Sarclisa (isatuximab-irfc) / ImmunoGen, AbbVie, Sanofi  >>  Phase 2
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74 Trials

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Trial + Data / EventsStatusPhNRegionInterventionsSponsorConditionsPrimary complStudy compl
Sarclisa (isatuximab-irfc) / Sanofi
IsAMyP, ACTRN12621001530819p: The efficacy of Isatuximab plus Pomalidomine and Dexamethasone in patients with amyloid light-chain (AL) amyloidosis who have not responded to previous therapy

Not yet recruiting
2
12
 
Intergroupe francophone du myelome , Sanofi
Amyloid light chain (AL) Amyloidosis
 
 
IBIS Study, ACTRN12621001037897p: An immuno-therapeutic salvage strategy for ‘functional’ high-risk (FHR) multiple myeloma incorporating Iberdomide, Isatuximab and Dexamethasone.

Not yet recruiting
2
50
 
Australasian Myeloma Research Consortium, Australasian Myeloma Research Consortium
Multiple Myeloma
 
 
IBIS Study, ACTRN12621001037897: An immune-therapeutic salvage strategy for ‘functional’ high-risk (FHR) multiple myeloma incorporating Iberdomide, Isatuximab, and Dexamethasone (Iber-IsaDex) – the IBIS study

Recruiting
2
50
 
Australasian Myeloma Research Consortium, Australasian Myeloma Research Consortium
Multiple Myeloma
 
 
2016-002739-14: Safety and Efficacy of Isatuximab in Lymphoblastic Leukemia

Terminated
2
43
Europe
isatuximab, SAR650984, Concentrate for solution for infusion
Sanofi-aventis recherche & développement, Sanofi-aventis recherche & développement
Haematological malignancy, Cancer of type T white blood cells, Diseases [C] - Cancer [C04]
 
 
ISLAY, NCT02999633 / 2016-002739-14: Safety and Efficacy of Isatuximab in Lymphoblastic Leukemia

Terminated
2
14
Europe, US, RoW
Isatuximab SAR650984, dexamethasone, acetaminophen, ranitidine, diphenhydramine
Sanofi, Sanofi-aventis recherche & développement
T-cell Type Acute Leukemia-Precursor, T-lymphoblastic Lymphoma/Leukaemia
11/17
11/17
2019-001027-12: Multicenter Open label Phase 2 study of Isatuximab plus Pomalidomide and Dexamethasone with Carfilzomib in Relapsed or Refractory Multiple Myeloma

Not yet recruiting
2
90
Europe
Pomalidomide, Carfilzomib, Isatuximab, Pomalidomide, Carfilzomib, Isatuximab, Capsule, Powder for solution for infusion, Solution for injection, Pomalidomide, Carfilzomib, Isatuximab
CHU de Poitiers, CHU de Poitiers
Multiple myeloma, Diseases [C] - Blood and lymphatic diseases [C15]
 
 
2019-004154-28: Safety, pharmacokinetics, and preliminary efficacy of isatuximab in patients awaiting kidney transplantation Seguridad, farmacocinética y eficacia preliminar de isatuximab (SAR650984) en pacientes en espera de trasplante renal

Terminated
2
42
Europe
isatuximab, SAR650984, Concentrate for solution for infusion
Sanofi-Aventis Recherche & Développement, Sanofi-Aventis Recherche & Développement
(Patients awaiting) kidney transplantation (Pacientes en espera de) trasplante renal, Kidney transplantation Trasplante renal, Body processes [G] - Immune system processes [G12]
 
 
2020-000946-32: Isa-RVD Study: A clinical research study to find out how well patients with newly diagnosed multiple myeloma respond to treatment with the combination of lenalidomide, subcutaneous (SQ) bortezomib and dexamethasone (RVD) and isatuximab.

Not yet recruiting
2
52
Europe
Isatuximab, Lenalidomide, Bortezomib, Dexamethasone, Concentrate for solution for infusion, Capsule, hard, Powder for solution for injection, Tablet, Solution for injection, Revlimid, Velcade, Dexamethasone
Cancer Trials Ireland, Sanofi-Aventis Recherche & Développement
Newly diagnosed multiple myeloma., Newly diagnosed multiple myeloma., Diseases [C] - Cancer [C04]
 
 
2020-000994-26: A study to investigate Isatuximab alone or in combination with CellProtect as maintenance treatment after stem cell transplantation in patients with newly diagnosed multiple myeloma

Not yet recruiting
2
60
Europe
CellProtect, Isatuximab, Infusion, Sarclisa
Karolinska Institutet, Sanofi-Aventis Deutschland GmbH, CellProtect
Multiple Myeloma, Multiple Myeloma, Diseases [C] - Cancer [C04]
 
 
2020-004425-23: Isatuximab in combination with bortezomib and lenalidomide with minimal dexamethasone in transplant-ineligible multiple myeloma

Not yet recruiting
2
50
Europe
Velcade, Revlimid, Dexamethasone, Sarclisa, Powder for injection, Capsule, Tablet, Concentrate and solvent for concentrate for solution for infusion, Velcade (bortezomib), Revlimid (lenalidomide), Dexamethasone, Sarclisa (Isatuximab)
Oslo University Hospital, Department of Hematology, Oslo University Hospital
Multiple myeloma, Multiple myleoma, Diseases [C] - Cancer [C04]
 
