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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05704049
Registration number
NCT05704049
Ethics application status
Date submitted
20/01/2023
Date registered
30/01/2023
Titles & IDs
Public title
A Study to Investigate Subcutaneous Isatuximab in Combination With Carfilzomib and Dexamethasone in Adult Participants With Relapsed and/or Refractory Multiple Myeloma
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Scientific title
A Randomized, Phase 2, Open Label Study Evaluating Subcutaneous Administration of Isatuximab in Combination With Carfilzomib and Dexamethasone in Adult Participants With Relapsed and/or Refractory Multiple Myeloma (RRMM)
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Secondary ID [1]
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U1111-1280-5090
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Secondary ID [2]
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ACT17453
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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:
Relapsed/Refractory 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 - Isatuximab
Treatment: Drugs - Carfilzomib
Treatment: Drugs - Dexamethasone
Treatment: Drugs - Dexamethasone IV
Treatment: Drugs - Montelukast
Treatment: Drugs - Acetaminophen
Treatment: Drugs - Diphenhydramine
Treatment: Drugs - Methylprednisolone
Experimental: Cohort 1: manual administration - Isatuximab will be administered manually for 8 minutes on Day 1 of Cycle 1 followed by 6 minutes from Day 8 of Cycle 1 and thereafter, in combination with carfilzomib and dexamethasone. Participants may receive other treatments as rescue medication or background medication.
Experimental: Part 1 Cohort 2: manual administration - Isatuximab will be administered manually for 6 minutes on Day 1 of Cycle 1 and thereafter, in combination with carfilzomib and dexamethasone. Participants may receive other treatments as rescue medication or background medication.
Experimental: Part 2 Randomized Cohort: OBDS to manual - Isatuximab will be administered in combination with carfilzomib and dexamethasone. Isatuximab will be administered via OBDS from Cycle 1 to 3. For Cycle 4 to 6, the method of administration will be switched for each participant from OBDS to manual administration. From Cycle 7 and onwards, participants can choose manual or OBDS. Participants may receive other treatments as rescue medication or background medication.
Experimental: Part 2 Randomized Cohort: Manual to OBDS - Isatuximab will be administered in combination with carfilzomib and dexamethasone. Isatuximab will be administered manually from Cycle 1 to 3. For Cycle 4 to 6, the method of administration will be switched for each participant from manual to OBDS administration. From Cycle 7 and onwards, participants can choose manual or OBDS. Participants may receive other treatments as rescue medication or background medication.
Treatment: Drugs: Isatuximab
Investigational medicinal product; Pharmaceutical form: Solution for Subcutaneous administration; Route of administration: Subcutaneous
Treatment: Drugs: Carfilzomib
Investigational medicinal product; Pharmaceutical form: Powder for solution for infusion; Route of administration: Intravenous
Treatment: Drugs: Dexamethasone
Investigational medicinal product/background treatment; ATC code: H02AB02; Pharmaceutical form: Tablet; Route of administration: Oral
Treatment: Drugs: Dexamethasone IV
Investigational medicinal product/background treatment; ATC code: H02AB02; Pharmaceutical form: Powder for solution for infusion; Route of administration: Intravenous
Treatment: Drugs: Montelukast
Background Treatment; ATC code: R03DC03; Pharmaceutical form: As per local commercial product; Route of administration: Oral
Treatment: Drugs: Acetaminophen
Background Treatment; ATC code: N02BE01; Pharmaceutical form: As per local commercial product; Route of administration: Oral or intravenous (IV)
Treatment: Drugs: Diphenhydramine
Background Treatment; ATC code: R06AA02; Pharmaceutical form: As per local commercial product; Route of administration: Oral or IV
Treatment: Drugs: Methylprednisolone
Background Treatment/Rescue medication; ATC code: H02AB04; Pharmaceutical form: As per local commercial product; Route of administration: IV
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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 defined as the proportion of participants with stringent complete response (sCR), complete response (CR), very good partial response (VGPR), and partial response (PR) according to the 2016 International Myeloma Working Group (IMWG) criteria assessed by Independent Review Committee (IRC).
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Timepoint [1]
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6 months after the Last Participant In (LPI) i.e., approximately 16 months
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Secondary outcome [1]
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Proportion of participants preferring OBDS over manual administration of isatuximab SC at Day 15 of Cycle 6
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Assessment method [1]
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Patient preference for method of administration defined as the proportion of participants preferring OBDS over manual administration of isatuximab SC at Day 15 of Cycle 6 using the patient experience and satisfaction questionnaire version 2 (PESQ v2).
