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Trial record 31 of 31 for:    Developmental Disabilities | ( Map: Alabama, United States )

Study of DOXIL/CAELYX (Pegylated Liposomal Doxorubicin) and VELCADE (Bortezomib) or VELCADE Monotherapy for the Treatment of Relapsed 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.
ClinicalTrials.gov Identifier: NCT00103506
Recruitment Status : Completed
First Posted : February 10, 2005
Results First Posted : May 25, 2015
Last Update Posted : October 19, 2015
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Multiple Myeloma
Interventions Drug: Bortezomib (VELCADE)
Drug: Doxorubicin hydrochloride (DOXIL/CAELYX)
Enrollment 646
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Velcade (Bortezomib) Monotherapy Doxil/Caelyx Plus Velcade (Bortezomib)
Hide Arm/Group Description Velcade (bortezomib) 1.3 milligram/meter per square (mg/m^2) by rapid (bolus) intravenous (IV) administration given on Day 1, 4, 8, and 11 of each 21-day cycle for up to 8 cycles. Velcade (bortezomib) 1.3 mg/m^2 by rapid (bolus) IV administration given on Day 1, 4, 8, and 11 of each 21-day cycle for up to 8 cycles. Doxorubicin hydrochloride (DOXIL/CAELYX) 30 mg/m^2 by IV infusion will be given on Day 4 of every 21-day cycle after the administration of VELCADE (bortezomib) up to 8 cycles.
Period Title: Overall Study
Started 322 324
Completed 0 0
Not Completed 322 324
Reason Not Completed
Study closed by sponsor             34             37
Death             257             253
Lost to Follow-up             13             13
Withdrawal by Subject             18             21
Arm/Group Title Velcade (Bortezomib) Monotherapy Doxil/Caelyx Plus Velcade (Bortezomib) Total
Hide Arm/Group Description Velcade (bortezomib) 1.3 milligram/meter per square (mg/m^2) by rapid (bolus) intravenous (IV) administration given on Day 1, 4, 8, and 11 of each 21-day cycle for up to 8 cycles. Velcade (bortezomib) 1.3 mg/m^2 by rapid (bolus) IV administration given on Day 1, 4, 8, and 11 of each 21-day cycle for up to 8 cycles. Doxorubicin hydrochloride (DOXIL/CAELYX) 30 mg/m^2 by IV infusion will be given on Day 4 of every 21-day cycle after the administration of VELCADE (bortezomib) up to 8 cycles. Total of all reporting groups
Overall Number of Baseline Participants 322 324 646
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 322 participants 324 participants 646 participants
61.5  (9.56) 61.4  (9.61) 61.4  (9.58)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 322 participants 324 participants 646 participants
Female
148
  46.0%
135
  41.7%
283
  43.8%
Male
174
  54.0%
189
  58.3%
363
  56.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 322 participants 324 participants 646 participants
ARGENTINA 6 9 15
AUSTRALIA 31 31 62
AUSTRIA 12 6 18
BELGIUM-LUXEMBURG 6 14 20
CANADA 20 23 43
CZECH REPUBLIC 14 22 36
FRANCE 21 28 49
GREAT BRITAIN 8 7 15
ISRAEL 25 21 46
ITALY 17 11 28
NETHERLANDS 29 32 61
POLAND 35 17 52
PORTUGAL 6 14 20
RUSSIA 38 34 72
SINGAPORE 3 2 5
SOUTH AFRICA 13 15 28
SPAIN 20 15 35
UNITED STATES OF AMERICA 18 23 41
1.Primary Outcome
Title Time to Progression (TTP)
Hide Description Median time to progression of disease is assessed according to International Myeloma Working Group (IMWG) criteria or death from any cause. IMWG criteria: increase of >=25% from lowest level in Serum M-component or (the absolute increase must be >=0.5 gram per deciliter [g/dL]); Urine M component or (the absolute increase must be >=200 milligram per 24 hour. Only in participants without measurable serum and urine M-protein levels: the difference between involved and uninvolved free light chain levels. The absolute increase >10 mg/dL. Bone marrow plasma cell percentage >=10%. Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing. Development of hypercalcemia. Participants who died or dropped out due to any reason without progression will be censored with the day of death or drop-out, respectively and who are alive at the end of the study without any progression was censored with the last available date.
