TriangleNCT03319667 · CITED IN SOURCE DOCUMENTS
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
An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.
- Phase
- PHASE3
- Status at capture
- ACTIVE NOT RECRUITING
- Registry last update
- 2026-05-04
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.
Open the original ClinicalTrials.gov record → · Download preserved record
What did the study report?
Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.
No posted result sections were captured. Registered plans do not establish that a treatment works.
Who could take part
- eligibility Criteria
- Inclusion Criteria: Inclusion criteria : * 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. 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.
- healthy Volunteers
- false
- maximum Age
- 80 Years
- minimum Age
- 18 Years
- sex
- ALL
- std Ages
- ADULT
- OLDER_ADULT
Treatment arms and interventions
- arm Groups
- description
- 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
- intervention Names
- Drug: Isatuximab SAR650984
- Drug: Bortezomib
- Drug: Lenalidomide
- Drug: Dexamethasone
- label
- Isatuximab/Bortezomib/Lenalidomide/Dexamethasone = IVRd arm
- type
- EXPERIMENTAL
- description
- 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
- intervention Names
- Drug: Bortezomib
- Drug: Lenalidomide
- Drug: Dexamethasone
- label
- Bortezomib/Lenalidomide/Dexamethasone = VRd arm
- type
- ACTIVE_COMPARATOR
- description
- 4-weeks cycles with IV isatuximab + oral lenalidomide + IV or oral dexamethasone
- intervention Names
- Drug: Isatuximab SAR650984
- Drug: Lenalidomide
- Drug: Dexamethasone
- label
- Isatuximab/Lenalidomide/Dexamethasone = IRd crossover arm
- type
- OTHER
- interventions
- arm Group Labels
- Isatuximab/Bortezomib/Lenalidomide/Dexamethasone = IVRd arm
- Isatuximab/Lenalidomide/Dexamethasone = IRd crossover arm
- description
- Pharmaceutical form: Solution for infusion Route of administration: Intravenous (IV)
- name
- Isatuximab SAR650984
- other Names
- Sarclisa
- type
- DRUG
- arm Group Labels
- Bortezomib/Lenalidomide/Dexamethasone = VRd arm
- Isatuximab/Bortezomib/Lenalidomide/Dexamethasone = IVRd arm
- description
- Pharmaceutical form: Lyophilized powder for injection Route of administration: Subcutaneous
- name
- Bortezomib
- other Names
- Velcade®
- type
- DRUG
- arm Group Labels
- Bortezomib/Lenalidomide/Dexamethasone = VRd arm
- Isatuximab/Bortezomib/Lenalidomide/Dexamethasone = IVRd arm
- Isatuximab/Lenalidomide/Dexamethasone = IRd crossover arm
- description
- Pharmaceutical form: Capsules Route of administration: Oral
- name
- Lenalidomide
- type
- DRUG
- arm Group Labels
- Bortezomib/Lenalidomide/Dexamethasone = VRd arm
- Isatuximab/Bortezomib/Lenalidomide/Dexamethasone = IVRd arm
- Isatuximab/Lenalidomide/Dexamethasone = IRd crossover arm
- description
- Pharmaceutical form: Tablets, ampoules or vials for injection Route of administration: Oral/Intravenous
- name
- Dexamethasone
- type
- DRUG
Study design
- allocation
- RANDOMIZED
- intervention Model
- PARALLEL
- intervention Model Description
- Parallel and crossover
- masking Info
- masking
- SINGLE
- who Masked
- OUTCOMES_ASSESSOR
- primary Purpose
- TREATMENT
Enrollment
- count
- 475
- type
- ACTUAL
Registered outcome plans (not posted results)
- primary Outcomes
- 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.
- measure
- Progression free survival (PFS)
- time Frame
- Up to approximately 100 months after the First Participant In (FPI)
- secondary Outcomes
- description
- Defined as the proportion of participants with CR and stringent complete response (sCR) as assessed by the IRC using the IMWG criteria.
- measure
- Complete response rate (CR)
- time Frame
- Up to approximately 100 months after the FPI
- description
- Proportion of participants with CR for whom MRD measurement is negative
- measure
- Minimal residual disease (MRD) negativity rate for participants with CR
- time Frame
- Up to approximately 100 months after the FPI
- description
- Proportion of participants with sCR, CR and VGPR as assessed by the IRC using the International Myeloma Working Group (IMWG) criteria
- measure
- Very good partial response (VGPR) or better rate
- time Frame
- Up to approximately 100 months after the FPI
- description
- Defined as the time from the date of randomization to death from any cause
- measure
- Overall survival (OS)
- time Frame
- Up to approximately 110 months after the FPI
- description
- 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
- measure
- Overall response rate (ORR)
- time Frame
- Up to approximately 100 months after the FPI assessment
- description
- Defined as the time from randomization to date of first documentation of PD as assessed by the IRC using the IMWG criteria
- measure
- Time to progression (TTP)
- time Frame
- Up to approximately 100 months after FPI
- description
- 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
- measure
- Duration of response (DOR)
- time Frame
- Up to approximately 100 months after the FPI
- description
- Time from randomization to the first IRC determined response (PR or better) that is subsequently confirmed
- measure
- Time to first response (TT1R)
- time Frame
- Up to approximately 100 months after the FPI
- 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
- measure
- Time to best response (TTBR)
- time Frame
- Up to approximately 100 months after the FPI
- 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
- measure
- PFS on next line of therapy (PFS2)
- time Frame
- Up to approximately 110 months after the FPI
- 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 participants
- measure
- PFS in MRD negative participants
- time Frame
- Up to approximately 100 months after the FPI
- description
- Defined as the proportion of participants with the maintenance of MRD negativity confirmed ≥12 months apart with no MRD positive test in between.
