Back to resultsClinical Benefit of SAR650984, Bortezomib, Lenalidomide and Dexamethasone Combination in NDMM Patients Not Eligible for Transplant (IMROZ)
Primary Purpose
Plasma Cell Myeloma
Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Isatuximab SAR650984
Bortezomib
Lenalidomide
Dexamethasone
Sponsored by
About this trial
This is an interventional treatment trial for Plasma Cell Myeloma focused on measuring Anti-CD38 monoclonal antibody
Eligibility Criteria
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.
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.
Sites / Locations
- Investigational Site Number :8400006
- Investigational Site Number :8400004
- Investigational Site Number :8400007
- Investigational Site Number :8400005
- Investigational Site Number :8400001
- Investigational Site Number :0360003
- Investigational Site Number :0360001
- Investigational Site Number :0360002
- Investigational Site Number :0360007
- Investigational Site Number :0360005
- Investigational Site Number :0360004
- Investigational Site Number :0360006
- Investigational Site Number :0360008
- Investigational Site Number :0560001
- Investigational Site Number :1560002
- Investigational Site Number :1560003
- Investigational Site Number :1560008
- Investigational Site Number :1560007
- Investigational Site Number :1560009
- Investigational Site Number :1560006
- Investigational Site Number :1560005
- Investigational Site Number :1560014
- Investigational Site Number :1560004
- Investigational Site Number :1560013
- Investigational Site Number :1560011
- Investigational Site Number :1560001
- Investigational Site Number :1560012
- Investigational Site Number :2030002
- Investigational Site Number :2030007
- Investigational Site Number :2030004
- Investigational Site Number :2030003
- Investigational Site Number :2030006
- Investigational Site Number :2030001
- Investigational Site Number :2080002
- Investigational Site Number :2080003
- Investigational Site Number :2080004
- Investigational Site Number :2500011
- Investigational Site Number :2500007
- Investigational Site Number :2500009
- Investigational Site Number :2500008
- Investigational Site Number :2500001
- Investigational Site Number :2500003
- Investigational Site Number :2500012
- Investigational Site Number :2500002
- Investigational Site Number :2500006
- Investigational Site Number :2500005
- Investigational Site Number :2500004
- Investigational Site Number :2500010
- Investigational Site Number :2760003
- Investigational Site Number :2760004
- Investigational Site Number :2760001
- Investigational Site Number :2760005
- Investigational Site Number :3000003
- Investigational Site Number :3000001
- Investigational Site Number :3000002
- Investigational Site Number :3800005
- Investigational Site Number :3800003
- Investigational Site Number :3800001
- Investigational Site Number :3800004
- Investigational Site Number :3800002
- Investigational Site Number :3920007
- Investigational Site Number :3920004
- Investigational Site Number :3920008
- Investigational Site Number :3920003
- Investigational Site Number :3920009
- Investigational Site Number :3920005
- Investigational Site Number :3920006
- Investigational Site Number :3920001
- Investigational Site Number :3920002
- Investigational Site Number :3920010
- Investigational Site Number :4400002
- Investigational Site Number :4400001
- Investigational Site Number :4840001
- Investigational Site Number :5540002
- Investigational Site Number :5540003
- Investigational Site Number :5540001
- Investigational Site Number :6160003
- Investigational Site Number :6160001
- Investigational Site Number :6160002
- Investigational Site Number :6160004
- Investigational Site Number :6200002
- Investigational Site Number :6200006
- Investigational Site Number :6200001
- Investigational Site Number :6200005
- Investigational Site Number :6200003
- Investigational Site Number :6430001
- Investigational Site Number :6430002
- Investigational Site Number :7240005
- Investigational Site Number :7240004
- Investigational Site Number :7240003
- Investigational Site Number :7240001
- Investigational Site Number :7520002
- Investigational Site Number :7520001
- Investigational Site Number :1580003
- Investigational Site Number :1580002
- Investigational Site Number :1580001
- Investigational Site Number :7920006
- Investigational Site Number :7920007
- Investigational Site Number :7920001
- Investigational Site Number :7920002
- Investigational Site Number :7920004
- Investigational Site Number :7920003
- Investigational Site Number :7920005
- Investigational Site Number :7920008
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Other
Arm Label
Isatuximab/Bortezomib/Lenalidomide/Dexamethasone = IVRd arm
Bortezomib/Lenalidomide/Dexamethasone = VRd arm
Isatuximab/Lenalidomide/Dexamethasone = IRd crossover arm
Arm Description
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
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
4-weeks cycles with IV isatuximab + oral lenalidomide + IV or oral dexamethasone
Outcomes
Primary Outcome Measures
Progression free survival (PFS)
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.
