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142 Trials

   

 
Trial + Data / EventsStatusPhNRegionInterventionsSponsorConditionsPrimary complStudy compl
sapropterin / Generic mfg.
2010-021343-41: Variations of blood phenylalanine and tyrosine in children with phenylketonuria under sapropterin

Ongoing
4
20
Europe
Soluble tablet, Kuvan
University Medical Center Groningen, Merck KGaA
Phenylketonuria (PKU) is an autosomal recessive metabolic genetic disorder by a mutation in the gene for the enzyme phenylalanine hydroxylase (PAH), rendering it nonfunctional. Left untreated, the disease will result in high concentrations of phenylalanine (Phe) in blood and tissues, likely resulting in severe mental retardation and behavioural problems. Treatment focusus on the restriction of dietary phenylalanine intake with supplementation of a synthetic phenylalaninefree amino acid mixture., Phenylketonuria (PKU) is an autosomal recessive metabolic genetic disorder. Untreated, PKU can lead to mental retardation and behavioural problems., Diseases [C] - Nutritional and Metabolic Diseases [C18]
 
 
KOGNITO, NCT01965912 / 2009-015844-41: Kuvan®'s Effect on the Cognition of Children With Phenylketonuria

Completed
4
34
Europe
Kuvan®, Sapropterin dihydrochloride
BioMarin Pharmaceutical
Phenylketonuria
01/23
01/23
NCT06396637: PD-1 Antibody and Sapropterin Dihydrochloride in Patients With PDAC

Recruiting
2
20
RoW
Sapropterin Dihydrochloride, PD-1 Antibody
Sun Yat-sen University, Innovent Biologics (Suzhou) Co. Ltd.
Pancreatic Adenocarcinoma Metastatic
04/25
04/25
NeurovEx, NCT02947750: Neurovascular Transduction During Exercise in Chronic Kidney Disease

Recruiting
2
150
US
6R-BH4, Tetrahydrobiopterin, Kuvan, Sapropterin dihydrochloride, 6R-BH4 placebo, Folic acid, Exercise training, Stretching, Control for exercise training, Histidine and beta-alanine supplementation, Histidine and beta-alanine placebo
Emory University, National Heart, Lung, and Blood Institute (NHLBI)
Renal Insufficiency, Chronic
10/24
10/24
NCT05299203: BH4 in the Prevention and Treatment of Radiation-induced Skin Reactions for Head and Neck Squamous Cell Carcinoma (Including Nasopharyngeal Carcinoma)

Not yet recruiting
1a/1b
18
NA
Sapropterin dihydrochloride tablets
West China Hospital
Head and Neck Squamous Cell Carcinoma
12/22
05/23
NCT06312748: Novel Approaches for Improving Vascular Function in Veterans With HFpEF

Recruiting
1
90
US
L-Citrulline, Placebo for L-Citrulline, BH4, Kuvan®, sapropterin dihydrochloride, Placebo for BH4, Atorvastatin, Lipitor®, Placebo for Atorvastatin
D. Walter Wray, US Department of Veterans Affairs
HFpEF - Heart Failure With Preserved Ejection Fraction, Inflammation
09/28
09/30
ChiCTR2100054693: Phase Ia/Ib clinical trial of Sapropterin dihydrochloride tablets in the prevention and treatment of radiation-induced skin reactions in intensity modulated radiotherapy for head and neck squamous cell carcinoma (including nasopharyngeal carcinoma)

Not yet recruiting
1
18
 
Dose Escalation: Sapropterin dihydrochloride tablets ;Dose Expansion: Sapropterin dihydrochloride tablets
West China Hospital, Sichuan University; West China Hospital, Sichuan University, Project funding
Head and neck squamous cell carcinoma (including nasopharyngeal carcinoma)
 
 
ATLAS, NCT04800692: The Effects of Therapy on Nitric Oxide Bioavailability in Patients With Intermittent Claudication

Recruiting
1
10
US
Tetrahydrobiopterin 10 mg/kg, sapropterin, kuvan, Tetrahydrobiopterin 20 mg/kg, L-Ascorbate, L-Arginine
Louis Messina, BioMarin Pharmaceutical
Claudication, Intermittent, Peripheral Artery Disease, Peripheral Vascular Diseases
07/25
12/25
NCT03136029: Exercise and NO in HFrEF

