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

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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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.

Participant Flow:   Overall Study
    VELCADE Subcutaneous   VELCADE Intravenous
STARTED   148 [1]   74 
COMPLETED   81 [2]   39 [2] 
NOT COMPLETED   67   35 
[1] One patient randomized and not dosed
[2] Completed 8 cycles

  Baseline Characteristics

  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