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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Indiana University Simon Cancer Center
Indianapolis, Indiana, United States
Presence of biochemical bone turnover
The presence of change in biochemical markers of bone turnover during treatment with sotatercept will be examined.
Time frame: Average of 3 months
Number of Adverse Events related to sotatercept
Time frame: Average of 21 days
Bone marrow density
Change in bone mineral density of the femoral neck, forearm and spine.
Time frame: Average of 12 months
Change in biochemical myeloma markers
The change in myeloma markers will be determined by quantifying immunoglobulins, SPEP, UPEP and free light chains.
Time frame: Average of 3 months
Size of target bone lesions
Measure the change in size of target bone lesions using x-ray of target skeletal lesions.
Time frame: Average of 6 months
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