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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
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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
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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
  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.

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
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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
  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
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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
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Time Frame No text entered.
Additional Description No text entered.

Frequency Threshold
Threshold above which other adverse events are reported   5  

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.

Other Adverse Events
    VELCADE Subcutaneous   VELCADE Intravenous
Total, other (not including serious) adverse events     
# participants affected / at risk   112/147 (76.19%)   66/74 (89.19%) 
Blood and lymphatic system disorders     
Leukopenia † 1     
# participants affected / at risk   29/147 (19.73%)   16/74 (21.62%) 
Eye disorders     
Chalazion † 1     
# participants affected / at risk   2/147 (1.36%)   4/74 (5.41%) 
Gastrointestinal disorders     
Abdominal pain upper † 1     
# participants affected / at risk   3/147 (2.04%)   8/74 (10.81%) 
Constipation † 1     
# participants affected / at risk   21/147 (14.29%)   11/74 (14.86%) 
Dyspepsia † 1     
# participants affected / at risk   4/147 (2.72%)   7/74 (9.46%) 
General disorders     
Chills † 1     
# participants affected / at risk   6/147 (4.08%)   4/74 (5.41%) 
Fatigue † 1     
# participants affected / at risk   17/147 (11.56%)   15/74 (20.27%) 
Oedema peripheral † 1     
# participants affected / at risk   9/147 (6.12%)   6/74 (8.11%) 
Infections and infestations     
Nasopharyngitis † 1     
# participants affected / at risk   4/147 (2.72%)   6/74 (8.11%) 
Upper respiratory tract infection † 1     
# participants affected / at risk   7/147 (4.76%)   7/74 (9.46%) 
Investigations     
Weight decreased † 1     
# participants affected / at risk   22/147 (14.97%)   2/74 (2.70%) 
Metabolism and nutrition disorders     
Hyperglycaemia † 1     
# participants affected / at risk   7/147 (4.76%)   5/74 (6.76%) 
Hyperkalaemia † 1     
# participants affected / at risk   7/147 (4.76%)   1/74 (1.35%) 
Musculoskeletal and connective tissue disorders     
Bone pain † 1     
# participants affected / at risk   12/147 (8.16%)   2/74 (2.70%) 
Muscle spasms † 1     
# participants affected / at risk   4/147 (2.72%)   5/74 (6.76%) 
Musculoskeletal pain † 1     
# participants affected / at risk   2/147 (1.36%)   4/74 (5.41%) 
Pain in extremity † 1     
# participants affected / at risk   8/147 (5.44%)   8/74 (10.81%) 
Nervous system disorders     
Dizziness † 1     
# participants affected / at risk   10/147 (6.80%)   2/74 (2.70%) 
Headache † 1     
# participants affected / at risk   5/147 (3.40%)   8/74 (10.81%) 
Paraesthesia † 1     
# participants affected / at risk   9/147 (6.12%)   6/74 (8.11%) 
Psychiatric disorders     
Insomnia † 1     
# participants affected / at risk   18/147 (12.24%)   8/74 (10.81%) 
Skin and subcutaneous tissue disorders     
Pruritis † 1     
# participants affected / at risk   7/147 (4.76%)   2/74 (2.70%) 
Rash † 1     
# participants affected / at risk   10/147 (6.80%)   5/74 (6.76%) 
Vascular disorders     
Hypertension † 1     
# participants affected / at risk   14/147 (9.52%)   3/74 (4.05%) 
Events were collected by systematic assessment
1 Term from vocabulary, MedDRA (13.0)



  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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  More Information
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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
e-mail: HVDVELDE@ITS.JNJ.COM


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

Responsible Party: Millennium Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00722566     History of Changes
Other Study ID Numbers: 26866138 MMY 3021
Study First Received: July 23, 2008
Results First Received: August 30, 2011
Last Updated: October 6, 2011
Health Authority: United States: Food and Drug Administration