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Timepoint [1]
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6 months from LPI i.e., approximately 16 months
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Secondary outcome [2]
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Incidence rate of infusion reactions (IRs)
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Assessment method [2]
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Timepoint [2]
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18 months after LPI i.e., approximately 28 months
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Secondary outcome [3]
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Number of participants with treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and changes in laboratory parameters
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Assessment method [3]
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Timepoint [3]
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From the signing of the informed consent to 30 days following the last administration of any study treatment i.e., up to approximately 45 months
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Secondary outcome [4]
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Incidence rate of injection site reactions (ISRs)
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Assessment method [4]
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Timepoint [4]
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18 months after LPI i.e., approximately 28 months
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Secondary outcome [5]
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PK concentration: trough plasma concentration (Ctrough)
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Assessment method [5]
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Blood samples will be collected for measurement of isatuximab concentrations.
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Timepoint [5]
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Cycle 2 Day 1 and Cycle 6 Day 1 (1 Cycle = 28 days)
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Secondary outcome [6]
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Proportion of participants with sCR, CR, VGPR, and PR according to the 2016 IMWG criteria assessed by IRC
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Assessment method [6]
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Timepoint [6]
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18 months after LPI i.e., approximately 28 months
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Secondary outcome [7]
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Duration of response (DOR)
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Assessment method [7]
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DOR defined as time from date of first IRC-determined response for participants achieving PR or better to first documentation of progressive disease (PD) determined by IRC or death, whichever occurred first.
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Timepoint [7]
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18 months after LPI i.e., approximately 28 months
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Secondary outcome [8]
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Time to first response (TT1R)
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Assessment method [8]
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TT1R defined as time from randomization to first IRC determined response (PR or better) that is subsequently confirmed.
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Timepoint [8]
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18 months after LPI i.e., approximately 28 months
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Secondary outcome [9]
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Time to best response (TTBR)
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Assessment method [9]
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TTBR defined as time from randomization to first occurrence of IRC determined best response (PR or better) that is subsequently confirmed.
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Timepoint [9]
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18 months after LPI i.e., approximately 28 months
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Secondary outcome [10]
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Progression free survival (PFS)
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Assessment method [10]
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PFS defined as time from the date of randomization to the date of first documentation of PD as determined by IRC or the date of death from any cause, whichever comes first.
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Timepoint [10]
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18 months after LPI i.e., approximately 28 months
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Secondary outcome [11]
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Overall survival (OS)
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Assessment method [11]
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OS defined as time from the date of randomization to death from any cause
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Timepoint [11]
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18 months after LPI i.e., approximately 28 months
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Secondary outcome [12]
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Incidence of participants with anti-drug antibodies (ADA) against isatuximab
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Assessment method [12]
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Timepoint [12]
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From Cycle 1 Day 1 to follow-up (90 days from last administration) i.e., approximately 13 months (1 Cycle = 28 days)
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Secondary outcome [13]
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Patient Expectations Questionnaire at Baseline (PEQ-BL v2) with isatuximab administered subcutaneously
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Assessment method [13]
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PEQ-BL v2 is a participant assessed questionnaire. It will be completed at baseline prior to study treatment administration or other study related procedures. This questionnaire has been designed to assess the expectations of the participants regarding both the treatment (side effects, worth taking) and the administration method (confidence, comfortability, pain, side effects, potential time-savings), as well as to understand previous treatment experience from the participant (experience with injection methods for oncology medication).
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Timepoint [13]
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Baseline
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Secondary outcome [14]
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Patient experience and satisfaction questionnaires (PESQ v2) with isatuximab administered subcutaneously
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Assessment method [14]
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PESQ v2 is a participant assessed questionnaire. It has been designed to follow up on participant experience and satisfaction regarding the treatment (side effects, worth taking and overall satisfaction) and the administration method (confidence, comfortability, pain, side effects, potential time-savings and overall satisfaction). The PESQ v2 includes items to assess preference on subcutaneous injection method. This questionnaire has been developed using industry standard for instrument development and has been debriefed and adapted based on qualitative interviews with oncology patients. The more general treatment expectations instrument (v1) was further adapted and debriefed with patients to assess manual and OBDS subcutaneous delivery (v2). The PESQ v2 contains a total of 9 items. There are 6 items that are administered for the duration of treatment, and 3 preference items administered only after patient experience of both manual and OBDS.
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Timepoint [14]
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18 months after LPI i.e., approximately 28 months
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Secondary outcome [15]
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Health state utility assessed using Health Resource Utilization and Productivity Questionnaire (HRUPQ)
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Assessment method [15]
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Medical resource utilization and participant productivity will be collected from participants through a specific questionnaire developed by Sanofi. The data collected include number, nature (emergency or routine) and duration of hospitalizations, emergency room visits and outpatient medical encounters and employment history.
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Timepoint [15]
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18 months after LPI i.e., approximately 28 months
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Secondary outcome [16]
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Health Related Quality of Life (HRQL)
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Assessment method [16]
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HRQL is assessed using the European Organization for Research and Treatment of Cancer (EORTC) myeloma module with 20 items (QLQ-MY20) and EORTC quality of life questionnaire with 30 questions (QLQ-C30); a total of 50 items. The EORTC QLQ-C30 provides a comprehensive assessment of the principal HRQL dimensions identified as relevant by cancer patients. The EORTC QLQ-MY20 is to be used in conjunction with the EORTC QLQ-C30 to assess symptoms and side effects due to the treatment or the disease which impact HRQL in participants with MM.