- measure
- Sustained MRD negativity ≥12 months rate
- time Frame
- Up to approximately 100 months after the FPI
Full 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 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.
Source references
- references
- citation
- 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.
- pmid
- 41758929
- type
- DERIVED
- citation
- 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.
- pmid
- 40109195
- type
- DERIVED
- citation
- 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.
- pmid
- 38832972
- type
- DERIVED
- citation
- 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.
- pmid
- 38573925
- type
- DERIVED
Source notices and limitations
Discovery and provenance
- release id
- ctgov-registry-7ad944f6deaf1f5cd6122126
- edge id
- nct-edge-1ba4f1bfb6cfd9adcfe1
- requested nct id
- NCT03319667
- primary nct id
- NCT03319667
- source kind
- fda_spl_label
- source record id
- 7bfd2975-f348-4a3b-890e-63006967b82a
- source file sha256
- a4bef6778baed183e5bcf581938b0b23d3576dfd9eb6150f2904934a750c5fef
- payload sha256
- 2a27fddace9c878d6cd89e9fbfcdf3b07875c8b3f642aa34cbd5a043afacacef
- payload
- application numbers
- BLA761113
- clinical indication matching status
- not_inferred
- end exclusive
- true
- id
- nct-edge-1ba4f1bfb6cfd9adcfe1
- link basis
- explicit_NCT_identifier_in_acquired_source
- nct id
- NCT03319667
- occurrences
- context exact
- igure 2 Newly Diagnosed Multiple Myeloma IMROZ The efficacy of SARCLISA in combination with bortezomib, lenalidomide, and dexamethasone was evaluated in IMROZ (NCT03319667), a multicenter, international, randomized, open-label, 2-arm, phase 3 study in patients with newly diagnosed multiple myeloma who are not eligible for stem ce
- end
- 10329
- exact text
- NCT03319667
- start
- 10318
- offset unit
- unicode_code_points
- source file
- /tmp/cancer-full-research/indications/raw/labels-00400.json
- source file sha256
- a4bef6778baed183e5bcf581938b0b23d3576dfd9eb6150f2904934a750c5fef
- source json pointer
- /results/72/clinical_studies/0
- source kind
- fda_spl_label
- source record id
- 7bfd2975-f348-4a3b-890e-63006967b82a
- source string basis
- parsed_JSON_string_unmodified
- source string sha256
- 3b3010e8ad2f5e474d906dbe664cbb8742cdde58432501380df9ae809bf7653b
- spl effective time
- 20260707
- spl set id
- a0473462-6f9d-4eca-a5bf-8620aea68e8a
- release id
- ctgov-registry-7ad944f6deaf1f5cd6122126
- edge id
- nct-edge-d7d1df80013a37711f89
- requested nct id
- NCT03319667
- primary nct id
- NCT03319667
- source kind
- nci_explicit_reference_or_link
- source record id
- Source null
- source file sha256
- d6d5c80c67e5b4a0e31dcb23f10af8ee613bf3cdea28b12cf6edeec4e8cb5efd
- payload sha256
- 4373cbbeaf40f6281512117fcfa8f12892dc62c1efc63d7bd8e1401179a71d20
- payload
- clinical indication matching status
- not_inferred
- end exclusive
- true
- id
- nct-edge-d7d1df80013a37711f89
- link basis
- explicit_NCT_identifier_in_acquired_source
- nct id
- NCT03319667
- occurrences
- context exact
- Professional&language=English'); return(false);">Level of evidence B3</a>]</li></ul></div></li><li>A prospective randomized trial (<a href="/clinicaltrials/NCT03319667">NCT03319667</a>) was conducted in 446 patients with newly diagnosed myeloma who were ineligible for transplant. Patients were randomly assigned in a 3:2 ratio
- end
- 165290
- exact text
- NCT03319667
- start
- 165279
- context exact
- amp;language=English'); return(false);">Level of evidence B3</a>]</li></ul></div></li><li>A prospective randomized trial (<a href="/clinicaltrials/NCT03319667">NCT03319667</a>) was conducted in 446 patients with newly diagnosed myeloma who were ineligible for transplant. Patients were randomly assigned in a 3:2 ratio to receive e
- end
- 165303
- exact text
- NCT03319667
- start
- 165292
- offset unit
- unicode_code_points
- source file
- /tmp/cancer-full-research/nci/raw/f296c0ceec7921f192.html
- source file sha256
- d6d5c80c67e5b4a0e31dcb23f10af8ee613bf3cdea28b12cf6edeec4e8cb5efd
- source json pointer
- Source null
- source kind
- nci_explicit_reference_or_link
- source record id
- Source null
- source retrieved at
- 2026-09-09T23:22:07.301466+00:00
- source string basis
- UTF-8_text_with_universal_newline_translation
- source string sha256
- 06d77adc5701fe0c36d2266d613a483252a6113e6a22b8858db2d23882bdc33b
- source title
- Plasma Cell Neoplasms (Including Multiple Myeloma) Treatment (PDQ®)–Health Professional Version
- source update dates
- context
- Updated: April 25, 2025
- datetime
- 2025-04-25T12:00:00Z
- display
- April 25, 2025
Preserved source evidence · Not medical advice