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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/NCT03319667
Registration number
NCT03319667
Ethics application status
Date submitted
18/09/2017
Date registered
24/10/2017
Date last updated
8/04/2024
Titles & IDs
Public title
Clinical Benefit of SAR650984, Bortezomib, Lenalidomide and Dexamethasone Combination in NDMM Patients Not Eligible for Transplant
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Scientific title
A Phase 3 Randomized, Open-label, Multicenter Study Assessing the Clinical Benefit of Isatuximab (SAR650984) in Combination With Bortezomib (Velcade®), Lenalidomide and Dexamethasone Versus Bortezomib, Lenalidomide and Dexamethasone in Patients With Newly Diagnosed Multiple Myeloma Not Eligible for Transplant
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Secondary ID [1]
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2017-002238-21
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Secondary ID [2]
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EFC12522
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Universal Trial Number (UTN)
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Trial acronym
IMROZ
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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 - Bortezomib
Treatment: Drugs - Lenalidomide
Treatment: Drugs - Dexamethasone
Experimental: Isatuximab/Bortezomib/Lenalidomide/Dexamethasone = IVRd arm - Induction treatment with 4x6-week cycles with intravenous (IV) isatuximab + subcutaneous (SC) bortezomib + oral lenalidomide + IV or oral dexamethasone
Continuous treatment with 4-week cycles with IV isatuximab + oral lenalidomide + IV or oral dexamethasone
Active Comparator: Bortezomib/Lenalidomide/Dexamethasone = VRd arm - Induction treatment with 4x6-week cycles with SC bortezomib + oral lenalidomide + IV or oral dexamethasone
Continuous treatment with 4-week cycles with oral lenalidomide + IV or oral dexamethasone
Other: Isatuximab/Lenalidomide/Dexamethasone = IRd crossover arm - 4-weeks cycles with IV isatuximab + oral lenalidomide + IV or oral dexamethasone
Treatment: Drugs: Isatuximab SAR650984
Pharmaceutical form: Solution for infusion
Route of administration: Intravenous (IV)
Treatment: Drugs: Bortezomib
Pharmaceutical form: Lyophilized powder for injection
Route of administration: Subcutaneous
Treatment: Drugs: Lenalidomide
Pharmaceutical form: Capsules
Route of administration: Oral
Treatment: Drugs: Dexamethasone
Pharmaceutical form: Tablets, ampoules or vials for injection
Route of administration: Oral/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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Progression free survival (PFS)
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Assessment method [1]
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Defined as the time from the date of randomization to the date of first documentation of progression disease (PD) as determined by the independent review committee (IRC) or the date of death from any cause, whichever occurs first.
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Timepoint [1]
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Up to approximately 100 months after the First Patient In (FPI)
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Secondary outcome [1]
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Complete response rate (CR)
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Assessment method [1]
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Defined as the proportion of patients with CR and stringent complete response (sCR) as assessed by the IRC using the IMWG criteria.
