A Study of Romosozumab in Women With Multiple Myeloma and Osteoporosis

Multiple Myeloma Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05775094
• Other study ID #: 23-038
• Status: Recruiting
• Phase: Phase 1
• Start date: March 7, 2023
• Est. completion date: March 2025

Study information

• Verified date: October 2023
• Source: Memorial Sloan Kettering Cancer Center
• Contact: Carlyn Tan, MD
• Phone: 646-608-3778
• Email: tanc4[@]mskcc.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: March 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell
• Osteoporosis

Intervention

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).

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)	Basking Ridge	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 Monmouth (Limited Protocol Activities)	Middletown	New Jersey
United States	Memorial Sloan Kettering Bergen (Limited Protocol Activities)	Montvale	New Jersey
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

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent change in bone formation marker, P1NP		up to 2 years
Secondary	Incidence and severity of adverse events	evaluating adverse events using NCI CTCAE v5.0.	up to 2 years

External Links

•   Memorial Sloan Kettering Cancer Center