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  
Number of Participants  
[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
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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.

Serious Adverse Events
    VELCADE Subcutaneous     VELCADE Intravenous  
Total, serious adverse events      
# participants affected / at risk     53/147 (36.05%)     26/74 (35.14%)  
Blood and lymphatic system disorders      
Anemia † 1    
# participants affected / at risk     0/147 (0.00%)     1/74 (1.35%)  
Neutropenia † 1    
# participants affected / at risk     1/147 (0.68%)     1/74 (1.35%)  
Splenomegaly † 1    
# participants affected / at risk     1/147 (0.68%)     0/74 (0.00%)  
Thrombocytopenia † 1    
# participants affected / at risk     1/147 (0.68%)     1/74 (1.35%)  
Cardiac disorders      
Angina Pectoris † 1    
# participants affected / at risk     1/147 (0.68%)     0/74 (0.00%)  
Arrhythmia † 1    
# participants affected / at risk     1/147 (0.68%)     0/74 (0.00%)  
Arteriosclerosis coronary artery † 1    
# participants affected / at risk     1/147 (0.68%)     0/74 (0.00%)  
Atrial Fibrillation † 1    
# participants affected / at risk     2/147 (1.36%)     0/74 (0.00%)  
Bradyarrhythmia † 1    
# participants affected / at risk     1/147 (0.68%)     0/74 (0.00%)  
Cardiac Arrest † 1    
# participants affected / at risk     0/147 (0.00%)     1/74 (1.35%)  
Cardiac failure † 1    
# participants affected / at risk     1/147 (0.68%)     0/74 (0.00%)  
Cardiac failure acute † 1    
# participants affected / at risk     1/147 (0.68%)     0/74 (0.00%)  
Coronary artery insufficiency † 1    
# participants affected / at risk     0/147 (0.00%)     1/74 (1.35%)  
Myocardial infarction † 1    
# participants affected / at risk     0/147 (0.00%)     1/74 (1.35%)  
Supraventricular tachycardia † 1    
# participants affected / at risk     0/147 (0.00%)     1/74 (1.35%)  
Tachycardia paroxysmal † 1    
# participants affected / at risk     0/147 (0.00%)     1/74 (1.35%)  
Ear and labyrinth disorders      
Acute vestibular syndrome † 1    
# participants affected / at risk     1/147 (0.68%)     0/74 (0.00%)  
Gastrointestinal disorders      
Abdominal discomfort † 1    
# participants affected / at risk     1/147 (0.68%)     0/74 (0.00%)  
Abdominal pain † 1    
# participants affected / at risk     1/147 (0.68%)     1/74 (1.35%)  
Diarrhoea † 1    
# participants affected / at risk     3/147 (2.04%)     3/74 (4.05%)  
Haematemesis † 1    
# participants affected / at risk     1/147 (0.68%)     0/74 (0.00%)  
Intestinal obstruction † 1    
# participants affected / at risk     1/147 (0.68%)     0/74 (0.00%)  
Mallory-Weiss syndrome † 1    
# participants affected / at risk     1/147 (0.68%)     0/74 (0.00%)  
Nausea † 1    
# participants affected / at risk     1/147 (0.68%)     0/74 (0.00%)  
Pancreatitis chronic † 1    
# participants affected / at risk     1/147 (0.68%)     0/74 (0.00%)  
Vomiting † 1    
# participants affected / at risk     1/147 (0.68%)     1/74 (1.35%)  
General disorders      
Asthenia † 1    
# participants affected / at risk     2/147 (1.36%)     0/74 (0.00%)  
Chest pain † 1    
# participants affected / at risk     1/147 (0.68%)     0/74 (0.00%)  
Malaise † 1    
# participants affected / at risk     1/147 (0.68%)     0/74 (0.00%)  
Multi-organ failure † 1    
# participants affected / at risk     1/147 (0.68%)     1/74 (1.35%)  
Pain † 1    
# participants affected / at risk     1/147 (0.68%)     0/74 (0.00%)  
Pyrexia † 1    