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Timepoint [1]
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Up to approximately 100 months after the FPI
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Secondary outcome [2]
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Minimal residual disease (MRD) negativity rate for patients with CR
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Assessment method [2]
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Proportion of patients with CR for whom MRD measurement is negative
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Timepoint [2]
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Up to approximately 100 months after the FPI
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Secondary outcome [3]
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Very good partial response (VGPR) or better rate
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Assessment method [3]
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Proportion of patients with sCR, CR and VGPR as assessed by the IRC using the International Myeloma Working Group (IMWG) criteria
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Timepoint [3]
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0
Up to approximately 100 months after the FPI
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Secondary outcome [4]
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Overall survival (OS)
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Assessment method [4]
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Defined as the time from the date of randomization to death from any cause
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Timepoint [4]
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Up to approximately 110 months after the FPI
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Secondary outcome [5]
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Overall response rate (ORR)
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Assessment method [5]
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Proportion of patients with best overall response (BOR) recorded as sCR, CR, VGPR, or partial response (PR) as assessed by the IRC using the IMWG criteria
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Timepoint [5]
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Up to approximately 100 months after the FPI assessment
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Secondary outcome [6]
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Time to progression (TTP)
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Assessment method [6]
0
0
Defined as the time from randomization to date of first documentation of PD as assessed by the IRC using the IMWG criteria
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Timepoint [6]
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0
Up to approximately 100 months after FPI
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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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Defined as the time from date of first IRC determined response to date of first IRC PD or death, whichever occurs first for patients achieving sCR, CR, VGPR, or PR
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Timepoint [7]
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0
Up to approximately 100 months after the FPI
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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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Time from randomization to the first IRC determined response (PR or better) that is subsequently confirmed
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Timepoint [8]
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Up to approximately 100 months after the FPI
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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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Defined as the time from randomization to the date of first occurrence of IRC determined best response (PR or better) that is subsequently confirmed
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Timepoint [9]
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Up to approximately 100 months after the FPI
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Secondary outcome [10]
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PFS on next line of therapy (PFS2)
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Assessment method [10]
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Defined as the time from randomization to the date of first documentation of disease progression (as assessed by investigator) after initiation of further anti-myeloma treatment, or death from any cause, whichever occurs first
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Timepoint [10]
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0
Up to approximately 110 months after the FPI
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Secondary outcome [11]
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PFS in MRD negative patients
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Assessment method [11]
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0
Defined as the time from the date of randomization to the date of first documentation of PD or the date of death from any cause, whichever comes first in MRD negative patients
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Timepoint [11]
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Up to approximately 100 months after the FPI
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Secondary outcome [12]
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Sustained MRD negativity =12 months rate
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Assessment method [12]
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Defined as the proportion of patients with the maintenance of MRD negativity confirmed =12 months apart with no MRD positive test in between.
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Timepoint [12]
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Up to approximately 100 months after the FPI
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Secondary outcome [13]
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Adverse Events
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Assessment method [13]
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Treatment-emergent adverse events/serious adverse events (TEAEs/SAEs) including infusion associated reactions (IARs), second primary malignancies, laboratory parameters, vital signs, weight, ECOG PS, and findings from physical examination
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Timepoint [13]
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Up to 30 days after end of treatment (EOT) visit
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Secondary outcome [14]
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Assessment of PK parameter: Ctrough
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Assessment method [14]
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Isatuximab: Pre-dose plasma isatuximab concentration (Ctrough)
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Timepoint [14]
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Cycle 1 Day 8/Day 15/Day 29 (pre-dose) and Day 1 (pre-dose) of Cycle 2, 3, 4, 5, 6, 7, 8, 9 and 10 (Duration of each cycle for Cycles 1-4: 6 weeks; Duration of each cycle for Cycles 5-10: 4 weeks)
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Secondary outcome [15]
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Immunogenicity
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Assessment method [15]
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Presence of anti-drug antibodies against isatuximab
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Timepoint [15]
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Up to approximately 100 months after the FPI
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Secondary outcome [16]
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Patient reported outcome (PRO): QLQ-C30
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Assessment method [16]
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Disease-specific HRQL will be assessed using the European Organization for Research and Treatment of Cancer (EORTC) core quality of life questionnaire (QLQ-C30)
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Timepoint [16]
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Up to approximately 100 months after the FPI
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Secondary outcome [17]
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PRO: QLQ-MY20
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Assessment method [17]
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Disease- and treatment-related quality of life will be assessed using the EORTC myeloma module (QLQ-MY20) questionnaire
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Timepoint [17]
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Up to approximately 100 months after the FPI
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Secondary outcome [18]
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PRO: EQ-5D-5L
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Assessment method [18]
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Health state utility and health status will be assessed using the European Quality of Life Group questionnaire with 5 dimensions and 5 levels per dimension (EQ-5D-5L)
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Timepoint [18]
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Up to approximately 100 months after the FPI
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Eligibility
Key inclusion criteria
Inclusion criteria :
- Multiple myeloma (IMWG criteria).
- Newly diagnosed multiple myeloma not eligible for transplant due to age (= 65 years)
or patients < 65 years with comorbidities impacting possibility of transplant.
