome [10]
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Time to Very Good Partial Response (VGPR) or Better
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Assessment method [10]
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Time to VGPR or better was defined as the time from randomization until onset of first VGPR or better.
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Timepoint [10]
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Up to 3 years
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Secondary outcome [11]
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Time to Complete Response (CR) or Better
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Assessment method [11]
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Time to CR or better was defined as the time from randomization until onset of first CR or better.
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Timepoint [11]
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Up to 3 years
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Eligibility
Key inclusion criteria
- Evidence of a response (Partial response [PR] or better based on investigator's
determination of response by international myeloma working group [IMWG] criteria) to
at least 1 prior treatment regimen
- Received at least 3 prior lines of therapy including a proteasome inhibitor (PI)
(greater than or equal to [>=] 2 cycles or 2 months of treatment) and an
immunomodulatory drug (IMiD) (>=2 cycles or 2 months of treatment) in any order during
the course of treatment (except for participants who discontinued either of these
treatments due to a severe allergic reaction within the first 2 cycles/months). A
single line of therapy may consist of 1 or more agents, and may include induction,
hematopoietic stem cell transplantation, and maintenance therapy. Radiotherapy,
bisphosphonate, or a single short course of corticosteroids (no more than the
equivalent of dexamethasone 40 milligram/day [mg/day] for 4 days) would not be
considered prior lines of therapy
- Documented multiple myeloma as defined by the criteria below:
1. Multiple myeloma diagnosis according to the IMWG diagnostic criteria
2. Measurable disease at Screening as defined by any of the following:
1. Serum M-protein level >=1.0 gram per deciliter (g/dL) or urine M-protein
level >=200 mg/24 hours; or
2. Light chain multiple myeloma without measurable disease in the serum or the
urine: Serum immunoglobulin free light chain (FLC) >=10 mg/dL and abnormal
serum immunoglobulin kappa lambda FLC ratio
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2
- Meet the clinical laboratory criteria as specified in the protocol
- Women of childbearing potential must have a negative urine or serum pregnancy test at
screening within 14 days prior to randomization
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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
- Received daratumumab or other anti-CD38 therapies previously
- Received anti-myeloma treatment within 2 weeks or 5 pharmacokinetic half-lives of the
treatment, whichever is longer, before the date of randomization. The only exception
is emergency use of a short course of corticosteroids (equivalent of dexamethasone 40
mg/day for a maximum of 4 days) before treatment
- Received autologous stem cell transplant within 12 weeks before the date of
randomization, or the participant has previously received allogeneic stem cell
transplant (regardless of timing)
- Plans to undergo a stem cell transplant prior to progression of disease on this study
(these participants should not be enrolled to reduce disease burden prior to
transplant)
- History of malignancy (other than multiple myeloma) unless all treatment of that
malignancy was completed at least 2 years before consent and the patient has no
evidence of disease. Further exceptions are squamous and basal cell carcinomas of the
skin and carcinoma in situ of the cervix, or breast, or other non-invasive lesion,
that in the opinion of the investigator, with concurrence with the sponsor's medical
monitor, is considered cured with minimal risk of recurrence within 3 years
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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 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 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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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
27/10/2017
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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
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Actual
12/01/2024
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Sample size
Target
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Accrual to date
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Final
522
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Royal Prince Alfred Hospital - Camperdown
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Recruitment hospital [2]
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St. Vincent's Hospital Melbourne - Fitzroy
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Recruitment hospital [3]
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Alfred Health - Melbourne
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Recruitment hospital [4]
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Fiona Stanley Hospital - Murdoch
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Recruitment hospital [5]
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Sir Charles Gairdner Hospital - Nedlands
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Recruitment hospital [6]
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Calvary Mater Newcastle Hospital - Waratah
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Recruitment hospital [7]
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The Queen Elizabeth Hospital - Woodville South
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Recruitment hospital [8]
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Princess Alexandra Hospital - Woolloongabba
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Recruitment postcode(s) [1]
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2050 - Camperdown
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Recruitment postcode(s) [2]
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3065 - Fitzroy
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Recruitment postcode(s) [3]
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3004 - Melbourne
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Recruitment postcode(s) [4]
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6150 - Murdoch
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Recruitment postcode(s) [5]
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6009 - Nedlands
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Recruitment postcode(s) [6]
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2298 - Waratah
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Recruitment postcode(s) [7]
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5011 - Woodville South
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Recruitment postcode(s) [8]
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4102 - Woolloongabba
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Massachusetts
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United States of America
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North Carolina
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Brazil
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Barretos
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Brazil
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Florianopolis
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Brazil
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Jau
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Brazil
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Joinville
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Brazil
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Passo Fundo
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Brazil
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Porto Alegre
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Brazil
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Rio de Janeiro
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Brazil
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Salvador
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Brazil
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Sao Jose do Rio Preto
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Brazil
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São Paulo
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Canada
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Alberta
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Canada
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British Columbia
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Canada
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Nova Scotia
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Canada
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Ontario
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Canada
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Quebec
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Czechia
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Brno
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Czechia
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Hradec Kralove
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Czechia
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Olomouc
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Czechia
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Ostrava
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Czechia
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Plzen
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Czechia
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Praha 10
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Czechia
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Praha 2
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France
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Caen
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France
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Lille Cedex
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France
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Nantes Cedex 1
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France
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Pessac
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France
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Pierre-Bénite
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France
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Poitiers
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France
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Vandoeuvre Les Nancy
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Greece
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Athens Attica