Secondary Outcome Measures
Complete response rate (CR)
Defined as the proportion of patients with CR and stringent complete response (sCR) as assessed by the IRC using the IMWG criteria.
Minimal residual disease (MRD) negativity rate for patients with CR
Proportion of patients with CR for whom MRD measurement is negative
Very good partial response (VGPR) or better rate
Proportion of patients with sCR, CR and VGPR as assessed by the IRC using the International Myeloma Working Group (IMWG) criteria
Overall survival (OS)
Defined as the time from the date of randomization to death from any cause
Overall response rate (ORR)
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
Time to progression (TTP)
Defined as the time from randomization to date of first documentation of PD as assessed by the IRC using the IMWG criteria
Duration of response (DOR)
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
Time to first response (TT1R)
Time from randomization to the first IRC determined response (PR or better) that is subsequently confirmed
Time to best response (TTBR)
Defined as the time from randomization to the date of first occurrence of IRC determined best response (PR or better) that is subsequently confirmed
PFS on next line of therapy (PFS2)
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
PFS in MRD negative patients
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
Sustained MRD negativity ≥12 months rate
Defined as the proportion of patients with the maintenance of MRD negativity confirmed ≥12 months apart with no MRD positive test in between.
Adverse Events
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
Assessment of PK parameter: Ctrough
Isatuximab: Pre-dose plasma isatuximab concentration (Ctrough)
Immunogenicity
Presence of anti-drug antibodies against isatuximab
Patient reported outcome (PRO): QLQ-C30
Disease-specific HRQL will be assessed using the European Organization for Research and Treatment of Cancer (EORTC) core quality of life questionnaire (QLQ-C30)
PRO: QLQ-MY20
Disease- and treatment-related quality of life will be assessed using the EORTC myeloma module (QLQ-MY20) questionnaire
PRO: EQ-5D-5L
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)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03319667
Brief Title
Clinical Benefit of SAR650984, Bortezomib, Lenalidomide and Dexamethasone Combination in NDMM Patients Not Eligible for Transplant
Acronym
IMROZ
Official 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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 7, 2017 (Actual)
Primary Completion Date
April 5, 2026 (Anticipated)
Study Completion Date
June 30, 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
The duration of the study for each patient will include a screening period of up to 4 weeks, an induction period of 24 weeks (4 cycles with a duration of 42 ± 3 days), a continuous treatment period and a crossover period (when applicable). The cycle duration is 28 ± 3 days during the continuous treatment and crossover periods.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Plasma Cell Myeloma
Keywords
Anti-CD38 monoclonal antibody
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Parallel and crossover
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
475 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Isatuximab/Bortezomib/Lenalidomide/Dexamethasone = IVRd arm
Arm Type
Experimental
Arm Description
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
Arm Title
Bortezomib/Lenalidomide/Dexamethasone = VRd arm
Arm Type
Active Comparator
Arm Description
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
Arm Title
Isatuximab/Lenalidomide/Dexamethasone = IRd crossover arm
Arm Type
Other
Arm Description
4-weeks cycles with IV isatuximab + oral lenalidomide + IV or oral dexamethasone
Intervention Type
Drug
Intervention Name(s)
Isatuximab SAR650984
Other Intervention Name(s)
Sarclisa
Intervention Description
Pharmaceutical form: Solution for infusion
Route of administration: Intravenous (IV)
Intervention Type
Drug
Intervention Name(s)
Bortezomib
Other Intervention Name(s)
Velcade®
Intervention Description
Pharmaceutical form: Lyophilized powder for injection
Route of administration: Subcutaneous
Intervention Type
Drug
Intervention Name(s)
Lenalidomide
Intervention Description
Pharmaceutical form: Capsules
Route of administration: Oral
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Intervention Description
Pharmaceutical form: Tablets, ampoules or vials for injection
Route of administration: Oral/Intravenous
Primary Outcome Measure Information:
Title
Progression free survival (PFS)
Description
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.