# participants affected / at risk     4/147 (2.72%)     0/74 (0.00%)  
Sudden death † 1    
# participants affected / at risk     1/147 (0.68%)     0/74 (0.00%)  
Hepatitis C † 1    
# participants affected / at risk     1/147 (0.68%)     0/74 (0.00%)  
Hepatobiliary disorders      
Cholecystitis acute † 1    
# participants affected / at risk     1/147 (0.68%)     0/74 (0.00%)  
Hepatic failure † 1    
# participants affected / at risk     1/147 (0.68%)     0/74 (0.00%)  
Hepatic function abnormal † 1    
# participants affected / at risk     0/147 (0.00%)     1/74 (1.35%)  
Hepatitis toxic † 1    
# participants affected / at risk     1/147 (0.68%)     0/74 (0.00%)  
Infections and infestations      
Bronchitis † 1    
# participants affected / at risk     1/147 (0.68%)     0/74 (0.00%)  
Escherichia sepsis † 1    
# participants affected / at risk     0/147 (0.00%)     1/74 (1.35%)  
Herpes Zoster † 1    
# participants affected / at risk     2/147 (1.36%)     0/74 (0.00%)  
Injection site abscess † 1    
# participants affected / at risk     0/147 (0.00%)     1/74 (1.35%)  
Pneumocystis jiroveci pneumonia † 1    
# participants affected / at risk     1/147 (0.68%)     0/74 (0.00%)  
Pneumonia † 1    
# participants affected / at risk     9/147 (6.12%)     5/74 (6.76%)  
Sepsis † 1    
# participants affected / at risk     0/147 (0.00%)     1/74 (1.35%)  
Sinusitis † 1    
# participants affected / at risk     1/147 (0.68%)     0/74 (0.00%)  
Skin infection † 1    
# participants affected / at risk     0/147 (0.00%)     1/74 (1.35%)  
Urinary tract infection † 1    
# participants affected / at risk     1/147 (0.68%)     0/74 (0.00%)  
Injury, poisoning and procedural complications      
Humerus fracture † 1    
# participants affected / at risk     1/147 (0.68%)     1/74 (1.35%)  
Perianal haematoma † 1    
# participants affected / at risk     1/147 (0.68%)     0/74 (0.00%)  
Metabolism and nutrition disorders      
Decreased appetite † 1    
# participants affected / at risk     2/147 (1.36%)     0/74 (0.00%)  
Dehydration † 1    
# participants affected / at risk     2/147 (1.36%)     0/74 (0.00%)  
Hypercalcemia † 1    
# participants affected / at risk     1/147 (0.68%)     1/74 (1.35%)  
Hypokalaemia † 1    
# participants affected / at risk     1/147 (0.68%)     0/74 (0.00%)  
Tumour lysis syndrome † 1    
# participants affected / at risk     2/147 (1.36%)     1/74 (1.35%)  
Musculoskeletal and connective tissue disorders      
Arthralgia † 1    
# participants affected / at risk     0/147 (0.00%)     1/74 (1.35%)  
Back pain † 1    
# participants affected / at risk     0/147 (0.00%)     1/74 (1.35%)  
Pathological fracture † 1    
# participants affected / at risk     1/147 (0.68%)     0/74 (0.00%)  
Neoplasms benign, malignant and unspecified (incl cysts and polyps)      
Colon cancer † 1    
# participants affected / at risk     0/147 (0.00%)     1/74 (1.35%)  
Lung neoplasm † 1    
# participants affected / at risk     0/147 (0.00%)     1/74 (1.35%)  
Plasmacytoma † 1    
# participants affected / at risk     1/147 (0.68%)     0/74 (0.00%)  
Nervous system disorders      
Brain oedema † 1    
# participants affected / at risk     0/147 (0.00%)     1/74 (1.35%)  
Cerebrovascular disorder † 1    
# participants affected / at risk     0/147 (0.00%)     1/74 (1.35%)  
Encephalopathy † 1    
# participants affected / at risk     0/147 (0.00%)     1/74 (1.35%)  
Ischaemic stroke † 1    
# participants affected / at risk     0/147 (0.00%)     1/74 (1.35%)  
Neuralgia † 1    
