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Trial record 31 of 108 for:    "Vascular Hemostatic Disease" | "Doxorubicin"

A Study of Thalidomide Plus Dexamethasone (Thal-Dex) Versus DOXIL plusThalidomide Plus Dexamethasone (DOXIL -Thal-Dex) in Patients With Newly Diagnosed Multiple Myeloma

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ClinicalTrials.gov Identifier: NCT00097981
Recruitment Status : Completed
First Posted : December 2, 2004
Results First Posted : November 27, 2008
Last Update Posted : April 7, 2017
Sponsor:
Collaborator:
Tibotec Therapeutics, a Division of Ortho Biotech Products, L.P., USA
Information provided by (Responsible Party):
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Multiple Myeloma
Interventions Drug: Thalidomide
Drug: Dexamethasone
Drug: DOXIL
Enrollment 225
Recruitment Details  
Pre-assignment Details A total of 225 participants were randomnly assigned to treatment, 113 participants to the thal/dex group and 112 participants to the DOXIL/thal/dex group.
Arm/Group Title Thalidomide + Dexamethasone DOXIL + Thalidomide + Dexamethasone
Hide Arm/Group Description Participants received thalidomide every night (at bedtime) without food on Days 1 to 28 and dosing was gradually increased during Cycle 1 starting at 50 mg on Days 1 to 7, 100 mg on Days 8 to 14, 150 mg on 15 to 21, and 200 mg on Days 22 to 28. Thalidomide 200 mg per day was administered for subsequent cycles. Dexamethasone 40 mg was administered by mouth on Days 1 to 4, 9 to 12 and 17 to 20. DOXIL 40 mg/m2 was administered intravenously on Day 1 and thalidomide every night (at bedtime) without food on Days 1-28 and dosing was gradually increased during Cycle 1 starting at 50 mg on Days 1 to 7, 100 mg on Days 8 to 14, 150 mg on 15 to 21, and 200 mg on Days 22 to 28. Thalidomide 200 mg per day was administered for subsequent cycles. Dexamethasone 40 mg was administered by mouth on Days 1 to 4, 9 to 12 and 17 to 20.
Period Title: Overall Study
Started 113 [1] 112 [1]
Received Study Medication 110 106
Completed 7 [2] 12 [2]
Not Completed 106 100
Reason Not Completed
Adverse Event             31             44
Withdrawal by Subject             10             8
Protocol Violation             1             1
Death             2             4
Physician Decision             7             1
Disease Progression             8             2
Transplant planned             28             27
Other             19             13
[1]
Enrollment at randomization
[2]
Completion of 2 or more cycles after CR or nCR, or completion of 12 cycles.
Arm/Group Title Thalidomide + Dexamethasone DOXIL + Thalidomide + Dexamethasone Total
Hide Arm/Group Description Participants received thalidomide every night (at bedtime) without food on Days 1 to 28 and dosing was gradually increased during Cycle 1 starting at 50 mg on Days 1 to 7, 100 mg on Days 8 to 14, 150 mg on 15 to 21, and 200 mg on Days 22 to 28. Thalidomide 200 mg per day was administered for subsequent cycles. Dexamethasone 40 mg was administered by mouth on Days 1 to 4, 9 to 12 and 17 to 20. DOXIL 40 mg/m2 was administered intravenously on Day 1 and thalidomide every night (at bedtime) without food on Days 1-28 and dosing was gradually increased during Cycle 1 starting at 50 mg on Days 1 to 7, 100 mg on Days 8 to 14, 150 mg on 15 to 21, and 200 mg on Days 22 to 28. Thalidomide 200 mg per day was administered for subsequent cycles. Dexamethasone 40 mg was administered by mouth on Days 1 to 4, 9 to 12 and 17 to 20. Total of all reporting groups
Overall Number of Baseline Participants 113 112 225
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 113 participants 112 participants 225 participants
60.29  (10.31) 60.62  (10.79) 60.45  (10.53)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 113 participants 112 participants 225 participants
Female
51
  45.1%
44
  39.3%
95
  42.2%
Male
62
  54.9%
68
  60.7%
130
  57.8%
1.Primary Outcome
Title Complete Response Rate: Number of Participants Who Achieved a Complete Response
Hide Description Complete response rate to study medication is defined as number of participants who acheived complete response by the local investigator according to the current European Group for Blood and Marrow Transplantation (EBMT) criteria. According to EBMT criteria, CR is defined as the absence of serum and urine monoclonal paraprotein + plus no increase in size or number of lytic bone lesions. Complete response was assessed at the beginning of every treatment cycle prior to treatment, starting at Cycle 2.