Time Frame
Up to approximately 100 months after the First Patient In (FPI)
Secondary Outcome Measure Information:
Title
Complete response rate (CR)
Description
Defined as the proportion of patients with CR and stringent complete response (sCR) as assessed by the IRC using the IMWG criteria.
Time Frame
Up to approximately 100 months after the FPI
Title
Minimal residual disease (MRD) negativity rate for patients with CR
Description
Proportion of patients with CR for whom MRD measurement is negative
Time Frame
Up to approximately 100 months after the FPI
Title
Very good partial response (VGPR) or better rate
Description
Proportion of patients with sCR, CR and VGPR as assessed by the IRC using the International Myeloma Working Group (IMWG) criteria
Time Frame
Up to approximately 100 months after the FPI
Title
Overall survival (OS)
Description
Defined as the time from the date of randomization to death from any cause
Time Frame
Up to approximately 110 months after the FPI
Title
Overall response rate (ORR)
Description
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
Time Frame
Up to approximately 100 months after the FPI assessment
Title
Time to progression (TTP)
Description
Defined as the time from randomization to date of first documentation of PD as assessed by the IRC using the IMWG criteria
Time Frame
Up to approximately 100 months after FPI
Title
Duration of response (DOR)
Description
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
Time Frame
Up to approximately 100 months after the FPI
Title
Time to first response (TT1R)
Description
Time from randomization to the first IRC determined response (PR or better) that is subsequently confirmed
Time Frame
Up to approximately 100 months after the FPI
Title
Time to best response (TTBR)
Description
Defined as the time from randomization to the date of first occurrence of IRC determined best response (PR or better) that is subsequently confirmed
Time Frame
Up to approximately 100 months after the FPI
Title
PFS on next line of therapy (PFS2)
Description
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
Time Frame
Up to approximately 110 months after the FPI
Title
PFS in MRD negative patients
Description
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
Time Frame
Up to approximately 100 months after the FPI
Title
Sustained MRD negativity ≥12 months rate
Description
Defined as the proportion of patients with the maintenance of MRD negativity confirmed ≥12 months apart with no MRD positive test in between.
Time Frame
Up to approximately 100 months after the FPI
Title
Adverse Events
Description
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
Time Frame
Up to 30 days after end of treatment (EOT) visit
Title
Assessment of PK parameter: Ctrough
Description
Isatuximab: Pre-dose plasma isatuximab concentration (Ctrough)
Time Frame
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)
Title
Immunogenicity
Description
Presence of anti-drug antibodies against isatuximab
Time Frame
Up to approximately 100 months after the FPI
Title
Patient reported outcome (PRO): QLQ-C30
Description
Disease-specific HRQL will be assessed using the European Organization for Research and Treatment of Cancer (EORTC) core quality of life questionnaire (QLQ-C30)
Time Frame
Up to approximately 100 months after the FPI
Title
PRO: QLQ-MY20
Description
Disease- and treatment-related quality of life will be assessed using the EORTC myeloma module (QLQ-MY20) questionnaire
Time Frame
Up to approximately 100 months after the FPI
Title
PRO: EQ-5D-5L
Description
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)
Time Frame
Up to approximately 100 months after the FPI
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Sciences & Operations
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Investigational Site Number :8400006
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33901
