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Background: A piperidinyl isoindole originally introduced as a non-barbiturate hypnotic, thalidomide was withdrawn from the market due to teratogenic effects.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

Clinical Trials

Selinexor in Combination With Immunomodulator （Thalidomide/Pomalidomide/Lenalidomide）in RRMM

Phase 2

Recruiting

Conditions: Multiple Myeloma

Interventions: Drug: Selinexor
Drug: Lenalidomide
Drug: Thalidomide
Drug: Pomalidomide
Drug: Dexamethasone

First Posted Date: 2021-06-28

Last Posted Date: 2023-02-27

Lead Sponsor: Juan Du

Target Recruit Count: 90

Registration Number: NCT04941937

Locations: 🇨🇳
Shanghai Changzheng Hospital, Shanghai, Shanghai, China

Selinexor in Combination With Thalidomide and Dexamethasone in RRMM

Phase 1

Not yet recruiting

Conditions: Multiple Myeloma

Interventions: Drug: Selinexor
Drug: Thalidomide
Drug: Dexamethasone

First Posted Date: 2021-05-18

Last Posted Date: 2021-05-18

Lead Sponsor: Li Zheng

Target Recruit Count: 48

Registration Number: NCT04891744

Locations: 🇨🇳
West China Hospital of Sichuan University, Chengdu, Sichuan, China

Thalidomide in the Treatment of Chronic Radiation Proctitis With Intractable Bleeding

Phase 2

Conditions: Chronic Radiation Proctitis

Interventions: Drug: Thalidomide

First Posted Date: 2020-12-22

Last Posted Date: 2020-12-22

Lead Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University

Target Recruit Count: 62

Registration Number: NCT04680195

Comparison of BTD and BCD Based Regimens in the Treatment of AL Amyloidosis

Phase 4

Conditions: Immunoglobulin Light-Chain Amyloidosis

Interventions: Drug: Thalidomide
Drug: Cyclophosphamide

First Posted Date: 2020-11-03

Last Posted Date: 2020-11-03

Lead Sponsor: Guangdong Provincial People's Hospital

Target Recruit Count: 70

Registration Number: NCT04612582

Locations: 🇨🇳
Guangdong Provincial People'S Hospital, Guangzhou, Guangdong, China

TPM Regimen (Thalidomide, Prednisone and Methotrexate) in LGLL

Phase 2

Recruiting

Conditions: Clpd-Nk
T-LGL Leukemia

Interventions: Drug: thalidomide + prednisone + methotrexate

First Posted Date: 2020-07-01

Last Posted Date: 2020-07-01

Lead Sponsor: Institute of Hematology & Blood Diseases Hospital, China

Target Recruit Count: 42

Registration Number: NCT04453345

Locations: 🇨🇳
Henan Cancer Hospital, Zhengzhou, Henan, China
🇨🇳
Tongji hopital, Huazhong University of Science and Technology, Wuhan, Hubei, China
🇨🇳
The Second Xiangya Hospital of Central South University, Changsha, Hunan, China

and more 6 locations