Time Frame From Cycle 2 until 28 days following completion of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat: Participants who were randomized to receive the treatment.
Arm/Group Title Thalidomide + Dexamethasone DOXIL + Thalidomide + Dexamethasone
Hide Arm/Group Description:
Participants received thalidomide every night (at bedtime) without food on Days 1 to 28 and dosing was gradually increased during Cycle 1 starting at 50 mg on Days 1 to 7, 100 mg on Days 8 to 14, 150 mg on 15 to 21, and 200 mg on Days 22 to 28. Thalidomide 200 mg per day was administered for subsequent cycles. Dexamethasone 40 mg was administered by mouth on Days 1 to 4, 9 to 12 and 17 to 20.
DOXIL 40 mg/m2 was administered intravenously on Day 1 and thalidomide every night (at bedtime) without food on Days 1-28 and dosing was gradually increased during Cycle 1 starting at 50 mg on Days 1 to 7, 100 mg on Days 8 to 14, 150 mg on 15 to 21, and 200 mg on Days 22 to 28. Thalidomide 200 mg per day was administered for subsequent cycles. Dexamethasone 40 mg was administered by mouth on Days 1 to 4, 9 to 12 and 17 to 20.
Overall Number of Participants Analyzed 113 112
Measure Type: Number
Unit of Measure: Participants
5 8
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Thalidomide + Dexamethasone, DOXIL + Thalidomide + Dexamethasone
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.49
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Stratified by International Prognostic Index (IPI) stage 1,2 and 3
2.Secondary Outcome
Title Overall Response: Number of Participants Who Achieved a Complete Response (CR) or Partial Response (PR)
Hide Description Overall response to study medication is defined as number of participants who acheived a complete response (CR) or partial response (PR) by the local investigator according to the current European Group for Blood and Marrow Transplantation (EBMT) criteria. According to EBMT criteria, CR is defined as the absence of serum and urine monoclonal paraprotein + plus no increase in size or number of lytic bone lesions; and PR is defined as not all CR criteria + 50 percentage or more reduction in serum monoclonal paraprotein.
Time Frame From Cycle 2 until 28 days following completion of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat: Participants who were randomized to receive the treatment.
Arm/Group Title Thalidomide + Dexamethasone DOXIL + Thalidomide + Dexamethasone
Hide Arm/Group Description:
Participants received thalidomide every night (at bedtime) without food on Days 1 to 28 and dosing was gradually increased during Cycle 1 starting at 50 mg on Days 1 to 7, 100 mg on Days 8 to 14, 150 mg on 15 to 21, and 200 mg on Days 22 to 28. Thalidomide 200 mg per day was administered for subsequent cycles. Dexamethasone 40 mg was administered by mouth on Days 1 to 4, 9 to 12 and 17 to 20.
DOXIL 40 mg/m2 was administered intravenously on Day 1 and thalidomide every night (at bedtime) without food on Days 1-28 and dosing was gradually increased during Cycle 1 starting at 50 mg on Days 1 to 7, 100 mg on Days 8 to 14, 150 mg on 15 to 21, and 200 mg on Days 22 to 28. Thalidomide 200 mg per day was administered for subsequent cycles. Dexamethasone 40 mg was administered by mouth on Days 1 to 4, 9 to 12 and 17 to 20.
Overall Number of Participants Analyzed 113 112
Measure Type: Number
Unit of Measure: Participants
81 76
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Thalidomide + Dexamethasone, DOXIL + Thalidomide + Dexamethasone
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.42
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Stratified by International Prognostic Index (IPI) stage 1,2 and 3
3.Secondary Outcome
Title Time to 1st Response
Hide Description Time to first response was defined as the interval from date of randomization to date of achieving a partial response (PR) or better according to the current European Group for Blood and Marrow Transplantation (EBMT) criteria. According to EBMT criteria, PR is defined as not all CR criteria + 50 percentage or more reduction in serum monoclonal paraprotein.
Time Frame From Cycle 2 until 28 days following completion of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat: Participants who were randomized to receive the treatment.