 
2020-004972-17: Isatuximab in combination with Lenalidomide-Dexamethasone compared to Lenalidomide-Dexamethasone in elderly patients (aged ≥70 years) with newly diagnosed myeloma: a randomized phase II study (SGZ-2019-12650) Isatuximab in Kombination mit Lenalidomid-Dexamethason im Vergleich zu Lenalidomid-Dexamethason bei älteren Patienten (≥70 Jahre) mit neu diagnostiziertem multiplem Myelom: eine randomisierte Phase II Studie (SGZ-2019-12650). (AGMT_MM-4)

Not yet recruiting
2
198
Europe
Lenalidomide 25mg, Lenalidomide 15mg, Lenalidomide 10mg, Lenalidomide 5mg, Dexamethasone, Concentrate for solution for infusion, SARCLISA
AGMT gGmbH, Sanofi-aventis GmbH Österreich
Newly diagnosed, symptomatic multiple myeloma in elderly patients, Newly diagnosed, symptomatic multiple myeloma in elderly patients, Diseases [C] - Cancer [C04]
 
 
2021-001992-17: ICE STUDY (Isatuximab in type 1 CryoglobulinEmia)

Not yet recruiting
2
21
Europe
Isatuximab, Solution for infusion, SARCLISA 500 mg, SARCLISA 100 mg
Assistance Publique - Hôpitaux de Paris / DRCI, SANOFI
Type I cryoglobulinemia, Type I cryoglobulinemia, Diseases [C] - Immune System Diseases [C20]
 
 
2020-004333-20: Efficacity assessment of isatuximab plus pomalidomide and dexamethasone in patients with AL amyloidosis who didn't reach at least a very good partial response with their previous treatment

Not yet recruiting
2
46
Europe
Isatuximab, IMNOVID, SAR650984, Concentrate for solution for infusion, Capsule, hard, SARCLISA, IMNOVID 4 mg, IMNOVID 2 mg, IMNOVID 1 mg
Intergroupe Francophone du Myélome, Intergroupe Francophone du Myelome, Sanofi
Previously treated AL amyloidosis Amylose AL traitée précédemment, Previously treated AL amyloidosis, Diseases [C] - Blood and lymphatic diseases [C15]
 
 
2020-004513-13: Treatment with Isatuximab and Autologous Hematopoietic Stem Cell Transplantation for Relapsed Multiple Myeloma Patients (Isabel study) Trattamento con Isatuximab e trapianto autologo di cellule staminali per pazienti con mieloma multiplo recidivato (studio Isabel)

Not yet recruiting
2
50
Europe
Soldesam, SOLDESAM, Isatuximab, [NA], [SOLDESAM], [SAR650984], Oral drops, Solution for injection, Concentrate for solution for infusion, SOLDESAM - 0.2% GOCCE ORALI, SOLUZIONE FLACONE 10 ML, SOLDESAM - 4 MG/ML SOLUZIONE INIETTABILE 3 FIALE 1 ML, SOLDESAM - 8 MG/2 ML SOLUZIONE INIETTABILE 3 FIALE 2 ML
EMN RESEARCH ITALY IMPRESA SOCIALE S.R.L., SANOFI S.r.l.
Relapsed Multiple Myeloma Mieloma Multiplo recidivato, Multiple Myeloma Mieloma Multiplo, Diseases [C] - Cancer [C04]
 
 
2021-000932-70: Randomized prospective trial evaluating the efficacy of the antiCD38 monoclonal antibody isatuximab in the treatment of pure cell red aplasia by major ABO mismatch after allogeneic hematopoietic stem cell transplantation Etude prospective randomisée évaluant l’efficacité de l’anticorps monoclonal anti CD38 Isatuximab dans le traitement des érythroblastopénies par incompatibilité ABO majeure après allogreffe de cellules souches hématopoïétiques

Not yet recruiting
2
90
Europe
isatuximab, Concentrate for solution for infusion, Sarclisa
ASSISTANCE PUBLIQUE -HOPITAUX DE PARIS, French Ministery
Pure cell red aplasia by major ABO mismatch after allogeneic hematopoietic stem cell transplantation Erythroblastopénies par incompatibilité ABO majeure après allogreffe de cellules souches hématopoïétiques., Pure cell red aplasia by major ABO mismatch after allogeneic hematopoietic stem cell transplantation Erythroblastopénies par incompatibilité ABO majeure après allogreffe de cellules souches hématopoïétiques., Diseases [C] - Blood and lymphatic diseases [C15]
 
 
2021-004895-32: A Phase 2 Study of Isatuximab in combination with Bortezomib, Cyclophosphamide and Dexamethasone followed by isatuximab and lenalidomide maintenance in Newly Diagnosed Patients with Multiple Myeloma and severe Renal Impairment