Recruiting
1
140
US
Antioxidant, Tetrahydrobiopterin (BH4), Kuvan, Exercise training
VA Office of Research and Development, University of Utah
Heart Failure With Reduced Ejection Fraction
05/25
05/26
NCT06481709: Study on Sapropterin Dihydrochloride Oral Suspension in Healthy Subjects

Completed
1
16
Canada
RLF-OD032, Sapropterin dihydrochloride, Kuvan
APR Applied Pharma Research s.a.
Bioavailability
08/24
08/24
Azixa (verubulin) / Immune Pharma
NCT04575727: Exploratory Evaluation of [11C]MPC6827

Recruiting
1
40
US
[11C]MPC6827, [11C]MPC
Columbia University
Neurodegenerative Diseases, Alzheimer Disease, Amyotrophic Lateral Sclerosis
09/24
09/25
Zalypsis (PM00104) / PharmaMar
2009-016054-40: Ensayo clínico de fase II, de optimización de dosis, abierto, de Zalypsis® (PM00104) en pacientes con mieloma múltiple recaído/refractario

Ongoing
2
55
Europe
Zalypsis, Dexametasona, PM00104, Dexamethason-ratiopharm 4 mg Tabletten Dexamethason-ratiopharm 8 mg Tabletten, Dexamethason-ratiopharm 4 mg Tabletten Dexamethason-ratiopharm 8 mg Tabletten
PharmaMar S.A.
Mieloma Múltiple recaído / refractario
 
 
Sarclisa (isatuximab-irfc) / Sanofi
2022-002253-26: International treatment-extension study in adult participants with multiple myeloma and who have derived clinical benefit from isatuximab

Not yet recruiting
4
70
Europe, RoW
isatuximab, dexamethasone, lenalidomide, pomalidomide, Pomalidomide, SAR650984, Concentrate for solution for infusion, Tablet, Capsule, Capsule, hard, Dexamethason 4 mg JENAPHARM®, Dexamethason 8 mg JENAPHARM®, Revlimid® 5 mg, Revlimid® 10 mg, Revlimid® 15 mg, Revlimid® 20 mg, Revlimid® 25 mg, Imnovid® (Pomalidomide) 1 mg hard capsule, Imnovid® (Pomalidomide) 2 mg hard capsule, Imnovid® (Pomalidomide) 3 mg hard capsule, Imnovid® (Pomalidomide) 4 mg hard capsule, Zelvina® 5 mg, Zelvina® 10 mg, Zelvina® 15 mg, Zelvina® 20 mg, Zelvina® 25 mg, JAMP Pomalidomide 1 mg capsules, JAMP Pomalidomide 2 mg capsules, JAMP Pomalidomide 3 mg capsules, JAMP Pomalidomide 4 mg capsules
Sanofi-aventis recherche & développement, SANOFI-AVENTIS RECHERCHE E DEVELOPPEMENT, Sanofi-aventis recherche & développement, Sanofi-aventis recherche & developpement
Multiple myeloma, Multiple myloma (cancer), Diseases [C] - Cancer [C04]
 
 
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 From first part of ICARIA-MM trial for r/r multiple myeloma
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
716
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)
More
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

Not yet recruiting
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
IRAKLIA, NCT05405166 / 2021-002485-41: SC Versus IV Isatuximab in Combination With Pomalidomide and Dexamethasone in RRMM

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)

Calendar Jan 2025 - Dec 2025: From GMMG HD7 trial for newly diagnosed multiple myeloma
Jan 2024 - Dec 2024: Submission for newly diagnosed multiple myeloma (transplant eligible)
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, EMN Research Italy, 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

Recruiting
3
482
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
03/28
03/33
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]
 
 
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
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
 
 
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
 
 
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]
 
 
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
 
 
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

Not yet recruiting
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
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]
 
 
2021-004895-32: 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
03/25
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
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
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
 
 
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

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
09/25
01/29
NCT03499808: S1702 Isatuximab in Treating Patients With Relapsed or Refractory Primary Amyloidosis

Active, not recruiting
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
12/23
07/25
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
01/25
01/26
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
03/25
03/25
REST, NCT04939844 / 2020-004425-23: - Replacing Steroids in the Transplant Ineligble

Active, not recruiting
2
51
Europe
Isatuximab, bortezomib, lenalidomide, dexamethason
Oslo University Hospital, Nordic Myeloma Study Group, St. Olavs Hospital, Helse Stavanger HF
Multiple Myeloma
06/24
10/26
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
UltraFrailMM, NCT06517017: Use of Isatuximab, Dexamethasone and Lenalidomide in a Go-Slow Fashion for Ultra-Frail Patients With Multiple Myeloma