Arm/Group Title Thalidomide + Dexamethasone DOXIL + Thalidomide + Dexamethasone
Hide Arm/Group Description:
Participants received thalidomide every night (at bedtime) without food on Days 1 to 28 and dosing was gradually increased during Cycle 1 starting at 50 mg on Days 1 to 7, 100 mg on Days 8 to 14, 150 mg on 15 to 21, and 200 mg on Days 22 to 28. Thalidomide 200 mg per day was administered for subsequent cycles. Dexamethasone 40 mg was administered by mouth on Days 1 to 4, 9 to 12 and 17 to 20.
DOXIL 40 mg/m2 was administered intravenously on Day 1 and thalidomide every night (at bedtime) without food on Days 1-28 and dosing was gradually increased during Cycle 1 starting at 50 mg on Days 1 to 7, 100 mg on Days 8 to 14, 150 mg on 15 to 21, and 200 mg on Days 22 to 28. Thalidomide 200 mg per day was administered for subsequent cycles. Dexamethasone 40 mg was administered by mouth on Days 1 to 4, 9 to 12 and 17 to 20.
Overall Number of Participants Analyzed 113 112
Median (95% Confidence Interval)
Unit of Measure: Days
44
(37 to 58)
58
(44 to 60)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Thalidomide + Dexamethasone, DOXIL + Thalidomide + Dexamethasone
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.42
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
4.Secondary Outcome
Title Time to Progression
Hide Description Time to progression is the interval between the date of randomization until disease progression or death due to progression.
Time Frame From randomization until death or as assessed up to 2 years post last participant last treatment visit
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat: Participants who were randomized to receive the treatment.
Arm/Group Title Thalidomide + Dexamethasone DOXIL + Thalidomide + Dexamethasone
Hide Arm/Group Description:
Participants received thalidomide every night (at bedtime) without food on Days 1 to 28 and dosing was gradually increased during Cycle 1 starting at 50 mg on Days 1 to 7, 100 mg on Days 8 to 14, 150 mg on 15 to 21, and 200 mg on Days 22 to 28. Thalidomide 200 mg per day was administered for subsequent cycles. Dexamethasone 40 mg was administered by mouth on Days 1 to 4, 9 to 12 and 17 to 20.
DOXIL 40 mg/m2 was administered intravenously on Day 1 and thalidomide every night (at bedtime) without food on Days 1-28 and dosing was gradually increased during Cycle 1 starting at 50 mg on Days 1 to 7, 100 mg on Days 8 to 14, 150 mg on 15 to 21, and 200 mg on Days 22 to 28. Thalidomide 200 mg per day was administered for subsequent cycles. Dexamethasone 40 mg was administered by mouth on Days 1 to 4, 9 to 12 and 17 to 20.
Overall Number of Participants Analyzed 113 112
Median (95% Confidence Interval)
Unit of Measure: Days
584 [1] 
(347 to NA)
408
(350 to 597)
[1]
Upper limit of 95% CI was not estimable due to insufficient number of events observed by end of study.
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Thalidomide + Dexamethasone, DOXIL + Thalidomide + Dexamethasone
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5162
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
5.Secondary Outcome
Title Overall Survival: Number of Participants Died Due to Any Cause
Hide Description [Not Specified]
Time Frame From randomization until death or as assessed up to 2 years post last participant last treatment visit
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat: Participants who were randomized to receive the treatment.
Arm/Group Title Thalidomide + Dexamethasone DOXIL + Thalidomide + Dexamethasone
Hide Arm/Group Description:
Participants received thalidomide every night (at bedtime) without food on Days 1 to 28 and dosing was gradually increased during Cycle 1 starting at 50 mg on Days 1 to 7, 100 mg on Days 8 to 14, 150 mg on 15 to 21, and 200 mg on Days 22 to 28. Thalidomide 200 mg per day was administered for subsequent cycles. Dexamethasone 40 mg was administered by mouth on Days 1 to 4, 9 to 12 and 17 to 20.
DOXIL 40 mg/m2 was administered intravenously on Day 1 and thalidomide every night (at bedtime) without food on Days 1-28 and dosing was gradually increased during Cycle 1 starting at 50 mg on Days 1 to 7, 100 mg on Days 8 to 14, 150 mg on 15 to 21, and 200 mg on Days 22 to 28. Thalidomide 200 mg per day was administered for subsequent cycles. Dexamethasone 40 mg was administered by mouth on Days 1 to 4, 9 to 12 and 17 to 20.
