Pomalidomide ( DrugBank: Pomalidomide )


5 diseases
告示番号疾患名(ページ内リンク)臨床試験数
28全身性アミロイドーシス9
51全身性強皮症6
85特発性間質性肺炎1
227オスラー病2
331特発性多中心性キャッスルマン病1

28. 全身性アミロイドーシス


臨床試験数 : 267 薬物数 : 241 - (DrugBank : 77) / 標的遺伝子数 : 68 - 標的パスウェイ数 : 180
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT05451771
(ClinicalTrials.gov)
October 26, 20226/7/2022Venetoclax-Dexamethasone in Relapsed and/or Refractory t(11;14) AmyloidosisAn Open-label Phase I/II Trial of Venetoclax-Dexamethasone in Relapsed and/or Refractory t(11;14) Systemic Light-Chain AmyloidosisAL AmyloidosisDrug: Venetoclax Oral Tablet, 200 mg;Device: FISH assay;Drug: Venetoclax Oral Tablet, 400 mg;Drug: Dexamethasone Oral, 10 mg;Drug: Dexamethasone Oral, 20 mg;Drug: Daratumumab Injection;Drug: Bendamustine;Drug: Pomalidomide;Drug: Ixazomib;Drug: Venetoclax MTD with DexamethasoneRajshekhar Chakraborty, MDGenentech, Inc.Recruiting18 YearsN/AAll53Phase 1/Phase 2United States
2NCT05066607
(ClinicalTrials.gov)
February 11, 202224/8/2021Isatuximab Plus Pomalidomide and Dexamethasone Association for Patients With AL Amyloidosis Not in VGPR or Better After Any Previous TherapyA Phase 2, Open Label, Multicenter, Single-stage Study to Evaluate the Efficacy of Isatuximab Plus Pomalidomide and Dexamethasone (IPd), in Patients With AL Amyloidosis Not in VGPR or Better After Any Previous TherapyAL AmyloidosisDrug: IsatuximabIntergroupe Francophone du MyelomeSanofi;Bristol-Myers SquibbRecruiting18 YearsN/AAll46Phase 2France
3NCT04270175
(ClinicalTrials.gov)
April 14, 202112/2/2020Daratumumab, Pomalidomide, and Dexamethasone (DPd) in Relapsed/Refractory Light Chain Amyloidosis Patients Previously Exposed to DaratumumabDaratumumab, Pomalidomide, and Dexamethasone (DPd) in Relapsed/Refractory Light Chain Amyloidosis Patients Previously Exposed to DaratumumabAmyloid;AL Amyloidosis;Refractory AL AmyloidosisDrug: Daratumumab;Drug: Pomalidomide;Drug: DexamethasoneWeill Medical College of Cornell UniversityJanssen Scientific Affairs, LLCRecruiting18 YearsN/AAll21Phase 2United States
4EUCTR2019-001962-13-IT
(EUCTR)
13/01/202121/10/2020Daratumumab and Pomalidomide in previously treated patients with AL amyloidosisA multi-center open label phase II study of daratumumab and pomalidomide in previously treated patients with AL amyloidosis - DarP-AL AL amyloidosis
MedDRA version: 20.0;Level: PT;Classification code 10002022;Term: Amyloidosis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Imnovid
Product Name: Pomalidomide
Product Code: [Pomalidomide]
INN or Proposed INN: pomalidomide
Product Name: Daratumumab
Product Code: [Daratumumab]
INN or Proposed INN: DARATUMUMAB
Trade Name: Imnovid
Product Name: Pomalidomide
Product Code: [Pomalidomide]
INN or Proposed INN: Pomalidomide
