Sarclisa (isatuximab-irfc) / ImmunoGen, AbbVie, Sanofi  >>  Phase 3
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20 Trials

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Trial + Data / EventsStatusPhNRegionInterventionsSponsorConditionsPrimary complStudy compl
Sarclisa (isatuximab-irfc) / Sanofi
ICARIA, NCT02990338 / 2016-003097-41: Multinational Clinical Study Comparing Isatuximab, Pomalidomide, and Dexamethasone to Pomalidomide and Dexamethasone in Refractory or Relapsed and Refractory Multiple Myeloma Patients

Checkmark Approved in combination with pomalidomide and dexamethasone based on ICARIA-MM trial
Mar 2020 - Mar 2020: Approved in combination with pomalidomide and dexamethasone based on ICARIA-MM trial
Checkmark Submitted for 3L r/r multiple myeloma (based on ICARIA trial)
Jul 2019 - Jul 2019: Submitted for 3L r/r multiple myeloma (based on ICARIA trial)
Checkmark Submitted MAA for RRMM (based on ICARIA trial) in EU
More
Completed
3
307
Europe, Canada, Japan, US, RoW
Isatuximab, SAR650984, Sarclisa, Pomalidomide, POMALYST IMNOVID, Dexamethasone
Sanofi
Plasma Cell Myeloma
11/18
11/23
2020-004602-59: Multicenter Open label Phase 3 study of Isatuximab plus Lenalidomide and Dexamethasone with/without Bortezomib in the Treatment of Newly diagnosed Non Frail transplant Ineligible Multiple Myeloma elderly patients (≥ 65; < 80 years).

Not yet recruiting
3
270
Europe
Isatuximab, Lenalidomide, Bortezomib, Isatuximab, Lenalidomide, Bortezomib, Solution for injection, Capsule, hard, Powder for solution for infusion, Isatuximab, Lenalidomide, Bortezomib
CHU DE POITIERS, CHU de Poitiers
Multiple Myeloma, Diseases [C] - Blood and lymphatic diseases [C15]
 
 
2020-005216-21: Treatment strategy adapted to residual disease: treatment of patients under 66 years of age with in Newly Diagnosed Multiple Myeloma Patients ≤66 years old and eligible for transplantation Stratégie de traitement adaptée en fonction de la maladie résiduelle : traitement de patients de moins de 66 ans, atteints de myélome multiple, nouvellement diagnostiqués et éligibles à la greffe

Not yet recruiting
3
788
Europe
Isatuximab, Iberdomide, Carfilzomib, Lenalidomide, SAR650984, CC-220, L01XX45, Concentrate for solution for infusion, Capsule, hard, Powder and solution for solution for injection, SARCLISA, KYPROLIS, REVLIMID
Intergroupe Francophone du Myélome, Intergroupe Francophone du Myélome, Sanofi Aventis, BMS/CELGENE, Amgen
Patients with multiple myeloma, newly diagnosed and eligible for autologous stem cell transplantation, patients under 66 years of age, with multiple myeloma, newly diagnosed and eligible for Autologous Stem Cells transplantation patients de moins de 66 ans, atteints de myélome multiple, nouvellement diagnostiqués et éligibles à la greffe, Diseases [C] - Cancer [C04]
 
 
IKEMA, NCT03275285 / 2017-001940-37: Multinational Clinical Study Comparing Isatuximab, Carfilzomib And Dexamethasone To Carfilzomib And Dexamethasone In Relapse And/Or Refractory Multiple Myeloma Patients

Checkmark PFS data from IKEMA trial in combination with carfilzomib and dexamethasone for 2L multiple myeloma
May 2022 - May 2022: PFS data from IKEMA trial in combination with carfilzomib and dexamethasone for 2L multiple myeloma
Checkmark Approved in Australia for multiple myeloma
May 2022 - May 2022: Approved in Australia for multiple myeloma
Checkmark Approved Sarclisa + carfilzomib for refractory multiple myeloma (based on IKEMA trial)
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Completed
3
302
Europe, Canada, Japan, US, RoW
isatuximab SAR650984, Sarclisa, carfilzomib, Kyprolis, dexamethasone
Sanofi
Plasma Cell Myeloma
01/22
01/25
2021-002485-41: Phase 3 study evaluating subcutaneous versus intravenous administration of isatuximab in combination with pomalidomide and dexamethasone in patients with relapsed/refractory multiple myeloma (RRMM) Estudio de fase III, para evaluar la administración subcutánea frente a la intravenosa de isatuximab en combinación con pomalidomida y dexametasona en pacientes con mieloma múltiple recidivante o resistente (MMRR)

Ongoing
3
534
Europe
isatuximab, Imnovid, Dexamethasone, SAR650984, Solution for injection, Capsule, hard, Tablet, Imnovid 1mg, Imnovid 2mg, Imnovid 3mg, Imnovid 4mg, Dexamethasone 4 mg JENAPHARM®, Dexamethasone 8 mg JENAPHARM®
Sanofi-aventis recherche & developpement, Sanofi-aventis recherche & developpement
Multiple Myeloma Mieloma Múltiple, Multiple Myeloma Mieloma Múltiple, Diseases [C] - Cancer [C04]
 
