Active — Not RecruitingPhase 1

A Study of Romosozumab in Women With Multiple Myeloma and Osteoporosis

United States10 participantsStarted 2023-03-07

Plain-language 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).

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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

What they're measuring

Percent change in bone formation marker, P1NP

Timeframe: up to 2 years

Trial details

NCT IDNCT05775094

SponsorMemorial Sloan Kettering Cancer Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-03

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