A Phase IIa Study of Sotatercept on Bone Mass and Turnover in Patients With Multiple Myeloma
Status:
Withdrawn
Trial end date:
2016-06-01
Target enrollment:
Participant gender:
Summary
Lytic bone disease continues to be one of the most devastating complications of multiple
myeloma (MM) despite recent and dramatic advancements in MM management, and bone lesions
persist and can continue to significantly impact a patient's morbidity, even when an
individual's myeloma is otherwise under good control. To date, no agent has been shown to
have a prolonged bone anabolic response in myeloma.
Preliminary studies treating healthy postmenopausal women with a single dose of sotatercept
demonstrated a rapid and sustained increase in serum biochemical markers of bone formation
and a decrease in markers of bone resorption. Similarly, the murine analog to sotatercept,
RAP-011, increases bone mineral density and strength in murine studies of both normal animals
and models of bone loss. We hypothesize that sotatercept will provide an anabolic response
for bone in myeloma patients with bone disease.