Not yet recruiting
2
51
Europe
Isatuximab 100mg/5ml, Isatuximab 500mg/25ml, Bortezomib, Cyclophosphamide monohydrate, Dexamethasone, Lenalidomide, SAR650984, Concentrate for solution for infusion, Powder for solution for injection, Oral solution, Capsule, hard, SARCLISA
Hellenic Society of Hematology (EAE), SANOFI-AVENTIS AEBE
newly diagnosed patients with multiple myeloma and severe renal impairment, Multiple Myeloma and renal impairment, Diseases [C] - Cancer [C04]
 
 
2021-004917-38: A Phase 2 Study of Isatuximab in combination with Pomalidomide and Dexamethasone in MM Patients who received one prior line of therapy containing Lenalidomide and a Proteasome Inhibitor

Not yet recruiting
2
108
Europe
Isatuximab 100 mg/ 5mL, Isatuximab 500 mg/ 25mL, Dexamethasone, Pomalidomide 1 mg, Pomalidomide 2 mg, Pomalidomide 3 mg, Pomalidomide 4 mg, SAR650984, Pomalidomide, Concentrate for solution for infusion, Oral solution, Solution for infusion, Capsule, hard, SARCLISA, Imnovid
Hellenic Society of Hematology (EAE), SANOFI-AVENTIS AEBE
Multiple myeloma patients who received one prior line of therapy containing Lenalidomide and a Proteasome Inhibitor., Patients with multiple myeloma how have already received one line of therapy., Diseases [C] - Cancer [C04]
 
 
SKylaRk, NCT04430894: KRDI in Transplant-Eligible MM

Active, not recruiting
2
50
US
Carfilzomib, Kyprolis, Isatuximab, Sarclisa, Lenalidomide, REVLIMID, Dexamethasone, Decadron
Massachusetts General Hospital, Amgen, Sanofi
Multiple Myeloma
07/22
03/26
ISAKIDS, NCT03860844 / 2018-002697-45: Isatuximab in Combination With Chemotherapy in Pediatric Patients With Relapsed/Refractory Acute Lymphoblastic Leukemia or Acute Myeloid Leukemia

Hourglass Jan 2022 - Dec 2022 : From trial in pediatrics with r/r AML/ALL
Terminated
2
67
Europe, US, RoW
Isatuximab, SAR650984, Sarclisa, Dexamethasone or equivalent, Fludarabine, Cytarabine, Liposomal daunorubicin, Daunorubicin (nonliposomal), Idarubicin, Filgrastim or equivalent, Mitoxantrone, Doxorubicin, Vincristine, Pegaspargase (PEG) Asparaginase, Cyclophosphamide, Etoposide, Methotrexate, L - Asparginase, Hydroxyurea, L - Asparaginase (Erwinase)
Sanofi
Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia
09/22
05/23
NCT04802031: Rapid-infusion Isatuximab in Relapsed/Refractory Multiple Myeloma

Withdrawn
2
0
NA
Rapid Infusion Isatuximab, Hu 38SB19, ISATUXIMAB, Isatuximab-irfc, SAR 650984, SAR650984, Sarclisa
Thomas Martin, MD
Relapsed Multiple Myeloma, Refractory Multiple Myeloma
11/22
12/22
ICE, NCT05114109 / 2021-001992-17: Isatuximab in Type I Cryoglobulinemia

Not yet recruiting
2
21
NA
Isatuximab Injection
Assistance Publique - Hôpitaux de Paris, SANOFI
Multiple Myeloma, Monoclonal Gammopathy of Undetermined Significance, Cryoglobulinemic Vasculitis
12/22
12/23
ICING, NCT04763616: Study of Isatuximab and Cemiplimab in Relapsed or Refractory Natural Killer/T-cell Lymphoid Malignancy

Recruiting
2
37
RoW
Isatuximab, Cemiplimab
Won Seog Kim, Sanofi
Natural Killer/T-cell Lymphoma, Relapsed Natural Killer/T-cell Lymphoma, Refractory Natural Killer/T-cell Lymphoma
04/23
04/26
IRIL, ACTRN12619000362190: A prospective Phase II study of Isatuximab Rescue for Inadequate response to Lenalidomide and Dexamethasone in transplant ineligible patients with newly diagnosed multiple myeloma

Active, not recruiting
2
135
 
Australasian Myeloma Research Consortium, Australasian Myeloma Research Consortium
Multiple Myeloma
 
 
IsAMyP, ACTRN12621001530819: The efficacy of Isatuximab plus Pomalidomine and Dexamethasone in patients with amyloid light-chain (AL) amyloidosis who have not responded to previous therapy

Active, not recruiting
2
16
 
Intergroupe francophone du myelome , Sanofi , Leukaemia Foundation
Amyloid light chain (AL) Amyloidosis
 
 
NCT04653246: Isatuximab, Lenalidomide, Bortezomib, and Dexamethasone in NDMM

Active, not recruiting
2
52
US
Isatuximab, Sarclisa, Lenalidomide, Revlimid, Bortezomib Injection, Dexamethasone
Jacob Laubach, MD, Sanofi
Multiple Myeloma, Newly Diagnosed Multiple Myeloma (NDMM), Autologous Stem Cell Transplant
12/25
01/29
NCT03499808: S1702 Isatuximab in Treating Patients With Relapsed or Refractory Primary Amyloidosis

