Romosozumab for Osteoporosis in Multiple Myeloma

Recruiting in Palo Alto (17 mi)

+7 other locations

Overseen byCarlyn R Tan, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Memorial Sloan Kettering Cancer Center

No Placebo Group

Trial Summary

What is the purpose of this trial?This trial is testing romosozumab, a medication that helps build and strengthen bones, in postmenopausal people with multiple myeloma. These patients often have weak bones due to osteoporosis and bone disease related to their condition. Romosozumab works by promoting new bone growth and preventing bone loss. Romosozumab is a recently approved monoclonal antibody that promotes bone formation and prevents bone resorption.

Eligibility Criteria

This trial is for postmenopausal women with multiple myeloma and osteoporosis. Participants must be over 18, able to follow study procedures, have documented MM, and show signs of bone weakness or fractures. They can't join if they've had certain treatments recently, have low vitamin D (unless corrected), abnormal calcium levels, a history of jawbone problems or recent serious heart events.

Inclusion Criteria

I have not had a menstrual cycle in the last 12 months.

I last took oral bisphosphonates more than 3 months ago.

My tests show a high number of plasma cells in my bone marrow or a confirmed plasmacytoma.

+8 more

Exclusion Criteria

I have had dental or oral surgery that hasn't fully healed.

My vitamin D levels are currently below 20 ng/mL.

I have had a heart attack or stroke in the last year.

+5 more

Participant Groups

The study tests Romosozumab's effects on bone formation and breakdown in women with both multiple myeloma and osteoporosis. It aims to determine the safety and effectiveness of this treatment for managing myeloma-related bone disease.

1Treatment groups

Experimental Treatment

Group I: RomosozumabExperimental Treatment1 Intervention

Romosozumab will be given on-label for osteoporosis at 210 mg administered SC once monthly for 12 months in conjunction with antimyeloma therapy.