Overall Number of Participants Analyzed 113 112
Measure Type: Number
Unit of Measure: Participants
21 22
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Thalidomide + Dexamethasone, DOXIL + Thalidomide + Dexamethasone
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.93
Comments [Not Specified]
Method Log Rank
Comments Stratified log-rank test
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.975
Confidence Interval (2-Sided) 95%
0.529 to 1.797
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Transplantation: Number of Participants Who Underwent Transplantation (Peripheral Stem Cell / Bone Marrow)
Hide Description [Not Specified]
Time Frame From randomization until death or as assessed up to 2 years post last participant last treatment visit
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat: Participants who were randomized to receive the treatment.
Arm/Group Title Thalidomide + Dexamethasone DOXIL + Thalidomide + Dexamethasone
Hide Arm/Group Description:
Participants received thalidomide every night (at bedtime) without food on Days 1 to 28 and dosing was gradually increased during Cycle 1 starting at 50 mg on Days 1 to 7, 100 mg on Days 8 to 14, 150 mg on 15 to 21, and 200 mg on Days 22 to 28. Thalidomide 200 mg per day was administered for subsequent cycles. Dexamethasone 40 mg was administered by mouth on Days 1 to 4, 9 to 12 and 17 to 20.
DOXIL 40 mg/m2 was administered intravenously on Day 1 and thalidomide every night (at bedtime) without food on Days 1-28 and dosing was gradually increased during Cycle 1 starting at 50 mg on Days 1 to 7, 100 mg on Days 8 to 14, 150 mg on 15 to 21, and 200 mg on Days 22 to 28. Thalidomide 200 mg per day was administered for subsequent cycles. Dexamethasone 40 mg was administered by mouth on Days 1 to 4, 9 to 12 and 17 to 20.
Overall Number of Participants Analyzed 113 112
Measure Type: Number
Unit of Measure: Participants
30 28
7.Secondary Outcome
Title Engraftment: Number of Participants Who Underwent Engraftment
Hide Description Engraftment is the process of transplanted stem cells reproducing new cells.
Time Frame From randomization until death or as assessed up to 2 years post last participant last treatment visit
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat: Participants who were randomized to receive the treatment and who underwent transplantation.
Arm/Group Title Thalidomide + Dexamethasone DOXIL + Thalidomide + Dexamethasone
Hide Arm/Group Description:
Participants received thalidomide every night (at bedtime) without food on Days 1 to 28 and dosing was gradually increased during Cycle 1 starting at 50 mg on Days 1 to 7, 100 mg on Days 8 to 14, 150 mg on 15 to 21, and 200 mg on Days 22 to 28. Thalidomide 200 mg per day was administered for subsequent cycles. Dexamethasone 40 mg was administered by mouth on Days 1 to 4, 9 to 12 and 17 to 20.
DOXIL 40 mg/m2 was administered intravenously on Day 1 and thalidomide every night (at bedtime) without food on Days 1-28 and dosing was gradually increased during Cycle 1 starting at 50 mg on Days 1 to 7, 100 mg on Days 8 to 14, 150 mg on 15 to 21, and 200 mg on Days 22 to 28. Thalidomide 200 mg per day was administered for subsequent cycles. Dexamethasone 40 mg was administered by mouth on Days 1 to 4, 9 to 12 and 17 to 20.
Overall Number of Participants Analyzed 30 28
Measure Type: Number
Unit of Measure: Participants
25 25
Time Frame 2 years
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Thalidomide + Dexamethasone DOXIL + Thalidomide + Dexamethasone
Hide Arm/Group Description Participants received thalidomide every night (at bedtime) without food on Days 1 to 28 and dosing was gradually increased during Cycle 1 starting at 50 mg on Days 1 to 7, 100 mg on Days 8 to 14, 150 mg on 15 to 21, and 200 mg on Days 22 to 28. Thalidomide 200 mg per day was administered for subsequent cycles. Dexamethasone 40 mg was administered by mouth on Days 1 to 4, 9 to 12 and 17 to 20. DOXIL 40 mg/m2 was administered intravenously on Day 1 and thalidomide every night (at bedtime) without food on Days 1-28 and dosing was gradually increased during Cycle 1 starting at 50 mg on Days 1 to 7, 100 mg on Days 8 to 14, 150 mg on 15 to 21, and 200 mg on Days 22 to 28. Thalidomide 200 mg per day was administered for subsequent cycles. Dexamethasone 40 mg was administered by mouth on Days 1 to 4, 9 to 12 and 17 to 20.