 
2021-004130-11: Extended VRD plus Early Rescue vs Isatuximab-VRD vs Isatuximab-V-Iberdomide-D for NDMM patients who are candidates for ASCT VRD extendido más rescate temprano vs. Isatuximab-VRD vs. Isatuximab-V-Iberdomida-D en MMND candidato a TASPE

Ongoing
3
480
Europe
Iberdomide, ISATUXIMAB, LENALIDOMIDA, BORTEZOMIB, DEXAMETHASONE, CC-220, Capsule, soft, Concentrate for solution for infusion, Capsule, hard, Powder for solution for injection, Tablet, SARCLISA, REVLIMID, BORTEZOMIB TEVA, DEXAMETASONA TAD
FUNDACION PETHEMA, FUNDACION PETHEMA
Newly-diagnosed multiple myeloma (NDMM) patients who are candidates for Autologous Stem Cell Transplant (ASCT). Mieloma múltiple de nuevo diagnóstico (MMND) candidatos a trasplante autólogo de células madre hematopoyéticas (TASPE)., Newly-diagnosed multiple myeloma (NDMM) Mieloma múltiple de nuevo diagnóstico (MMND), Diseases [C] - Cancer [C04]
 
 
BENEFIT, NCT04751877: Multicenter Open Label Phase 3 Study of Isatuximab Plus Lenalidomide and Dexamethasone With/Without Bortezomib in the Treatment of Newly Diagnosed Non Frail Transplant Ineligible Multiple Myeloma Elderly Patients (≥ 65; < 80 Years).

Active, not recruiting
3
270
Europe
Isatuximab, Lenalidomide, Bortezomib, Dexamethasone
Poitiers University Hospital, Intergroupe Francophone du Myelome, Sanofi
Multiple Myeloma, Myeloma
04/24
08/27
NCT06216158: Iberdomide vs. Iberdomide Plus Isatuximab Maintenance Therapy Post ASCT in Newly Diagnosed Multiple Myeloma

Recruiting
3
411
Europe
Iberdomide, Isatuximab, Sarclisa, Dexamethasone
University of Heidelberg Medical Center, KKS Netzwerk, Wuerzburg University Hospital, Sanofi, Bristol-Myers Squibb
Multiple Myeloma
12/28
06/29
NCT06182774: Fixed Duration vs Continuous Daratumumab in Transplant Ineligible Older Adults With Newly Diagnosed Multiple Myeloma

Recruiting
3
570
Canada
Daratumumab, Lenalidomide, Dexamethasone, Isatuximab
Canadian Cancer Trials Group, Canadian Institutes of Health Research (CIHR), Myeloma Canada
Multiple Myeloma
01/32
07/32
IRAKLIA, NCT05405166 / 2021-002485-41: SC Versus IV Isatuximab in Combination With Pomalidomide and Dexamethasone in RRMM

Hourglass Jan 2025 - Jun 2025 : Regulatory submission in EU for multiple myeloma
Hourglass Jan 2025 - Jun 2025 : Regulatory submission in US for multiple myeloma
Active, not recruiting
3
531
Europe, Canada, Japan, US, RoW
Isatuximab IV, SAR650984, SARCLISA®, Isatuximab SC, Dexamethasone, Pomalidomide, Pomalyst or equivalent, Montelukast, Paracetamol / Acetaminophen, Diphenhydramine, Methylprednisolone
Sanofi, Sanofi-aventis recherche & developpement
Plasma Cell Myeloma Recurrent
11/24
03/27
MIDAS, NCT04934475: MInimal Residual Disease Adapted Strategy

Active, not recruiting
3
791
Europe, RoW
Isatuximab, Carfilzomib, Revlimid, Dexamethasone, ASCT
Intergroupe Francophone du Myelome, Amgen, Sanofi, Bristol-Myers Squibb
Multiple Myeloma
09/24
09/28
GMMG-HD7, NCT03617731 / 2017-004768-37: Trial on the Effect of Isatuximab to Lenalidomide/Bortezomib/Dexamethasone (RVd) Induction and Lenalidomide Maintenance in Patients With Newly Diagnosed Myeloma (GMMG HD7)

Jan 2025 - Dec 2025: From GMMG HD7 trial for newly diagnosed multiple myeloma
Hourglass Jan 2025 - Jun 2025 : Regulatory submission in US for 1L TE MM
Hourglass Oct 2021 - Dec 2021 : From first part of trial in newly diagnosed multiple myeloma
Active, not recruiting
3
662
Europe
Lenalidomide, Revlimid, Bortezomib, Velcade, Dexamethasone, Isatuximab
University of Heidelberg Medical Center
Multiple Myeloma
05/25
12/25
IsKia, NCT04483739 / 2019-004844-32: Isa-KRd vs KRd in Newly Diagnosed Multiple Myeloma Patients Eligible for Autologous Stem Cell Transplantation ( TRIAL)