Trade Name: Imnovid
Product Name: Pomalidomide
Product Code: [Pomalidomide]
INN or Proposed INN: pomalidomide
FONDAZIONE I.R.C.C.S. POLICLINICO SAN MATTEONULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
40Phase 2Italy
5NCT01807286
(ClinicalTrials.gov)
January 20146/3/2013Pomalidomide With Melphalan and Dexamethasone for Untreated Systemic AL AmyloidosisA Phase I/II Clinical Trial of Pomalidomide With Melphalan and Dexamethasone in Patients With Newly Diagnosed Untreated Systemic AL Amyloidosis: Trial Stopped During Phase IMyelomaDrug: Pomalidomide;Drug: Melphalan;Drug: Dexamethasone;Behavioral: QuestionnairesM.D. Anderson Cancer CenterCelgeneTerminated18 YearsN/ABoth3Phase 1United States
6NCT01728259
(ClinicalTrials.gov)
March 201313/11/2012First-line Pomalidomide, Bortezomib, and Dexamethasone For AL Amyloidosis or LCDDPhase I Study of Pomalidomide, Bortezomib, and Dexamethasone (PVD) as First-Line Treatment of AL Amyloidosis or Light Chain Deposition DiseaseLight Chain Deposition Disease;Primary Systemic AmyloidosisDrug: pomalidomide;Drug: bortezomib;Drug: dexamethasone;Other: Laboratory Biomarker AnalysisBarbara Ann Karmanos Cancer InstituteNational Cancer Institute (NCI)Active, not recruiting18 YearsN/AAll36Phase 1United States;Canada;New Zealand
7NCT01570387
(ClinicalTrials.gov)
June 201227/2/2012A Phase I/II Trial of Pomalidomide and Dexamethasone in Subjects With Previously-Treated AL AmyloidosisA Phase I/II Trial of Pomalidomide and Dexamethasone in Subjects With Previously-Treated AL AmyloidosisAL AmyloidosisDrug: Pomalidomide;Drug: DexamethasoneBoston Medical CenterCelgene CorporationCompleted18 YearsN/AAll27Phase 1/Phase 2United States
8EUCTR2011-001787-22-IT
(EUCTR)
02/05/201212/01/2012Treatment with pomalidomide and dexamethasone for previously treated patients with AL amyloidosis.An open-label, phase II study of Pomalidomide and Dexamethasone (PDex) for previously treated patients with AL amyloidosis - PDex Previously treated AL amyloidosis
MedDRA version: 14.1;Level: PT;Classification code 10002022;Term: Amyloidosis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: pomalidomide
Product Code: CC-4047
INN or Proposed INN: Pomalidomide
INN or Proposed INN: DEXAMETHASONE SODIUM SULFATE
OSPEDALE POLICLINICO S. MATTEONULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Phase 2Italy
9NCT01510613
(ClinicalTrials.gov)
February 201211/1/2012Pomalidomide and Dexamethasone (PDex) in AL AmyloidosisAn Open-label, Phase II Study of Pomalidomide and Dexamethasone (PDex) for Previously Treated Patients With AL Amyloidosis.Primary Amyloidosis of Light Chain TypeDrug: Pomalidomide and DexamethasoneIRCCS Policlinico S. MatteoNULLCompleted18 YearsN/AAll28Phase 2Italy

