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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: January 18, 2017
Last verified: January 2017
Results First Received: June 23, 2014  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: No masking;   Primary Purpose: Treatment
Condition: Multiple Myeloma
Intervention: Drug: Zoledronic acid

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Zoledronic Acid Single dose Zoledronic Acid (Zoledronate) 4mg IV over at least 15 minutes (or dose corrected for creatinine clearance x1) followed by Aminobisphosphonates (aBP) cessation during study period.

Participant Flow:   Overall Study
    Zoledronic Acid
STARTED   29 
COMPLETED   28 
NOT COMPLETED   1 
Clinical Disease Progression                1 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Zoledronic Acid Single dose Zoledronic Acid (Zoledronate) 4mg IV over at least 15 minutes (or dose corrected for creatinine clearance x1) followed by Aminobisphosphonates (aBP) cessation during study period

Baseline Measures
   Zoledronic Acid 
Overall Participants Analyzed 
[Units: Participants]
 29 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      19  65.5% 
>=65 years      10  34.5% 
Age 
[Units: Years]
Median (Full Range)
 60 
 (46 to 85) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      13  44.8% 
Male      16  55.2% 
Region of Enrollment 
[Units: Participants]
 
United States   29 
ISS Stage [1] 
[Units: Participants]
 
Stage I   11 
Stage II   9 
Stage III   9 
[1] International Staging System (ISS) stage
Therapy 
[Units: Participants]
 
Bortezomib + lenalidomide   14 
Bortezomib + Other   10 
Other   5 
Autologous Transplant 
[Units: Participants]
Count of Participants
 
Yes   13 
No   16 
Bone Lesions 
[Units: Participants]
 
> 3 bone lesions   20 
≤ 3 bone lesions   9 


  Outcome Measures

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


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Only 6 month biomarker data--but sufficient to change dosing regimen


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr Noopur Raje
Organization: Massachusetts General Hospital
phone: 6177260711
e-mail: nraje@partners.org


Publications:

Responsible Party: Noopur Raje, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00577642     History of Changes
Other Study ID Numbers: 07-144
ASCO CDA
Study First Received: December 18, 2007
Results First Received: June 23, 2014
Last Updated: January 18, 2017