NCT03839459

Denosumab for Smoldering Multiple Myeloma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: University of Rochester · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will assess the safety and tolerability of denosumab in smoldering multiple myeloma subjects as well to see if denosumab can reduce subjects' risk of getting multiple myeloma.

Detailed description

This is an open label, Phase II trial of denosumab 120mg subcutaneous (SC) for patients with smoldering multiple myeloma (SMM). Subjects will be recruited from the James P. Wilmot Cancer Center, University of Rochester in Rochester, New York. Patients seen in the inpatient or outpatient setting with histologically confirmed SMM will be evaluated for this study. 20 patients will be treated as follows: Denosumab: day 1 = 120mg SC every 4 weeks for 12 cycles. Cycles will be 28 days in length. Patients will be followed after completion of the study per standard of care for progression free survival for an additional 2 years after the last dose of denosumab. All patients will take daily vitamin D and calcium supplements of at least 1200mg elemental calcium and 800IU of vitamin D unless documented hypercalcemia develops on study. Pre-existing hypocalcemia must be corrected prior to initiating therapy with denosumab. Serum vitamin D levels will be checked during screening and should be repleted to a total 25-hydroxyvitamin D level ≥30ng/mL.

Conditions

• Smoldering Multiple Myeloma

Interventions

Type	Name	Description
DRUG	Denosumab	120mg of Denosumab will be administered subcutaneously once every 4 weeks

Timeline

• Start date: 2019-04-19
• Primary completion: 2022-09-16
• Completion: 2025-01-30
• First posted: 2019-02-15
• Last updated: 2026-01-28
• Results posted: 2023-02-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study