Bone Marker Assessment of Multiple Myeloma Patients Treated With Aminobisphosphonates

• Status: Completed
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this research study is to define the time a molecule in the participants bones called NTX begins to rise after receiving treatment with bisphosphonates. NTX is measured in the urine to determine the rate of bone breakdown. Tracking this marker may help identify a more optimal dosing schedule of bisphosphonate therapy. Bisphosphonate drugs like zoledronic acid, which will be used in this study, are used to reduce pain and bone fractures in people with multiple myeloma. There is some laboratory data to suggest that they may work against myeloma. Participants will have already undergone bisphosphonate therapy and may have received zoledronic acid as treatment. Typically these agents are continued indefinitely. Due to concerns of their long-term side effects we are looking at alternate strategies for reducing the frequency of these agents.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Massachusetts General Hospital
• Collaborators: American Society of Clinical Oncology; Brigham and Women's Hospital; Dana-Farber Cancer Institute
• Treatments: Zoledronic Acid

Criteria

Inclusion Criteria:

• Men or women 18 years of age or older

• Confirmed diagnosis of multiple myeloma(MM) by Durie and Dalmon staging criteria on IV bisphosphonate therapy with either pamidronate or zoledronic acid for 8-12 months

• MM patients in either CR (complete response) or PR (partial response) by EBMT criteria

• ECOG Performance Status of 0-2

Exclusion Criteria:

• MM patients on active anti-MM therapy (maintenance regimens allowed)

• Renal failure with serum creatinine >2mg/dL and/or creatinine clearance of <30ml/min

• Relapsed, refractory or progressive disease

• Any condition or situation that, in the opinion of the investigator, may put the subject at significant risk, confound the results of the study, or interfere significantly with the subject's participation in the study

• Hypersensitivity or any contraindication to a single dose of zoledronic acid