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Bortezomib With Melphalan and Prednisone for Multiple Myeloma (MVP)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT00734149
First received: December 26, 2007
Last updated: May 30, 2013
Last verified: May 2013
Results First Received: February 11, 2013  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Multiple Myeloma
Interventions: Drug: Bortezomib
Drug: Melphalan
Drug: Prednisone

  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
Recruitment period occurred from July 2004 to December 2007 at Duke University Medical Center.

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
Bortezomib+Melphalan+Prednisone Bortezomib 1.3 mg/m2 is administered intravenously in a 3-5 second bolus on days 1, 4, 8, and 11 of a 28 day cycle. Six cycles are planned. On days when both melphalan and bortezomib are given, melphalan is given at least one hour prior to bortezomib. Melphalan 6 mg/m2 is administered orally on an empty stomach daily on days 1-7 of each cycle. Prednisone 60 mg/m2 is administered orally daily on days 1-7 of each cycle.

Participant Flow:   Overall Study
    Bortezomib+Melphalan+Prednisone  
STARTED     45  
COMPLETED     44  
NOT COMPLETED     1  
Withdrawal by Subject                 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
Bortezomib+Melphalan+Prednisone Bortezomib 1.3 mg/m2 is administered intravenously in a 3-5 second bolus on days 1, 4, 8, and 11 of a 28 day cycle. Six cycles are planned. On days when both melphalan and bortezomib are given, melphalan is given at least one hour prior to bortezomib. Melphalan 6 mg/m2 is administered orally on an empty stomach daily on days 1-7 of each cycle. Prednisone 60 mg/m2 is administered orally daily on days 1-7 of each cycle.

Baseline Measures
    Bortezomib+Melphalan+Prednisone  
Number of Participants  
[units: participants]
  45  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     27  
>=65 years     18  
Gender  
[units: participants]
 
Female     19  
Male     26  



  Outcome Measures
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1.  Primary:   Response   [ Time Frame: 6 weeks following completion of treatment ]

2.  Secondary:   Number of Patients With Any Grade or Severe Adverse Event   [ Time Frame: At any time during the study and up to 30 days after stopping the study drug ]

3.  Secondary:   Median Duration of Response   [ Time Frame: up to 4 years ]


  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
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  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: Cristina Gasparetto, MD
Organization: Duke University Medical Center
phone: 919-668-1017
e-mail: gaspa001@mc.duke.edu


No publications provided


Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00734149     History of Changes
Other Study ID Numbers: Pro00008089, 6019
Study First Received: December 26, 2007
Results First Received: February 11, 2013
Last Updated: May 30, 2013
Health Authority: United States: Institutional Review Board