Not yet recruiting
2
40
US
Isatuximab, Dexamethasone, Lenalidomide
University of Utah, Sanofi
Multiple Myeloma, Plasma Cell Leukemia
11/26
11/27
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 Research Italy
Relapsed Multiple Myeloma
11/23
03/27
MODIFY, NCT06762769: Isatuximab and Iberdomide As Immunotherapy for High Risk in Smouldering Myeloma

Not yet recruiting
2
63
NA
Isatuximab, Ibderomide, Dexamethasone
University College, London, Sanofi, Bristol Myers Squibb Pharmaceuticals Limited
Smouldering Myeloma
09/29
09/30
NCT04614558: Isatuximab in Patients With Monoclonal Gammopathy of Renal Significance

Recruiting
2
27
US
Isatuximab, Sarclisa
Columbia University, Genzyme, a Sanofi Company
Monoclonal Gammopathy
04/25
06/25
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
Isa-RVD, NCT05123131: Study in Patients With Newly Diagnosed Multiple Myeloma

Recruiting
2
43
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
04/25
04/30
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

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
12/25
12/26
ISABELA, NCT05922501: Isatuximab, Bela Maf, Pom, and Dex in Relapsed/Refractory Multiple Myeloma

Not yet recruiting
2
50
US
Isatuximab, SAR650984, Belantamab mafodotin, GSK2857916, Pomalidomide, Dexamethasone
Massachusetts General Hospital, Sanofi, GlaxoSmithKline
Relapsed Cancer, Refractory Multiple Myeloma, Multiple Myeloma
12/25
12/26
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
12/25
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
209
Europe, Canada, US, RoW
Belantamab mafodotin, GSK3174998, Feladilimab, Nirogacestat, Dostarlimab, Isatuximab, Lenalidomide, Dexamethasone, Pomalidomide
GlaxoSmithKline
Multiple Myeloma
02/29
02/29
(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
04/26
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

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
NCT04891809: Isatuximab in Combination With Rd Compared to Rd in Elderly Patients (Aged ≥70 Years) With NDMM

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

Recruiting
2
49
US
Isatuximab, Pomalidomide, Dexamethasone
UNC Lineberger Comprehensive Cancer Center, Genzyme, a Sanofi Company
Multiple Myeloma, Relapse, Refractory, Aging, Co-morbidity
12/28
12/28
NCT04883242: Isatuximab, Carfilzomib, Pomalidomide, and Dexamethasone for the Treatment of Relapsed or Refractory Multiple Myeloma

Recruiting
2
37
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
12/29
12/29
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
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
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
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
07/27
03/28
NCT01749969: SAR650984 (Isatuximab), Lenalidomide, and Dexamethasone in Combination in RRMM Patients

Hourglass Jul 2020 - Dec 2020 : From P1b trial for r/r multiple myeloma
Checkmark EHA 2016
May 2016 - May 2016: EHA 2016
Checkmark ASCO 2016
May 2016 - May 2016: ASCO 2016
More
Completed
1b
57
US
isatuximab SAR650984, Sarclisa, lenalidomide, Revlimid, dexamethasone
Sanofi
Plasma Cell Myeloma
06/23
06/23
NCT03733717: Evaluation of Pharmacokinetics, Safety, and Preliminary Efficacy of Isatuximab in Chinese Patients With Relapsed and/or Refractory Multiple Myeloma

Hourglass Jan 2020 - Dec 2020 : First data from P1 trial in Chinese patients with r/r multiple myeloma
Completed
1
25
RoW
Isatuximab SAR650984, Sarclisa
Sanofi
Multiple Myeloma
09/20
08/23
CyBorDSAR, NCT02513186: 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

Hourglass Jan 2023 - Dec 2023 : From trial in combination with bortezomib for multiple myeloma
Completed
1
90
Europe
lenalidomide, Revlimid, bortezomib, Velcade, cyclophosphamide, Endoxan, dexamethasone, isatuximab SAR650984, Sarclisa
Sanofi
Plasma Cell Myeloma
01/22
01/24
NCT04912427: Isatuximab, Velcade, and Dexamethasone in Patients With Multiple Myeloma and Severe KIDNEY Disease

