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
NCT ID: NCT03319667
Last Updated: 2024-11-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
475 participants
INTERVENTIONAL
2017-12-07
2027-06-30
Brief Summary
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-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 participants 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 participants 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 participants 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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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
Isatuximab SAR650984
Pharmaceutical form: Solution for infusion
Route of administration: Intravenous (IV)
Bortezomib
Pharmaceutical form: Lyophilized powder for injection
Route of administration: Subcutaneous
Lenalidomide
Pharmaceutical form: Capsules
Route of administration: Oral
Dexamethasone
Pharmaceutical form: Tablets, ampoules or vials for injection
Route of administration: Oral/Intravenous
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
Bortezomib
Pharmaceutical form: Lyophilized powder for injection
Route of administration: Subcutaneous
Lenalidomide
Pharmaceutical form: Capsules
Route of administration: Oral
Dexamethasone
Pharmaceutical form: Tablets, ampoules or vials for injection
Route of administration: Oral/Intravenous
Isatuximab/Lenalidomide/Dexamethasone = IRd crossover arm
4-weeks cycles with IV isatuximab + oral lenalidomide + IV or oral dexamethasone
Isatuximab SAR650984
Pharmaceutical form: Solution for infusion
Route of administration: Intravenous (IV)
Lenalidomide
Pharmaceutical form: Capsules
Route of administration: Oral
Dexamethasone
Pharmaceutical form: Tablets, ampoules or vials for injection
Route of administration: Oral/Intravenous
Interventions
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Isatuximab SAR650984
Pharmaceutical form: Solution for infusion
Route of administration: Intravenous (IV)
Bortezomib
Pharmaceutical form: Lyophilized powder for injection
Route of administration: Subcutaneous
Lenalidomide
Pharmaceutical form: Capsules
Route of administration: Oral
Dexamethasone
Pharmaceutical form: Tablets, ampoules or vials for injection
Route of administration: Oral/Intravenous
Other Intervention Names
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Eligibility Criteria
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Inclusion 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.
Exclusion Criteria
* 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.
18 Years
80 Years
ALL
No
Sponsors
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Sanofi
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Sciences & Operations
Role: STUDY_DIRECTOR
Sanofi
Locations
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Investigational Site Number: 8400006
Fort Myers, Florida, United States
Investigational Site Number: 8400004
St. Petersburg, Florida, United States
Investigational Site Number: 8400007
Kansas City, Missouri, United States
Investigational Site Number: 8400005
Nashville, Tennessee, United States
Investigational Site Number: 8400001
Houston, Texas, United States
Investigational Site Number : 0360003
Liverpool, New South Wales, Australia
Investigational Site Number : 0360001
Waratah, New South Wales, Australia
Investigational Site Number : 0360002
Wollongong, New South Wales, Australia
Investigational Site Number : 0360007
South Brisbane, Queensland, Australia
Investigational Site Number : 0360005
Clayton, Victoria, Australia
Investigational Site Number : 0360004
Heidelberg West, Victoria, Australia
Investigational Site Number : 0360006
Nedlands, Western Australia, Australia
Investigational Site Number : 0360008
West Perth, Western Australia, Australia
Investigational Site Number : 0560001
Liège, , Belgium
Investigational Site Number : 1560002
Beijing, , China
Investigational Site Number : 1560003
Beijing, , China
Investigational Site Number : 1560008
Changchun, , China
Investigational Site Number : 1560007
Fuzhou, , China
Investigational Site Number : 1560009
Guangzhou, , China
Investigational Site Number : 1560006
Guangzhou, , China
Investigational Site Number : 1560005
Hangzhou, , China
Investigational Site Number : 1560014
Hangzhou, , China
Investigational Site Number : 1560004
Nanjing, , China
Investigational Site Number : 1560013
Shanghai, , China
Investigational Site Number : 1560011
Shenyang, , China
Investigational Site Number : 1560001
Tianjin, , China
Investigational Site Number : 1560012
Wuhan, , China
Investigational Site Number : 2030002
Brno, , Czechia
Investigational Site Number : 2030007
Hradec Králové, , Czechia
Investigational Site Number : 2030004
Olomouc, , Czechia
Investigational Site Number : 2030003
Ostrava - Poruba, , Czechia
Investigational Site Number : 2030006
Pilsen, , Czechia
Investigational Site Number : 2030001
Prague, , Czechia
Investigational Site Number : 2080002
Aalborg, , Denmark
Investigational Site Number : 2080003
Aarhus N, , Denmark
Investigational Site Number : 2080004
Odense C, , Denmark
Investigational Site Number : 2500011
Bayonne, , France
Investigational Site Number : 2500007
Caen, , France
Investigational Site Number : 2500009
Dijon, , France
Investigational Site Number : 2500008
La Roche-sur-Yon, , France
Investigational Site Number : 2500001
Lille, , France
Investigational Site Number : 2500003
Nantes, , France
Investigational Site Number : 2500012
Paris, , France