Time Frame Up to 1 year and 4 months (From date of first participant randomization [20 December 2004] up to interim analysis cut-off date [28 April 2006])
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) included all the randomized participants.
Arm/Group Title Velcade (Bortezomib) Monotherapy Doxil/Caelyx Plus Velcade (Bortezomib)
Hide Arm/Group Description:
Velcade (bortezomib) 1.3 milligram/meter per square (mg/m^2) by rapid (bolus) intravenous (IV) administration given on Day 1, 4, 8, and 11 of each 21-day cycle for up to 8 cycles.
Velcade (bortezomib) 1.3 mg/m^2 by rapid (bolus) IV administration given on Day 1, 4, 8, and 11 of each 21-day cycle for up to 8 cycles. Doxorubicin hydrochloride (DOXIL/CAELYX) 30 mg/m^2 by IV infusion will be given on Day 4 of every 21-day cycle after the administration of VELCADE (bortezomib) up to 8 cycles.
Overall Number of Participants Analyzed 322 324
Median (95% Confidence Interval)
Unit of Measure: Months
6.5
(5.6 to 7.1)
9.3
(8.2 to 11.1)
2.Secondary Outcome
Title Overall Survival
Hide Description The OS is defined as the time from the date of first dose of study drug to date of death from any cause. If the participant is alive or the vital status is unknown, the participant will be censored at the date the participant will be last known to be alive.
Time Frame Up to 9 years and 5 months (From date of first participant randomization [20 December 2004] to cut-off date for final survival analysis (16 May 2014)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Velcade (Bortezomib) Monotherapy Doxil/Caelyx Plus Velcade (Bortezomib)
Hide Arm/Group Description:
Velcade (bortezomib) 1.3 milligram/meter per square (mg/m^2) by rapid (bolus) intravenous (IV) administration given on Day 1, 4, 8, and 11 of each 21-day cycle for up to 8 cycles.
Velcade (bortezomib) 1.3 mg/m^2 by rapid (bolus) IV administration given on Day 1, 4, 8, and 11 of each 21-day cycle for up to 8 cycles. Doxorubicin hydrochloride (DOXIL/CAELYX) 30 mg/m^2 by IV infusion will be given on Day 4 of every 21-day cycle after the administration of VELCADE (bortezomib) up to 8 cycles.
Overall Number of Participants Analyzed 322 324
Median (95% Confidence Interval)
Unit of Measure: months
30.8
(25.2 to 36.5)
33.0
(28.9 to 37.1)
3.Secondary Outcome
Title Number of Participants With Serious Adverse Events (SAEs)
Hide Description A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Time Frame Up to 1 year and 11 months (From date of first participant randomization [20 December 2004] to cut-off date for safety update (28 November 2006)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all the participants who received at least one dose of study drug. Here ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.
Arm/Group Title Velcade (Bortezomib) Monotherapy Doxil/Caelyx Plus Velcade (Bortezomib)
Hide Arm/Group Description:
Velcade (bortezomib) 1.3 milligram/meter per square (mg/m^2) by rapid (bolus) intravenous (IV) administration given on Day 1, 4, 8, and 11 of each 21-day cycle for up to 8 cycles.
Velcade (bortezomib) 1.3 mg/m^2 by rapid (bolus) IV administration given on Day 1, 4, 8, and 11 of each 21-day cycle for up to 8 cycles. Doxorubicin hydrochloride (DOXIL/CAELYX) 30 mg/m^2 by IV infusion will be given on Day 4 of every 21-day cycle after the administration of VELCADE (bortezomib) up to 8 cycles.
Overall Number of Participants Analyzed 318 318
Measure Type: Number
Unit of Measure: Participants
105 120
Time Frame [Not Specified]
Adverse Event Reporting Description Safety population included all the participants who received at least one dose of study drug.
 
Arm/Group Title Velcade (Bortezomib) Monotherapy Doxil/Caelyx Plus Velcade (Bortezomib)
Hide Arm/Group Description Velcade (bortezomib) 1.3 milligram/meter per square (mg/m^2) by rapid (bolus) intravenous (IV) administration given on Day 1, 4, 8, and 11 of each 21-day cycle for up to 8 cycles. Velcade (bortezomib) 1.3 mg/m^2 by rapid (bolus) IV administration given on Day 1, 4, 8, and 11 of each 21-day cycle for up to 8 cycles. Doxorubicin hydrochloride (DOXIL/CAELYX) 30 mg/m^2 by IV infusion will be given on Day 4 of every 21-day cycle after the administration of VELCADE (bortezomib) up to 8 cycles.