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Israel
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Hadera
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Israel
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Haifa
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Israel
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Jerusalem
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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
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Italy
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Bologna
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Italy
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Milano
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Italy
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Palermo
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Italy
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Pavia
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Italy
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Piacenza
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Italy
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Roma
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Italy
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Torino
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Japan
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Fukuoka
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Japan
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Fukuyama
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Japan
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Gifu
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Gunma
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Iwate
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Kyoto
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Matsuyama
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Nagoya
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Japan
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Niigata
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Japan
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Okayama
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Japan
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Osaka
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Japan
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Sendai-City
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Japan
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Shibukawa
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Japan
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Shibuya
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Korea, Republic of
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Busan
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Korea, Republic of
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Goyang-Si
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Korea, Republic of
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Incheon
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Seoul
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Ulsan
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Brzozow
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Bydgoszcz
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Poland
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Chorzów
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Poland
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Gdynia
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Poland
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Krakow
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Poland
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Legnica
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Poland
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Lublin
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Poland
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Poznan
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Poland
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Warszawa
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Russian Federation
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Dzerzhinsk
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Russian Federation
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Ekaterinburg
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Russian Federation
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Moscow
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0
0
Russian Federation
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State/province [78]
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Nizny Novgorod
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Country [79]
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Russian Federation
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Penza
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Country [80]
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Russian Federation
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Ryazan
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Russian Federation
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Saint-Petersburg
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Russian Federation
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Samara
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Russian Federation
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St-Petersburg
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Russian Federation
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Syktyvkar
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Spain
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Badalona
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Spain
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Barcelona
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Spain
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Girona
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Spain
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Granada
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Spain
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La Laguna
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Spain
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Leon
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Spain
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Madrid
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Spain
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Pamplona
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Spain
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Pozuelo de Alarcon
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Spain
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Salamanca
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Spain
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Valencia
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Sweden
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Falun
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Sweden
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Helsingborg
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Sweden
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Huddinge
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Sweden
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Lund
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Sweden
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Umea
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Sweden
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Uppsala
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Taiwan
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Changhua
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Taiwan
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Taichung City
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Taiwan
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Taichung,
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Taiwan
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Tainan
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Taiwan
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Taipei
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Taiwan
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Taoyuan
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Ukraine
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Cherkasy
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Ukraine
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Dnepropetrovsk
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Ukraine
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Ivano-Frankivsk
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Ukraine
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Kharkiv
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Ukraine
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Kiev
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Ukraine
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Lviv
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Ukraine
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Mykolaiv
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Ukraine
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Poltava
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United Kingdom
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Blackpool
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United Kingdom
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Bournemouth
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United Kingdom
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Leicester
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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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Nottingham
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United Kingdom
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Surrey
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United Kingdom
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Wolverhampton
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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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Summary
Brief summary
The purpose of this study is to show that subcutaneous (SC) administration of daratumumab
co-formulated with recombinant human hyaluronidase PH20 (Dara SC) is non-inferior to
intravenous (IV) administration of daratumumab (Dara IV) in terms of the overall response
rate (ORR) and maximum trough concentration (Ctrough).
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03277105
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Contacts
Principal investigator
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Janssen Research & Development, LLC Clinical Trial
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Janssen Research & Development, LLC
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Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03277105
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