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

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: July 25, 2008
Last Update Posted: October 10, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Information provided by (Responsible Party):
Millennium Pharmaceuticals, Inc.
Results First Submitted: August 30, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (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
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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.
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Reporting Groups
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 
[Units: Participants]
<=18 years   0   0   0 
Between 18 and 65 years   74   37   111 
>=65 years   74   37   111 
[Units: Years]
Mean (Standard Deviation)
 64.3  (8.96)   64.0  (12.11)   64.2  (10.09) 
[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
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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
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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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