Bone Marker Assessment of Multiple Myeloma Patients Treated With Aminobisphosphonates

Completed · Phase 2

Conditions studied: Multiple Myeloma

In brief

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.

Key facts

Study ID

NCT00577642

Run by

Massachusetts General Hospital

People needed

29

Starts

2007-10-01

Expected to finish

2012-12-01

Last updated by the study team

2017-03-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Massachusetts General Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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