Completed
2
43
US
Isatuximab, Hu 38SB19, SAR 650984, SAR650984, Laboratory Biomarker Analysis
SWOG Cancer Research Network, National Cancer Institute (NCI)
Amorphous, Eosinophilic, and Acellular Deposit, Constipation, Diarrhea, Early Satiety, Gastrointestinal Hemorrhage, Hepatomegaly, Lymphadenopathy, Macroglossia, Nausea, Primary Systemic Amyloidosis, Purpura, Recurrent Primary Amyloidosis, Refractory Primary Amyloidosis
08/23
09/23
IMPEDE, NCT04835129: Isatuximab, Pomalidomide, Elotuzumab and Dexamethasone in Relapsed And/or Refractory Multiple Myeloma

Recruiting
2
53
US
Isatuximab (for run-in portion), Sarclisa, SAR-650984, isatuximab-irfc, Isatuximab (for expansion), Pomalidomide, Pomalyst, Imnovid, Elotuzumab, Empliciti, HuLuc63, Dexamethasone, Baycadron, Decadron, DexPak, TaperDex, Zema-Pak, ZoDex, Zonacort
Medical College of Wisconsin
Multiple Myeloma
01/26
01/27
NCT05346809: Isatuximab During Stem Cell Collection and Transplant in Patients With Multiple Myeloma and Lymphoma

Recruiting
2
39
US
Isatuximab, Sarclisa, Standard Procedures
Divaya Bhutani, Genzyme, a Sanofi Company
Lymphoma, Multiple Myeloma, Non-Hodgkin Lymphoma, Relapsed Hodgkin's Disease, Adult
09/26
09/26
REST, NCT04939844 / 2020-004425-23: - Replacing Steroids in the Transplant Ineligble

Completed
2
51
Europe
Isatuximab, bortezomib, lenalidomide, dexamethason
Oslo University Hospital, Nordic Myeloma Study Group, St. Olavs Hospital, Helse Stavanger HF
Multiple Myeloma
08/24
08/24
NCT04943302: Isatuximab and Bendamustine in Systemic Light Chain Amyloidosis

Withdrawn
2
0
NA
Bendamustine Hydrochloride, Isatuximab
Tufts Medical Center, Sanofi
Amyloidosis, Light Chain (AL) Amyloidosis
09/24
01/26
NCT06648889: Isatuximab in Adult Patients With Cytologic or Molecular Relapsed/Refractory CD38 Positive T-cell Acute Lymphoblastic Leukemia

Recruiting
2
40
Europe
Isatuximab, Bortezomib
Goethe University, Sanofi
T-ALL
02/28
08/28
EAE116, NCT05147493 / 2021-004895-32: A Phase 2 Study of Isatuximab in Combination With Bortezomib, Cyclophosphamide and Dexamethasone Followed by Isatuximab and Lenalidomide Maintenance in Newly Diagnosed Patients With Multiple Myeloma and Severe Renal Impairment

Not yet recruiting
2
51
Europe
Isatuximab, Bortezomib, Cyclophosphamide, Dexamethasone, Lenalidomide
Hellenic Society of Hematology, Sanofi
Multiple Myeloma, Renal Impairment, Neoplasms, Plasma Cell, Neoplasms by Histologic Type, Neoplasms, Paraproteinemias, Blood Protein Disorders, Hematologic Diseases
12/24
02/25
GMMG-CONCEPT, NCT03104842 / 2016-000432-17: Evaluation iNduction, Consolidation and Maintenance Treatment With Isatuximab , Carfilzomib, LEnalidomide and Dexamethasone

Checkmark Data from CONCEPT trial in combination with carfilzomib, lenalidomide, and dexamethasone for MM at ASH 2022
Dec 2022 - Dec 2022: Data from CONCEPT trial in combination with carfilzomib, lenalidomide, and dexamethasone for MM at ASH 2022
Active, not recruiting
2
246
Europe
Isatuximab, Carfilzomib, Lenalidomide, Dexamethasone
Universitätsklinikum Hamburg-Eppendorf
Multiple Myeloma
05/26
09/26
ISABEL, NCT04965155: A Trial for Relapsed Multiple Myeloma Patients (Isatuximab-dexamethasone)

Active, not recruiting
2
50
Europe
Isatuximab-dexamethasone
EMN Trial Office S.r.l. Impresa Sociale
Relapsed Multiple Myeloma
11/23
03/27
NCT04614558: Isatuximab in Patients With Monoclonal Gammopathy of Renal Significance

Recruiting
2
27
US
Isatuximab, Sarclisa
Columbia University, Genzyme, a Sanofi Company
Monoclonal Gammopathy
04/26
06/26
NCT04287855: Multicenter Open Label Phase 2 Study of Isatuximab Plus Pomalidomide and Dexamethasone With Carfilzomib in Relapsed or Refractory Multiple Myeloma

