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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03319667




Registration number
NCT03319667
Ethics application status
Date submitted
18/09/2017
Date registered
24/10/2017

Titles & IDs
Public title
A Study to Investigate the Clinical Benefit of Isatuximab in Combination With Bortezomib, Lenalidomide and Dexamethasone in Adults With Newly Diagnosed Multiple Myeloma Not Eligible for Transplant
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
Secondary ID [1] 0 0
U1111-1194-2121
Secondary ID [2] 0 0
EFC12522
Universal Trial Number (UTN)
Trial acronym
IMROZ
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Plasma Cell Myeloma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Other cancer types

Intervention/exposure
Study type
Interventional
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 - 1. Induction treatment with 4x6-week cycles with intravenous (IV) isatuximab + subcutaneous (SC) bortezomib + oral lenalidomide + IV or oral dexamethasone
2. Continuous treatment with 4-week cycles with IV isatuximab + oral lenalidomide + IV or oral dexamethasone

Active comparator: Bortezomib/Lenalidomide/Dexamethasone = VRd arm - 1. Induction treatment with 4x6-week cycles with SC bortezomib + oral lenalidomide + IV or oral dexamethasone
2. 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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression free survival (PFS)
Timepoint [1] 0 0
Up to approximately 100 months after the First Participant In (FPI)
Secondary outcome [1] 0 0
Complete response rate (CR)
Timepoint [1] 0 0
Up to approximately 100 months after the FPI
Secondary outcome [2] 0 0
Minimal residual disease (MRD) negativity rate for participants with CR
Timepoint [2] 0 0
Up to approximately 100 months after the FPI
Secondary outcome [3] 0 0
Very good partial response (VGPR) or better rate
Timepoint [3] 0 0
Up to approximately 100 months after the FPI
Secondary outcome [4] 0 0
Overall survival (OS)
Timepoint [4] 0 0
Up to approximately 110 months after the FPI
Secondary outcome [5] 0 0
Overall response rate (ORR)
Timepoint [5] 0 0
Up to approximately 100 months after the FPI assessment
Secondary outcome [6] 0 0
Time to progression (TTP)
Timepoint [6] 0 0
Up to approximately 100 months after FPI
Secondary outcome [7] 0 0
Duration of response (DOR)
Timepoint [7] 0 0
Up to approximately 100 months after the FPI
Secondary outcome [8] 0 0
Time to first response (TT1R)
Timepoint [8] 0 0
Up to approximately 100 months after the FPI
Secondary outcome [9] 0 0
Time to best response (TTBR)
Timepoint [9] 0 0
Up to approximately 100 months after the FPI
Secondary outcome [10] 0 0
PFS on next line of therapy (PFS2)
Timepoint [10] 0 0
Up to approximately 110 months after the FPI
Secondary outcome [11] 0 0
PFS in MRD negative participants
Timepoint [11] 0 0
Up to approximately 100 months after the FPI
Secondary outcome [12] 0 0
Sustained MRD negativity =12 months rate
Timepoint [12] 0 0
Up to approximately 100 months after the FPI
Secondary outcome [13] 0 0
Adverse Events
Timepoint [13] 0 0
Up to 30 days after end of treatment (EOT) visit
Secondary outcome [14] 0 0
Assessment of PK parameter: Ctrough
Timepoint [14] 0 0
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)
Secondary outcome [15] 0 0
Immunogenicity
Timepoint [15] 0 0
Up to approximately 100 months after the FPI
Secondary outcome [16] 0 0
participants reported outcome (PRO): QLQ-C30
Timepoint [16] 0 0
Up to approximately 100 months after the FPI
Secondary outcome [17] 0 0
PRO: QLQ-MY20
Timepoint [17] 0 0
Up to approximately 100 months after the FPI
Secondary outcome [18] 0 0
PRO: EQ-5D-5L
Timepoint [18] 0 0
Up to approximately 100 months after the FPI

Eligibility
Key inclusion criteria
Inclusion criteria :