Active, not recruiting
3
302
Europe, RoW
Carfilzomib Lenalidomide Dexamethasone, KRd, Isatuximab Carfilzomib Lenalidomide Dexamethasone, Isa-KRD
European Myeloma Network B.V., EMN Trial Office S.r.l. Impresa Sociale, Sanofi, Amgen
Multiple Myeloma
07/25
12/32
IMROZ, NCT03319667 / 2017-002238-21: 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

Jan 2024 - Dec 2024: Submission for newly diagnosed multiple myeloma (based on IMROZ trial)
Hourglass Oct 2023 - Dec 2023 : Pivotal data readout from IMROZ trial for 1L multiple myeloma
Hourglass Oct 2021 - Mar 2022 : Regulatory submissions for NDMM (based on IMROZ trial) in EU
Hourglass Jan 2021 - Dec 2021 : Primary data from IMROZ trial for newly diagnosed multiple myeloma
Active, not recruiting
3
475
Europe, Japan, US, RoW
Isatuximab SAR650984, Sarclisa, Bortezomib, Velcade®, Lenalidomide, Dexamethasone
Sanofi
Plasma Cell Myeloma
04/26
06/27
GEM21menos65, NCT05558319: NDMM Patients Candidates for ASCT Comparing Extended VRD Plus vs. Isa-VRD vs. Isa-V-Iberdomide

Not yet recruiting
3
480
Europe
Bortezomib, Isatuximab, Iberdomide, Lenalidomide, Dexamethasone
PETHEMA Foundation, Bristol-Myers Squibb, Sanofi, Adknoma, Start from scratch
Newly Diagnosed Multiple Myeloma
04/27
04/29
AlloRelapseMM, NCT05675319: Allogeneic Stem Cell Transplantation vs. Conventional Therapy as Salvage Therapy for Relapsed / Progressive Patients With Multiple Myeloma After First-line Therapy

Terminated
3
28
Europe
Allogeneic Stem Cells, carfilzomib/lenalidomide/dexamethasone (KRD), elotuzumab/lenalidomide/dexamethasone (ERD), daratumumab/bortezomib/dexamethasone (DVD), daratumumab/lenalidomide/dexamethasone (DRD), ixazomib/lenalidomide/dexamethasone (IRD), pomalidomide/bortezomib/dexamethasone (PVD), carfilzomib/daratumumab/dexamethasone (KDD), Autologous Stem Cells, daratumumab/pomalidomide/dexamethasone (DPD), isatuximab/carfilzomib/dexamethasone (Isa-KD), selinexor/bortezomib/dexamethasone (SVD)
Universitätsklinikum Hamburg-Eppendorf, Gemeinsamer Bundesausschuss (G-BA), Staburo GmbH
Multiple Myeloma
03/25
03/25
ITHACA, NCT04270409 / 2019-003139-47: Isatuximab in Combination With Lenalidomide and Dexamethasone in High-risk Smoldering Multiple Myeloma

Active, not recruiting
3
337
Europe, Canada, Japan, US, RoW
Isatuximab SAR650984, Sarclisa, Lenalidomide, Dexamethasone, Montelukast or equivalent, Acetaminophen, Diphenhydramine or equivalent, Methylprednisolone or equivalent
Sanofi
Plasma Cell Myeloma
10/30
10/33
2019-001258-25: A phase II and phase III trial comparing treatment escalation and de-escalation strategies in newly diagnosed patients with multiple myeloma suitable for stem cell transplant (TE)

Ongoing
2/3
1400
Europe
Isatuximab, Revlimid (Lenalidomide), Cyclophosphamide, Dexamethasone, Bortezomib, L04AX04, Solvent for solution for infusion, Capsule, hard, Tablet, Solution for injection, Kyprolis, Revlimid (Lenalidomide), Cyclophosphamide, Dexamethasone, Bortezomib
University of Leeds, Cancer Research UK, Sanofi S.A, Celgene Corporation
Newly diagnosed multiple myeloma, Multiple myeloma, Diseases [C] - Cancer [C04]
 
 
GRAAL-2024, NCT06860269: A 3-cohort Randomized Study Evaluating the Role of New Immunotherapeutic Agents and of Allogeneic Hematopoietic Stem Cell Transplantation (HSCT) in Frontline Therapy of Adults With Acute Lymphoblastic Leukemia

Not yet recruiting
2/3
1200
NA
Randomization + Blinatumomab + chemotherapy, Randomization + Standard frontline T-ALL chemotherapy backbone, Randomization + Isatuximab + Standard frontline T-ALL chemotherapy backbone, Randomization + Blinatumomab + Ponatinib + chemotherapy, Randomization 1 + Allo HSCT, Randomization 2 + Allo HSCT
Assistance Publique - Hôpitaux de Paris
Acute Lymphoblastic Leukemia
03/35
03/35
ELIAS, NCT05665140: Expression-linked and R-ISS-adapted Stratification for First Line Therapy in Multiple Myeloma Patients

Recruiting
2/3
100
Europe
Isatuximab, Sarclisa®, Lenalidomide, Lenalidomid®, Bortezomib, Velcade®, Dexamethasone, autologous stem cell transplant
University Hopsital Schleswig Holstein Campus Lübeck
Newly Diagnosed Multiple Myeloma
08/27
10/28

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