Active, not recruiting
2
82
Europe
Isatuximab, Carfilzomib, Pomalidomide, Dexamethasone
Poitiers University Hospital, Sanofi, Celgene, Amgen, Intergroupe Francophone du Myelome
Multiple Myeloma in Relapse, Multiple Myeloma, Refractory
04/25
04/26
IsAMYP, NCT05066607: Isatuximab Plus Pomalidomide and Dexamethasone Association for Patients With AL Amyloidosis Not in VGPR or Better After Any Previous Therapy

Recruiting
2
46
Europe
Isatuximab, Pomalidomide, Dexamethasone
Intergroupe Francophone du Myelome, Sanofi, Bristol-Myers Squibb
AL Amyloidosis
03/26
03/26
MODIFY, NCT06762769: Isatuximab and Iberdomide as Immunotherapy for High Risk in Smouldering Myeloma

Recruiting
2
63
Europe
Isatuximab, Iberdomide, Dexamethasone
University College, London, Sanofi, Bristol Myers Squibb Pharmaceuticals Limited
Smouldering Myeloma
11/32
11/32
Isa-RVD, NCT05123131: Study in Patients With Newly Diagnosed Multiple Myeloma

Active, not recruiting
2
54
Europe
Isatuximab, Bortezomib, Lenalidomide, Dexamethasone (IV)
Cancer Trials Ireland, Sanofi, Dana-Farber Cancer Institute
Multiple Myeloma
06/25
12/27
NCT02960555: Isatuximab With or Without Lenalidomide in Patients With High Risk Smoldering Multiple Myeloma (ISAMAR)

Active, not recruiting
2
61
US
Isatuximab, Hu 38SB19, Isatuximab-irfc, SAR 650984, SAR650984, Sarclisa, Laboratory Biomarker Analysis
M.D. Anderson Cancer Center, National Cancer Institute (NCI)
Smoldering Plasma Cell Myeloma
04/27
04/30
GEM-AnitoFIRST, NCT07045909: Efficacy and Safety of Anitocabtagene Autoleucel in Participants With Newly Diagnosed Multiple Myeloma

Recruiting
2
30
Europe
Daratumumab, Isatuximab, Bortezomib, Lenalidomide, Cyclophosphamide, Fludarabine, Anitocabtagene Autoleucel
PETHEMA Foundation
De Novo Multiple Myeloma, Anitocabtagene Autoleucel
03/28
03/30
NCT07053436: Horizon Two Adaptive Platform Study in High Risk Newly Diagnosed Multiple Myeloma

Not yet recruiting
2
300
NA
Bispecific Monoclonal Antibody and Triplet Therapy, Linvoseltamab, Monoclonal Antibody with Stem Cell Transplant, Isatuximab
Multiple Myeloma Research Consortium
High Risk Newly Diagnosed Multiple Myeloma
10/35
10/35
UltraFrailMM, NCT06517017: Use of Isatuximab, Dexamethasone and Lenalidomide in a Go-Slow Fashion for Ultra-Frail Patients With Multiple Myeloma

Recruiting
2
40
US
Isatuximab, Dexamethasone, Lenalidomide
University of Utah, Sanofi
Multiple Myeloma, Plasma Cell Leukemia
11/26
11/27
EAE115, NCT05298683 / 2021-004917-38: A Phase 2 Study of Isatuximab in Combination With Pomalidomide and Dexamethasone in MM Patients Who Received One Prior Line of Therapy Containing Lenalidomide and a Proteasome Inhibitor

Not yet recruiting
2
108
Europe
Isatuximab, Pomalidomide, Dexamethasone, Acetaminophen (paracetamol), Ranitidine (or equivalent), Diphenhydramine (or equivalent)
Hellenic Society of Hematology, Sanofi
Multiple Myeloma, Renal Impairment, Neoplasms, Plasma Cell, Neoplasms by Histologic Type, Neoplasms, Paraproteinemias, Blood Protein Disorders, Hematologic Diseases
11/25
01/26
NCT04240054: Bortezomib, Isatuximab, Cyclophosphamide and Dexamethasone Induction in Transplant-Eligible Multiple Myeloma Patients with Renal Insufficiency

Recruiting
2
41
US
Bortezomib, Velcade, Isatuximab, SAR650984, Cyclophosphamide, Cytoxan, Neosar, cytophosphane, Dexamethasone, Baycadron, Decadron, DexPak, TaperDex, Zema-Pak, ZoDex, Zonacort
Medical College of Wisconsin
Multiple Myeloma
12/29
12/30
ISABELA, NCT05922501: Isatuximab, Bela Maf, Pom, and Dex in Relapsed/Refractory Multiple Myeloma

Recruiting
2
50
US
Isatuximab, SAR650984, Belantamab mafodotin, GSK2857916, Pomalidomide, Dexamethasone
Massachusetts General Hospital, Sanofi, GlaxoSmithKline
Relapsed Cancer, Refractory Multiple Myeloma, Multiple Myeloma
12/28
12/30
NCT05776979: Post-Transplant Maintenance Therapy With Isatuximab Plus Lenalidomide for High-Risk Multiple Myeloma Patients

