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)

Memorial Sloan Kettering Cancer Center7 sites in 1 country10 target enrollmentMarch 7, 2023

ConditionsOsteoporosis Multiple Myeloma

InterventionsRomosozumab

DrugsRomosozumab

Overview

Phase: Phase 1
Intervention: Romosozumab
Conditions: Osteoporosis
Sponsor: Memorial Sloan Kettering Cancer Center
Enrollment: 10
Locations: 7
Primary Endpoint: Percent change in bone formation marker, P1NP
Status: Active, not recruiting
Last Updated: 4 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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).

Registry

clinicaltrials.gov

Start Date

March 7, 2023

End Date

March 1, 2027

Last Updated

4 months ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Memorial Sloan Kettering Cancer Center

Responsible Party

Sponsor

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:
•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 \[CT\])

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).