All-Cause Mortality
Thalidomide + Dexamethasone DOXIL + Thalidomide + Dexamethasone
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Thalidomide + Dexamethasone DOXIL + Thalidomide + Dexamethasone
Affected / at Risk (%) Affected / at Risk (%)
Total   48/110 (43.64%)   53/106 (50.00%) 
Blood and lymphatic system disorders     
Anaemia * 1  2/110 (1.82%)  3/106 (2.83%) 
Coagulopathy * 1  1/110 (0.91%)  2/106 (1.89%) 
Disseminated Intravascular Coagulation * 1  0/110 (0.00%)  1/106 (0.94%) 
Febrile Neutropenia * 1  1/110 (0.91%)  1/106 (0.94%) 
Neutropenia * 1  0/110 (0.00%)  2/106 (1.89%) 
Pancytopenia * 1  0/110 (0.00%)  1/106 (0.94%) 
Thrombocytopenia * 1  1/110 (0.91%)  2/106 (1.89%) 
Cardiac disorders     
Acute Myocardial Infarction * 1  1/110 (0.91%)  0/106 (0.00%) 
Angina Pectoris * 1  1/110 (0.91%)  1/106 (0.94%) 
Arrhythmia * 1  0/110 (0.00%)  1/106 (0.94%) 
Atrial Fibrillation * 1  3/110 (2.73%)  3/106 (2.83%) 
Bundle Branch Block Right * 1  1/110 (0.91%)  0/106 (0.00%) 
Cardiac Arrest * 1  1/110 (0.91%)  0/106 (0.00%) 
Cardiac Failure Congestive * 1  1/110 (0.91%)  3/106 (2.83%) 
Cardio-Respiratory Arrest * 1  0/110 (0.00%)  1/106 (0.94%) 
Coronary Artery Disease * 1  0/110 (0.00%)  1/106 (0.94%) 
Myocardial Infarction * 1  2/110 (1.82%)  1/106 (0.94%) 
Supraventricular Tachycardia * 1  0/110 (0.00%)  3/106 (2.83%) 
Gastrointestinal disorders     
Abdominal Pain * 1  1/110 (0.91%)  0/106 (0.00%) 
Constipation * 1  1/110 (0.91%)  0/106 (0.00%) 
Duodenal Ulcer Haemorrhage * 1  0/110 (0.00%)  1/106 (0.94%) 
Gastrointestinal Haemorrhage * 1  1/110 (0.91%)  2/106 (1.89%) 
Gastrooesophageal Reflux Disease * 1  1/110 (0.91%)  0/106 (0.00%) 
Ileus * 1  0/110 (0.00%)  1/106 (0.94%) 
Intestinal Obstruction * 1  0/110 (0.00%)  1/106 (0.94%) 
Large Intestine Perforation * 1  1/110 (0.91%)  0/106 (0.00%) 
Nausea * 1  1/110 (0.91%)  0/106 (0.00%) 
Pancreatitis * 1  1/110 (0.91%)  1/106 (0.94%) 
Small Intestinal Obstruction * 1  1/110 (0.91%)  0/106 (0.00%) 
Stomatitis * 1  1/110 (0.91%)  0/106 (0.00%) 
Tongue Disorder * 1  1/110 (0.91%)  0/106 (0.00%) 
Vomiting * 1  1/110 (0.91%)  0/106 (0.00%) 
General disorders     
Asthenia * 1  3/110 (2.73%)  3/106 (2.83%) 
Chest Pain * 1  0/110 (0.00%)  1/106 (0.94%) 
Chills * 1  1/110 (0.91%)  0/106 (0.00%) 
Disease Progression * 1  0/110 (0.00%)  1/106 (0.94%) 
Fatigue * 1  1/110 (0.91%)  1/106 (0.94%) 
Mass * 1  1/110 (0.91%)  0/106 (0.00%) 
Mucosal Inflammation * 1  0/110 (0.00%)  1/106 (0.94%) 
Non-Cardiac Chest Pain * 1  1/110 (0.91%)  0/106 (0.00%) 
Oedema * 1  1/110 (0.91%)  0/106 (0.00%) 
Oedema Peripheral * 1  0/110 (0.00%)  1/106 (0.94%) 
Pyrexia * 1  1/110 (0.91%)  4/106 (3.77%) 
