Clinical Benefit of SAR650984, Bortezomib, Lenalidomide and Dexamethasone Combination in NDMM Patients Not Eligible for Transplant

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 - Imroz

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-002238-21-LT

Enrollment

440

Registered

2017-09-27

Start date

2017-10-25

Completion date

Unknown

Last updated

2024-10-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Plasma cell myeloma MedDRA version: 21.1 Level: PT Classification code 10035226 Term: Plasma cell myeloma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Interventions

Product Name: isatuximab Product Code: SAR650984 Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: Isatuximab Current Sponsor code: SAR650984 Other descriptive name: SAR6

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: -Multiple myeloma (International Myeloma Working Group [IMWG] criteria). -Newly diagnosed multiple myeloma not eligible for transplant due to age (= 65 years) or patients =65 years) yes F.1.3.1 Number of subjects for this age range 220

Exclusion criteria

Exclusion criteria: -Age 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.

Design outcomes

Primary

Measure	Time frame
Main 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 Objective: -To evaluate in both randomized 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,time to progression (TTP) overall and by MRD status,PFS by MRD status,duration of response (DOR) overall and by MRD status,time to first response (TT1R),time to best response (TTBR),progression-free survival on next line of therapy (PFS2),sustained MRD negativity >12 months rate,safety,PK profile of isatuximab in combination with bortezomib, lenalidomide, and dexamethasone (IVRd arm only),immunogenicity of isatuximab in patients receiving isatuximab (IVRd and crossover arms),disease-specific and generic health-related quality of life (HRQL), disease and treatment-related symptoms, health state utility, and health status.;Primary end point(s): Progression free survival (PFS): 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;Timepoint(s) of evaluation of this end point: Up to approximately 100 months after the First Patient In (FPI)	—

Measure

Time frame

Main 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 Objective: -To evaluate in both randomized 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,time to progression (TTP) overall and by MRD status,PFS by MRD status,duration of response (DOR) overall and by MRD status,time to first response (TT1R),time to best response (TTBR),progression-free survival on next line of therapy (PFS2),sustained MRD negativity >12 months rate,safety,PK profile of isatuximab in combination with bortezomib, lenalidomide, and dexamethasone (IVRd arm only),immunogenicity of isatuximab in patients receiving isatuximab (IVRd and crossover arms),disease-specific and generic health-related quality of life (HRQL), disease and treatment-related symptoms, health state utility, and health status.;Primary end point(s): Progression free survival (PFS): 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;Timepoint(s) of evaluation of this end point: Up to approximately 100 months after the First Patient In (FPI)

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Secondary

Measure	Time frame
Secondary end point(s): 1. Complete response (CR): proportion of patients with CR and stringent complete response (sCR) as assessed by the IRC using the IMWG criteria 2. Minimal residual disease (MRD) negativity rate for patients with CR: proportion of patients with CR for whom MRD measurement is negative 3. 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 4. Overall survival (OS): time from the date of randomization to death from any cause 5. 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 6. Time to progression (TTP): time from randomization to date of first documentation of PD as assessed by the IRC using the IMWG criteria 7. Duration of response (DOR): 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 8. Time to first response (TT1R): time from randomization to the first IRC determined response (PR or better) that is subsequently confirmed 9. Time to best response (TTBR): time from randomization to the date of first occurrence of IRC determined best response (PR or better) that is subsequently confirmed 10. PFS on next line of therapy (PFS2): 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 11. PFS in MRD negative patients: 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 12. Sustained MRD negativity =12 months rate: proportion of patients with the maintenance of MRD negativity confirmed =12 months apart with no MRD positive te	—

Measure

Time frame

Secondary end point(s): 1. Complete response (CR): proportion of patients with CR and stringent complete response (sCR) as assessed by the IRC using the IMWG criteria 2. Minimal residual disease (MRD) negativity rate for patients with CR: proportion of patients with CR for whom MRD measurement is negative 3. 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 4. Overall survival (OS): time from the date of randomization to death from any cause 5. 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 6. Time to progression (TTP): time from randomization to date of first documentation of PD as assessed by the IRC using the IMWG criteria 7. Duration of response (DOR): 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 8. Time to first response (TT1R): time from randomization to the first IRC determined response (PR or better) that is subsequently confirmed 9. Time to best response (TTBR): time from randomization to the date of first occurrence of IRC determined best response (PR or better) that is subsequently confirmed 10. PFS on next line of therapy (PFS2): 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 11. PFS in MRD negative patients: 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 12. Sustained MRD negativity =12 months rate: proportion of patients with the maintenance of MRD negativity confirmed =12 months apart with no MRD positive te

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Countries

Australia, Belgium, China, Czechia, Czech Republic, Denmark, France, Germany, Greece, Italy, Japan, Lithuania, Mexico, New Zealand, Poland, Portugal, Russian Federation, Spain, Sweden, Taiwan, Turkey, United States

Contacts

Public ContactClinical Study Unit

Sanofi AB

clinicaltrials.sweden@sanofi.com+46 86345000

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026