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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/NCT03194867
Registration number
NCT03194867
Ethics application status
Date submitted
19/06/2017
Date registered
21/06/2017
Date last updated
19/04/2023
Titles & IDs
Public title
Isatuximab in Combination With Cemiplimab in Relapsed/Refractory Multiple Myeloma (RRMM) Patients
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Scientific title
A Phase 1/2 Study to Evaluate Safety, Pharmacokinetics and Efficacy of Isatuximab in Combination With Cemiplimab in Patients With Relapsed/Refractory Multiple Myeloma
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Secondary ID [1]
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2017-001431-39
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Secondary ID [2]
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TCD14906
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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:
Plasma Cell 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 - Isatuximab SAR650984
Treatment: Drugs - Cemiplimab REGN2810
Experimental: Isatuximab/cemiplimab (Regimen 1) - Isatuximab on Days 1, 8, 15, and 22, then Days 1 and 15 in 28-day cycles up to disease progression.
Cemiplimab on Days 1 and 15 in 28-day cycle up to disease progression.
Experimental: Isatuximab/cemiplimab (Regimen 2) - Isatuximab on Days 1, 8, 15, and 22, then Days 1 and 15 in 28-day cycles up to disease progression.
Cemiplimab on Day 1 in 28-day cycle up to disease progression.
Active Comparator: Isatuximab - Isatuximab on Days 1, 8, 15 and 22, then Day 1 and 15 in 28-day cycles up to disease progression.
Treatment: Drugs: Isatuximab SAR650984
Pharmaceutical form: solution for infusion
Route of administration: intravenous
Treatment: Drugs: Cemiplimab REGN2810
Pharmaceutical form: solution for infusion
Route of administration: intravenous
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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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Dose Limiting Toxicities (DLTs)
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Assessment method [1]
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DLTs are following AEs in Cycle 1 unless due to disease progression or an obviously unrelated cause: Grade (G) 4 neutropenia >7 days; G 3 to 4 neutropenia with fever or documented infection; G 3 to 4 thrombocytopenia with bleeding requiring intervention; G 4 non-hematological AE; G =2 uveitis; G 3 non-hematological AE >3 days despite supportive care (with defined exceptions); Delay in initiation of the 2nd cycle >14 days for related laboratory abnormalities/AE
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Timepoint [1]
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Up to 4 weeks
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Primary outcome [2]
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Adverse events (AEs) and changes in laboratory tests and vital signs
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Assessment method [2]
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Number of patients with AEs and changes in laboratory tests and vital signs according to the National Cancer Institute - Common Toxicity Criteria (NCI-CTC) version 4.03 Grade scaling
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Timepoint [2]
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Up to 90 days following the last administration of study treatment for ongoing related AE, ongoing serious AE and new related AE until resolution or stabilization
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Primary outcome [3]
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Overall Response Rate (ORR)
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Assessment method [3]
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ORR is defined as the proportion of patients with complete response (CR) (including sCR [stringent complete response]), very good partial response (VGPR) and partial response (PR)
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Timepoint [3]
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Up to 6 months from last patient in (LPI) for primary efficacy analysis, and up to 12 months from LPI for the final analysis
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Secondary outcome [1]
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Clinical Benefit Rate (CBR)
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Assessment method [1]
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CBR is defined as the proportion of patients with CR (including sCR), VGPR, PR and minimal response (MR)
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Timepoint [1]
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Up to 6 months from LPI for primary efficacy analysis, and up to 12 months from LPI for the final analysis
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Secondary outcome [2]
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Duration of Response (DOR)
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Assessment method [2]
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DOR is defined as the time from the date of the first response (=PR) that is subsequently confirmed to the date of first confirmed disease progression or death, whichever happens first
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Timepoint [2]
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Up to 6 months from LPI for primary efficacy analysis, and up to 12 months from LPI for the final analysis
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Secondary outcome [3]
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Time to Response (TTR)
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Assessment method [3]
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TTR is defined as time from first study treatment administration to first response (=PR) that is subsequently confirmed
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Timepoint [3]
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Up to 6 months from LPI for primary efficacy analysis, and up to 12 months from LPI for the final analysis
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Secondary outcome [4]
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Progression Free Survival (PFS)
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Assessment method [4]
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PFS is defined as time from the first study treatment administration to the date of first documentation of progressive disease that is subsequently confirmed or the date of death from any cause
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Timepoint [4]
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Up to 6 months from LPI for primary efficacy analysis, and up to 12 months from LPI for the final analysis
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Secondary outcome [5]
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Overall Survival (OS)
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Assessment method [5]
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OS defined as the time from the first study treatment administration to death from any cause
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Timepoint [5]
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Up to 12 months from LPI for the final analysis
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Secondary outcome [6]
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Assessment of PK parameter: partial AUC
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Assessment method [6]
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AUC is area under the drug concentration versus time curve
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Timepoint [6]
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Up to 4 weeks
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Secondary outcome [7]
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Assessment of PK parameter: Cmax
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Assessment method [7]
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Cmax is maximum drug concentration observed
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Timepoint [7]
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Up to 4 weeks
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Secondary outcome [8]
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Antibodies to isatuximab
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Assessment method [8]
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Levels of anti isatuximab antibodies in plasma samples will be determined
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Timepoint [8]
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Up to 12 months from LPI for the final analysis
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Secondary outcome [9]
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Antibodies to cemiplimab
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Assessment method [9]
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Levels of anti cemiplimab antibodies in serum samples will be determined
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Timepoint [9]
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Up to 12 months from LPI for the final analysis
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Eligibility
Key inclusion criteria
Inclusion criteria:
- Patients must have a known diagnosis of multiple myeloma with evidence of measurable
disease, as defined below:
- Serum M-protein =1 g/dL (=0.5 g/dL in case of immunoglobulin A [IgA] disease),
AND/OR
- Urine M-protein =200 mg/24 hours, OR
- In the absence of measurable M-protein, serum immunoglobulin free light chain =10
mg/dL, and abnormal serum immunoglobulin kappa lambda free light chain ratio
(<0.26 or >1.65).