# participants affected / at risk     2/147 (1.36%)     0/74 (0.00%)  
Paraparesis † 1    
# participants affected / at risk     2/147 (1.36%)     0/74 (0.00%)  
Paraplegia † 1    
# participants affected / at risk     1/147 (0.68%)     0/74 (0.00%)  
Peripheral neuropathy motor † 1    
# participants affected / at risk     2/147 (1.36%)     1/74 (1.35%)  
Peripheral sensorimotor neuropathy † 1    
# participants affected / at risk     1/147 (0.68%)     0/74 (0.00%)  
Peripheral sensory neuropathy † 1    
# participants affected / at risk     2/147 (1.36%)     2/74 (2.70%)  
Spinal cord compression † 1    
# participants affected / at risk     1/147 (0.68%)     0/74 (0.00%)  
Syncope † 1    
# participants affected / at risk     0/147 (0.00%)     1/74 (1.35%)  
Toxic encephalopathy † 1    
# participants affected / at risk     1/147 (0.68%)     0/74 (0.00%)  
Vascular encephalopathy † 1    
# participants affected / at risk     0/147 (0.00%)     1/74 (1.35%)  
Psychiatric disorders      
Confusional state † 1    
# participants affected / at risk     0/147 (0.00%)     1/74 (1.35%)  
Neurosis † 1    
# participants affected / at risk     1/147 (0.68%)     0/74 (0.00%)  
Renal and urinary disorders      
Dysuria † 1    
# participants affected / at risk     1/147 (0.68%)     0/74 (0.00%)  
Haematuria † 1    
# participants affected / at risk     1/147 (0.68%)     0/74 (0.00%)  
Renal failure † 1    
# participants affected / at risk     3/147 (2.04%)     2/74 (2.70%)  
Renal failure acute † 1    
# participants affected / at risk     1/147 (0.68%)     0/74 (0.00%)  
Renal impairment † 1    
# participants affected / at risk     0/147 (0.00%)     1/74 (1.35%)  
Urinary retention † 1    
# participants affected / at risk     1/147 (0.68%)     0/74 (0.00%)  
Reproductive system and breast disorders      
Vulval ulceration † 1    
# participants affected / at risk     1/147 (0.68%)     0/74 (0.00%)  
Respiratory, thoracic and mediastinal disorders      
Allergic bronchitis † 1    
# participants affected / at risk     1/147 (0.68%)     0/74 (0.00%)  
Bronchospasm † 1    
# participants affected / at risk     1/147 (0.68%)     0/74 (0.00%)  
Chronic obstructive pulmonary disease † 1    
# participants affected / at risk     2/147 (1.36%)     1/74 (1.35%)  
Cough † 1    
# participants affected / at risk     1/147 (0.68%)     0/74 (0.00%)  
Dyspnoea † 1    
# participants affected / at risk     2/147 (1.36%)     1/74 (1.35%)  
Lung disorder † 1    
# participants affected / at risk     0/147 (0.00%)     1/74 (1.35%)  
Nasal congestion † 1    
# participants affected / at risk     1/147 (0.68%)     0/74 (0.00%)  
Pleural effusion † 1    
# participants affected / at risk     0/147 (0.00%)     1/74 (1.35%)  
Pleurisy † 1    
# participants affected / at risk     1/147 (0.68%)     1/74 (1.35%)  
Vascular disorders      
Haematoma † 1    
# participants affected / at risk     1/147 (0.68%)     0/74 (0.00%)  
Hypotension † 1    
# participants affected / at risk     0/147 (0.00%)     1/74 (1.35%)  
Orthostatic hypotension † 1    
# participants affected / at risk     2/147 (1.36%)     1/74 (1.35%)  
Events were collected by systematic assessment
1 Term from vocabulary, MedDRA (13.0)




  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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  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


No publications provided by Millennium Pharmaceuticals, Inc.

Publications automatically indexed to this study:

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