NCT01116128

Dasatinib in Combination With Melphalan and Prednisone to Treat Relapsed and Refractory Multiple Myeloma Patients

A Multicenter, Open-label, Phase Ii Study of Dasatinib in Combination With Melphalan and Prednisone (D-MP) in Advanced, Relapsed / Refractory Multiple Myeloma Patients

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Fondazione EMN Italy Onlus · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Clinically demonstrated efficacy of Melphalan and Prednisone in MM subjects as well as the confirmed inhibitory effect of dasatinib on several tyrosine kinase receptors and pathways implicated in the pathophysiology of MM. Additionally, as a SRC inhibitor, dasatinib plays an important role on bone metabolism through inhibition of osteoclast-mediated bone resorption in vitro. Dasatinib could, thus, be beneficial on bone density of patients on study, through blockage of osteolysis and control of bone lesions.

Detailed description

Primary Objective: To determine whether the combination of dasatinib with melphalan and prednisone provides therapeutic benefits and is safe in patients with relapsed/refractory Multiple Myeloma. Study design, dose and mode of administration, and duration of treatment: Multicenter, open-label, single arm, two-stage, Phase II study of dasatinib in combination with melphalan and prednisone (D-MP) in advanced, refractory MM patients. The three drugs will be concurrently administered through 6 cycles; each cycle will be 28 days long (1 cycle = 4 weeks), for a total of 24 weeks of treatment. The treatment schedule will be the following: * Melphalan 0,18 mg/Kg/day from day 1 to day 4 for 6 cycles; * Prednisone 1,5 mg/Kg/day from day 1 to day 4 for 6 cycles; * Dasatinib 100 mg QD continuously (from day 1 to day 28). After the 6 cycles of D-MP treatment, Dasatinib will be continuously administered alone as maintenance, until occurrence of progressive disease, unacceptable toxicity or informed consent withdrawal. This is a two-stage Phase II trial according to Simon with a bivariate endpoint design, by which treatment efficacy and safety are jointly evaluated. This design allows the trial to be early stopped after the first stage if the number of observed partial responses (PR) is inadequate and the number of observed toxicities is too high. In the first stage of the protocol 17 patients are required.

Conditions

• Myeloma

Interventions

Type	Name	Description
DRUG	dasatinib	100 mg QD continuously (from day 1 to day 28)
DRUG	melphalan	0,18 mg/Kg/day from day 1 to day 4 for 6 cycles
DRUG	prednisone	1,5 mg/Kg/day from day 1 to day 4 for 6 cycles

Timeline

• Start date: 2008-02-01
• Primary completion: 2011-05-01
• Completion: 2011-05-01
• First posted: 2010-05-04
• Last updated: 2011-06-14

Locations

1 site across 1 country: Italy