* Multiple myeloma (IMWG criteria).
* Newly diagnosed multiple myeloma not eligible for transplant due to age (= 65 years) or participants < 65 years with comorbidities impacting possibility of transplant.
* Evidence of measurable disease.
* Written informed consent.
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
7/12/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/06/2027
Actual
Sample size
Target
Accrual to date
Final
475
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
Investigational Site Number : 0360003 - Liverpool
Recruitment hospital [2] 0 0
Investigational Site Number : 0360001 - Waratah
Recruitment hospital [3] 0 0
Investigational Site Number : 0360002 - Wollongong
Recruitment hospital [4] 0 0
Investigational Site Number : 0360007 - South Brisbane
Recruitment hospital [5] 0 0
Investigational Site Number : 0360005 - Clayton
Recruitment hospital [6] 0 0
Investigational Site Number : 0360004 - Heidelberg West
Recruitment hospital [7] 0 0
Investigational Site Number : 0360006 - Nedlands
Recruitment hospital [8] 0 0
Investigational Site Number : 0360008 - West Perth
Recruitment postcode(s) [1] 0 0
2170 - Liverpool
Recruitment postcode(s) [2] 0 0
2298 - Waratah
Recruitment postcode(s) [3] 0 0
2500 - Wollongong
Recruitment postcode(s) [4] 0 0
4101 - South Brisbane
Recruitment postcode(s) [5] 0 0
3168 - Clayton
Recruitment postcode(s) [6] 0 0
3081 - Heidelberg West
Recruitment postcode(s) [7] 0 0
6009 - Nedlands
Recruitment postcode(s) [8] 0 0
6005 - West Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Florida
Country [2] 0 0
United States of America
State/province [2] 0 0
Missouri
Country [3] 0 0
United States of America
State/province [3] 0 0
Tennessee
Country [4] 0 0
United States of America
State/province [4] 0 0
Texas
Country [5] 0 0
Belgium
State/province [5] 0 0
Liège
Country [6] 0 0
China
State/province [6] 0 0
Beijing
Country [7] 0 0
China
State/province [7] 0 0
Changchun
Country [8] 0 0
China
State/province [8] 0 0
Fuzhou
Country [9] 0 0
China
State/province [9] 0 0
Guangzhou
Country [10] 0 0
China
State/province [10] 0 0
Hangzhou
Country [11] 0 0
China
State/province [11] 0 0
Nanjing
Country [12] 0 0
China
State/province [12] 0 0
Shanghai
Country [13] 0 0
China
State/province [13] 0 0
Shenyang
Country [14] 0 0
China
State/province [14] 0 0
Tianjin
Country [15] 0 0
China
State/province [15] 0 0
Wuhan
Country [16] 0 0
Czechia
State/province [16] 0 0
Brno
Country [17] 0 0
Czechia
State/province [17] 0 0
Hradec Kralove
Country [18] 0 0
Czechia
State/province [18] 0 0
Olomouc
Country [19] 0 0
Czechia
State/province [19] 0 0
Ostrava - Poruba
Country [20] 0 0
Czechia
State/province [20] 0 0
Plzen
Country [21] 0 0
Czechia
State/province [21] 0 0
Praha 2
Country [22] 0 0
Denmark
State/province [22] 0 0
Aalborg
Country [23] 0 0
Denmark
State/province [23] 0 0
Aarhus N
Country [24] 0 0
Denmark
State/province [24] 0 0
Odense C
Country [25] 0 0
France
State/province [25] 0 0
Bayonne
Country [26] 0 0
France
State/province [26] 0 0
Caen
Country [27] 0 0
France
State/province [27] 0 0
Dijon
Country [28] 0 0
France
State/province [28] 0 0
La Roche Sur Yon
Country [29] 0 0
France
State/province [29] 0 0
Lille
Country [30] 0 0
France
State/province [30] 0 0
Nantes
Country [31] 0 0
France
State/province [31] 0 0
Paris
Country [32] 0 0
France