Investigational Site Number : 2500002
Pessac, , France
Investigational Site Number : 2500006
Pierre-Bénite, , France
Investigational Site Number : 2500005
Poitiers, , France
Investigational Site Number : 2500004
Toulouse, , France
Investigational Site Number : 2500010
Vandœuvre-lès-Nancy, , France
Investigational Site Number : 2760003
Berlin, , Germany
Investigational Site Number : 2760004
Frankfurt am Main, , Germany
Investigational Site Number : 2760001
Heidelberg, , Germany
Investigational Site Number : 2760005
Tübingen, , Germany
Investigational Site Number : 3000003
Athens, , Greece
Investigational Site Number : 3000001
Athens, , Greece
Investigational Site Number : 3000002
Thessaloniki, , Greece
Investigational Site Number : 3800005
Ancona, , Italy
Investigational Site Number : 3800003
Bergamo, , Italy
Investigational Site Number : 3800001
Bologna, , Italy
Investigational Site Number : 3800004
Brescia, , Italy
Investigational Site Number : 3800002
Torino, , Italy
Investigational Site Number : 3920007
Nagoya, Aichi-ken, Japan
Investigational Site Number : 3920004
Higashiibaraki-gun, Ibaraki, Japan
Investigational Site Number : 3920008
Konan-ku, Yokohama-shi, Kanagawa, Japan
Investigational Site Number : 3920003
Kumamoto, Kumamoto, Japan
Investigational Site Number : 3920009
Sendai, Miyagi, Japan
Investigational Site Number : 3920005
Okayama, Okayama-ken, Japan
Investigational Site Number : 3920006
Sunto-gun, Shizuoka, Japan
Investigational Site Number : 3920001
Shibuya-ku, Tokyo, Japan
Investigational Site Number : 3920002
Shinjuku-ku, Tokyo, Japan
Investigational Site Number : 3920010
Yamagata, , Japan
Investigational Site Number : 4400002
Klaipėda, , Lithuania
Investigational Site Number : 4400001
Vilnius, , Lithuania
Investigational Site Number : 4840001
Monterrey, Nuevo León, Mexico
Investigational Site Number : 5540002
Takapuna, Auckland, New Zealand
Investigational Site Number : 5540003
Hamilton, Waikato Region, New Zealand
Investigational Site Number : 5540001
Auckland, , New Zealand
Investigational Site Number : 6160004
Poznan, Greater Poland Voivodeship, Poland
Investigational Site Number : 6160003
Lodz, Lódzkie, Poland
Investigational Site Number : 6160001
Warsaw, Masovian Voivodeship, Poland
Investigational Site Number : 6160002
Gdansk, Pomeranian Voivodeship, Poland
Investigational Site Number : 6200002
Braga, , Portugal
Investigational Site Number : 6200006
Coimbra, , Portugal
Investigational Site Number : 6200001
Lisbon, , Portugal
Investigational Site Number : 6200005
Porto, , Portugal
Investigational Site Number : 6200003
Porto, , Portugal
Investigational Site Number : 6430001
Moscow, , Russia
Investigational Site Number : 6430002
Moscow, , Russia
Investigational Site Number : 7240005
Barcelona, Barcelona [Barcelona], Spain
Investigational Site Number : 7240004
Barcelona, Barcelona [Barcelona], Spain
Investigational Site Number : 7240003
Madrid, , Spain
Investigational Site Number : 7240001
Murcia, , Spain
Investigational Site Number : 7520002
Lund, , Sweden
Investigational Site Number : 7520001
Stockholm, , Sweden
Investigational Site Number : 1580003
Changhua, , Taiwan
Investigational Site Number : 1580002
Taichung, , Taiwan
Investigational Site Number : 1580001
Taipei, , Taiwan
Investigational Site Number : 7920006
Adana, , Turkey (Türkiye)
Investigational Site Number : 7920007
Ankara, , Turkey (Türkiye)
Investigational Site Number : 7920001
Ankara, , Turkey (Türkiye)
Investigational Site Number : 7920002
Istanbul, , Turkey (Türkiye)
Investigational Site Number : 7920004
Izmir, , Turkey (Türkiye)
Investigational Site Number : 7920003
Izmir, , Turkey (Türkiye)
Investigational Site Number : 7920005
Kayseri, , Turkey (Türkiye)
Investigational Site Number : 7920008
Samsun, , Turkey (Türkiye)
Countries
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References
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Manier S, Dimopoulos MA, Leleu XP, Moreau P, Cavo M, Goldschmidt H, Orlowski RZ, Tron M, Tekle C, Bregeault MF, Shafer AT, Beksac M, Facon T. Isatuximab plus bortezomib, lenalidomide, and dexamethasone for transplant-ineligible newly diagnosed multiple myeloma patients: a frailty subgroup analysis of the IMROZ trial. Haematologica. 2025 Sep 1;110(9):2139-2150. doi: 10.3324/haematol.2024.287200. Epub 2025 Mar 20.
Facon T, Dimopoulos MA, Leleu XP, Beksac M, Pour L, Hajek R, Liu Z, Minarik J, Moreau P, Romejko-Jarosinska J, Spicka I, Vorobyev VI, Besemer B, Ishida T, Janowski W, Kalayoglu-Besisik S, Parmar G, Robak P, Zamagni E, Goldschmidt H, Martin TG, Manier S, Mohty M, Oprea C, Bregeault MF, Mace S, Berthou C, Bregman D, Klippel Z, Orlowski RZ; IMROZ Study Group. Isatuximab, Bortezomib, Lenalidomide, and Dexamethasone for Multiple Myeloma. N Engl J Med. 2024 Oct 31;391(17):1597-1609. doi: 10.1056/NEJMoa2400712. Epub 2024 Jun 3.
Thoren K, Menad S, Nouadje G, Mace S. Isatuximab-Specific Immunofixation Electrophoresis Assay to Remove Interference in Serum M-Protein Measurement in Patients with Multiple Myeloma. J Appl Lab Med. 2024 Jul 1;9(4):661-671. doi: 10.1093/jalm/jfae028.
Other Identifiers
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U1111-1194-2121
Identifier Type: REGISTRY
Identifier Source: secondary_id
2024-514417-34
Identifier Type: REGISTRY
Identifier Source: secondary_id
2017-002238-21
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
EFC12522
Identifier Type: -
Identifier Source: org_study_id
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