All-Cause Mortality
Velcade (Bortezomib) Monotherapy Doxil/Caelyx Plus Velcade (Bortezomib)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Velcade (Bortezomib) Monotherapy Doxil/Caelyx Plus Velcade (Bortezomib)
Affected / at Risk (%) Affected / at Risk (%)
Total   105/318 (33.02%)   120/318 (37.74%) 
Blood and lymphatic system disorders     
Anaemia * 1  4/318 (1.26%)  3/318 (0.94%) 
Febrile Neutropenia * 1  2/318 (0.63%)  5/318 (1.57%) 
Leukopenia * 1  0/318 (0.00%)  1/318 (0.31%) 
Neutropenia * 1  0/318 (0.00%)  2/318 (0.63%) 
Pancytopenia * 1  0/318 (0.00%)  2/318 (0.63%) 
Thrombocytopenia * 1  0/318 (0.00%)  9/318 (2.83%) 
Cardiac disorders     
Acute Myocardial Infarction * 1  0/318 (0.00%)  1/318 (0.31%) 
Angina Pectoris * 1  1/318 (0.31%)  0/318 (0.00%) 
Angina Unstable * 1  1/318 (0.31%)  0/318 (0.00%) 
Arrhythmia * 1  1/318 (0.31%)  0/318 (0.00%) 
Atrial Fibrillation * 1  2/318 (0.63%)  0/318 (0.00%) 
Atrial Flutter * 1  0/318 (0.00%)  1/318 (0.31%) 
Cardiac Arrest * 1  0/318 (0.00%)  1/318 (0.31%) 
Cardiac Failure * 1  2/318 (0.63%)  0/318 (0.00%) 
Cardiac Failure Chronic * 1  0/318 (0.00%)  1/318 (0.31%) 
Cardiac Failure Congestive * 1  2/318 (0.63%)  2/318 (0.63%) 
Cardio-Respiratory Arrest * 1  1/318 (0.31%)  0/318 (0.00%) 
Myocardial Infarction * 1  1/318 (0.31%)  2/318 (0.63%) 
Nodal Arrhythmia * 1  0/318 (0.00%)  1/318 (0.31%) 
Right Ventricular Failure * 1  1/318 (0.31%)  1/318 (0.31%) 
Tachyarrhythmia * 1  0/318 (0.00%)  1/318 (0.31%) 
Ear and labyrinth disorders     
Deafness * 1  0/318 (0.00%)  1/318 (0.31%) 
Vertigo * 1  3/318 (0.94%)  0/318 (0.00%) 
Endocrine disorders     
Adrenal Insufficiency * 1  0/318 (0.00%)  1/318 (0.31%) 
Hypercorticoidism * 1  0/318 (0.00%)  1/318 (0.31%) 
Inappropriate Antidiuretic Hormone Secretion * 1  1/318 (0.31%)  0/318 (0.00%) 
Eye disorders     
Cataract * 1  0/318 (0.00%)  1/318 (0.31%) 
Corneal Erosion * 1  0/318 (0.00%)  1/318 (0.31%) 
Diplopia * 1  1/318 (0.31%)  0/318 (0.00%) 
Retinal Vein Thrombosis * 1  1/318 (0.31%)  0/318 (0.00%) 
Gastrointestinal disorders     
Abdominal Pain * 1  2/318 (0.63%)  2/318 (0.63%) 
Diarrhoea * 1  6/318 (1.89%)  7/318 (2.20%) 
Dyspepsia * 1  0/318 (0.00%)  1/318 (0.31%) 
Dysphagia * 1  0/318 (0.00%)  2/318 (0.63%) 
Faecaloma * 1  0/318 (0.00%)  1/318 (0.31%) 
Flatulence * 1  1/318 (0.31%)  0/318 (0.00%) 
Gastric Ulcer * 1  0/318 (0.00%)  2/318 (0.63%) 
Gastroduodenal Haemorrhage * 1  0/318 (0.00%)  1/318 (0.31%) 
Gastrointestinal Haemorrhage * 1  1/318 (0.31%)  3/318 (0.94%) 
Gastrooesophageal Reflux Disease * 1  0/318 (0.00%)  1/318 (0.31%) 
Haematemesis * 1  2/318 (0.63%)  2/318 (0.63%) 
Ileus * 1  0/318 (0.00%)  1/318 (0.31%) 
Ileus Paralytic * 1  1/318 (0.31%)  1/318 (0.31%) 