Recruiting
2
61
US
Isatuximab, SAR650984, lenalidomide
M.D. Anderson Cancer Center, Sanofi
Multiple Myeloma
12/27
12/27
DREAMM 5, NCT04126200 / 2019-001138-32: Platform Study of Belantamab Mafodotin as Monotherapy and in Combination With Anti-cancer Treatments in Participants With Relapsed/Refractory Multiple Myeloma (RRMM)

Hourglass Jul 2021 - Dec 2021 : From DREAMM-5 trial in combination with nirogacestat for r/r multiple myeloma
Hourglass Feb 2020 - Mar 2020 : Initiation of P1b sub-study of P2 DREAMM-5 trial in combination with nirogacestat for relapsed/refractory multiple myeloma
Checkmark From DREAMM 5 trial in R/R multiple myeloma patients at ASH 2019
Nov 2019 - Nov 2019: From DREAMM 5 trial in R/R multiple myeloma patients at ASH 2019
Checkmark Initiation of DREAMM-5 trial in r/r multiple myeloma
More
Active, not recruiting
2
208
Europe, Canada, US, RoW
Belantamab mafodotin, GSK3174998, Feladilimab, Nirogacestat, Dostarlimab, Isatuximab, Lenalidomide, Dexamethasone, Pomalidomide
GlaxoSmithKline
Multiple Myeloma
04/25
03/27
(CMRG)-008, NCT04786028: A Study of Isatuximab Added to Standard CyBorD Induction and Lenalidomide Maintenance Treatments in ND-TEMM

Active, not recruiting
2
72
Canada
Isatuximab
Canadian Myeloma Research Group
Multiple Myeloma
03/26
06/27
NCT05145400: Isa-Rd for Frail and/or Much Older Patients With Newly Diagnosed Multiple Myeloma

Recruiting
2
50
US
Isatuximab, Lenalidomide, REVLIMID, Dexamethasone
UNC Lineberger Comprehensive Cancer Center, Genzyme, a Sanofi Company
Multiple Myeloma, Cancer
03/26
03/31
NCT06115135: A Study of Venetoclax in Combination With Isatuximab and Dexamethasone for Relapsed/Refractory Multiple Myeloma

Recruiting
2
39
US
Venetoclax, VENCLEXTA
Oncotherapeutics
Multiple Myeloma in Relapse, Multiple Myeloma, Refractory
04/26
12/27
NCT04850599: Isatuximab, Carfilzomib, and Pomalidomide for the Treatment of Relapsed or Refractory Multiple Myeloma

Active, not recruiting
2
5
US
Carfilzomib, Kyprolis, PR-171, Isatuximab, Hu 38SB19, Isatuximab-irfc, SAR 650984, SAR650984, Sarclisa, Pomalidomide, 4-Aminothalidomide, Actimid, CC-4047, Imnovid, Pomalyst
OHSU Knight Cancer Institute, Oregon Health and Science University, Sanofi
Recurrent Plasma Cell Myeloma, Refractory Plasma Cell Myeloma
10/26
02/29
NCT05873205: Open-Label, Phase II Trial of Isatuximab for Patients With Refractory Immune Cytopenias After Allogeneic Hematopoietic Cell Transplantation

Recruiting
2
25
US
Isatuximab
Memorial Sloan Kettering Cancer Center, Sanofi
Blood Cancer, Refractory Immune Cytopenias
06/26
06/26
EMAT, NCT05690984: Elimination of Minimal Residual Disease After Transplant

Recruiting
2
31
US
Dexamethasone, Decadron, Dexasone, Diodex, Hexadrol, Maxidex, Isatuximab, Sarclisa, Lenalidomide, Revlimid
Medical College of Wisconsin
Multiple Myeloma
06/26
07/26
NCT05669989: International Treatment-extension Study in Adult Participants With Multiple Myeloma and Who Have Derived Clinical Benefit From Isatuximab

Active, not recruiting
2
70
Europe, Japan, US, RoW
Isatuximab intravenous (IV), SARCLISA®, SAR650984, Cemiplimab (SAR439684), Dexamethasone, Lenalidomide, Pomalidomide, Isatuximab subcutaneous (SC), Carfilzomib
Sanofi
Plasma Cell Myeloma
11/26
11/26
ErythroSIM, NCT05559827: Efficacy of the antiCD38 Monoclonal Antibody Isatuximab in the Treatment of PCRA by Major ABO Mismatch After Allogeneic Hematopoietic Stem Cell Transplantation

Not yet recruiting
2
90
NA
Isatuximab
Assistance Publique - Hôpitaux de Paris
Immunological Pure Red Cell Aplasia
10/26
10/26
AGMT-MM04, NCT04891809: Isatuximab in Combination With Rd Compared to Rd in Elderly Patients (Aged ≥70 Years) With NDMM

Active, not recruiting
2
198
Europe, RoW
Isatuximab-Irfc 20 MG/ML [Sarclisa], Lenalidomide, Dexamethasone Oral
Arbeitsgemeinschaft medikamentoese Tumortherapie, University of Navarra, Medical University of Vienna, Assign Data Management and Biostatistics GmbH, WiSP GmbH, Sanofi
Newly Diagnosed Multiple Myeloma
12/27
12/28
NCT04558931 / 2020-000994-26: Clinical Trial for Autologus NK Cells Alone or in Combination With Isatuximab as Maintenance for Multiple Myeloma