51. 全身性強皮症


臨床試験数 : 525 薬物数 : 565 - (DrugBank : 148) / 標的遺伝子数 : 114 - 標的パスウェイ数 : 217
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT01559129
(ClinicalTrials.gov)
August 9, 201219/3/2012Study of Pomalidomide (CC-4047) to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Effectiveness for Patients With Systemic Sclerosis With Interstitial Lung DiseaseA Phase 2, Proof-Of-Concept, Multicenter, Randomized, Double-Blind, Placebo- Controlled, Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of Pomalidomide (CC-4047) in Subjects With Systemic Sclerosis With Interstitial Lung DiseaseScleroderma, Systemic;Sclerosis, Systemic;Systemic Scleroderma;Systemic Sclerosis;Interstitial Lung DiseaseDrug: Pomalidomide (CC-4047);Drug: PlaceboCelgeneNULLTerminated18 Years80 YearsAll23Phase 2United States;Australia;France;Germany;Italy;Poland;Russian Federation;Spain;Switzerland;United Kingdom
2EUCTR2010-023047-15-PL
(EUCTR)
17/07/201214/05/2012A study to see if pomalidomide is safe and works to treat patients with sclerosis affecting the skin on the whole body and that also have lung diseaseA Phase 2, Proof-of-Concept, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of Pomalidomide (CC-4047) In Subjects with Systemic Sclerosis with Interstitial Lung Disease systemic sclerosis associated with interstitial lung disease
MedDRA version: 16.0;Level: LLT;Classification code 10025109;Term: Lung involvement in systemic sclerosis;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Product Name: Pomalidomide
Product Code: CC-4047
INN or Proposed INN: Pomalidomide
Celgene CorporationNULLNot RecruitingFemale: yes
Male: yes
88Phase 2France;United States;Spain;Poland;Australia;Russian Federation;Germany;Italy;United Kingdom;Switzerland
3EUCTR2010-023047-15-IT
(EUCTR)
20/03/201228/12/2011A study to see if pomalidomide is safe and works to treat patients with sclerosis affecting the skin on the whole body and that also have lung diseaseA Phase 2, Proof-of-Concept, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study To Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of Pomalidomide (CC-4047) in Subjects with Diffuse Cutaneous Systemic Sclerosis with Interstitial Lung Disease Diffuse cutaneous systemic sclerosis with interstitial lung disease
MedDRA version: 14.1;Level: LLT;Classification code 10025109;Term: Lung involvement in systemic sclerosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 14.1;Level: SOC;Classification code 10038738;Term: Respiratory, thoracic and mediastinal disorders;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Product Name: Pomalidomide
Product Code: CC-4047
INN or Proposed INN: Pomalidomide
Other descriptive name: Pomalidomide
CELGENE CORPORATIONNULLNot RecruitingFemale: yes
Male: yes
88Phase 2United States;Poland;Spain;Australia;Germany;United Kingdom;Italy
4EUCTR2010-023047-15-DE
(EUCTR)
15/03/201208/12/2011A study to see if pomalidomide is safe and works to treat patients with sclerosis affecting the skin on the whole body and that also have lung diseaseA Phase 2 Proof-of-Concept, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of Pomalidomide (CC-4047) In Subjects with Systemic Sclerosis with Interstitial Lung Disease systemic sclerosis associated with interstitial lung disease
MedDRA version: 16.1;Level: LLT;Classification code 10025109;Term: Lung involvement in systemic sclerosis;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Trade Name: Imnovid 1 mg hard capsules
INN or Proposed INN: Pomalidomide
Celgene CorporationNULLNot RecruitingFemale: yes
Male: yes
88Phase 2France;United States;Poland;Spain;Australia;Russian Federation;Germany;Italy;United Kingdom;Switzerland;Sweden
5EUCTR2010-023047-15-GB
(EUCTR)
08/03/201215/12/2011A study to see if pomalidomide is safe and works to treat patients with sclerosis affecting the skin on the whole body and that also have lung diseaseA Phase 2, Proof-of-Concept, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of Pomalidomide (CC-4047) In Subjects with Systemic Sclerosis with Interstitial Lung Disease systemic sclerosis associated with interstitial lung disease
MedDRA version: 17.0;Level: LLT;Classification code 10025109;Term: Lung involvement in systemic sclerosis;System Organ Class: 100000004855 ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Trade Name: Imnovid 1 mg hard capsules
INN or Proposed INN: Pomalidomide
Celgene CorporationNULLNot Recruiting Female: yes
Male: yes
88 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noFrance;United States;Poland;Spain;Australia;Russian Federation;Germany;Italy;Switzerland;United Kingdom
6EUCTR2010-023047-15-ES
(EUCTR)
02/03/201219/01/2012A study to see if pomalidomide is safe and works to treat patients with sclerosis affecting the skin on the whole body and that also have lung diseaseA Phase 2, Proof-of-Concept, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of Pomalidomide (CC-4047) In Subjects with Diffuse Cutaneous Systemic Sclerosis with Interstitial Lung Disease diffuse cutaneous systemic sclerosis associated with interstitial lung disease
MedDRA version: 14.1;Level: LLT;Classification code 10025109;Term: Lung involvement in systemic sclerosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Product Name: Pomalidomida
Product Code: CC-4047
INN or Proposed INN: Pomalidomida
Celgene CorporationNULLNot RecruitingFemale: yes
Male: yes
88Phase 2France;United States;Poland;Spain;Australia;Germany;Italy;United Kingdom;Switzerland;Sweden

