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Thalidomide

Generic Name
Thalidomide
Brand Names
Thalomid, Thalidomide BMS (previously Thalidomide Celgene), Thalidomide Lipomed
Drug Type
Small Molecule
Chemical Formula
C13H10N2O4
CAS Number
50-35-1
Unique Ingredient Identifier
4Z8R6ORS6L
Background

A piperidinyl isoindole originally introduced as a non-barbiturate hypnotic, thalidomide was withdrawn from the market due to teratogenic effects. It has been reintroduced and used for a number of inflammatory disorders and cancers. Thalidomide displays immunosuppressive and anti-angiogenic activity through modulating the release of inflammatory mediators like tumor necrosis factor-alpha (TNF-a) and other cytokine action. Due to severe teratogenicity, pregnancy must be excluded before the start of treatment and patients must enrol in the THALIDOMID Risk Evaluation and Mitigation Strategy (REMS) program to ensure contraception adherence.

Indication

Thalidomide is primarily used for the acute treatment and maintenance therapy to prevent and suppress the cutaneous manifestations of moderate to severe erythema nodosum leprosum (ENL).

Associated Conditions
Aphthous Stomatitis, Chronic Graft-Versus-Host Disease, Erythema Nodosum Leprosum, Multiple Myeloma (MM), Primary Amyloidosis, Uremic Pruritus, Waldenström's Macroglobulinemia (WM), Moderate Erythema nodosum leprosum, Refractory Graft versus host disease, Severe Erythema nodosum leprosum, Treatment naive multiple myeloma
Associated Therapies
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Thalidomide Results in Diminished Ovarian Reserve in Reproductive Age Female IBD Patients

Not Applicable
Conditions
Crohn Disease
Interventions
First Posted Date
2016-12-20
Last Posted Date
2016-12-20
Lead Sponsor
Sixth Affiliated Hospital, Sun Yat-sen University
Target Recruit Count
90
Registration Number
NCT02998827

The Effective and Safety of Thalidomide in NTDT

Phase 2
Conditions
Thalassemia
Interventions
First Posted Date
2016-12-16
Last Posted Date
2017-03-22
Lead Sponsor
Xiao-Lin Yin
Target Recruit Count
30
Registration Number
NCT02995707
Locations
🇨🇳

NO.3 Hospital of the Chinese People's Liberation Army, Nanjing, Guangxi, China

Thalidomide/Dexamethasone Treatment And PET Evaluation In Organ Involvemenet of Cardiac Amyloidosis

Phase 2
Conditions
Cardiac Amyloidosis
Interventions
First Posted Date
2016-11-17
Last Posted Date
2017-10-26
Lead Sponsor
Seoul National University Hospital
Target Recruit Count
30
Registration Number
NCT02966522
Locations
🇰🇷

Seoul National University Hospital, Seoul, Korea, Republic of

Induced Adult Refractory Active Crohn's Disease Clinical Relieving by Using Thalidomide

Early Phase 1
Conditions
Crohn Disease
Interventions
Drug: placebo(for thalidomide)
Drug: Thalidomide
First Posted Date
2016-11-06
Last Posted Date
2016-11-06
Lead Sponsor
Sixth Affiliated Hospital, Sun Yat-sen University
Target Recruit Count
72
Registration Number
NCT02956538
Locations
🇨🇳

Department of Gastroenterology, Guangzhou, Guangdong, China

Patients With Newly Diagnosed Multiple Myeloma Comparing KTd vs. KRd Induction Therapy and Investigating a K-mono Maintenance Strategy

Phase 2
Completed
Conditions
Multiple Myeloma
Interventions
First Posted Date
2016-09-08
Last Posted Date
2024-03-29
Lead Sponsor
Arbeitsgemeinschaft medikamentoese Tumortherapie
Target Recruit Count
124
Registration Number
NCT02891811
Locations
🇦🇹

Bezirkskrankenhaus Kufstein, Innere Medizin, Interne II u. onkologische Tagesklinik, Kufstein, Austria

🇦🇹

Univ.Klinikum Krems, Klin. Abt. f. Innere Medizin 2, Mitterweng, Austria

🇦🇹

Ordensklinikum Linz - Elisabethinen, I. Interne Abt. Haemato-Onkologie, Linz, Austria

and more 18 locations

Study to Evaluate the Safety, Tolerability, Preliminary Efficacy and Pharmacokinetics of Simmitecan Monotherapy and Combination in Patients With Advanced Solid Tumors

Phase 1
Conditions
Advanced Solid Tumor
Advanced/Metastatic Colorectal Cancer
Interventions
First Posted Date
2016-08-17
Last Posted Date
2017-07-14
Lead Sponsor
Haihe Biopharma Co., Ltd.
Target Recruit Count
243
Registration Number
NCT02870036
Locations
🇨🇳

Beijing Cancer Hospital, Beijin, Beijing, China

🇨🇳

Harbin Medical University Cancer Hospital, Harbin, Heilongjiang, China

🇨🇳

Tongji Hospital of Tongji Medical College,Huazhong University of Science and Technology, Wuhan, Hubei, China

and more 6 locations

EDOCH Alternating With DHAP for New Diagnosed Younger MCL

First Posted Date
2016-08-08
Last Posted Date
2019-06-14
Lead Sponsor
Institute of Hematology & Blood Diseases Hospital, China
Target Recruit Count
55
Registration Number
NCT02858804
Locations
🇨🇳

Shuhua Yi, Tianjin, China

The Efficacy of TCD Following by TP Maintenance Therapy in Newly Diagnosed WM

Phase 4
Conditions
Waldenström Macroglobulinemia
Interventions
First Posted Date
2016-07-26
Last Posted Date
2016-07-26
Lead Sponsor
Institute of Hematology & Blood Diseases Hospital, China
Target Recruit Count
44
Registration Number
NCT02844309
Locations
🇨🇳

Shuhua Yi, Tianjin, China

Conmana Combined With Thalidomide to Treat NSCLC

Phase 4
Conditions
NSCLC
Interventions
First Posted Date
2016-05-20
Last Posted Date
2016-05-20
Lead Sponsor
Henan Provincial People's Hospital
Target Recruit Count
67
Registration Number
NCT02778893
Locations
🇨🇳

XZhang, Zhengzhou, Henan, China

Efficacy Study of Thalidomide in Gastrointestinal Vascular Malformation Related Bleeding

Phase 2
Withdrawn
Conditions
Vascular Malformation
Gastrointestinal Hemorrhage
Interventions
Drug: Placebo
Drug: Thalidomide
First Posted Date
2016-04-28
Last Posted Date
2016-04-28
Lead Sponsor
Shanghai Jiao Tong University School of Medicine
Registration Number
NCT02754960
Locations
🇨🇳

Gastroenterology department; Ren Ji Hospital, Shanghai, Shanghai, China

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