Expired Study
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Boston, Massachusetts 02114


Purpose:

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.


Study summary:

- 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.


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 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


Study is Available At:


Original ID:

07-144


NCT ID:

NCT00577642


Secondary ID:

ASCO CDA


Study Acronym:


Brief Title:

Bone Marker Assessment of Multiple Myeloma Patients Treated With Aminobisphosphonates


Official Title:

A Phase II Study of Bone Marker Assessment of Multiple Myeloma Patients Treated With AminoBisphosphonates


Overall Status:

Completed


Study Phase:

Phase 2


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Massachusetts General Hospital


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Non-Randomized, Endpoint Classificati


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

28


Enrollment Type:

Actual


Overall Contact Information

Official Name:Noopur Raje, MD
Principal Investigator
Massachusetts General Hospital

Study Dates

Start Date:October 2007
Completion Date:December 2012
Completion Type:Actual
Primary Completion Date:December 2012
Primary Completion Type:Actual
Verification Date:May 2013
Last Changed Date:May 7, 2013
First Received Date:December 18, 2007

Study Outcomes

Outcome Type:Primary Outcome
Measure:To assess the proportion of patients with urinary NTX levels less than or equal to 50nmol/mmol following a single dose of zoledronic acid.
Time Frame:6 months
Safety Issues:True
Outcome Type:Secondary Outcome
Measure:Gather baseline information on markers of disease activity, bone turnover, bone remodeling, and osteoclast activating factors in this patient population.
Time Frame:6 months
Safety Issues:True

Study Interventions

Intervention Type:Drug
Name:Zoledronic acid
Description:4mg IV over at least 15 minutes or corrected for creatinine clearance x 1
Other Name:Zometa

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Massachusetts General Hospital
Agency Class:Other
Agency Type:Collaborator
Agency Name:Brigham and Women's Hospital

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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