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

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. Identifier: NCT00722566
Recruitment Status : Completed
First Posted : July 25, 2008
Results First Posted : October 4, 2011
Last Update Posted : October 10, 2011
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Information provided by (Responsible Party):
Millennium Pharmaceuticals, Inc.

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

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

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

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

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact:  
Name/Title: Helgi Van de Velde, M.D., Ph.D.
Organization: Johnson & Johnson Pharmaceutical Research & Development

Publications automatically indexed to this study by Identifier (NCT Number):

Responsible Party: Millennium Pharmaceuticals, Inc. Identifier: NCT00722566     History of Changes
Other Study ID Numbers: 26866138 MMY 3021
First Submitted: July 23, 2008
First Posted: July 25, 2008
Results First Submitted: August 30, 2011
Results First Posted: October 4, 2011
Last Update Posted: October 10, 2011