Clinical Trials of Drug – Thalidomide, and Its Derivatives

Abstract

In the clinic, I am following (114) patients suffering from Multiple Myeloma (MM), treated with a single dose capsule daily containing (50- 100 mg) of the drug. Thalidomide [1,2] has shown its efficacy in multiple myeloma [3,4], particularly in combination with cortisone. Currently it is used in combination with Melphalan and Prednisone (MPT) [5,6,7] as first-line therapy or in combination with Dexamethasone [8,9] (Dex-Tal) in relapsing patients. Bortezomib (Velcade®) is a very active drug in patients with multiple myeloma. It has been used in experimental protocols in various stages of the disease (first-line therapy or relapse). Many studies have shown a clear superiority of Bortezomib in combination with high-dose Dexamethasone or other drugs (Thalidomide, Doxorubicin, Cyclophosphamide), compared to conventional therapy.Recently Bortezomib (Velcade®) in association with Melphalan and Prednisone (VMP) has been approved as an alternative to the previous reference (MPT) scheme in patients not candidates for autologous transplantation [10,11,12]. Since it is not eliminated by the kidney it is the drug of first choice in patients with renal insufficiency. In pharmacokinetics profile in patients with multiple myeloma after oral administration of a single dose capsule containing (100mg) of the drug,HPLC – Technique is used for the determination of molecules [13].

Keywords: Multiple Myeloma (MM), Thalidomide, Lenalidomide Velcade®, Melphalan and Prednisone (MPT), HPLC-Technique.