- Patients must have received prior treatment with an immunomodulatory drug (IMiD) (for
=2 cycles or =2 months of treatment) and a proteasome inhibitor (PI) (for =2 cycles or
=2 months of treatment).
- Patients must have received at least 3 prior lines of therapy (Note: Induction therapy
and stem cell transplant ± maintenance will be considered as one line).
- Patient must have achieved MR or better with any anti-myeloma therapy (ie, primary
refractory disease is not eligible).
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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
Exclusion criteria:
- Prior exposure to isatuximab or participated clinical studies with isatuximab.
- Prior exposure to any agent (approved or investigational) that blocks the programmed
cell death-1 (PD-1)/PD-L1 pathway.
- Evidence of other immune related disease/conditions.
- History of non-infectious pneumonitis requiring steroids or current pneumonitis;
history of the thoracic radiation.
- Has received a live-virus vaccination within 30 days of planned treatment start.
Seasonal flu vaccines that do not contain live virus are permitted.
- Has allogenic haemopoietic stem cell (HSC) transplant.
- Prior treatment with idelalisib (a PI3K inhibitor).
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) >2.
- Poor bone marrow reserve.
- Poor organ function.
The above information is not intended to contain all considerations relevant to a patient's
potential participation in a clinical trial.
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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 1/Phase 2
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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
25/01/2018
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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
5/04/2023
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Sample size
Target
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Accrual to date
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Final
109
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Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
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Recruitment hospital [1]
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Investigational Site Number :0360003 - Wollongong
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Recruitment hospital [2]
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Investigational Site Number :0360002 - Richmond
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Recruitment hospital [3]
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Investigational Site Number :0360001 - West Perth
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Recruitment postcode(s) [1]
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2500 - Wollongong
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Recruitment postcode(s) [2]
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3121 - Richmond
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Recruitment postcode(s) [3]
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6005 - West Perth
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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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Colorado
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Country [2]
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United States of America
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State/province [2]
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Kansas
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Country [3]
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United States of America
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State/province [3]
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New York
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Country [4]
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United States of America
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State/province [4]
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Pennsylvania
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Country [5]
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Brazil
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State/province [5]
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Goiás
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Country [6]
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Brazil
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State/province [6]
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Rio Grande Do Sul
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Country [7]
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Brazil
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State/province [7]
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São Paulo
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Canada
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State/province [8]
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Quebec
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Czechia
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State/province [9]
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Brno
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Country [10]
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Czechia
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State/province [10]
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Ostrava - Poruba
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Czechia
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State/province [11]
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Praha 2
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Country [12]
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France
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State/province [12]
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Lille
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France
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State/province [13]
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Nantes
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Country [14]
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France
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State/province [14]
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Pierre Benite
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Country [15]
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France
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State/province [15]
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Villejuif
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Country [16]
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Greece
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State/province [16]
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Athens
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Hungary
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Budapest
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Italy
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State/province [18]
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Milano
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Italy
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State/province [19]
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Brescia
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Country [20]
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Italy
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State/province [20]
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Torino
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Country [21]
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Spain
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State/province [21]
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Barcelona [Barcelona]
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Country [22]
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Spain
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State/province [22]
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Catalunya [Cataluña]
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Country [23]
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Spain
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State/province [23]
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Valenciana, Comunidad
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Country [24]
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Spain
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State/province [24]
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Madrid
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Sanofi
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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
Primary Objectives:
- To evaluate the safety and tolerability of the combination of isatuximab (also known as
SAR650984) and cemiplimab (also known as REGN2810) in patients with relapse/refractory
multiple myeloma.
- To compare the overall response of the combination of isatuximab and cemiplimab versus
isatuximab alone in patients with RRMM based on International Myeloma Working Group
(IMWG) criteria.
Secondary Objectives:
- To evaluate the efficacy as assessed by clinical benefit rate (CBR), duration of
response (DOR), time to response (TTR), progression free survival (PFS), and overall
survival (OS).
- To assess the pharmacokinetics (PK) of isatuximab and cemiplimab when given in
combination.
- To assess the immunogenicity of isatuximab and cemiplimab when given in combination.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03194867
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Clinical Sciences & Operations
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Address
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Sanofi
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Country
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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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Address
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03194867
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