Plasma Cell MyelomaPhase 3IMROZNCT03319667
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
A Phase 3 study testing Isatuximab SAR650984, Bortezomib and Lenalidomide in people with Plasma Cell Myeloma, run by Sanofi at 104 sites in 21 countries.
Trial 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 participants with newly diagnosed multiple myeloma (NDMM) not eligible for… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Plasma Cell Myeloma
- What is being tested?
- Isatuximab SAR650984, Bortezomib and Lenalidomide
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 475 participants
- Where
- 104 sitesin 21 countries
- Study dates
- 7 Dec 2017to 30 Jun 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
104 sites in 21 countries.
104 sites in 21 countries
China13 sites
Investigational Site Number : 1560002
Beijing, 100034
Investigational Site Number : 1560003
Beijing, 100191
Investigational Site Number : 1560008
Changchun, 130021
Investigational Site Number : 1560007
Fuzhou, 350001
Investigational Site Number : 1560009
Guangzhou, 510060
Investigational Site Number : 1560006
Guangzhou, 510080
Investigational Site Number : 1560005
Hangzhou, 310003
Investigational Site Number : 1560014
Hangzhou, 310003
Investigational Site Number : 1560004
Nanjing, 210029
Investigational Site Number : 1560013
Shanghai, 200025
Investigational Site Number : 1560011
Shenyang, 110022
Investigational Site Number : 1560001
Tianjin, 300020
Investigational Site Number : 1560012
Wuhan, 430022
France12 sites
Investigational Site Number : 2500011
Bayonne, 64100
Investigational Site Number : 2500007
Caen, 14033
Investigational Site Number : 2500009
Dijon, 21000
Investigational Site Number : 2500008
La Roche-sur-Yon, 85925
Investigational Site Number : 2500001
Lille, 59037
Investigational Site Number : 2500003
Nantes, 44093
Investigational Site Number : 2500012
Paris, 75012
Investigational Site Number : 2500002
Pessac, 33600
Investigational Site Number : 2500006
Pierre-Bénite, 69495
Investigational Site Number : 2500005
Poitiers, 86021
Investigational Site Number : 2500004
Toulouse, 31059
Investigational Site Number : 2500010
Vandœuvre-lès-Nancy, 54511
Japan10 sites
Investigational Site Number : 3920004
Higashiibaraki-gun, Ibaraki, 311-3193
Investigational Site Number : 3920008
Konan-ku, Yokohama-shi, Kanagawa, 234-0054
Investigational Site Number : 3920003
Kumamoto, Kumamoto, 860-8556
Investigational Site Number : 3920007
Nagoya, Aichi-ken, 467-8602
Investigational Site Number : 3920005
Okayama, Okayama-ken, 701-1192
Investigational Site Number : 3920009
Sendai, Miyagi, 983-8520
Investigational Site Number : 3920001
Shibuya-ku, Tokyo, 150-8935
Investigational Site Number : 3920002
Shinjuku-ku, Tokyo, 162-8666
Investigational Site Number : 3920006
Sunto-gun, Shizuoka, 411-8777
Investigational Site Number : 3920010
Yamagata, 990-9585
Australia8 sites
Investigational Site Number : 0360005
Clayton, Victoria, 3168
Investigational Site Number : 0360004
Heidelberg West, Victoria, 3081
Investigational Site Number : 0360003
Liverpool, New South Wales, 2170
Investigational Site Number : 0360006
Nedlands, Western Australia, 6009
Investigational Site Number : 0360007
South Brisbane, Queensland, 4101
Investigational Site Number : 0360001
Waratah, New South Wales, 2298
Investigational Site Number : 0360008
West Perth, Western Australia, 6005
Investigational Site Number : 0360002
Wollongong, New South Wales, 2500
Turkey (Türkiye)8 sites
Investigational Site Number : 7920006
Adana, 01250
Investigational Site Number : 7920007
Ankara, 06500
Investigational Site Number : 7920001
Ankara, 06620
Investigational Site Number : 7920002
Istanbul, 34390
Investigational Site Number : 7920004
Izmir, 35040
Investigational Site Number : 7920003
Izmir, 35340
Investigational Site Number : 7920005
Kayseri, 38039
Investigational Site Number : 7920008
Samsun, 55139
Czechia6 sites
Investigational Site Number : 2030002
Brno, 62500
Investigational Site Number : 2030007
Hradec Králové, 50005
Investigational Site Number : 2030004
Olomouc, 77900
Investigational Site Number : 2030003
Ostrava - Poruba, 70852
Investigational Site Number : 2030006
Pilsen, 30599
Investigational Site Number : 2030001
Prague, 12808
United States5 sites
Investigational Site Number: 8400006
Fort Myers, Florida, 33901
Investigational Site Number: 8400001
Houston, Texas, 77030
Investigational Site Number: 8400007
Kansas City, Missouri, 64132
Investigational Site Number: 8400005
Nashville, Tennessee, 37203
Investigational Site Number: 8400004
St. Petersburg, Florida, 33705
Italy5 sites
