Clinical Trial Finder

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.

Exclusion Criteria:

• - Assigned male at birth.

• - Received teriparatide or other PTH analog use within 12 months prior to study entry.

• - Receiving concurrent antiresorptive therapy.

• - History of cardiovascular event (myocardial infarction and/or stroke) within the past 12 months of study entry.

• - History of non-healed dental or oral surgery.

• - History of osteonecrosis of the jaw.

• - 25 (OH) vitamin D levels < 20 ng/mL.

Vitamin D repletion will be permitted and subjects may be rescreened once 25 (OH) vitamin D level ≥ 20 ng/mL.

• - Current hyper- or hypocalcemia, defined as albumin-adjusted serum calcium outside the normal range per institutional standard (<8.5 or >10.5 mg/dL).

Arms

Experimental: Romosozumab

Romosozumab will be given on-label for osteoporosis at 210 mg administered SC once monthly for 12 months in conjunction with antimyeloma therapy.

Interventions

Drug: - Romosozumab

Romosozumab will be administered 210 mg SC as two 105 mg prefilled syringes once every 4 weeks x 12 months. No dose adjustments for romosozumab will be permitted. All efforts will be made to administer romosozumab within the defined study visit windows (+/- 14 days).