A Study of Romosozumab in Women With Multiple Myeloma and Osteoporosis
- Registration Number
- NCT05775094
- Lead Sponsor
- Memorial Sloan Kettering Cancer Center
- Brief 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 10
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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:
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Evidence of end organ damage that can be attributed to the underlying plasma cell proliferative disorder:
- 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)
- Renal insufficiency: creatinine clearance < 40 mL/min or serum creatinine 177µmol/L (>2 mg/dL)
- Anemia: hemoglobin > 2 g/dL below the lower limit of normal, or a hemoglobin value <10 g/dL
- Bone lesions: one or more osteolytic lesions on skeletal radiography, CT, or PET/CT
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Clonal bone marrow plasma cell percentage ≥ 60%; or
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Involved: uninvolved serum free light chain (FLC) ratio ≥ 100 (involved FLC level be ≥ 10 mg/dL; or
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>1 focal lesion on MRI studies (at least 5 mm in size)
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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])
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Postmenopausal female, defined as last menstrual cycle at least 12 months prior to study enrollment
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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)
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Within 12 months prior to study entry, ≤ 4 doses of prior intravenous (IV) bisphosphonate with the last dose ≥ 3 months prior to study entry.
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Prior oral bisphosphonates are allowed if the last dose was ≥ 3 months prior to study entry.
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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.
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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.
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Ability to comply with all study-related procedures in the investigator's judgment
-
18 years of age or older
- 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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Romosozumab Romosozumab Romosozumab will be given on-label for osteoporosis at 210 mg administered SC once monthly for 12 months in conjunction with antimyeloma therapy.
- Primary Outcome Measures
Name Time Method Percent change in bone formation marker, P1NP up to 2 years
- Secondary Outcome Measures
Name Time Method Incidence and severity of adverse events up to 2 years evaluating adverse events using NCI CTCAE v5.0.
Trial Locations
- Locations (7)
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
🇺🇸Basking Ridge, New Jersey, United States
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
🇺🇸Middletown, New Jersey, United States
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
🇺🇸Montvale, New Jersey, United States
Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)
🇺🇸Commack, New York, United States
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
🇺🇸Harrison, New York, United States
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
🇺🇸New York, New York, United States
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
🇺🇸Uniondale, New York, United States