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Bone Marker Assessment of Multiple Myeloma Patients Treated With Aminobisphosphonates

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00577642
First Posted: December 20, 2007
Last Update Posted: March 10, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Brigham and Women's Hospital
Dana-Farber Cancer Institute
American Society of Clinical Oncology
Information provided by (Responsible Party):
Noopur Raje, Massachusetts General Hospital
  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.

Condition Intervention Phase
Multiple Myeloma Drug: Zoledronic acid Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of Bone Marker Assessment of Multiple Myeloma Patients Treated With AminoBisphosphonates

Resource links provided by NLM:


Further study details as provided by Noopur Raje, Massachusetts General Hospital:

Primary Outcome Measures:
  • Number of Participants With Urinary NTX Levels Less Than or Equal to 50nmol/mmol Cr [ Time Frame: 6 months ]
    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.


Enrollment: 29
Study Start Date: October 2007
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Single arm
Single arm biomarker study after a single dose of zoledronic acid
Drug: Zoledronic acid
4mg IV over at least 15 minutes or corrected for creatinine clearance x 1
Other Name: Zometa

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00577642


Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Brigham and Women's Hospital
Dana-Farber Cancer Institute
American Society of Clinical Oncology
Investigators
Principal Investigator: Noopur Raje, MD Massachusetts General Hospital
  More Information

Publications:
Responsible Party: Noopur Raje, Director Center for Multiple Myeloma, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00577642     History of Changes
Other Study ID Numbers: 07-144
ASCO CDA
First Submitted: December 18, 2007
First Posted: December 20, 2007
Results First Submitted: June 23, 2014
Results First Posted: March 10, 2017
Last Update Posted: March 10, 2017
Last Verified: January 2017

Keywords provided by Noopur Raje, Massachusetts General Hospital:
aminobisphosphonates

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Zoledronic acid
Bone Density Conservation Agents
Physiological Effects of Drugs