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Bone Marker Assessment of Multiple Myeloma Patients Treated With Aminobisphosphonates

This study has been completed.
Sponsor:
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
ClinicalTrials.gov Identifier:
NCT00577642
First received: December 18, 2007
Last updated: May 7, 2013
Last verified: May 2013
History of Changes
  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: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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:

MedlinePlus related topics: Multiple Myeloma
U.S. FDA Resources

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Gather baseline information on markers of disease activity, bone turnover, bone remodeling, and osteoclast activating factors in this patient population. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Enrollment: 28
Study Start Date: October 2007
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    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 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: December 18, 2007
Last Updated: May 7, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by 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
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013