Isatuximab SAR650984

DRUG17 trials

Conditions

Hematological MalignancyImmune System DisorderLymphomaMultiple MyelomaNeoplasmNon-small Cell Lung CancerPlasma Cell MyelomaProstate Cancer

Phase 1

Phase 1/2 Dose Escalation and Efficacy Study of Anti-CD38 Monoclonal Antibody in Patients With Selected CD38+ Hematological Malignancies

CompletedNCT01084252

SanofiHematological Malignancy

Start: 2010-05-11End: 2023-07-13Updated: 2024-11-01

SAR650984 (Isatuximab), Lenalidomide, and Dexamethasone in Combination in RRMM Patients

CompletedNCT01749969

SanofiPlasma Cell Myeloma

Start: 2013-02-06End: 2023-06-20Updated: 2023-07-13

SAR650984, Pomalidomide and Dexamethasone in Combination in RRMM Patients

CompletedNCT02283775

SanofiPlasma Cell Myeloma

Start: 2015-05-15End: 2021-05-26Updated: 2021-07-09

Study of Isatuximab Combined With Bortezomib + Cyclophosphamide + Dexamethasone (VCD) and Bortezomib + Lenalidomide + Dexamethasone (VRD) in Newly Diagnosed Multiple Myeloma (MM) Non Eligible for Transplant or No Intent for Immediate Transplantation

CompletedNCT02513186

SanofiPlasma Cell Myeloma

Start: 2015-09-30End: 2024-01-22Updated: 2024-01-29

Isatuximab Single Agent Study in Japanese Relapsed AND Refractory Multiple Myeloma Patients

CompletedNCT02812706

SanofiMultiple Myeloma

Start: 2016-09-05End: 2022-09-28Updated: 2024-04-01

Isatuximab in Combination With Cemiplimab in Relapsed/Refractory Multiple Myeloma (RRMM) Patients

CompletedNCT03194867

SanofiPlasma Cell Myeloma

Start: 2018-02-21End: 2023-04-05Updated: 2024-06-14

Isatuximab in Combination With REGN2810 (Cemiplimab) in Patients With Advanced Malignancies

TerminatedNCT03367819

SanofiNon-small Cell Lung Cancer, Prostate Cancer

Start: 2018-01-04End: 2021-03-10Updated: 2022-05-16

Safety, Preliminary Efficacy and PK of Isatuximab (SAR650984) Alone or in Combination With Atezolizumab in Patients With Advanced Malignancies

TerminatedNCT03637764

SanofiNeoplasm

Start: 2018-08-06End: 2022-05-11Updated: 2023-07-10

Evaluation of Pharmacokinetics, Safety, and Preliminary Efficacy of Isatuximab in Chinese Patients With Relapsed and/or Refractory Multiple Myeloma

CompletedNCT03733717

SanofiMultiple Myeloma

Start: 2018-10-22End: 2023-08-25Updated: 2023-09-08

A Study of Isatuximab-based Therapy in Participants With Lymphoma

TerminatedNCT03769181

SanofiLymphoma

Start: 2018-12-11End: 2022-11-08Updated: 2025-09-23

Safety, Pharmacokinetics, and Preliminary Efficacy of Isatuximab in Patients Awaiting Kidney Transplantation

TerminatedNCT04294459

SanofiImmune System Disorder

Start: 2020-06-18End: 2022-05-02Updated: 2025-09-17

Phase 2

Safety and Efficacy of Isatuximab in Lymphoblastic Leukemia

TerminatedNCT02999633

SanofiT-cell Type Acute Leukemia-Precursor, T-lymphoblastic Lymphoma/Leukaemia

Start: 2017-03-08End: 2017-11-14Updated: 2022-03-21

Safety, Pharmacokinetics, and Efficacy of Subcutaneous Isatuximab in Adults With Warm Autoimmune Hemolytic Anemia (wAIHA)

TerminatedNCT04661033

SanofiWarm Autoimmune Hemolytic Anemia (wAIHA)

Start: 2021-09-09End: 2023-06-26Updated: 2024-12-05

Phase 3

Multinational Clinical Study Comparing Isatuximab, Carfilzomib And Dexamethasone To Carfilzomib And Dexamethasone In Relapse And/Or Refractory Multiple Myeloma Patients

CompletedNCT03275285

SanofiPlasma Cell Myeloma

Start: 2017-10-25End: 2025-01-03Updated: 2026-02-09

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

Active, not recruitingNCT03319667

SanofiPlasma Cell Myeloma

Start: 2017-12-07End: 2027-06-30Updated: 2024-11-27

Isatuximab in Combination With Lenalidomide and Dexamethasone in High-risk Smoldering Multiple Myeloma