Large Intestine Perforation * 1  0/318 (0.00%)  1/318 (0.31%) 
Mallory-Weiss Syndrome * 1  0/318 (0.00%)  2/318 (0.63%) 
Nausea * 1  3/318 (0.94%)  7/318 (2.20%) 
Rectal Haemorrhage * 1  0/318 (0.00%)  1/318 (0.31%) 
Rectal Prolapse * 1  1/318 (0.31%)  0/318 (0.00%) 
Small Intestinal Obstruction * 1  1/318 (0.31%)  1/318 (0.31%) 
Stomatitis * 1  0/318 (0.00%)  1/318 (0.31%) 
Upper Gastrointestinal Haemorrhage * 1  0/318 (0.00%)  2/318 (0.63%) 
Vomiting * 1  2/318 (0.63%)  13/318 (4.09%) 
General disorders     
Asthenia * 1  1/318 (0.31%)  2/318 (0.63%) 
Catheter Related Complication * 1  1/318 (0.31%)  0/318 (0.00%) 
Chest Pain * 1  3/318 (0.94%)  0/318 (0.00%) 
Chills * 1  1/318 (0.31%)  0/318 (0.00%) 
Death * 1  1/318 (0.31%)  0/318 (0.00%) 
Fatigue * 1  0/318 (0.00%)  3/318 (0.94%) 
General Physical Health Deterioration * 1  0/318 (0.00%)  1/318 (0.31%) 
Hyperthermia * 1  1/318 (0.31%)  0/318 (0.00%) 
Influenza Like Illness * 1  0/318 (0.00%)  1/318 (0.31%) 
Multi-Organ Failure * 1  0/318 (0.00%)  1/318 (0.31%) 
Oedema Peripheral * 1  1/318 (0.31%)  0/318 (0.00%) 
Pain * 1  0/318 (0.00%)  1/318 (0.31%) 
Pyrexia * 1  8/318 (2.52%)  15/318 (4.72%) 
Sudden Cardiac Death * 1  1/318 (0.31%)  0/318 (0.00%) 
Sudden Death * 1  0/318 (0.00%)  1/318 (0.31%) 
Immune system disorders     
Hypersensitivity * 1  0/318 (0.00%)  1/318 (0.31%) 
Infections and infestations     
Abdominal Infection * 1  0/318 (0.00%)  1/318 (0.31%) 
Bacterial Sepsis * 1  1/318 (0.31%)  0/318 (0.00%) 
Bronchitis * 1  1/318 (0.31%)  0/318 (0.00%) 
Bronchitis Acute * 1  2/318 (0.63%)  0/318 (0.00%) 
Bronchitis Chronic * 1  2/318 (0.63%)  0/318 (0.00%) 
Bronchopneumonia * 1  1/318 (0.31%)  3/318 (0.94%) 
Candidiasis * 1  0/318 (0.00%)  1/318 (0.31%) 
Catheter Related Infection * 1  0/318 (0.00%)  2/318 (0.63%) 
Cellulitis * 1  1/318 (0.31%)  1/318 (0.31%) 
Diarrhoea Infectious * 1  1/318 (0.31%)  0/318 (0.00%) 
Ear Infection * 1  0/318 (0.00%)  1/318 (0.31%) 
Furuncle * 1  0/318 (0.00%)  1/318 (0.31%) 
Gastroenteritis * 1  3/318 (0.94%)  1/318 (0.31%) 
Genitourinary Tract Infection * 1  1/318 (0.31%)  0/318 (0.00%) 
Herpes Zoster * 1  3/318 (0.94%)  5/318 (1.57%) 
Herpes Zoster Disseminated * 1  1/318 (0.31%)  1/318 (0.31%) 
Infection * 1  1/318 (0.31%)  1/318 (0.31%) 
Klebsiella Sepsis * 1  1/318 (0.31%)  0/318 (0.00%) 
Laryngitis * 1  1/318 (0.31%)  0/318 (0.00%) 
Lobar Pneumonia * 1  1/318 (0.31%)  0/318 (0.00%) 
Lower Respiratory Tract Infection * 1  3/318 (0.94%)  3/318 (0.94%) 
Meningitis Bacterial * 1  1/318 (0.31%)  0/318 (0.00%) 
Neutropenic Sepsis * 1  0/318 (0.00%)  1/318 (0.31%) 
Opportunistic Infection * 1  0/318 (0.00%)  1/318 (0.31%) 
Orchitis * 1  0/318 (0.00%)  1/318 (0.31%) 
Osteomyelitis * 1  0/318 (0.00%)  1/318 (0.31%) 