Recruiting
2
62
Europe
CellProtect, Autologous NK cell, Isatuximab, Sarclisa
Karolinska Institutet, Sanofi, XNK Therapeutics AB, Sweden
Multiple Myeloma
12/27
12/32
BOREALIS, NCT05272826: Study of Iberdomide, Bortezomib, Dexamethasone With Isatuximab Added on Demand for ND-NTE MM Patients

Recruiting
2
75
Canada
Iberdomide, CC-220, Bortezomib, Velcade, Dexamethasone, Decadron, Isatuximab, Sarclisa
Canadian Myeloma Research Group
Multiple Myeloma
03/28
03/31
NCT05911321: Isa-Pom-Dex in Elderly/Frail Subjects With RRMM

Active, not recruiting
2
6
US
Isatuximab, Pomalidomide, Dexamethasone
UNC Lineberger Comprehensive Cancer Center, Genzyme, a Sanofi Company
Multiple Myeloma, Relapse, Refractory, Aging, Co-morbidity
06/25
03/28
NCT04883242: Isatuximab, Carfilzomib, Pomalidomide, and Dexamethasone for the Treatment of Relapsed or Refractory Multiple Myeloma

Active, not recruiting
2
30
US
Carfilzomib, Kyprolis, PR-171, Carfilnat, CFZ, Dexamethasone, Aacidexam, Adexone, Aknichthol Dexa, Alba-Dex, Alin, Alin Depot, Alin Oftalmico, Amplidermis, Anemul mono, Auricularum, Auxiloson, Baycadron, Baycuten, Baycuten N, Cortidexason, Cortisumman, Decacort, Decadrol, Decadron, Decadron DP, Decalix, Decameth, Decasone R.p., Dectancyl, Dekacort, Deltafluorene, Deronil, Desamethasone, Desameton, Dexa-Mamallet, Dexa-Rhinosan, Dexa-Scheroson, Dexa-sine, Dexacortal, Dexacortin, Dexafarma, Dexafluorene, Dexalocal, Dexamecortin, Dexameth, Dexamethasone Intensol, Dexamethasonum, Dexamonozon, Dexapos, Dexinoral, Dexone, Dinormon, Dxevo, Fluorodelta, Fortecortin, Gammacorten, Hemady, Hexadecadrol, Hexadrol, Lokalison-F, Loverine, Methylfluorprednisolone, Millicorten, Mymethasone, Orgadrone, Spersadex, TaperDex, Visumetazone, ZoDex, Isatuximab, Hu 38SB19, Isatuximab-irfc, SAR 650984, SAR650984, Sarclisa, SAR-650984, Pomalidomide, 4-Aminothalidomide, Actimid, CC-4047, Imnovid, Pomalyst, CC4047, Bone Marrow Biopsy, Bone Marrow Aspiration, Skeletal Survey X-Ray, Computed Tomography, CAT Scan, Computed Axial Tomography, Positron Emission Tomography, PET scan, Magnetic Resonance Imaging, MRI
University of Washington, Genzyme, a Sanofi Company
Recurrent Multiple Myeloma, Refractory Multiple Myeloma
12/26
12/31
RAMP UP, NCT05344833: Post-Autologous Transplant Maintenance With Isatuximab and Lenalidomide in Minimal Residual Disease Positive Multiple Myeloma

Recruiting
2
50
US
Isatuximab, Lenalidomide
University of Illinois at Chicago, Huntsman Cancer Institute
Multiple Myeloma
12/30
12/30
Islands, NCT02812706: Isatuximab Single Agent Study in Japanese Relapsed AND Refractory Multiple Myeloma Patients

Checkmark For multiple myeloma in Japanese patients
Jun 2019 - Jun 2019: For multiple myeloma in Japanese patients
Hourglass Jan 2018 - Dec 2018 : Data from ISLANDS trial in Japanese patients
Completed
1/2
36
Japan
Isatuximab SAR650984, Sarclisa
Sanofi
Multiple Myeloma
07/18
09/22
NCT01084252 / 2013-001418-13: Phase 1/2 Dose Escalation and Efficacy Study of Anti-CD38 Monoclonal Antibody in Patients With Selected CD38+ Hematological Malignancies

Checkmark For multiple myeloma in Japanese patients
Jun 2019 - Jun 2019: For multiple myeloma in Japanese patients
Checkmark ASCO 2016
May 2016 - May 2016: ASCO 2016
Completed
1/2
351
Europe, US, RoW
Isatuximab SAR650984, Sarclisa, Dexamethasone
Sanofi
Hematological Malignancy
12/18
07/23
NCT03367819 / 2017-002846-61: Isatuximab in Combination With REGN2810 (Cemiplimab) in Patients With Advanced Malignancies

