Velcade, Trisenox, Vitamin C and Melphalan for Myeloma Patients

This study has been completed.
Sponsor:
Collaborator:
Cephalon
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00469209
First received: May 3, 2007
Last updated: August 1, 2012
Last verified: August 2012
Results First Received: March 23, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Myeloma
Interventions: Drug: Trisenox (Arsenic Trioxide)
Drug: Velcade (Bortezomib)
Drug: Melphalan
Drug: Vitamin C (Ascorbic 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
Recruitment period June 2006 to December 2008. All participants recruited at UT MD Anderson Cancer 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
No Bortezomib Melphalan 100 mg/m^2 intravenous (IV) days -4,-3 + Arsenic Trioxide 0.25 mg/kg IV for 7 days + Vitamin C IV daily
Bortezomib 1.0 mg/m^2 Bortezomib (Level 1) 1.0 mg/m^2 IV push on Days -9, -6, and -3, Melphalan 100 mg/m^2 IV days -4,-3 + Arsenic Trioxide 0.25 mg/kg IV for 7 days + Vitamin C IV daily
Bortezomib 1.5 mg/m^2 Bortezomib (Level 2) 1.5 mg/m^2 IV push on Days -9, -6, and -3, Melphalan + Arsenic Trioxide 0.25 mg/kg IV for 7 days + Vitamin C IV daily

Participant Flow:   Overall Study
    No Bortezomib     Bortezomib 1.0 mg/m^2     Bortezomib 1.5 mg/m^2  
STARTED     20     20     20  
COMPLETED     19     20     19  
NOT COMPLETED     1     0     1  
Adverse Event                 1                 0                 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
No Bortezomib Melphalan 100 mg/m^2 intravenous (IV) days -4,-3 + Arsenic Trioxide 0.25 mg/kg IV for 7 days + Vitamin C IV daily
Bortezomib 1.0 mg/m^2 Bortezomib (Level 1) 1.0 mg/m^2 IV push on Days -9, -6, and -3, Melphalan 100 mg/m^2 IV days -4,-3 + Arsenic Trioxide 0.25 mg/kg IV for 7 days + Vitamin C IV daily
Bortezomib 1.5 mg/m^2 Bortezomib (Level 2) 1.5 mg/m^2 IV push on Days -9, -6, and -3, Melphalan + Arsenic Trioxide 0.25 mg/kg IV for 7 days + Vitamin C IV daily
Total Total of all reporting groups

Baseline Measures
    No Bortezomib     Bortezomib 1.0 mg/m^2     Bortezomib 1.5 mg/m^2     Total  
Number of Participants  
[units: participants]
  20     20     20     60  
Age  
[units: years]
Median ( Full Range )
  61  
  ( 47 to 70 )  
  59  
  ( 45 to 67 )  
  64  
  ( 49 to 75 )  
  60  
  ( 45 to 75 )  
Gender  
[units: participants]
       
Female     12     9     6     27  
Male     8     11     14     33  
Region of Enrollment  
[units: participants]
       
United States     20     20     20     60  



  Outcome Measures

1.  Primary:   Number of Patients Reaching Complete Response (CR)   [ Time Frame: Baseline through Day 180, with assessments at Day 90 and Day 180 ]

2.  Secondary:   Time to Toxicity   [ Time Frame: Baseline to event occurence (assessed weekly first 30 days) ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes


  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
No text entered.


  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: Muzaffar H. Qazilbash, MD
Organization: University of Texas M.D. Anderson Cancer Center
phone: 713-745-3458
e-mail: CR_Study_Registration@mdanderson.org


No publications provided


Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00469209     History of Changes
Other Study ID Numbers: 2005-0893
Study First Received: May 3, 2007
Results First Received: March 23, 2010
Last Updated: August 1, 2012
Health Authority: United States: Institutional Review Board