Investigational Site Number : 3800005
Ancona, 60032
Investigational Site Number : 3800003
Bergamo, 24127
Investigational Site Number : 3800001
Bologna, 40138
Investigational Site Number : 3800004
Brescia, 25123
Investigational Site Number : 3800002
Torino, 10126
Portugal5 sites
Investigational Site Number : 6200002
Braga, 4710-243
Investigational Site Number : 6200006
Coimbra, 3000-075
Investigational Site Number : 6200001
Lisbon, 1070
Investigational Site Number : 6200005
Porto, 4200-319
Investigational Site Number : 6200003
Porto, 4200
Germany4 sites
Investigational Site Number : 2760003
Berlin, 13125
Investigational Site Number : 2760004
Frankfurt am Main, 60590
Investigational Site Number : 2760001
Heidelberg, 69120
Investigational Site Number : 2760005
Tübingen, 72076
Poland4 sites
Investigational Site Number : 6160002
Gdansk, Pomeranian Voivodeship, 80-952
Investigational Site Number : 6160003
Lodz, Lódzkie, 93-510
Investigational Site Number : 6160004
Poznan, Greater Poland Voivodeship, 60-631
Investigational Site Number : 6160001
Warsaw, Masovian Voivodeship, 02-781
Spain4 sites
Investigational Site Number : 7240005
Barcelona, Barcelona [Barcelona], 08035
Investigational Site Number : 7240004
Barcelona, Barcelona [Barcelona], 08041
Investigational Site Number : 7240003
Madrid, 28034
Investigational Site Number : 7240001
Murcia, 30008
Denmark3 sites
Investigational Site Number : 2080002
Aalborg, 9000
Investigational Site Number : 2080003
Aarhus N, 8200
Investigational Site Number : 2080004
Odense C, 5000
Greece3 sites
Investigational Site Number : 3000003
Athens, 10676
Investigational Site Number : 3000001
Athens, 11528
Investigational Site Number : 3000002
Thessaloniki, 57010
New Zealand3 sites
Investigational Site Number : 5540001
Auckland, 2025
Investigational Site Number : 5540003
Hamilton, Waikato Region, 3204
Investigational Site Number : 5540002
Takapuna, Auckland, 1309
Taiwan3 sites
Investigational Site Number : 1580003
Changhua, 500
Investigational Site Number : 1580002
Taichung, 40447
Investigational Site Number : 1580001
Taipei, 100
Lithuania2 sites
Investigational Site Number : 4400002
Klaipėda, LT-92288
Investigational Site Number : 4400001
Vilnius, 08661
Russia2 sites
Investigational Site Number : 6430001
Moscow, 125284
Investigational Site Number : 6430002
Moscow, 129301
Sweden2 sites
Investigational Site Number : 7520002
Lund, 221 85
Investigational Site Number : 7520001
Stockholm, 14186
Mexico1 site
Investigational Site Number : 4840001
Monterrey, Nuevo León, 64460
About this study
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
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 participants with newly diagnosed multiple myeloma (NDMM) not eligible for transplant.
Read more
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.
Read the detailed description
The duration of the study for each participant 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.
- Conditions
- Plasma Cell Myeloma
- Being tested
- Isatuximab SAR650984, Bortezomib, Lenalidomide, Dexamethasone
- Keywords
- Anti-CD38 monoclonal antibody
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Isatuximab SAR650984Drug
Also called Sarclisa
Pharmaceutical form: Solution for infusion
Route of administration: Intravenous (IV)
BortezomibDrug
Also called Velcade®
Pharmaceutical form: Lyophilized powder for injection
Route of administration: Subcutaneous
LenalidomideDrug
Pharmaceutical form: Capsules
Route of administration: Oral
DexamethasoneDrug
Pharmaceutical form: Tablets, ampoules or vials for injection
Route of administration: Oral/Intravenous
| Study group | Role | What they receive |
|---|---|---|
| Isatuximab/Bortezomib/Lenalidomide/Dexamethasone = IVRd arm | Experimental | 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 Receives: Drug: Isatuximab SAR650984; Drug: Bortezomib; Drug: Lenalidomide; Drug: Dexamethasone |
| Bortezomib/Lenalidomide/Dexamethasone = VRd arm | Active comparator | 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 Receives: Drug: Bortezomib; Drug: Lenalidomide; Drug: Dexamethasone |
| Isatuximab/Lenalidomide/Dexamethasone = IRd crossover arm | Other | 4-weeks cycles with IV isatuximab + oral lenalidomide + IV or oral dexamethasone Receives: Drug: Isatuximab SAR650984; Drug: Lenalidomide; Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to approximately 100 months after the First Participant In (FPI)
Secondary outcomes (18)
Complete response rate (CR)
Defined as the proportion of participants with CR and stringent complete response (sCR) as assessed by the IRC using the IMWG criteria.