Hepatobiliary disorders     
Cholelithiasis * 1  0/110 (0.00%)  1/106 (0.94%) 
Infections and infestations     
Abscess * 1  1/110 (0.91%)  0/106 (0.00%) 
Appendicitis * 1  1/110 (0.91%)  0/106 (0.00%) 
Bacteraemia * 1  0/110 (0.00%)  2/106 (1.89%) 
Bacterial Infection * 1  0/110 (0.00%)  1/106 (0.94%) 
Catheter Related Infection * 1  0/110 (0.00%)  1/106 (0.94%) 
Cellulitis * 1  0/110 (0.00%)  1/106 (0.94%) 
Diverticulitis * 1  0/110 (0.00%)  1/106 (0.94%) 
Endocarditis Enterococcal * 1  1/110 (0.91%)  0/106 (0.00%) 
Fungal Infection * 1  0/110 (0.00%)  1/106 (0.94%) 
Infection * 1  0/110 (0.00%)  1/106 (0.94%) 
Oesophageal Candidiasis * 1  0/110 (0.00%)  1/106 (0.94%) 
Pneumonia * 1  5/110 (4.55%)  7/106 (6.60%) 
Pneumonia Pneumococcal * 1  1/110 (0.91%)  0/106 (0.00%) 
Pneumonia Staphylococcal * 1  1/110 (0.91%)  0/106 (0.00%) 
Sepsis * 1  3/110 (2.73%)  2/106 (1.89%) 
Staphylococcal Infection * 1  1/110 (0.91%)  0/106 (0.00%) 
Urinary Tract Infection * 1  1/110 (0.91%)  0/106 (0.00%) 
Urosepsis * 1  0/110 (0.00%)  1/106 (0.94%) 
Injury, poisoning and procedural complications     
Accidental Overdose * 1  0/110 (0.00%)  1/106 (0.94%) 
Compression Fracture * 1  1/110 (0.91%)  0/106 (0.00%) 
Fall * 1  0/110 (0.00%)  1/106 (0.94%) 
Hip Fracture * 1  0/110 (0.00%)  1/106 (0.94%) 
Spinal Compression Fracture * 1  1/110 (0.91%)  0/106 (0.00%) 
Investigations     
Ejection Fraction Decreased * 1  0/110 (0.00%)  1/106 (0.94%) 
International Normalised Ratio Increased * 1  1/110 (0.91%)  1/106 (0.94%) 
Metabolism and nutrition disorders     
Anorexia * 1  0/110 (0.00%)  1/106 (0.94%) 
Dehydration * 1  4/110 (3.64%)  3/106 (2.83%) 
Diabetes Mellitus * 1  1/110 (0.91%)  0/106 (0.00%) 
Diabetic Ketoacidosis * 1  0/110 (0.00%)  1/106 (0.94%) 
Electrolyte Imbalance * 1  1/110 (0.91%)  0/106 (0.00%) 
Hyperglycaemia * 1  7/110 (6.36%)  1/106 (0.94%) 
Hyperkalaemia * 1  1/110 (0.91%)  1/106 (0.94%) 
Hypocalcaemia * 1  1/110 (0.91%)  1/106 (0.94%) 
Hypoglycaemia * 1  1/110 (0.91%)  1/106 (0.94%) 
Hypokalaemia * 1  1/110 (0.91%)  1/106 (0.94%) 
Hyponatraemia * 1  2/110 (1.82%)  1/106 (0.94%) 
Hypovolaemia * 1  0/110 (0.00%)  1/106 (0.94%) 
Malnutrition * 1  1/110 (0.91%)  0/106 (0.00%) 
Musculoskeletal and connective tissue disorders     
Arthralgia * 1  0/110 (0.00%)  1/106 (0.94%) 
Back Pain * 1  0/110 (0.00%)  1/106 (0.94%) 
Joint Effusion * 1  0/110 (0.00%)  1/106 (0.94%) 
Myopathy Steroid * 1  1/110 (0.91%)  1/106 (0.94%) 
Pain in Extremity * 1  0/110 (0.00%)  1/106 (0.94%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Multiple Myeloma * 1  0/110 (0.00%)  1/106 (0.94%) 
Nervous system disorders     
Cerebral Haemorrhage * 1  0/110 (0.00%)  1/106 (0.94%) 