- Evidence of measurable disease.
- Written informed consent.
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Minimum age
18
Years
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Maximum age
80
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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:
- Age < 18 years.
- Prior treatment for multiple myeloma.
- Any other prior or ongoing disease/health conditions incompatible with the study
objectives.
- Organ function values not met.
- Eastern Cooperative Oncology Group (ECOG) Performance Status ( PS) > 2.
- Hypersensitivity to the study medications.
- Pregnant, breastfeeding, or woman of child bearing potential unwilling to use
recommended contraception methods.
- Male participants who disagree to follow the study contraceptive counseling.
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
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
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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
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
7/12/2017
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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
30/06/2027
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Actual
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Sample size
Target
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Accrual to date
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Final
475
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
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Recruitment hospital [1]
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Investigational Site Number :0360003 - Liverpool
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Recruitment hospital [2]
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Investigational Site Number :0360001 - Waratah
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Recruitment hospital [3]
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Investigational Site Number :0360002 - Wollongong
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Recruitment hospital [4]
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Investigational Site Number :0360007 - South Brisbane
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Recruitment hospital [5]
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Investigational Site Number :0360005 - Clayton
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Recruitment hospital [6]
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Investigational Site Number :0360004 - Heidelberg West
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Recruitment hospital [7]
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Investigational Site Number :0360006 - Nedlands
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Recruitment hospital [8]
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Investigational Site Number :0360008 - West Perth
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Recruitment postcode(s) [1]
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2170 - Liverpool
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Recruitment postcode(s) [2]
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2298 - Waratah
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Recruitment postcode(s) [3]
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2500 - Wollongong
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Recruitment postcode(s) [4]
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4101 - South Brisbane
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Recruitment postcode(s) [5]
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3168 - Clayton
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Recruitment postcode(s) [6]
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3081 - Heidelberg West
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Recruitment postcode(s) [7]
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6009 - Nedlands
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Recruitment postcode(s) [8]
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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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Florida
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Missouri
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Texas
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Belgium
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Liège
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China
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Beijing
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China
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Changchun
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China
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Fuzhou
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China
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Guangzhou
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China
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Hangzhou
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Nanjing
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Wuhan
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Brno
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Olomouc
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Istanbul
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Izmir
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Kayseri
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Turkey
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Samsun
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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 Objective:
-To demonstrate the benefit of isatuximab in combination with bortezomib, lenalidomide, and
dexamethasone in the prolongation of progression free survival (PFS) as compared to
bortezomib, lenalidomide, and dexamethasone, in patients with newly diagnosed multiple
myeloma (NDMM) not eligible for transplant.
Secondary Objectives:
- To evaluate in both randomized (isatuximab, bortezomib, lenalidomide and dexamethasone
combination (IVRd) and bortezomib, lenalidomide and dexamethasone combination (VRd))
arms:
- Complete response (CR) rate, as defined by the International Myeloma Working Group
(IMWG) criteria.
- Minimal residual disease (MRD) negativity rate in patients with CR.
- Very good partial response or better rate, as defined by the IMWG criteria.
- Overall survival (OS).
- To evaluate the overall response rate (ORR) as per IMWG criteria.
- To evaluate the time to progression (TTP) overall and by MRD status.
- To evaluate PFS by MRD status.
- To evaluate the duration of response (DOR) overall and by MRD status.
- To evaluate time to first response (TT1R).
- To evaluate time to best response (TTBR).
- To evaluate progression-free survival on next line of therapy (PFS2).
- To evaluate the sustained MRD negativity >12 months rate.
- To evaluate safety.
- To determine the pharmacokinetic (PK) profile of isatuximab in combination with
bortezomib, lenalidomide, and dexamethasone (IVRd arm only).
- To evaluate the immunogenicity of isatuximab in patients receiving isatuximab (IVRd and
crossover arms).
- To assess disease-specific and generic health-related quality of life (HRQL), disease
and treatment-related symptoms, health state utility, and health status.
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https://clinicaltrials.gov/ct2/show/NCT03319667
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Sanofi
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Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03319667
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