A Study of Romosozumab in Women With Multiple Myeloma and Osteoporosis

NCT05775094 | Active Not Recruiting Phase 1 FDA Drug

• 1 other identifier: 23-038
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 7

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).

Conditions

Osteoporosis; Multiple Myeloma

Keywords

Romosozumab; 23-038

Outcome Measures

Primary Outcomes (1)

• Percent change in bone formation marker, P1NP

  up to 2 years

Secondary Outcomes (1)

• Incidence and severity of adverse events

  up to 2 years

Study Arms (1)

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.

Drug: Romosozumab

Interventions

Romosozumab DRUG

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).

Romosozumab

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Postmenopausal women are at high risk for fractures.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• (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).

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead

Study Sites (7)

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)

Basking Ridge, New Jersey, 07920, United States

Location

Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

Middletown, New Jersey, 07748, United States

Location

Memorial Sloan Kettering Bergen (Limited Protocol Activities)

Montvale, New Jersey, 07645, United States

Location

Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)

Commack, New York, 11725, United States

Location

Memorial Sloan Kettering Westchester (Limited Protocol Activities)

Harrison, New York, 10604, United States

Location

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, 10065, United States

Location

Memorial Sloan Kettering Nassau (Limited Protocol Activities)

Uniondale, New York, 11553, United States

Location

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Conditions

Osteoporosis; Multiple Myeloma

Interventions

romosozumab

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Carlyn Tan, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is an open-label, single-arm.

Study Record Dates

• First Submitted: March 7, 2023
• First Posted: March 20, 2023
• Study Start: March 7, 2023
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: December 19, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share

Locations

US (7)