Pneumococcal Bacteraemia * 1  0/318 (0.00%)  1/318 (0.31%) 
Pneumococcal Sepsis * 1  1/318 (0.31%)  2/318 (0.63%) 
Pneumocystis JiroveCI Pneumonia * 1  0/318 (0.00%)  1/318 (0.31%) 
Pneumonia * 1  20/318 (6.29%)  16/318 (5.03%) 
Pneumonia Aspergillus * 1  1/318 (0.31%)  0/318 (0.00%) 
Pneumonia Legionella * 1  0/318 (0.00%)  1/318 (0.31%) 
Pneumonia Pneumococcal * 1  0/318 (0.00%)  1/318 (0.31%) 
Pseudomonas Infection * 1  0/318 (0.00%)  2/318 (0.63%) 
Respiratory Tract Infection * 1  2/318 (0.63%)  3/318 (0.94%) 
Respiratory Tract Infection Bacterial * 1  0/318 (0.00%)  1/318 (0.31%) 
Sepsis * 1  0/318 (0.00%)  1/318 (0.31%) 
Septic Embolus * 1  0/318 (0.00%)  1/318 (0.31%) 
Septic Shock * 1  1/318 (0.31%)  3/318 (0.94%) 
Sinusitis * 1  1/318 (0.31%)  0/318 (0.00%) 
Skin Infection * 1  1/318 (0.31%)  0/318 (0.00%) 
Staphylococcal Sepsis * 1  0/318 (0.00%)  2/318 (0.63%) 
Upper Respiratory Tract Infection * 1  2/318 (0.63%)  4/318 (1.26%) 
Urinary Tract Infection * 1  2/318 (0.63%)  0/318 (0.00%) 
Urosepsis * 1  1/318 (0.31%)  0/318 (0.00%) 
Injury, poisoning and procedural complications     
Drug Toxicity * 1  0/318 (0.00%)  1/318 (0.31%) 
Fall * 1  1/318 (0.31%)  1/318 (0.31%) 
Skeletal Injury * 1  0/318 (0.00%)  1/318 (0.31%) 
Spinal Compression Fracture * 1  0/318 (0.00%)  1/318 (0.31%) 
Thoracic Vertebral Fracture * 1  1/318 (0.31%)  0/318 (0.00%) 
Investigations     
Blood Creatinine Increased * 1  2/318 (0.63%)  3/318 (0.94%) 
Blood Glucose Increased * 1  0/318 (0.00%)  1/318 (0.31%) 
Ejection Fraction Decreased * 1  0/318 (0.00%)  2/318 (0.63%) 
Troponin I Increased * 1  1/318 (0.31%)  0/318 (0.00%) 
Metabolism and nutrition disorders     
Anorexia * 1  0/318 (0.00%)  2/318 (0.63%) 
Dehydration * 1  6/318 (1.89%)  6/318 (1.89%) 
Gout * 1  0/318 (0.00%)  1/318 (0.31%) 
Hypercalcaemia * 1  1/318 (0.31%)  1/318 (0.31%) 
Hyperkalaemia * 1  1/318 (0.31%)  0/318 (0.00%) 
Hypoalbuminaemia * 1  1/318 (0.31%)  1/318 (0.31%) 
Hypoglycaemia * 1  1/318 (0.31%)  0/318 (0.00%) 
Hypokalaemia * 1  1/318 (0.31%)  3/318 (0.94%) 
Hyponatraemia * 1  1/318 (0.31%)  1/318 (0.31%) 
Musculoskeletal and connective tissue disorders     
Arthralgia * 1  2/318 (0.63%)  0/318 (0.00%) 
Back Pain * 1  3/318 (0.94%)  0/318 (0.00%) 
Bone Lesion * 1  1/318 (0.31%)  1/318 (0.31%) 
Bone Pain * 1  1/318 (0.31%)  1/318 (0.31%) 
Bursitis * 1  0/318 (0.00%)  1/318 (0.31%) 
Joint Instability * 1  0/318 (0.00%)  1/318 (0.31%) 
Musculoskeletal Chest Pain * 1  0/318 (0.00%)  1/318 (0.31%) 
Myalgia * 1  1/318 (0.31%)  0/318 (0.00%) 
Osteonecrosis * 1  0/318 (0.00%)  1/318 (0.31%) 
Pain in Extremity * 1  2/318 (0.63%)  0/318 (0.00%) 
Pathological Fracture * 1  0/318 (0.00%)  2/318 (0.63%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Cancer Pain * 1  1/318 (0.31%)  0/318 (0.00%) 