Measured: Up to approximately 100 months after the FPI
Minimal residual disease (MRD) negativity rate for participants with CR
Proportion of participants with CR for whom MRD measurement is negative
Measured: Up to approximately 100 months after the FPI
Very good partial response (VGPR) or better rate
Proportion of participants with sCR, CR and VGPR as assessed by the IRC using the International Myeloma Working Group (IMWG) criteria
Measured: Up to approximately 100 months after the FPI
Overall survival (OS)
Defined as the time from the date of randomization to death from any cause
Measured: Up to approximately 110 months after the FPI
Overall response rate (ORR)
Proportion of participants with best overall response (BOR) recorded as sCR, CR, VGPR, or partial response (PR) as assessed by the IRC using the IMWG criteria
Measured: Up to approximately 100 months after the FPI assessment
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
Measured: Up to approximately 100 months after FPI
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 participants achieving sCR, CR, VGPR, or PR
Measured: Up to approximately 100 months after the FPI
Time to first response (TT1R)
Time from randomization to the first IRC determined response (PR or better) that is subsequently confirmed
Measured: Up to approximately 100 months after the FPI
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
Measured: Up to approximately 100 months after the FPI
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
Measured: Up to approximately 110 months after the FPI
PFS in MRD negative participants
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 participants
Measured: Up to approximately 100 months after the FPI
Sustained MRD negativity ≥12 months rate
Defined as the proportion of participants with the maintenance of MRD negativity confirmed ≥12 months apart with no MRD positive test in between.
Measured: Up to approximately 100 months after the FPI
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
Measured: Up to 30 days after end of treatment (EOT) visit
Assessment of PK parameter: Ctrough
Isatuximab: Pre-dose plasma isatuximab concentration (Ctrough)
Measured: 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)
Immunogenicity
Presence of anti-drug antibodies against isatuximab
Measured: Up to approximately 100 months after the FPI
participants 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)
Measured: Up to approximately 100 months after the FPI
PRO: QLQ-MY20
Disease- and treatment-related quality of life will be assessed using the EORTC myeloma module (QLQ-MY20) questionnaire
Measured: Up to approximately 100 months after the FPI
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)
Measured: Up to approximately 100 months after the FPI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2017
- Study start7 Dec 2017
- Primary completion5 Apr 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Plasma Cell MyelomaStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel and crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 475 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03319667
- Sponsor's protocol ID
- EFC12522
- Other IDs
- U1111-1194-2121, 2024-514417-34, 2017-002238-21, 2017
- Acronym
- IMROZ
- Status last verified
- Apr 2026
- First submitted
- 18 Sep 2017
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Publications
Orlowski RZ, Dimopoulos MA, Leleu X, Facon T, Ishida T, Hajek R, Spicka I, Romejko-Jarosinska J, Vorobyev V, Besemer B, Besisik SK, Robak P, Jelinek T, Goldschmidt H, Martin T, Mohty M, Mace S, Kodas E, Tekle C, Shafer AT, Moreau P. Isatuximab, bortezomib, lenalidomide, and dexamethasone for multiple myeloma: dynamics of MRD negativity in the IMROZ study. Blood. 2026 Jun 4;147(23):2760-2769. doi: 10.1182/blood.2025030120.
PubMed 41758929Manier 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.
PubMed 40109195Facon 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.
PubMed 38832972Thoren 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.
PubMed 38573925
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03319667
- Acronym / sponsor ID
- IMROZ / EFC12522
- Conditions
- Plasma Cell Myeloma
- Keywords
- Anti-CD38 monoclonal antibody
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 475 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- 7 Dec 2017 (actual)
- Primary completion
- 5 Apr 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 24 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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.