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Timepoint [16]
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18 months after LPI i.e., approximately 28 months
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Secondary outcome [17]
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European Quality of Life Group questionnaire with 5 dimensions and 5 levels per dimension (EQ-5D-5L)
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Assessment method [17]
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Health status is assessed using the EQ-5D-5L, a standardized measure of health status that provides a simple, generic measure of health utility, and consists of 2 sections: descriptive and VAS. The descriptive system consists of 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The VAS records the respondent's self-rated health on a 20 cm vertical VAS with endpoints labelled 'the best health you can imagine' and 'the worst health you can imagine'. This information can be used as a quantitative measure of health as judged by the individual respondents.
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Timepoint [17]
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18 months after LPI i.e., approximately 28 months
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Eligibility
Key inclusion criteria
Participants must have a documented diagnosis of multiple myeloma (MM)
* Participants with measurable disease defined as at least one of the following:
* Serum M-protein =0.5 g/dL measured using serum protein immunoelectrophoresis and/or
* Urine M-protein =200 mg/24 hours measured using urine protein immunoelectrophoresis and/or
* Serum free light chain (FLC) assay: Involved FLC assay =10 mg/dL (=100 mg/L) and an abnormal serum FLC ratio (<0.26 or >1.65).
* Participant with relapsed and/or refractory MM with at least 1 prior line of therapy and no more than 3 prior lines of therapy.
* A female participant is eligible to participate if she is not pregnant, not breastfeeding, and either is not a female of childbearing potential (FCBP) or agrees to practice complete abstinence or use approved contraception methods.
* Male participants agree to practice true abstinence or agree to use approved contraception methods while receiving study treatment, during dose interruptions and at least 5 months following study treatment discontinuation, even if has undergone a successful vasectomy.
* Capable of giving signed informed consent.
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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
* Primary refractory MM defined as participants who have never achieved at least a minimal response (MR) with any treatment during the disease course
* Participants with prior anti-CD38 treatment if: a) administered <9 months before first isatuximab administration or randomization as applicable or, b) Intolerant to the anti-CD38 previously received
* Prior treatment with carfilzomib
* Known history of allergy to captisol (a cyclodextrin derivative used to solubilize carfilzomib), prior hypersensitivity to sucrose, histidine (as base and hydrochloride salt), polysorbate 80, or any of the components (active substance or excipient) of study treatment that are not amenable to premedication with steroids, or intolerance to arginine and Poloxamer 188 that would prohibit further treatment with these agents
* Uncontrolled or active infection with hepatitis A, B, and C virus; known acquired immunodeficiency syndrome (AIDS)-related illness; active primary amyloid light chain (AL) amyloidosis
* Any severe acute or chronic medical condition which could impair the ability of the participant to participate in the study or interfere with interpretation of study results (eg, systemic infection unless specific anti-infective therapy is employed) or participant unable to comply with the study procedures.
The above information is not intended to contain all considerations relevant to a 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 2
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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
5/04/2023
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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
1/03/2027
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Actual
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Sample size
Target
71
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,VIC
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Recruitment hospital [1]
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Investigational Site Number : 0360002 - Wollongong
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Recruitment hospital [2]
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Investigational Site Number : 0360001 - Fitzroy
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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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3065 - Fitzroy
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Recruitment outside Australia
Country [1]
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Brazil
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State/province [1]
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Rio Grande Do Sul
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Country [2]
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Brazil
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State/province [2]
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São Paulo
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Country [3]
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Czechia
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State/province [3]
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Brno
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Country [4]
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Czechia
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State/province [4]
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Olomouc
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Country [5]
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Czechia
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State/province [5]
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Ostrava - Poruba
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Country [6]
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Czechia
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State/province [6]
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Praha 2
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Country [7]
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Greece
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State/province [7]
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Athens
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Country [8]
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Greece
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State/province [8]
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Thessaloniki
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Country [9]
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Japan
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State/province [9]
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Chiba
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Country [10]
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Japan
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State/province [10]
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Okayama
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Country [11]
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Portugal
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State/province [11]
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Braga
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Country [12]
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Portugal
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State/province [12]
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Lisboa
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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
The main purpose of this study is to measure the efficacy (Myeloma response) of subcutaneous (SC) isatuximab treatment in combination with carfilzomib and dexamethasone in adult participants with RRMM having received 1 to 3 prior lines of therapy. After confirmation of the feasibility of SC isatuximab by manual administration, patient will be randomized to 1 of the 2 delivery methods of SC isatuximab.
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Trial website
https://clinicaltrials.gov/study/NCT05704049
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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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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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Country
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Phone
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Fax
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Email
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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?
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
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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?
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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/NCT05704049