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Background: A piperidinyl isoindole originally introduced as a non-barbiturate hypnotic, thalidomide was withdrawn from the market due to teratogenic effects.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

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: Drug: Carfilzomib
Drug: Thalidomide
Drug: Lenalidomide
Drug: Dexamethasone

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: Drug: Simmitecan
Drug: 5-fluorouracil and Leucovorin Calcium
Drug: Thalidomide

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

Phase 4

Conditions: Mantle Cell Lymphoma

Interventions: Drug: Etoposide
Drug: Cytarabine
Drug: Thalidomide
Drug: Doxorubicin
Drug: Dexamethasone
Drug: Cyclophosphamide
Drug: Prednisone
Drug: Cisplatin
Drug: Vincristine
Drug: Rituximab

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: Drug: Thalidomide

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: Drug: Conmana
Drug: Thalidomide

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

Chidamide Combined With VDDT Regimen in the Relapse and Refractory Diffuse Large B Cell Lymphoma

Phase 2

Conditions: Diffuse Large B-cell Lymphoma

Interventions: Drug: Chidamide
Drug: Vinorelbine
Drug: Liposomal Doxorubicin or mitoxantrone
Drug: Dexamethasone
Drug: Thalidomide

First Posted Date: 2016-04-11

Last Posted Date: 2020-04-01

Lead Sponsor: Henan Cancer Hospital

Target Recruit Count: 20

Registration Number: NCT02733380

Locations: 🇨🇳
Henan Cancer Hospital/The affiliated Cancer Hospital of ZhengZhou university, ZhengZhou, Henan, China

the Efficiency of Thalidomide for Recurrent Small Intestinal Bleeding Due to Gastrointestinal Vascular Malformation

Phase 3

Completed

Conditions: Gastrointestinal Vascular Malformation

Interventions: Drug: placebo
Drug: Thalidomide (100mg)
Drug: Thalidomide (50mg)

First Posted Date: 2016-03-14

Last Posted Date: 2023-06-23

Lead Sponsor: Shanghai Jiao Tong University School of Medicine

Target Recruit Count: 150

Registration Number: NCT02707484

Locations: 🇨🇳
Peking Union Medical College Hospital, Beijing, Beijing, China
🇨🇳
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, Shanghai, China
🇨🇳
Xinqiao Hospital of Chongqing, Chongqing, Chongqing, China

and more 7 locations