Country
United States
Facility Name
Investigational Site Number :8400004
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33705
Country
United States
Facility Name
Investigational Site Number :8400007
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64132
Country
United States
Facility Name
Investigational Site Number :8400005
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Investigational Site Number :8400001
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Investigational Site Number :0360003
City
Liverpool
State/Province
New South Wales
ZIP/Postal Code
2170
Country
Australia
Facility Name
Investigational Site Number :0360001
City
Waratah
State/Province
New South Wales
ZIP/Postal Code
2298
Country
Australia
Facility Name
Investigational Site Number :0360002
City
Wollongong
State/Province
New South Wales
ZIP/Postal Code
2500
Country
Australia
Facility Name
Investigational Site Number :0360007
City
South Brisbane
State/Province
Queensland
ZIP/Postal Code
4101
Country
Australia
Facility Name
Investigational Site Number :0360005
City
Clayton
State/Province
Victoria
ZIP/Postal Code
3168
Country
Australia
Facility Name
Investigational Site Number :0360004
City
Heidelberg West
State/Province
Victoria
ZIP/Postal Code
3081
Country
Australia
Facility Name
Investigational Site Number :0360006
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Facility Name
Investigational Site Number :0360008
City
West Perth
State/Province
Western Australia
ZIP/Postal Code
6005
Country
Australia
Facility Name
Investigational Site Number :0560001
City
Liège
ZIP/Postal Code
4000
Country
Belgium
Facility Name
Investigational Site Number :1560002
City
Beijing
ZIP/Postal Code
100034
Country
China
Facility Name
Investigational Site Number :1560003
City
Beijing
ZIP/Postal Code
100191
Country
China
Facility Name
Investigational Site Number :1560008
City
Changchun
ZIP/Postal Code
130021
Country
China
Facility Name
Investigational Site Number :1560007
City
Fuzhou
ZIP/Postal Code
350001
Country
China
Facility Name
Investigational Site Number :1560009
City
Guangzhou
ZIP/Postal Code
510060
Country
China
Facility Name
Investigational Site Number :1560006
City
Guangzhou
ZIP/Postal Code
510080
Country
China
Facility Name
Investigational Site Number :1560005
City
Hangzhou
ZIP/Postal Code
310003
Country
China
Facility Name
Investigational Site Number :1560014
City
Hangzhou
ZIP/Postal Code
310003
Country
China
Facility Name
Investigational Site Number :1560004
City
Nanjing
ZIP/Postal Code
210029
Country
China
Facility Name
Investigational Site Number :1560013
City
Shanghai
ZIP/Postal Code
200025
Country
China
Facility Name
Investigational Site Number :1560011
City
Shenyang
ZIP/Postal Code
110022
Country
China
Facility Name
Investigational Site Number :1560001
City
Tianjin
ZIP/Postal Code
300020
Country
China
Facility Name
Investigational Site Number :1560012
City
Wuhan
ZIP/Postal Code
430022
Country
China
Facility Name
Investigational Site Number :2030002
City
Brno
ZIP/Postal Code
62500
Country
Czechia
Facility Name
Investigational Site Number :2030007
City
Hradec Kralove
ZIP/Postal Code
50005
Country
Czechia
Facility Name
Investigational Site Number :2030004
City
Olomouc
ZIP/Postal Code
77900
Country
Czechia
Facility Name
Investigational Site Number :2030003
City
Ostrava - Poruba
ZIP/Postal Code
70852
Country
Czechia
Facility Name
Investigational Site Number :2030006
City
Plzen
ZIP/Postal Code
30599
Country
Czechia
Facility Name
Investigational Site Number :2030001
City
Praha 2
ZIP/Postal Code
12808
Country
Czechia
Facility Name
Investigational Site Number :2080002
City
Aalborg
ZIP/Postal Code
9000
Country
Denmark
Facility Name
Investigational Site Number :2080003
City
Aarhus N
ZIP/Postal Code
8200
Country
Denmark
Facility Name
Investigational Site Number :2080004
City
Odense C
ZIP/Postal Code
5000
Country
