NCT05775094进行中（未招募）1 期
A Pilot Study of Romosozumab Efficacy and Safety for the Management of Myelomarelated OsteoLytic Disease in Postmenopausal Women With Multiple Myeloma and Osteoporosis (REMOLD-MM)
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 10
- 试验地点
- 7
- 主要终点
- Percent change in bone formation marker, P1NP
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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:
- •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
- •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
排除标准
- •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).
研究组 & 干预措施
Romosozumab
Experimental
Romosozumab will be given on-label for osteoporosis at 210 mg administered SC once monthly for 12 months in conjunction with antimyeloma therapy.
干预措施: Romosozumab (Drug)
结局指标
主要结局
Percent change in bone formation marker, P1NP
时间窗: up to 2 years
次要结局
- Incidence and severity of adverse events(up to 2 years)
研究者
研究点 (7)
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