Colon Cancer * 1  0/318 (0.00%)  1/318 (0.31%) 
Tumour Lysis Syndrome * 1  1/318 (0.31%)  2/318 (0.63%) 
Nervous system disorders     
Autonomic Neuropathy * 1  1/318 (0.31%)  0/318 (0.00%) 
Balance Disorder * 1  1/318 (0.31%)  0/318 (0.00%) 
Cauda Equina Syndrome * 1  2/318 (0.63%)  1/318 (0.31%) 
Cerebral Haemorrhage * 1  0/318 (0.00%)  1/318 (0.31%) 
Cerebral Infarction * 1  0/318 (0.00%)  1/318 (0.31%) 
Cerebral Ischaemia * 1  0/318 (0.00%)  1/318 (0.31%) 
Coordination Abnormal * 1  0/318 (0.00%)  1/318 (0.31%) 
Dizziness * 1  1/318 (0.31%)  2/318 (0.63%) 
Lumbar Radiculopathy * 1  1/318 (0.31%)  0/318 (0.00%) 
Neuralgia * 1  1/318 (0.31%)  0/318 (0.00%) 
Neuropathy * 1  1/318 (0.31%)  0/318 (0.00%) 
Neuropathy Peripheral * 1  1/318 (0.31%)  2/318 (0.63%) 
Paralysis * 1  1/318 (0.31%)  0/318 (0.00%) 
Paraparesis * 1  1/318 (0.31%)  0/318 (0.00%) 
Paraplegia * 1  1/318 (0.31%)  0/318 (0.00%) 
Polyneuropathy * 1  1/318 (0.31%)  1/318 (0.31%) 
Polyneuropathy in Malignant Disease * 1  1/318 (0.31%)  0/318 (0.00%) 
Quadriparesis * 1  1/318 (0.31%)  0/318 (0.00%) 
Spinal Cord Compression * 1  0/318 (0.00%)  3/318 (0.94%) 
Syncope * 1  4/318 (1.26%)  4/318 (1.26%) 
Tremor * 1  0/318 (0.00%)  1/318 (0.31%) 
Psychiatric disorders     
Agitation * 1  1/318 (0.31%)  0/318 (0.00%) 
Anxiety * 1  1/318 (0.31%)  0/318 (0.00%) 
Completed Suicide * 1  1/318 (0.31%)  0/318 (0.00%) 
Nervousness * 1  1/318 (0.31%)  0/318 (0.00%) 
Suicidal Ideation * 1  1/318 (0.31%)  0/318 (0.00%) 
Renal and urinary disorders     
Calculus Bladder * 1  0/318 (0.00%)  1/318 (0.31%) 
Haematuria * 1  0/318 (0.00%)  1/318 (0.31%) 
Nephritis Interstitial * 1  1/318 (0.31%)  0/318 (0.00%) 
Renal Colic * 1  0/318 (0.00%)  1/318 (0.31%) 
Renal Failure * 1  2/318 (0.63%)  3/318 (0.94%) 
Renal Failure Acute * 1  5/318 (1.57%)  4/318 (1.26%) 
Renal Failure Chronic * 1  1/318 (0.31%)  0/318 (0.00%) 
Renal Impairment * 1  2/318 (0.63%)  0/318 (0.00%) 
Urinary Bladder Haemorrhage * 1  0/318 (0.00%)  1/318 (0.31%) 
Urinary Retention * 1  2/318 (0.63%)  1/318 (0.31%) 
Reproductive system and breast disorders     
Benign Prostatic Hyperplasia * 1  0/318 (0.00%)  1/318 (0.31%) 
Epididymitis * 1  1/318 (0.31%)  0/318 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Acute Pulmonary Oedema * 1  1/318 (0.31%)  2/318 (0.63%) 
Chronic Obstructive Pulmonary Disease * 1  1/318 (0.31%)  0/318 (0.00%) 
Dyspnoea * 1  6/318 (1.89%)  2/318 (0.63%) 
Dyspnoea Exertional * 1  0/318 (0.00%)  1/318 (0.31%) 
Interstitial Lung Disease * 1  1/318 (0.31%)  0/318 (0.00%) 
Pneumonitis * 1  0/318 (0.00%)  2/318 (0.63%) 
Pulmonary Embolism * 1  2/318 (0.63%)  2/318 (0.63%) 