85. 特発性間質性肺炎


臨床試験数 : 627 薬物数 : 443 - (DrugBank : 120) / 標的遺伝子数 : 99 - 標的パスウェイ数 : 212
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT01135199
(ClinicalTrials.gov)
June 201028/5/2010Pomalidomide for Cough in Patients With Idiopathic Pulmonary FibrosisSafety and Efficacy of Pomalidomide in the Treatment of Refractory Cough in Patients With Idiopathic Pulmonary Fibrosis (IPF): A Pilot StudyPulmonary FibrosisDrug: pomalidomide (CC-4047Stanford UniversityCelgene CorporationWithdrawn18 YearsN/ABoth0Phase 2United States

227. オスラー病


臨床試験数 : 56 薬物数 : 72 - (DrugBank : 21) / 標的遺伝子数 : 23 - 標的パスウェイ数 : 136
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT03910244
(ClinicalTrials.gov)
October 17, 20198/4/2019Pomalidomide for the Treatment of Bleeding in HHTPomalidomide for the Treatment of Bleeding in Hereditary Hemorrhagic TelangiectasiaTelangiectasia, Hereditary HemorrhagicDrug: Pomalidomide Oral Product;Drug: Placebo oral capsuleThe Cleveland ClinicRTI InternationalRecruiting18 YearsN/AAll159Phase 2United States
2NCT02287558
(ClinicalTrials.gov)
January 27, 20156/11/2014Pomalidomide in Hereditary Hemorrhagic Telangiectasia and Transfusion-Dependent Vascular Ectasia: a Phase I StudyA Phase I Single Arm Study to Assess the Safety and Efficacy of Pomalidomide in Patients With Bleeding Due to Hereditary Hemorrhagic Telangiectasia and Refractory AngiodysplasiaHereditary Hemorrhagic Telangiectasia;Idiopathic Vascular EctasiaDrug: PomalidomideThe Cleveland ClinicNULLCompleted18 YearsN/AAll9Phase 1United States

331. 特発性多中心性キャッスルマン病


臨床試験数 : 33 薬物数 : 41 - (DrugBank : 21) / 標的遺伝子数 : 22 - 標的パスウェイ数 : 123
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT02228512
(ClinicalTrials.gov)
August 15, 201427/8/2014Study of Pomalidomide Combined With Modified DA-EPOCH and Rituximab in KSHV-Associated LymphomasPhase I/II Study of Pomalidomide Combined With Modified DA-EPOCH and Rituximab in KSHV-Associated Lymphomas (Primary Effusion Lymphoma and Large Cell Lymphoma Arising in KSHV-Associated Multicentric Castleman Disease)Large Cell Lymphoma Arising in KSHV-associated Multicentric Castleman Disease;Primary Effusion LymphomaDrug: Pomalidomide;Drug: Rituximab;Drug: Prednisone;Drug: Etoposide;Drug: Doxorubicin;Drug: Vincristine;Drug: CyclophosphamideNational Cancer Institute (NCI)NULLWithdrawn18 Years99 YearsAll0Phase 1/Phase 2United States