A Study of Romosozumab in Women with Multiple Myeloma and Osteoporosis

Trial Title: A Study of Romosozumab in Women with Multiple Myeloma and Osteoporosis

NCT ID: NCT05775094

Condition: Osteoporosis
Multiple Myeloma

Conditions: Official terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Osteoporosis

Conditions: Keywords:
Romosozumab
23-038

Study type: Interventional

Study phase: Phase 1

Overall status: Active, not recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Intervention model description: This is an open-label, single-arm.

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Romosozumab
Description: 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).
Arm group label: Romosozumab

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).

Criteria for eligibility:
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 (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).

Gender: All

Gender based: Yes

Gender description: Postmenopausal women are at high risk for fractures.

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)

Address:
City: Basking Ridge
Zip: 07920
Country: United States

Facility:
Name: Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

Address:
City: Middletown
Zip: 07748
Country: United States

Facility:
Name: Memorial Sloan Kettering Bergen (Limited Protocol Activities)

Address:
City: Montvale
Zip: 07645
Country: United States

Facility:
Name: Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)

Address:
City: Commack
Zip: 11725
Country: United States

Facility:
Name: Memorial Sloan Kettering Cancer Center (All Protocol Activities)

Address:
City: New York
Zip: 10065
Country: United States

Facility:
Name: Memorial Sloan Kettering Nassau (Limited Protocol Activities)

Address:
City: Uniondale
Zip: 11553
Country: United States

Facility:
Name: Memorial Sloan Kettering Westchester (Limited Protocol Activities)

Address:
City: West Harrison
Zip: 10604
Country: United States

Start date: March 7, 2023

Completion date: March 2026

Lead sponsor:
Agency: Memorial Sloan Kettering Cancer Center
Agency class: Other

Source: Memorial Sloan Kettering Cancer Center

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05775094
http://www.mskcc.org/mskcc/html/44.cfm