Denmark
Facility Name
Investigational Site Number :2500011
City
Bayonne
ZIP/Postal Code
64100
Country
France
Facility Name
Investigational Site Number :2500007
City
Caen
ZIP/Postal Code
14033
Country
France
Facility Name
Investigational Site Number :2500009
City
Dijon
ZIP/Postal Code
21000
Country
France
Facility Name
Investigational Site Number :2500008
City
La Roche Sur Yon
ZIP/Postal Code
85925
Country
France
Facility Name
Investigational Site Number :2500001
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
Investigational Site Number :2500003
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Name
Investigational Site Number :2500012
City
Paris
ZIP/Postal Code
75012
Country
France
Facility Name
Investigational Site Number :2500002
City
Pessac
ZIP/Postal Code
33600
Country
France
Facility Name
Investigational Site Number :2500006
City
Pierre Benite
ZIP/Postal Code
69495
Country
France
Facility Name
Investigational Site Number :2500005
City
Poitiers Cedex
ZIP/Postal Code
86021
Country
France
Facility Name
Investigational Site Number :2500004
City
TOULOUSE Cedex 9
ZIP/Postal Code
31059
Country
France
Facility Name
Investigational Site Number :2500010
City
Vandoeuvre-les-nancy
ZIP/Postal Code
54511
Country
France
Facility Name
Investigational Site Number :2760003
City
Berlin
ZIP/Postal Code
13125
Country
Germany
Facility Name
Investigational Site Number :2760004
City
Frankfurt am Main
ZIP/Postal Code
60590
Country
Germany
Facility Name
Investigational Site Number :2760001
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
Investigational Site Number :2760005
City
Tübingen
ZIP/Postal Code
72076
Country
Germany
Facility Name
Investigational Site Number :3000003
City
Athens
ZIP/Postal Code
10676
Country
Greece
Facility Name
Investigational Site Number :3000001
City
Athens
ZIP/Postal Code
11528
Country
Greece
Facility Name
Investigational Site Number :3000002
City
Thessaloniki
ZIP/Postal Code
57010
Country
Greece
Facility Name
Investigational Site Number :3800005
City
Ancona
ZIP/Postal Code
60032
Country
Italy
Facility Name
Investigational Site Number :3800003
City
Bergamo
ZIP/Postal Code
24127
Country
Italy
Facility Name
Investigational Site Number :3800001
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
Investigational Site Number :3800004
City
Brescia
ZIP/Postal Code
25123
Country
Italy
Facility Name
Investigational Site Number :3800002
City
Torino
ZIP/Postal Code
10126
Country
Italy
Facility Name
Investigational Site Number :3920007
City
Nagoya-shi
State/Province
Aichi
ZIP/Postal Code
467-8602
Country
Japan
Facility Name
Investigational Site Number :3920004
City
Higashiibaraki-gun
State/Province
Ibaraki
ZIP/Postal Code
311-3193
Country
Japan
Facility Name
Investigational Site Number :3920008
City
Konan-ku, Yokohama-shi
State/Province
Kanagawa
ZIP/Postal Code
234-0054
Country
Japan
Facility Name
Investigational Site Number :3920003
City
Kumamoto-shi
State/Province
Kumamoto
ZIP/Postal Code
860-8556
Country
Japan
Facility Name
Investigational Site Number :3920009
City
Sendai-shi
State/Province
Miyagi
ZIP/Postal Code
983-8520
Country
Japan
Facility Name
Investigational Site Number :3920005
City
Okayama-shi
State/Province
Okayama
ZIP/Postal Code
701-1192
Country
Japan
Facility Name
Investigational Site Number :3920006
City
Sunto-gun
State/Province
Shizuoka
ZIP/Postal Code
411-8777
Country
Japan
Facility Name
Investigational Site Number :3920001
City
Shibuya-ku
State/Province
Tokyo
ZIP/Postal Code
150-8935
Country
Japan
Facility Name
Investigational Site Number :3920002
City
Shinjuku-ku
State/Province
Tokyo
ZIP/Postal Code
162-8666
Country
Japan
Facility Name
Investigational Site Number :3920010
City
Yamagata-shi
ZIP/Postal Code
990-9585
Country
Japan
Facility Name
Investigational Site Number :4400002
City
Klaipeda
ZIP/Postal Code
LT-92288
Country
Lithuania
Facility Name
Investigational Site Number :4400001
