A Study of Romosozumab in Women With Multiple Myeloma and Osteoporosis
Study Details
Study Description
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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. |
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).
|
Outcome Measures
Primary Outcome Measures
- Percent change in bone formation marker, P1NP [up to 2 years]
Secondary Outcome Measures
- Incidence and severity of adverse events [up to 2 years]
evaluating adverse events using NCI CTCAE v5.0.
Eligibility Criteria
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
- 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:
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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)
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Renal insufficiency: creatinine clearance < 40 mL/min or serum creatinine 177µmol/L (>2 mg/dL)
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Anemia: hemoglobin > 2 g/dL below the lower limit of normal, or a hemoglobin value <10 g/dL
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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:
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osteoporosis on dual X-ray absorptiometry (DXA) scan; or
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fragility fracture of the spine or hip; or
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morphometric spine fracture; or
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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 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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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
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18 years of age or older
Exclusion Criteria:
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Assigned male at birth
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Received denosumab within 12 months prior to study entry
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Received teriparatide or other PTH analog use within 12 months prior to study entry
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Receiving concurrent antiresorptive therapy
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History of cardiovascular event (myocardial infarction and/or stroke) within the past 12 months of study entry
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History of non-healed dental or oral surgery
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History of osteonecrosis of the jaw
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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.
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Current hyper- or hypocalcemia, defined as albumin-adjusted serum calcium outside the normal range per institutional standard (<8.5 or >10.5 mg/dL).
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities) | Basking Ridge | New Jersey | United States | 07920 |
| 2 | Memorial Sloan Kettering Monmouth (Limited Protocol Activities) | Middletown | New Jersey | United States | 07748 |
| 3 | Memorial Sloan Kettering Bergen (Limited Protocol Activities) | Montvale | New Jersey | United States | 07645 |
| 4 | Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities) | Commack | New York | United States | 11725 |
| 5 | Memorial Sloan Kettering Westchester (Limited Protocol Activities) | Harrison | New York | United States | 10604 |
| 6 | Memorial Sloan Kettering Cancer Center (All Protocol Activities) | New York | New York | United States | 10065 |
| 7 | Memorial Sloan Kettering Nassau (Limited Protocol Activities) | Uniondale | New York | United States | 11553 |
Sponsors and Collaborators
- Memorial Sloan Kettering Cancer Center
Investigators
- Principal Investigator: Carlyn Tan, MD, Memorial Sloan Kettering Cancer Center
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 23-038