Active, not recruitingNCT04270409

SanofiPlasma Cell Myeloma

Start: 2020-06-16End: 2033-10-21Updated: 2025-12-12

Unknown Phase

A Prospective, Non-interventional, Multinational, Observational Study With Isatuximab in Patients With Relapsed and/or Refractory Multiple Myeloma (RRMM)

Active, not recruitingNCT04458831

SanofiPlasma Cell Myeloma

Start: 2020-08-13End: 2026-02-23Updated: 2025-06-27

2026-02-27

Selection of isatuximab dosing regimen in pediatric patients with leukemia using population pharmacokinetics.

2025-12-03

Real-world survey of triplet versus quadruplet regimen preferences in transplant-ineligible (TIE) or deferred patients with newly diagnosed (ND) multiple myeloma (MM)

Blood2025-11-03

Final results of a multi-center phase 2 trial of isatuximab-lenalidomide in patients with high risk smoldering multiple myeloma (HRSMM)

Blood2025-11-03

Efficacy and safety of isa-vrd in elderly patients with or without frailty criteria: Pooled analysis of imroz and phase 1b studies in newly diagnosed multiple myeloma patients

Blood2025-11-03

Clonotypic peptide mass spectrometry to monitor m-protein reduction in patients with relapsed/refractory multiple myeloma from ikema Study

Blood2025-11-03

A comparison between subcutaneous isa-vrd from the isasocut study and intravenous isa-vrd from the imroz study in patients with transplant- ineligible newly diagnosed multiple myeloma

Blood2025-11-03

Isatuximab, bortezomib, lenalidomide, and dexamethasone (Isa-VRd) in newly diagnosed multiple myeloma (NDMM): Outcomes in patients with 1q21+ status in the phase 3 IMROZ study.

Journal of Clinical Oncology2025-05-28

Impact of patient frailty on the choice of induction treatment for transplant-ineligible (TIE) newly diagnosed (ND) multiple myeloma (MM).

Journal of Clinical Oncology2025-05-28

Positron emission tomography with computed tomography (PET/CT) and minimal residual disease (MRD) for efficacy assessment in transplant-ineligible newly diagnosed myeloma (Ti NDMM) patients (pts): IMROZ analysis.

Journal of Clinical Oncology2025-05-28

Isatuximab plus bortezomib, lenalidomide, and dexamethasone for transplant-ineligible newly diagnosed multiple myeloma patients: a frailty subgroup analysis of the IMROZ trial.

2025-03-203 citations

Phase 1 study of isatuximab monotherapy in Chinese patients with relapsed/refractory multiple myeloma.

2024-11-11

Isatuximab, Bortezomib, Lenalidomide, and Dexamethasone (Isa-VRd) in Patients with Newly Diagnosed Multiple Myeloma (NDMM): Analyses of Minimal Residual Disease (MRD) Negativity Dynamics in the Phase 3 Imroz Study

Blood2024-11-055 citations

Real-World Experience with Isatuximab in Patients with Relapsed and/or Refractory Multiple Myeloma (RRMM): Iona-MM Second Interim Analysis

Blood2024-11-052 citations

Blood2024-11-051 citations

Isatuximab, Bortezomib, Lenalidomide, and Dexamethasone (Isa-VRd) in Patients with Newly Diagnosed Multiple Myeloma (NDMM) Not Eligible or with No Immediate Intent for Transplant: Long-Term Efficacy and Safety in a Phase 1b Study

Blood2024-11-051 citations

Isatuximab Plus Bortezomib, Lenalidomide, and Dexamethasone (Isa-VRd) Versus Vrd in Chinese Patients with Newly Diagnosed Multiple Myeloma Who Are Ineligible for Transplant: IMROZ Subgroup Analysis

Blood2024-11-051 citations

Anti-HLA serologic response to CD38-targeting desensitization therapy is challenged by peripheral memory B cells in highly sensitized kidney transplant candidates.

2024-08-1013 citations

Isatuximab plus carfilzomib-dexamethasone versus carfilzomib-dexamethasone in patients with relapsed multiple myeloma (IKEMA): overall survival analysis of a phase 3, randomised, controlled trial.

2024-07-2414 citations

Isatuximab, Bortezomib, Lenalidomide, and Dexamethasone for Multiple Myeloma

New England Journal of Medicine2024-06-03191 citations

79 more papers not shown

Isatuximab SAR650984

Sponsors

Conditions

Phase 1

Phase 2

Phase 3

Unknown Phase

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