Pulmonary Fibrosis * 1  1/318 (0.31%)  0/318 (0.00%) 
Pulmonary Hypertension * 1  0/318 (0.00%)  2/318 (0.63%) 
Pulmonary Oedema * 1  0/318 (0.00%)  1/318 (0.31%) 
Respiratory Failure * 1  1/318 (0.31%)  1/318 (0.31%) 
Skin and subcutaneous tissue disorders     
Epidermal Necrosis * 1  0/318 (0.00%)  1/318 (0.31%) 
Jessner's Lymphocytic Infiltration * 1  1/318 (0.31%)  0/318 (0.00%) 
Palmar-Plantar Erythrodysaesthesia Syndrome * 1  0/318 (0.00%)  1/318 (0.31%) 
Rash * 1  0/318 (0.00%)  1/318 (0.31%) 
Swelling Face * 1  1/318 (0.31%)  0/318 (0.00%) 
Vascular disorders     
Deep Vein Thrombosis * 1  1/318 (0.31%)  0/318 (0.00%) 
Hypotension * 1  2/318 (0.63%)  4/318 (1.26%) 
Orthostatic Hypotension * 1  2/318 (0.63%)  2/318 (0.63%) 
Phlebitis * 1  0/318 (0.00%)  1/318 (0.31%) 
Thrombophlebitis * 1  0/318 (0.00%)  1/318 (0.31%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA Version 9.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Velcade (Bortezomib) Monotherapy Doxil/Caelyx Plus Velcade (Bortezomib)
Affected / at Risk (%) Affected / at Risk (%)
Total   299/318 (94.03%)   313/318 (98.43%) 
Blood and lymphatic system disorders     
Anaemia * 1  67/318 (21.07%)  80/318 (25.16%) 
Leukopenia * 1  23/318 (7.23%)  28/318 (8.81%) 
Neutropenia * 1  71/318 (22.33%)  113/318 (35.53%) 
Thrombocytopenia * 1  89/318 (27.99%)  104/318 (32.70%) 
Eye disorders     
Conjunctivitis * 1  17/318 (5.35%)  24/318 (7.55%) 
Gastrointestinal disorders     
Abdominal Pain * 1  23/318 (7.23%)  32/318 (10.06%) 
Abdominal Pain Upper * 1  13/318 (4.09%)  24/318 (7.55%) 
Constipation * 1  98/318 (30.82%)  99/318 (31.13%) 
Diarrhoea * 1  122/318 (38.36%)  142/318 (44.65%) 
Dyspepsia * 1  13/318 (4.09%)  27/318 (8.49%) 
Nausea * 1  125/318 (39.31%)  152/318 (47.80%) 
Stomatitis * 1  11/318 (3.46%)  55/318 (17.30%) 
Vomiting * 1  67/318 (21.07%)  93/318 (29.25%) 
General disorders     
Asthenia * 1  56/318 (17.61%)  70/318 (22.01%) 
Chills * 1  18/318 (5.66%)  25/318 (7.86%) 
Fatigue * 1  88/318 (27.67%)  115/318 (36.16%) 
Influenza Like Illness * 1  13/318 (4.09%)  18/318 (5.66%) 
Oedema Peripheral * 1  27/318 (8.49%)  32/318 (10.06%) 
Pyrexia * 1  67/318 (21.07%)  91/318 (28.62%) 
Infections and infestations     
Bronchitis * 1  14/318 (4.40%)  25/318 (7.86%) 
Herpes Simplex * 1  18/318 (5.66%)  32/318 (10.06%) 
Herpes Zoster * 1  26/318 (8.18%)  30/318 (9.43%) 
Nasopharyngitis * 1  20/318 (6.29%)  25/318 (7.86%) 
Pneumonia * 1  9/318 (2.83%)  18/318 (5.66%) 
Upper Respiratory Tract Infection * 1  32/318 (10.06%)  30/318 (9.43%) 
Investigations     
Aspartate Aminotransferase Increased * 1  11/318 (3.46%)  16/318 (5.03%) 
Blood Creatinine Increased * 1  7/318 (2.20%)  16/318 (5.03%) 
Weight Decreased * 1  12/318 (3.77%)  37/318 (11.64%) 