Hourglass Jan 2021 - Dec 2021 : Data of isatuximab in combination with cemiplimab in patients with mCRPC or NSCLC
Terminated
1/2
44
Europe, US, RoW
Isatuximab SAR650984, Sarclisa, Cemiplimab REGN2810
Sanofi
Prostate Cancer, Non-small Cell Lung Cancer
03/21
03/21
NCT07217184: Sub-study of Belantamab Mafodotin (GSK2857916) in Combination With Isatuximab in Participants With RRMM

Active, not recruiting
1/2
30
Europe, Canada, US, RoW
Belantamab mafodotin, GSK2857916, Isatuximab
GlaxoSmithKline
Multiple Myeloma
04/25
03/27
NCT04294459: Safety, Pharmacokinetics, and Preliminary Efficacy of Isatuximab in Patients Awaiting Kidney Transplantation

Terminated
1/2
23
Europe, US
Isatuximab SAR650984, Sarclisa, Acetaminophen (paracetamol) or equivalent, Ranitidine or equivalent, Diphenhydramine or equivalent, Methylprednisolone or equivalent, Montelukast or equivalent
Sanofi
Immune System Disorder
05/22
05/22
NCT03637764 / 2018-000390-67: Safety, Preliminary Efficacy and PK of Isatuximab (SAR650984) Alone or in Combination With Atezolizumab in Patients With Advanced Malignancies

Hourglass Apr 2021 - Dec 2021 : From trial in combination with or without Tecentriq for advanced malignancies
Terminated
1/2
107
Europe, Canada, US, RoW
Isatuximab SAR650984, Sarclisa, Atezolizumab, Tecentriq®
Sanofi
Neoplasm
05/22
05/22
Morpheus-CRC, NCT03555149 / 2017-004566-99: A Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatment Combinations in Patients With Metastatic Colorectal Cancer

Hourglass Jan 2022 - Dec 2022 : From trial in combination with tecentriq for metastatic CRC
Hourglass Oct 2020 - Dec 2020 : P1b/2 data from trial in combination with Stivarga and AB928 for mCRC
Terminated
1/2
96
Europe, US, RoW
Regorafenib, Atezolizumab, Imprime PGG, Bevacizumab, Isatuximab, Selicrelumab, Idasanutlin, AB928, LOAd703, Delolimogene mupadenorepvec
Hoffmann-La Roche
Colorectal Cancer
09/22
09/22
NCT03769181 / 2018-002442-37: A Study of Isatuximab-based Therapy in Participants With Lymphoma

Hourglass Jul 2021 - Dec 2021 : Proof of concept data from trial in combination with Libtayo for lymphoma
Terminated
1/2
58
Europe, RoW
isatuximab SAR650984, Sarclisa, cemiplimab REGN2810
Sanofi
Lymphoma
11/22
11/22
NCT03194867 / 2017-001431-39: Isatuximab in Combination With Cemiplimab in Relapsed/Refractory Multiple Myeloma (RRMM) Patients

Hourglass Jan 2021 - Dec 2021 : From trial in combination with isatuximab for r/r multiple myeloma
Hourglass Jan 2020 - Dec 2020 : OS secondary analysis data from trial in combination with isatuximab for r/r multiple myeloma
Completed
1/2
109
Europe, Canada, US, RoW
Isatuximab SAR650984, Sarclisa, Cemiplimab REGN2810
Sanofi
Plasma Cell Myeloma
04/23
04/23
CC-92480-MM-002, NCT03989414 / 2018-004767-31: A Study to Determine the Recommended Dose and Regimen and to Evaluate the Safety and Preliminary Efficacy of CC-92480 in Combination With Standard Treatments in Participants With Relapsed or Refractory Multiple Myeloma (RRMM) and Newly Diagnosed Multiple Myeloma (NDMM)

Active, not recruiting
1/2
424
Europe, Canada, US, RoW
CC-92480, BMS-986348, mezigdomide, Bortezomib, Dexamethasone, Daratumumab, Carfilzomib, Elotuzumab, Isatuximab
Celgene
Multiple Myeloma
11/26
11/26
Indapta-Trial-1, NCT06119685: IDP-023 as a Single Agent and in Combination With Antibody Therapies in Patients With Advanced Hematologic Cancers

Recruiting
1/2
128
US
IDP-023, Rituximab, Rituxan, Daratumumab, Darzalex, Interleukin-2, Proleukin, Cyclophosphamide, Fludarabine, Mesna, Isatuximab, Sarclisa
Indapta Therapeutics, INC.
NHL, Multiple Myeloma, Blood Cancer, Refractory Non-Hodgkin Lymphoma, Relapsed Non-Hodgkin Lymphoma, Refractory Multiple Myeloma, Relapsed Multiple Myeloma
12/25
12/29
NCT04643002 / 2020-003024-16: Isatuximab in Combination With Novel Agents in RRMM - Master Protocol

Recruiting
1/2
258
Europe, US, RoW
Isatuximab, SAR650984, Sarclisa®, Dexamethasone, Pomalidomide, Pomalyst®, Belantamab mafodotin, BLENREP®, Pegenzileukin, SAR444245, SAR439459, Belumosudil, SAR445761,, Rezurock, Evorpacept, ALX148
Sanofi
Plasma Cell Myeloma Refractory
09/27
04/28

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