Panobinostat/Velcade in Multiple Myeloma

Summary

Multiple myeloma (MM) accounts for approximately 1% of all malignancies and 10% of hematological tumors, representing the second most frequently occurring hematological malignancy in the United States. At any one time, 50,000 people suffer from MM, and approximately 15,000 are diagnosed each year. The median age is approximately 65 years, although occasionally MM occurs in the second decade of life. Bortezomib and panobinostat intravenous (IV) are active agents in multiple myeloma and appear to work through different biochemical pathways, suggesting that there may be a synergistic effect using the combination. Both compounds have shown anabolic bone effect, which has been associated to significant anti-myeloma activity. Primary objectives: * To assess the toxicity of bortezomib combined with one of 4 doses of panobinostat IV in patients with relapsed/refractory multiple myeloma, and * To find the most appropriate doses of bortezomib and panobinostat IV in the combination. Secondary objective: * To assess the effect of bortezomib in combination with panobinostat IV on inducing osteoblast activation in patients with relapsed/refractory myeloma.

Timeline

Start

2009-04

Primary completion

2013-08

Completion

2013-08

Drugs

Indications