Phase II High Pulse Dose Clinical Trial of Orally Administered ITF2357 In Patients With Relapsed/Refractory Multiple Myeloma
Multiple myeloma (MM) is a B-cell neoplasm that manifests as one or more lytic bone lesions,
monoclonal protein in the blood or urine and disease in the bone marrow (BM). The malignant
plasma cells accumulate in the BM and intricate interactions occur between the BM
microenvironment and the MM cells, frequently causing bone destruction, which in turn
stimulates tumour growth. The tumour itself, its products and the host response to it result
in the multitude of symptoms and organ dysfunction characteristic of MM, including bone
pain, renal failure, susceptibility to infections, anaemia and hypercalcemia. The median age
at diagnosis is 68 years and men are more frequently affected than women.
ITF2357 is a novel and proprietary molecule synthesized by Italfarmaco S.p.A. Research
Laboratories, provided with an established and powerful HDAC-inhibitory activity. It is
being developend for a range of possible clinical applications both in oncohaematological
conditions and in chronic inflammatory diseases. The former application is consistent with
the well known antitumor pharmacological properties of HDAC-inhibitors as a family (i.e.
cell-cycle arrest, pro-apoptotic and cell-differentiating effects); the latter application
(chronic inflammation) is based of the demonstrated anticytokine effect of ITF2357.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To assess the safety of ITF2357 administered once weekly at high pulse dose in patients with relapsing/refractory multiple myeloma.
Giorgio La Nasa, MD
Presidio Ospedaliero R. Binaghi, Cagliari - Italy
Italy: Ministry of Health