Bone Marker Assessment of Multiple Myeloma Patients Treated With Aminobisphosphonates
| Status: | Completed |
|---|---|
| Conditions: | Blood Cancer, Hematology |
| Therapuetic Areas: | Hematology, Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/30/2013 |
| Start Date: | October 2007 |
| End Date: | December 2011 |
A Phase II Study of Bone Marker Assessment of Multiple Myeloma Patients Treated With AminoBisphosphonates
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.
- Each participant will receive a single dose of zoledronic acid intravenously after the
screening procedures.
- Participants will then return to the clinic once every month for 6 months and have the
following tests and procedures performed: Medical history update; physical exam; ECOG
Performance Status; blood tests; and urine tests.
- After 6 months there will be an end of study visit, where the following procedures will
take place: medical history update; bone marrow aspirate and biopsy; skeletal survey.
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 or PR 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
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