Metabolism and nutrition disorders     
Anorexia * 1  43/318 (13.52%)  58/318 (18.24%) 
Decreased Appetite * 1  9/318 (2.83%)  30/318 (9.43%) 
Hypocalcaemia * 1  9/318 (2.83%)  19/318 (5.97%) 
Hypokalaemia * 1  15/318 (4.72%)  23/318 (7.23%) 
Hypomagnesaemia * 1  12/318 (3.77%)  17/318 (5.35%) 
Musculoskeletal and connective tissue disorders     
Arthralgia * 1  27/318 (8.49%)  34/318 (10.69%) 
Back Pain * 1  37/318 (11.64%)  38/318 (11.95%) 
Bone Pain * 1  25/318 (7.86%)  10/318 (3.14%) 
Musculoskeletal Chest Pain * 1  12/318 (3.77%)  20/318 (6.29%) 
Myalgia * 1  20/318 (6.29%)  10/318 (3.14%) 
Pain in Extremity * 1  47/318 (14.78%)  34/318 (10.69%) 
Nervous system disorders     
Dizziness * 1  27/318 (8.49%)  32/318 (10.06%) 
Dysgeusia * 1  9/318 (2.83%)  18/318 (5.66%) 
Headache * 1  56/318 (17.61%)  59/318 (18.55%) 
Neuralgia * 1  63/318 (19.81%)  54/318 (16.98%) 
Neuropathy * 1  38/318 (11.95%)  35/318 (11.01%) 
Neuropathy Peripheral * 1  46/318 (14.47%)  36/318 (11.32%) 
Paraesthesia * 1  31/318 (9.75%)  41/318 (12.89%) 
Peripheral Sensory Neuropathy * 1  42/318 (13.21%)  41/318 (12.89%) 
Polyneuropathy * 1  27/318 (8.49%)  26/318 (8.18%) 
Psychiatric disorders     
Depression * 1  16/318 (5.03%)  9/318 (2.83%) 
Insomnia * 1  43/318 (13.52%)  35/318 (11.01%) 
Respiratory, thoracic and mediastinal disorders     
Cough * 1  38/318 (11.95%)  58/318 (18.24%) 
Dyspnoea * 1  22/318 (6.92%)  32/318 (10.06%) 
Epistaxis * 1  12/318 (3.77%)  18/318 (5.66%) 
Skin and subcutaneous tissue disorders     
Dry Skin * 1  7/318 (2.20%)  28/318 (8.81%) 
Palmar-Plantar Erythrodysaesthesia Syndrome * 1  1/318 (0.31%)  62/318 (19.50%) 
Pruritus * 1  16/318 (5.03%)  20/318 (6.29%) 
Rash * 1  29/318 (9.12%)  48/318 (15.09%) 
Vascular disorders     
Hypertension * 1  17/318 (5.35%)  15/318 (4.72%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA Version 9.0
Study stopped in terms of primary endpoint based on its results at planned interim analysis (28 Apr 2006). However, Long-term follow-up for survival continued until 16 May 2014.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
A copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested in writing, such publication will be withheld for up to an additional 60 days.
Results Point of Contact
Name/Title: Project Physician
Organization: Janssen R&D UK
Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT00103506     History of Changes
Other Study ID Numbers: CR004117
DOXILMMY3001 ( Other Identifier: Janssen Research & Development, LLC )
2004-001842-34 ( EudraCT Number )
First Submitted: February 9, 2005
First Posted: February 10, 2005
Results First Submitted: May 8, 2015
Results First Posted: May 25, 2015
Last Update Posted: October 19, 2015