Phase 2
Completed N=29
Bone Marker Assessment of Multiple Myeloma Patients Treated With Aminobisphosphonates
Source: ClinicalTrials.gov NCT00577642 ↗Enrolled (actual)
29
Serious AEs
0.0%
Results posted
Mar 2017
Primary outcomePrimary: Number of Participants With Urinary NTX Levels Less Than or Equal to 50nmol/mmol Cr — 28; 1 Participants — p=<0.05
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Urinary NTX Levels Less Than or Equal to 50nmol/mmol Cr |
28; 1 | <0.05 sig |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00577642). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.