Denosumab in Treating Patients with Multiple Myeloma with Kidney Insufficiency

Active:	No
Cancer Type:	Multiple Myeloma Plasma cell neoplasm	NCT ID:	NCT02833610
Trial Phases:	Phase II	Protocol IDs:	15-571 (primary) NCI-2016-01375
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	Dana-Farber Harvard Cancer Center
NCI Full Details:	http://clinicaltrials.gov/show/NCT02833610

Summary

This phase II trial studies how well denosumab works in treating patients with multiple myeloma with kidney insufficiency. Bone disease is a common and serious complication of multiple myeloma. Standard therapy includes the use of medications that strengthen the bones to lower the risk of bone complications called bisphosphonates. A limitation of current therapies is that they cannot be administered in patients with severe kidney dysfunction which is another common complication in multiple myeloma. Denosumab is a monoclonal protein against RANK ligand. It works to prevent bone loss by blocking a certain receptor in the body to decrease bone breakdown. It is believed to be safe to use in patients with kidney dysfunction.

Objectives

PRIMARY OBJECTIVE:
I. To assess the effect of denosumab 120 mg every 4 weeks (Q4W) on serum c-terminal telopeptide (sCTX) levels in multiple myeloma (MM) patients with renal insufficiency, defined as a creatinine clearance (CrCl) < 30 mL/min.

SECONDARY OBJECTIVES:
I. To assess the safety and tolerability of denosumab in MM patients with renal insufficiency.
II. To assess the incidence of hypocalcemia in patients with renal insufficiency receiving denosumab.
III. To assess the effect of denosumab on bone mineral density.
IV. To assess the effect of denosumab on urinary n-terminal telopeptide (uNTX).
V. To evaluate the proportions of subjects who have a documented skeletal-related event (SRE).

EXPLORATORY OBJECTIVE:
I. To assess the effect of denosumab on bone turnover markers which may include osteocalcin and procollagen 1 n-terminal propeptide (P1NP).

OUTLINE:
Patients receive denosumab subcutaneously (SC) on day 1. Treatment repeats every 4 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 12 weeks for 2 years.

Treatment Sites in Georgia

Emory University Hospital - Atlanta
1364 Clifton Road NE
Atlanta, GA 30322
www.emoryhealthcare.org

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