State/province [32] 0 0
Pessac
Country [33] 0 0
France
State/province [33] 0 0
Pierre Benite
Country [34] 0 0
France
State/province [34] 0 0
Poitiers Cedex
Country [35] 0 0
France
State/province [35] 0 0
TOULOUSE Cedex 9
Country [36] 0 0
France
State/province [36] 0 0
Vandoeuvre-les-nancy
Country [37] 0 0
Germany
State/province [37] 0 0
Berlin
Country [38] 0 0
Germany
State/province [38] 0 0
Frankfurt am Main
Country [39] 0 0
Germany
State/province [39] 0 0
Heidelberg
Country [40] 0 0
Germany
State/province [40] 0 0
Tübingen
Country [41] 0 0
Greece
State/province [41] 0 0
Athens
Country [42] 0 0
Greece
State/province [42] 0 0
Thessaloniki
Country [43] 0 0
Italy
State/province [43] 0 0
Ancona
Country [44] 0 0
Italy
State/province [44] 0 0
Bergamo
Country [45] 0 0
Italy
State/province [45] 0 0
Bologna
Country [46] 0 0
Italy
State/province [46] 0 0
Brescia
Country [47] 0 0
Italy
State/province [47] 0 0
Torino
Country [48] 0 0
Japan
State/province [48] 0 0
Aichi
Country [49] 0 0
Japan
State/province [49] 0 0
Ibaraki
Country [50] 0 0
Japan
State/province [50] 0 0
Kanagawa
Country [51] 0 0
Japan
State/province [51] 0 0
Kumamoto
Country [52] 0 0
Japan
State/province [52] 0 0
Miyagi
Country [53] 0 0
Japan
State/province [53] 0 0
Okayama
Country [54] 0 0
Japan
State/province [54] 0 0
Shizuoka
Country [55] 0 0
Japan
State/province [55] 0 0
Tokyo
Country [56] 0 0
Japan
State/province [56] 0 0
Yamagata-shi
Country [57] 0 0
Lithuania
State/province [57] 0 0
Klaipeda
Country [58] 0 0
Lithuania
State/province [58] 0 0
Vilnius
Country [59] 0 0
Mexico
State/province [59] 0 0
Nuevo León
Country [60] 0 0
New Zealand
State/province [60] 0 0
Auckland
Country [61] 0 0
New Zealand
State/province [61] 0 0
Waikato
Country [62] 0 0
Poland
State/province [62] 0 0
Lódzkie
Country [63] 0 0
Poland
State/province [63] 0 0
Mazowieckie
Country [64] 0 0
Poland
State/province [64] 0 0
Pomorskie
Country [65] 0 0
Poland
State/province [65] 0 0
Wielkopolskie
Country [66] 0 0
Portugal
State/province [66] 0 0
Braga
Country [67] 0 0
Portugal
State/province [67] 0 0
Coimbra
Country [68] 0 0
Portugal
State/province [68] 0 0
Lisboa
Country [69] 0 0
Portugal
State/province [69] 0 0
Porto
Country [70] 0 0
Russian Federation
State/province [70] 0 0
Moscow
Country [71] 0 0
Spain
State/province [71] 0 0
Barcelona [Barcelona]
Country [72] 0 0
Spain
State/province [72] 0 0
Madrid
Country [73] 0 0
Spain
State/province [73] 0 0
Murcia
Country [74] 0 0
Sweden
State/province [74] 0 0
Lund
Country [75] 0 0
Sweden
State/province [75] 0 0
Stockholm
Country [76] 0 0
Taiwan
State/province [76] 0 0
Changhua
Country [77] 0 0
Taiwan
State/province [77] 0 0
Taichung
Country [78] 0 0
Taiwan
State/province [78] 0 0
Taipei
Country [79] 0 0
Turkey
State/province [79] 0 0
Adana
Country [80] 0 0
Turkey
State/province [80] 0 0
Ankara
Country [81] 0 0
Turkey
State/province [81] 0 0
Istanbul
Country [82] 0 0
Turkey
State/province [82] 0 0
Izmir
Country [83] 0 0
Turkey
State/province [83] 0 0
Kayseri
Country [84] 0 0
Turkey
State/province [84] 0 0
Samsun

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Sanofi
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Sciences & Operations
Address 0 0
Sanofi
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


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/NCT03319667