Thalidomide

Generic Name: Thalidomide

Brand Names: Thalomid, Thalidomide BMS (previously Thalidomide Celgene), Thalidomide Lipomed

Drug Type: Small Molecule

Chemical Formula: C_₁₃H_₁₀N_₂O_₄

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Background: A piperidinyl isoindole originally introduced as a non-barbiturate hypnotic, thalidomide was withdrawn from the market due to teratogenic effects.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: -

Clinical Trials

Bortezomib, Doxorubicin Hydrochloride Liposome, and Thalidomide as First-line Therapy in Treating Patients With Previously Untreated Stage I, II, or III Multiple Myeloma

Phase 2

Completed

Conditions: Multiple Myeloma and Plasma Cell Neoplasm

Interventions: Drug: bortezomib
Drug: pegylated liposomal doxorubicin hydrochloride
Drug: thalidomide

First Posted Date: 2007-09-03

Last Posted Date: 2017-02-23

Lead Sponsor: Roswell Park Cancer Institute

Target Recruit Count: 46

Registration Number: NCT00523848

Locations: 🇺🇸
Roswell Park Cancer Institute, Buffalo, New York, United States

UFUR Plus Thalidomide for Advanced Hepatocellular Carcinoma

Phase 2

Completed

Conditions: Hepatocellular Carcinoma

Interventions: Drug: Thalidomide
Drug: Tegafur/Uracil

First Posted Date: 2007-08-23

Last Posted Date: 2011-10-17

Lead Sponsor: National Taiwan University Hospital

Target Recruit Count: 44

Registration Number: NCT00519688

Locations: 🇨🇳
Department of Oncology , National Taiwan University Hospital, Taipei, Taiwan

Velcade,Thalidomide, and Dexamethasone Versus Velcade and Dexamethasone Versus Velcade, Melphalan, and Prednisone

Phase 3

Completed

Conditions: Multiple Myeloma

Interventions: Drug: Bortezomib
Drug: Dexamethasone
Drug: Melphalan
Drug: Thalidomide
Drug: Prednisone

First Posted Date: 2007-07-26

Last Posted Date: 2014-05-01

Lead Sponsor: Millennium Pharmaceuticals, Inc.

Target Recruit Count: 502

Registration Number: NCT00507416

Locations: 🇺🇸
Hematology Oncology Consultants Inc., Columbus, Ohio, United States
🇺🇸
S. Florida Oncology/ Hematology, West Palm Beach, Florida, United States
🇺🇸
Hematology-Oncology Clinic, Baton Rouge, Louisiana, United States

and more 219 locations

Biochemotherapy With Temozolomide for Metastatic Melanoma

Phase 2

Terminated

Conditions: Melanoma

Interventions: Drug: Temozolomide
Drug: Velban
Drug: Cisplatin
Drug: Interleukin-2
Drug: Intron-A
Drug: Thalidomide

First Posted Date: 2007-07-23

Last Posted Date: 2020-09-24

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 5

Registration Number: NCT00505635

Locations: 🇺🇸
U.T.M.D. Anderson Cancer Center, Houston, Texas, United States

Safety and Efficacy Study of Thalomid in Patients With Chronic Pancreatitis

Phase 2

Terminated

Conditions: Chronic Pancreatitis

First Posted Date: 2007-05-04

Last Posted Date: 2008-01-16

Lead Sponsor: Winthrop University Hospital

Target Recruit Count: 10

Registration Number: NCT00469703

Bortezomib, Doxorubicin Hydrochloride Liposome, and Dexamethasone Followed by Thalidomide and Dexamethasone With or Without Bortezomib in Treating Patients With Multiple Myeloma

Phase 2

Completed

Conditions: Multiple Myeloma and Plasma Cell Neoplasm

Interventions: Drug: bortezomib
Drug: dexamethasone
Drug: pegylated liposomal doxorubicin hydrochloride
Drug: thalidomide

First Posted Date: 2007-04-11

Last Posted Date: 2016-01-22

Lead Sponsor: Memorial Sloan Kettering Cancer Center

Target Recruit Count: 45

Registration Number: NCT00458705

Locations: 🇺🇸
Memorial Sloan-Kettering Cancer Center, New York, New York, United States

Thalidomide at Low Dose for the Treatment of Patient With Myelodysplastic Syndromes - THAL-SMD-200

Phase 2

Completed

Conditions: Myelodysplastic Syndromes

First Posted Date: 2007-04-04

Last Posted Date: 2007-04-04

Lead Sponsor: Groupe Francophone des Myelodysplasies

Target Recruit Count: 112

Registration Number: NCT00455910

Locations: 🇫🇷
CHU Albert Michallon, Grenoble, France
🇫🇷
CH d'Avignon, Avignon, France
🇫🇷
Hopital Avicenne, Bobigny, France

and more 17 locations

Efficacy and Safety Study of 3 Thalidomide Doses for the Treatment of Relapsed Refractory Multiple Myeloma

Phase 3

Completed

Conditions: Multiple Myeloma

Interventions: Drug: Thalidomide
Drug: Dexamethasone

First Posted Date: 2007-03-27

Last Posted Date: 2019-11-18

Lead Sponsor: Celgene

Target Recruit Count: 499

Registration Number: NCT00452569

Locations: 🇵🇱
Klinika Hematologii Nowotworow Krwi i Transplantacji - Szpiku Akademii Medycznej, Wroclaw, Poland
🇮🇳
Department of Medical Oncology/Regional Cancer Centre, Trivandrum, India
🇮🇳
Department of Medical Oncology, Deenanath Mangeshkar Hospital, Pune, India

and more 82 locations