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Background: A piperidinyl isoindole originally introduced as a non-barbiturate hypnotic, thalidomide was withdrawn from the market due to teratogenic effects.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

PEG-Interferon Alfa-2b and Thalidomide in Treating Patients With Recurrent or Metastatic Melanoma

Phase 2

Completed

Conditions: Intraocular Melanoma
Melanoma (Skin)

First Posted Date: 2005-10-13

Last Posted Date: 2013-04-08

Lead Sponsor: Barbara Ann Karmanos Cancer Institute

Target Recruit Count: 32

Registration Number: NCT00238329

Locations: 🇺🇸
Barbara Ann Karmanos Cancer Institute, Detroit, Michigan, United States

Melphalan, Prednisone and Thalidomide Versus Melphalan and Prednisone in Elderly Myeloma Patients

Phase 3

Completed

Conditions: Multiple Myeloma

First Posted Date: 2005-10-05

Last Posted Date: 2018-08-02

Lead Sponsor: Gruppo Italiano per lo Studio del Mieloma Multiplo

Target Recruit Count: 400

Registration Number: NCT00232934

Locations: 🇮🇹
Divisione di Ematologia e Trapianto di Midollo Osseo- Ospedale Cervello, Palermo, Italy
🇮🇹
Dipartimento di Biotecnologie ed Ematologia - Università La Sapienza, Roma, Italy
🇮🇹
Istituto di Ematologia - Università Cattolica, Roma, Italy

and more 10 locations

Arsenic Trioxide, Thalidomide, Dexamethasone, and Ascorbic Acid in Treating Patients With Relapsed or Refractory Multiple Myeloma

Phase 2

Terminated

Conditions: Multiple Myeloma and Plasma Cell Neoplasm

Interventions: Dietary Supplement: ascorbic acid
Drug: arsenic trioxide
Drug: dexamethasone
Drug: thalidomide

First Posted Date: 2005-09-28

Last Posted Date: 2012-05-28

Lead Sponsor: OHSU Knight Cancer Institute

Target Recruit Count: 2

Registration Number: NCT00227682

Locations: 🇺🇸
OHSU Knight Cancer Institute, Portland, Oregon, United States

A Trial of Thalidomide and Capecitabine in Metastatic Renal Cell Carcinoma

Phase 2

Completed

Conditions: Kidney Neoplasms

First Posted Date: 2005-09-27

Last Posted Date: 2009-04-14

Lead Sponsor: Stanford University

Target Recruit Count: 30

Registration Number: NCT00226980

Locations: 🇺🇸
Stanford University School of Medicine, Stanford, California, United States

A Study Evaluating Efficacy, Toxicity, Harvest Yield and Quality of Life

Phase 2

Completed

Conditions: Multiple Myeloma

Interventions: Drug: Doxil
Drug: Thalidomide
Drug: Dexamethasone

First Posted Date: 2005-09-22

Last Posted Date: 2017-07-02

Lead Sponsor: University of Kansas Medical Center

Target Recruit Count: 25

Registration Number: NCT00222105

Thalidomide to Patients With Previously Untreated Multiple Myeloma

Phase 3

Completed

Conditions: Multiple Myeloma

Interventions: Drug: thalidomide
Drug: placebo

First Posted Date: 2005-09-22

Last Posted Date: 2014-03-07

Lead Sponsor: Norwegian University of Science and Technology

Target Recruit Count: 363

Registration Number: NCT00218855

Locations: 🇳🇴
Department of Haematology, St. Olavs hospital/NTNU, Trondheim, Norway

Phase III Randomized Trial of Thalidomide/Dexamethasone Versus Vincristine+Adriamycin+Dexamethasone (VAD)

Phase 3

Terminated

Conditions: Multiple Myeloma

Interventions: Drug: zoledronic acid
Drug: vincristine
Drug: dexamethasone
Drug: adriamycin
Drug: thalidomide

First Posted Date: 2005-09-22

Last Posted Date: 2014-04-17

Lead Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Target Recruit Count: 90

Registration Number: NCT00215943

Locations: 🇺🇸
Morton Plant Hospital, Clearwater, Florida, United States
🇺🇸
Fawcett Memorial Hospital, Port Charlotte, Florida, United States
🇺🇸
Watson Clinic, Lakeland, Florida, United States

and more 2 locations

IFM 99-02 Thalidomide in Myeloma

Phase 3

Completed

Conditions: Multiple Myeloma

Interventions: Drug: Biphosphonates
Drug: Thalidomide

First Posted Date: 2005-09-22

Last Posted Date: 2010-04-02

Lead Sponsor: University Hospital, Toulouse

Target Recruit Count: 800

Registration Number: NCT00222053

Locations: 🇫🇷
Médecine Interne, CHU Purpan, Toulouse, France
🇫🇷
Médecine Interne, Hôpital Rangueil, Toulouse, France
🇫🇷
Rhumatologie, CHU Rangueil, Toulouse, France

and more 2 locations