Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

A Study of Subcutaneous and Intravenous VELCADE in Patients With Previously Treated Multiple Myeloma

This study has been completed.
Sponsor:
Collaborator:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Information provided by (Responsible Party):
Millennium Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00722566
First received: July 23, 2008
Last updated: October 6, 2011
Last verified: October 2011
Results First Received: August 30, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Multiple Myeloma
Interventions: Drug: VELCADE Administered by subcutaneous injection
Drug: VELCADE Administered by intravenous infusion

  Participant Flow


  Baseline Characteristics
  Hide Baseline Characteristics

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
VELCADE Subcutaneous VELCADE 1.3 mg/m^2 administered by subcutaneous injection on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles.
VELCADE Intravenous VELCADE 1.3 mg/m^2 administered by intravenous infusion on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles.
Total Total of all reporting groups

Baseline Measures
   VELCADE Subcutaneous   VELCADE Intravenous   Total 
Overall Participants Analyzed 
[Units: Participants]
 148   74   222 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   74   37   111 
>=65 years   74   37   111 
Age 
[Units: Years]
Mean (Standard Deviation)
 64.3  (8.96)   64.0  (12.11)   64.2  (10.09) 
Gender 
[Units: Participants]
     
Female   74   27   101 
Male   74   47   121 
Region of Enrollment 
[Units: Participants]
     
France   22   14   36 
Belgium   7   5   12 
Germany   2   4   6 
Netherlands   6   4   10 
United Kingdom   6   3   9 
Ukraine   51   17   68 
Russian Federation   26   9   35 
Poland   20   7   27 
Argentina   5   8   13 
India   3   3   6 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Patients With Overall Response (Complete Response + Partial Response)   [ Time Frame: Over 4 cycles (prior to the addition of dexamethasone) ]

2.  Secondary:   Number of Patients With Complete Response   [ Time Frame: Over 4 cycles (prior to the addition of dexamethasone) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

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