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Bone Marker Assessment of Multiple Myeloma Patients Treated With Aminobisphosphonates

Primary Purpose

Multiple Myeloma

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Zoledronic acid
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Myeloma focused on measuring aminobisphosphonates

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Massachusetts General Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Single arm

Arm Description

Single arm biomarker study after a single dose of zoledronic acid

Outcomes

Primary Outcome Measures

Number of Participants With Urinary NTX Levels Less Than or Equal to 50nmol/mmol Cr
Number of participants with urinary NTX levels less than or equal to 50 nmol/mmol creatinine (Cr) for the duration of study followup, following a single dose Zoledronic Acid (Zoledronate) 4mg IV over at least 15 minutes (or dose corrected for creatinine clearance x1). Dose administration was followed by Aminobisphosphonates (aBP) treatment cessation during study period.

Secondary Outcome Measures

Full Information

First Posted
December 18, 2007
Last Updated
January 18, 2017
Sponsor
Massachusetts General Hospital
Collaborators
Brigham and Women's Hospital, Dana-Farber Cancer Institute, American Society of Clinical Oncology
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1. Study Identification

Unique Protocol Identification Number
NCT00577642
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
October 2007 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
Brigham and Women's Hospital, Dana-Farber Cancer Institute, American Society of Clinical Oncology

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed Description
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 (Eastern Cooperative Oncology Group) 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
Keywords
aminobisphosphonates

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
29 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Single arm
Arm Type
Other
Arm Description
Single arm biomarker study after a single dose of zoledronic acid
Intervention Type
Drug
Intervention Name(s)
Zoledronic acid
Other Intervention Name(s)
Zometa
Intervention Description
4mg IV over at least 15 minutes or corrected for creatinine clearance x 1
Primary Outcome Measure Information:
Title
Number of Participants With Urinary NTX Levels Less Than or Equal to 50nmol/mmol Cr
Description
Number of participants with urinary NTX levels less than or equal to 50 nmol/mmol creatinine (Cr) for the duration of study followup, following a single dose Zoledronic Acid (Zoledronate) 4mg IV over at least 15 minutes (or dose corrected for creatinine clearance x1). Dose administration was followed by Aminobisphosphonates (aBP) treatment cessation during study period.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Noopur Raje, MD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
24958808
Citation
Patel CG, Yee AJ, Scullen TA, Nemani N, Santo L, Richardson PG, Laubach JP, Ghobrial IM, Schlossman RL, Munshi NC, Anderson KC, Raje NS. Biomarkers of bone remodeling in multiple myeloma patients to tailor bisphosphonate therapy. Clin Cancer Res. 2014 Aug 1;20(15):3955-61. doi: 10.1158/1078-0432.CCR-14-0434. Epub 2014 Jun 23.
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Bone Marker Assessment of Multiple Myeloma Patients Treated With Aminobisphosphonates

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