City
Vilnius
ZIP/Postal Code
08661
Country
Lithuania
Facility Name
Investigational Site Number :4840001
City
Monterrey
State/Province
Nuevo León
ZIP/Postal Code
64460
Country
Mexico
Facility Name
Investigational Site Number :5540002
City
Takapuna
State/Province
Auckland
ZIP/Postal Code
1309
Country
New Zealand
Facility Name
Investigational Site Number :5540003
City
Hamilton
State/Province
Waikato
ZIP/Postal Code
3204
Country
New Zealand
Facility Name
Investigational Site Number :5540001
City
Auckland
ZIP/Postal Code
2025
Country
New Zealand
Facility Name
Investigational Site Number :6160003
City
Lodz
State/Province
Lódzkie
ZIP/Postal Code
93-510
Country
Poland
Facility Name
Investigational Site Number :6160001
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
02-781
Country
Poland
Facility Name
Investigational Site Number :6160002
City
Gdansk
State/Province
Pomorskie
ZIP/Postal Code
80-952
Country
Poland
Facility Name
Investigational Site Number :6160004
City
Poznan
State/Province
Wielkopolskie
ZIP/Postal Code
60-631
Country
Poland
Facility Name
Investigational Site Number :6200002
City
Braga
ZIP/Postal Code
4710-243
Country
Portugal
Facility Name
Investigational Site Number :6200006
City
Coimbra
ZIP/Postal Code
3000-075
Country
Portugal
Facility Name
Investigational Site Number :6200001
City
Lisboa
ZIP/Postal Code
1070
Country
Portugal
Facility Name
Investigational Site Number :6200005
City
Porto
ZIP/Postal Code
4200-319
Country
Portugal
Facility Name
Investigational Site Number :6200003
City
Porto
ZIP/Postal Code
4200
Country
Portugal
Facility Name
Investigational Site Number :6430001
City
Moscow
ZIP/Postal Code
125284
Country
Russian Federation
Facility Name
Investigational Site Number :6430002
City
Moscow
ZIP/Postal Code
129301
Country
Russian Federation
Facility Name
Investigational Site Number :7240005
City
Barcelona
State/Province
Barcelona [Barcelona]
ZIP/Postal Code
08035
Country
Spain
Facility Name
Investigational Site Number :7240004
City
Barcelona
State/Province
Barcelona [Barcelona]
ZIP/Postal Code
08041
Country
Spain
Facility Name
Investigational Site Number :7240003
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Investigational Site Number :7240001
City
Murcia
ZIP/Postal Code
30008
Country
Spain
Facility Name
Investigational Site Number :7520002
City
Lund
ZIP/Postal Code
221 85
Country
Sweden
Facility Name
Investigational Site Number :7520001
City
Stockholm
ZIP/Postal Code
14186
Country
Sweden
Facility Name
Investigational Site Number :1580003
City
Changhua
ZIP/Postal Code
500
Country
Taiwan
Facility Name
Investigational Site Number :1580002
City
Taichung
ZIP/Postal Code
40447
Country
Taiwan
Facility Name
Investigational Site Number :1580001
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Facility Name
Investigational Site Number :7920006
City
Adana
ZIP/Postal Code
01250
Country
Turkey
Facility Name
Investigational Site Number :7920007
City
Ankara
ZIP/Postal Code
06500
Country
Turkey
Facility Name
Investigational Site Number :7920001
City
Ankara
Country
Turkey
Facility Name
Investigational Site Number :7920002
City
Istanbul
ZIP/Postal Code
34390
Country
Turkey
Facility Name
Investigational Site Number :7920004
City
Izmir
ZIP/Postal Code
35040
Country
Turkey
Facility Name
Investigational Site Number :7920003
City
Izmir
ZIP/Postal Code
35340
Country
Turkey
Facility Name
Investigational Site Number :7920005
City
Kayseri
ZIP/Postal Code
38039
Country
Turkey
Facility Name
Investigational Site Number :7920008
City
Samsun
ZIP/Postal Code
55139
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
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
Learn more about this trial
Clinical Benefit of SAR650984, Bortezomib, Lenalidomide and Dexamethasone Combination in NDMM Patients Not Eligible for Transplant
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