Detailed description
The duration of the study for each participant 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Parallel and crossover
| Arm | Type | Receives |
|---|---|---|
| Isatuximab/Bortezomib/Lenalidomide/Dexamethasone = IVRd arm | Experimental | Drug: Isatuximab SAR650984, Drug: Bortezomib, Drug: Lenalidomide, Drug: Dexamethasone1. 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 |
| Bortezomib/Lenalidomide/Dexamethasone = VRd arm | Active comparator | Drug: Bortezomib, Drug: Lenalidomide, Drug: Dexamethasone1. 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 |
| Isatuximab/Lenalidomide/Dexamethasone = IRd crossover arm | Other | Drug: Isatuximab SAR650984, Drug: Lenalidomide, Drug: Dexamethasone4-weeks cycles with IV isatuximab + oral lenalidomide + IV or oral dexamethasone |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Isatuximab SAR650984Also: SarclisaPharmaceutical form: Solution for infusion Route of administration: Intravenous (IV) | Drug | Isatuximab/Bortezomib/Lenalidomide/Dexamethasone = IVRd arm, Isatuximab/Lenalidomide/Dexamethasone = IRd crossover arm |
| BortezomibAlso: Velcade®Pharmaceutical form: Lyophilized powder for injection Route of administration: Subcutaneous | Drug | Bortezomib/Lenalidomide/Dexamethasone = VRd arm, Isatuximab/Bortezomib/Lenalidomide/Dexamethasone = IVRd arm |
| LenalidomidePharmaceutical form: Capsules Route of administration: Oral | Drug | Bortezomib/Lenalidomide/Dexamethasone = VRd arm, Isatuximab/Bortezomib/Lenalidomide/Dexamethasone = IVRd arm, Isatuximab/Lenalidomide/Dexamethasone = IRd crossover arm |
| DexamethasonePharmaceutical form: Tablets, ampoules or vials for injection Route of administration: Oral/Intravenous | Drug | Bortezomib/Lenalidomide/Dexamethasone = VRd arm, Isatuximab/Bortezomib/Lenalidomide/Dexamethasone = IVRd arm, Isatuximab/Lenalidomide/Dexamethasone = IRd crossover arm |
Primary outcome
Progression free survival (PFS)
Time frame: Up to approximately 100 months after the First Participant In (FPI)
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.
18 secondary outcomes
Complete response rate (CR)
Time frame: Up to approximately 100 months after the FPI
Minimal residual disease (MRD) negativity rate for participants with CR
Time frame: Up to approximately 100 months after the FPI
Very good partial response (VGPR) or better rate
Time frame: Up to approximately 100 months after the FPI
Overall survival (OS)
Time frame: Up to approximately 110 months after the FPI
Overall response rate (ORR)
Time frame: Up to approximately 100 months after the FPI assessment
Time to progression (TTP)
Time frame: Up to approximately 100 months after FPI
Duration of response (DOR)
Time frame: Up to approximately 100 months after the FPI
Time to first response (TT1R)
Time frame: Up to approximately 100 months after the FPI
Time to best response (TTBR)
Time frame: Up to approximately 100 months after the FPI
PFS on next line of therapy (PFS2)
Time frame: Up to approximately 110 months after the FPI
PFS in MRD negative participants
Time frame: Up to approximately 100 months after the FPI
Sustained MRD negativity ≥12 months rate
Time frame: Up to approximately 100 months after the FPI
Adverse Events
Time frame: Up to 30 days after end of treatment (EOT) visit
Assessment of PK parameter: 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)
Immunogenicity
Time frame: Up to approximately 100 months after the FPI
participants reported outcome (PRO): QLQ-C30
Time frame: Up to approximately 100 months after the FPI
PRO: QLQ-MY20
Time frame: Up to approximately 100 months after the FPI
PRO: EQ-5D-5L
Time frame: Up to approximately 100 months after the FPI
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.
- Derived from this study: PubMed 41758929Orlowski RZ, Dimopoulos MA, Leleu X, Facon T, Ishida T, Hajek R, Spicka I, Romejko-Jarosinska J, Vorobyev V, Besemer B, Besisik SK, Robak P, Jelinek T, Goldschmidt H, Martin T, Mohty M, Mace S, Kodas E, Tekle C, Shafer AT, Moreau P. Isatuximab, bortezomib, lenalidomide, and dexamethasone for multiple myeloma: dynamics of MRD negativity in the IMROZ study. Blood. 2026 Jun 4;147(23):2760-2769. doi: 10.1182/blood.2025030120.
- Derived from this study: PubMed 40109195Manier 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.
- Derived from this study: PubMed 38832972Facon 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.
- Derived from this study: PubMed 38573925Thoren 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.
- EFC12522 Plain Language Results SummaryLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Sciences & Operations study director
Sanofi
104 sites in 21 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Isatuximab SAR650984, Bortezomib and Lenalidomide in people with Plasma Cell Myeloma, run by Sanofi at 104 sites in 21 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 104 sites in China, France, Japan, Australia, Turkey (Türkiye) and 16 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression free survival (PFS) (time frame: Up to approximately 100 months after the First Participant In (FPI)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03319667, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2026.