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A piperidinyl isoindole originally introduced as a non-barbiturate hypnotic, thalidomide was withdrawn from the market due to teratogenic effects.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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Open Label of Thalidomide in Treatment of Women With Chronic Pelvic Pain Associated With Endometriosis

Phase 1
Terminated
Conditions
Interventions
First Posted Date
2009-12-09
Last Posted Date
2011-12-20
Lead Sponsor
University of North Carolina, Chapel Hill
Target Recruit Count
9
Registration Number
NCT01028781
Locations
🇺🇸

UNC Chapel Hill, Chapel Hill, North Carolina, United States

Lenalidomide, Thalidomide and Dexamethasone in Treating Participants With Relapsed or Refractory Multiple Myeloma

First Posted Date
2009-08-27
Last Posted Date
2020-11-04
Lead Sponsor
M.D. Anderson Cancer Center
Target Recruit Count
77
Registration Number
NCT00966693
Locations
🇺🇸

M D Anderson Cancer Center, Houston, Texas, United States

Fludarabine, Cyclophosphamide, and Thalidomide in Treating Patients With Angioimmunoblastic T-Cell Lymphoma

Phase 2
Conditions
First Posted Date
2009-08-13
Last Posted Date
2013-08-26
Lead Sponsor
Cancer Research UK
Target Recruit Count
37
Registration Number
NCT00958854
Locations
🇬🇧

Cancer Research UK and University College London Cancer Trials Centre, Exeter, England, United Kingdom

Thalidomide for the Treatment of Primary Sclerosing Cholangitis (PSC)

Phase 2
Terminated
Conditions
Interventions
First Posted Date
2009-08-06
Last Posted Date
2012-02-27
Lead Sponsor
Mayo Clinic
Target Recruit Count
1
Registration Number
NCT00953615
Locations
🇺🇸

Mayo Clinic, Rochester, Minnesota, United States

Melphalan+Prednisolon With or Without Thalidomide in Previously Untreated Elderly Patients With Multiple Myeloma

First Posted Date
2009-07-08
Last Posted Date
2013-08-15
Lead Sponsor
Cigdem Sahinbas YILMAZ
Target Recruit Count
122
Registration Number
NCT00934154
Locations
🇹🇷

Ankara Numune Education and Research Hospital,Hematology Department, Ankara, Turkey

🇹🇷

Baskent University School of Medicine Education and Research Hospital, Hematology Department, Adana, Turkey

🇹🇷

Gazi University School of Medicine, Hematology Department, Ankara, Turkey

and more 6 locations

Adjuvant Therapy With Thalidomide for Chemoembolization in Advanced Hepatocellular Carcinoma

First Posted Date
2009-06-16
Last Posted Date
2011-04-19
Lead Sponsor
Fudan University
Target Recruit Count
200
Registration Number
NCT00921531
Locations
🇨🇳

Liver Cancer Institute, Shanghai, Shanghai, China

Trial for Patients Not Qualifying for TT4 and TT5 Protocols Because of Prior Therapy

First Posted Date
2009-03-30
Last Posted Date
2024-07-25
Lead Sponsor
University of Arkansas
Target Recruit Count
160
Registration Number
NCT00871013
Locations
🇺🇸

University of Arkansas for Medical Sciences, Little Rock, Arkansas, United States

UARK 2008-02 A Trial for High-risk Myeloma Evaluating Accelerating and Sustaining Complete Remission

First Posted Date
2009-03-25
Last Posted Date
2024-07-03
Lead Sponsor
University of Arkansas
Target Recruit Count
90
Registration Number
NCT00869232
Locations
🇺🇸

University of Arkansas for Medical Sciences, Little Rock, Arkansas, United States

Thalidomide Plus Peginterferon and Ribavirin in Patients With Interferon Resistance

Phase 2
Conditions
Interventions
First Posted Date
2009-03-06
Last Posted Date
2009-03-06
Lead Sponsor
Valme University Hospital
Target Recruit Count
10
Registration Number
NCT00856804
Locations
🇪🇸

Hospital de Valme, Sevilla, Spain

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