A Phase 3 interventional study of Isatuximab SAR650984 and Bortezomib in Plasma Cell Myeloma, sponsored by Sanofi. Active, not recruiting at 104 sites in 21 countries. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-05-04.
Sponsored by Sanofi · Phase 3, Interventional, and Treatment
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:
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.
3,760 studies on the registry are indexed under Multiple Myeloma; 769 are open to participants now.
This study's enrollment of 475 is above the median of 41 across 3,005 interventional studies indexed under Multiple Myeloma.
Browse Multiple Myeloma studies →Sanofi is the lead sponsor of 1,557 studies on the registry; 91 are open to participants now.
Of its 205 completed or terminated interventional studies of FDA-regulated products, 123 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Inclusion criteria :
Exclusion criteria:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Drug: Isatuximab SAR650984 · Drug: Bortezomib · Drug: Lenalidomide · Drug: Dexamethasone
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
Drug: Bortezomib · Drug: Lenalidomide · Drug: Dexamethasone
4-weeks cycles with IV isatuximab + oral lenalidomide + IV or oral dexamethasone
Drug: Isatuximab SAR650984 · Drug: Lenalidomide · Drug: Dexamethasone
Pharmaceutical form: Solution for infusion Route of administration: Intravenous (IV)
Also known as: Sarclisa
Pharmaceutical form: Lyophilized powder for injection Route of administration: Subcutaneous
Also known as: Velcade®
Pharmaceutical form: Capsules Route of administration: Oral
Pharmaceutical form: Tablets, ampoules or vials for injection Route of administration: Oral/Intravenous
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.
Time frame: Up to approximately 100 months after the First Participant In (FPI)
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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: Up to 30 days after end of treatment (EOT) visit
Assessment of PK parameter: Ctrough
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)
Immunogenicity
Presence of anti-drug antibodies against isatuximab
Time frame: 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)
Time frame: 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
Time frame: 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)
Time frame: Up to approximately 100 months after the FPI
Showing the first 100 of 104 sites across 21 countries. Choose a country and city above to see the rest.
Plan to share: 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
This study is active, not recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Isatuximab · Bortezomib