Terminated
1
1
US
Isatuximab, Sarclisa, Bortezomib, Velcade, Dexamethasone
Washington University School of Medicine, Sanofi
Multiple Myeloma
12/22
01/24
NCT04083898: Isatuximab, Bendamustine, and Prednisone in Refractory Multiple Myeloma

Hourglass Apr 2020 - Jun 2020 : From trial in combination with bendamustine for penta-refractory multiple myeloma
Terminated
1
15
US
Isatuximab, Bendamustine, Bendeka, Treanda, Prednisone, Deltasone, Rayos, Prednisone Intensol
Washington University School of Medicine, Sanofi
Multiple Myeloma
03/23
03/24
NCT04045795: Multi-center, Open-label, Phase 1b Study in Patients With Relapsed/Refractory Multiple Myeloma (RRMM)

Completed
1
56
Europe, Japan, US, RoW
isatuximab SAR650984 IV, Sarclisa, pomalidomide, Pomalyst®, dexamethasone, Decadron®, isatuximab SAR650984 SC, Investigational injector device
Sanofi
Multiple Myeloma
03/24
03/24
NCI-2023-09969, NCT06203912: Donor Immune Cells (TGFbi NK Cells) and Isatuximab for the Treatment of Relapsed or Refractory Multiple Myeloma

Recruiting
1
30
US
Biospecimen Collection, Biological Sample Collection, Biospecimen Collected, Specimen Collection, Bone Marrow Aspiration and Biopsy, Cyclophosphamide, (-)-Cyclophosphamide, 2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide, monohydrate, Asta B 518, B-518, Carloxan, Ciclofosfamida, Ciclofosfamide, Cicloxal, Clafen, Claphene, CP monohydrate, CTX, CYCLO-cell, Cycloblastin, Cycloblastine, Cyclophospham, Cyclophosphamid monohydrate, Cyclophosphamide Monohydrate, Cyclophosphamidum, Cyclophosphan, Cyclophosphane, Cyclophosphanum, Cyclostin, Cyclostine, Cytophosphan, Cytophosphane, Cytoxan, Fosfaseron, Genoxal, Genuxal, Ledoxina, Mitoxan, Neosar, Revimmune, Syklofosfamid, WR- 138719, WR-138719, 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, Echocardiography, EC, Isatuximab, Hu 38SB19, Isatuximab-irfc, SAR 650984, SAR-650984, SAR650984, Sarclisa, Questionnaire Administration, Universal Donor Expanded TGF-beta-imprinted NK Cells, Allogeneic TGFBi Expanded NK Cells, UD TGF-betai NK Cells, Universal Donor TGF-beta Imprinted Expanded NK Cells
Elvira Umyarova, Sanofi
Recurrent Multiple Myeloma, Refractory Multiple Myeloma
12/24
12/24
TTI-622-01, NCT03530683: A Clinical Trial to Learn About the Study Medicine Called Maplirpacept (PF-07901801), Alone and When Used in Combination With Other Medicines to Treat Participants With Advanced Hematological Malignancies, Including Lymphoma, Leukemia and Multiple Myeloma

Checkmark First patient dosed in combination with azacitidine for TP53-mutated AML
Aug 2021 - Aug 2021: First patient dosed in combination with azacitidine for TP53-mutated AML
Checkmark Data from trial for lymphoma
Apr 2021 - Apr 2021: Data from trial for lymphoma
Terminated
1
189
US
Maplirpacept (PF-07901801), SIRPα-IgG4 Fc, TTI-622, Azacitidine, VIDAZA, Venetoclax, VENCLEXTA, Carfilzomib, KYPROLIS, Dexamethasone, Anti-CD20 Targeting agent, Ruxience or Rituxan, Isatuximab, Sarclisa
Pfizer
Lymphoma, Multiple Myeloma, Acute Myeloid Leukemia, Diffuse Large B-Cell Lymphoma
07/24
07/24
NCT02332850: Phase Ib Study of SAR650984 in Combination With Carfilzomib for Treatment of Relapsed or Refractory Multiple Myeloma

Active, not recruiting
1
83
Canada, US
Isatuximab, SAR 650984, Carfilzomib, Kyprolis, PR-171, Dexamethasone, Orgadrone, Spersadex, Visumetazone
Thomas Martin, MD, Amgen, Sanofi
Multiple Myeloma
12/24
12/24
 

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