Denosumab for Smoldering Multiple Myeloma

  • STATUS
    Not Recruiting
  • End date
    Jun 1, 2024
  • participants needed
    20
  • sponsor
    University of Rochester
Updated on 19 August 2022
vasectomy
calcium
hysterectomy
anemia
multiple myeloma
vitamin d
renal failure
denosumab
a hemoglobin
bone lesions
hypercalcemia
bone marrow plasma cells

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.

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.

Details
Condition Smoldering Multiple Myeloma
Treatment Denosumab
Clinical Study IdentifierNCT03839459
SponsorUniversity of Rochester
Last Modified on19 August 2022

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