A Study of Romosozumab in Women With Multiple Myeloma and Osteoporosis

Inclusion Criteria

• •Documented MM per International Myeloma Working Group diagnostic criteria (evidence of myeloma defining event attributed to underlying plasma cell disorder): i. Clonal plasma cells in the bone marrow ≥ 10% or presence of a biopsy proven plasmacytoma; and ii. Any one or more of the following myeloma defining events:
• •Evidence of end organ damage that can be attributed to the underlying plasma cell proliferative disorder:
• •1. Hypercalcemia: serum calcium \>0.25 mmol/L (\>1 mg/dL) higher than the upper limit of normal or \>2.75 mmol/L (\>11 mg/dL)
• •2. Renal insufficiency: creatinine clearance \< 40 mL/min or serum creatinine 177µmol/L (\>2 mg/dL)
• •3. Anemia: hemoglobin \> 2 g/dL below the lower limit of normal, or a hemoglobin value \<10 g/dL
• •4. Bone lesions: one or more osteolytic lesions on skeletal radiography, CT, or PET/CT
• •Clonal bone marrow plasma cell percentage ≥ 60%; or
• •Involved: uninvolved serum free light chain (FLC) ratio ≥ 100 (involved FLC level be ≥ 10 mg/dL; or
• •\>1 focal lesion on MRI studies (at least 5 mm in size)
• •Presence of lytic bone lesion(s) due to MM based on radiographic evidence with at least one measurable lesion (≥0.5 cm in its largest diameter by computerized tomography \[CT\])
• •Postmenopausal female, defined as last menstrual cycle at least 12 months prior to study enrollment
• •Must have one of the following:
• •* osteoporosis on dual X-ray absorptiometry (DXA) scan; or
• •* fragility fracture of the spine or hip; or
• •* morphometric spine fracture; or
• •* osteopenia with elevated risk of fracture (calculated by the FRAX online calculator)
• •Within 12 months prior to study entry, ≤ 4 doses of prior intravenous (IV) bisphosphonate with the last dose ≥ 3 months prior to study entry.
• •Prior oral bisphosphonates are allowed if the last dose was ≥ 3 months prior to study entry.
• •Prior denosumab use is allowed for the following:
• •* For patients who received ≤ 5 consecutive doses of denosumab with the last dose of denosumab received ≥ 3 months prior to study entry.
• •* For patients who received ≥ 6 doses of denosumab, IV bisphosphonate should be given at least 1 month after the last dose of denosumab (if the last dose of denosumab was within the past 2 years). Patients are then eligible ≥ 3 months after IV bisphosphonate is received. If ≤ 2 years have elapsed since the last dose of denosumab, IV bisphosphonate is not required, and patients are eligible for the study.
• •Signed informed consent form(s). Individuals with impaired decision-making capacity may enroll if legally authorized representatives consent on behalf of individuals with impaired decision-making capacity.
• •Ability to comply with all study-related procedures in the investigator's judgment
• •18 years of age or older