A Study of Romosozumab in Women With Multiple Myeloma and Osteoporosis

• Status: Recruiting
• Trial end date: 2025-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to measure the effect of romosozumab on bone formation and breakdown (resorption) and determine if romosozumab is a safe treatment for osteoporosis and myeloma-related bone disease (MBD) in postmenopausal people with multiple myeloma (MM).

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Memorial Sloan Kettering Cancer Center

Criteria

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 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.

• 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 denosumab within 12 months prior to study entry

• 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).