Cerebrovascular Accident * 1  0/110 (0.00%)  1/106 (0.94%) 
Grand Mal Convulsion * 1  0/110 (0.00%)  1/106 (0.94%) 
Hemiparesis * 1  0/110 (0.00%)  1/106 (0.94%) 
Sleep Apnoea Syndrome * 1  0/110 (0.00%)  1/106 (0.94%) 
Syncope * 1  4/110 (3.64%)  5/106 (4.72%) 
Tremor * 1  1/110 (0.91%)  0/106 (0.00%) 
Psychiatric disorders     
Anxiety * 1  1/110 (0.91%)  0/106 (0.00%) 
Psychotic Disorder * 1  0/110 (0.00%)  1/106 (0.94%) 
Renal and urinary disorders     
Haematuria * 1  0/110 (0.00%)  1/106 (0.94%) 
Polyuria * 1  1/110 (0.91%)  0/106 (0.00%) 
Renal Failure * 1  5/110 (4.55%)  3/106 (2.83%) 
Renal Failure Acute * 1  1/110 (0.91%)  2/106 (1.89%) 
Reproductive system and breast disorders     
Vaginal Haemorrhage * 1  1/110 (0.91%)  0/106 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Acute Respiratory Distress Syndrome * 1  0/110 (0.00%)  1/106 (0.94%) 
Asthma * 1  1/110 (0.91%)  0/106 (0.00%) 
Bronchospasm * 1  1/110 (0.91%)  0/106 (0.00%) 
Chronic Obstructive Airways Disease Exacerbated * 1  1/110 (0.91%)  0/106 (0.00%) 
Chronic Obstructive Pulmonary Disease * 1  0/110 (0.00%)  1/106 (0.94%) 
Cryptogenic Organising Pneumonia * 1  0/110 (0.00%)  1/106 (0.94%) 
Dyspnoea * 1  2/110 (1.82%)  1/106 (0.94%) 
Hypoxia * 1  0/110 (0.00%)  2/106 (1.89%) 
Interstitial Lung Disease * 1  0/110 (0.00%)  1/106 (0.94%) 
Pleural Effusion * 1  1/110 (0.91%)  0/106 (0.00%) 
Pneumonitis * 1  0/110 (0.00%)  1/106 (0.94%) 
Pulmonary Embolism * 1  6/110 (5.45%)  4/106 (3.77%) 
Pulmonary Hypertension * 1  0/110 (0.00%)  1/106 (0.94%) 
Respiratory Distress * 1  1/110 (0.91%)  0/106 (0.00%) 
Respiratory Failure * 1  0/110 (0.00%)  3/106 (2.83%) 
Skin and subcutaneous tissue disorders     
Decubitus Ulcer * 1  0/110 (0.00%)  1/106 (0.94%) 
Stevens-Johnson Syndrome * 1  1/110 (0.91%)  0/106 (0.00%) 
Surgical and medical procedures     
Arthrectomy * 1  1/110 (0.91%)  0/106 (0.00%) 
Vascular disorders     
Deep Vein Thrombosis * 1  5/110 (4.55%)  4/106 (3.77%) 
Haematoma * 1  1/110 (0.91%)  0/106 (0.00%) 
Haemorrhage * 1  0/110 (0.00%)  1/106 (0.94%) 
Hypertension * 1  2/110 (1.82%)  1/106 (0.94%) 
Hypotension * 1  2/110 (1.82%)  1/106 (0.94%) 
Orthostatic Hypotension * 1  1/110 (0.91%)  0/106 (0.00%) 
Shock * 1  0/110 (0.00%)  1/106 (0.94%) 
Thrombophlebitis * 1  0/110 (0.00%)  1/106 (0.94%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA Version 8.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Thalidomide + Dexamethasone DOXIL + Thalidomide + Dexamethasone
Affected / at Risk (%) Affected / at Risk (%)
Total   110/110 (100.00%)   104/106 (98.11%) 
Blood and lymphatic system disorders     
Anaemia * 1  21/110 (19.09%)  31/106 (29.25%) 
Leukopenia * 1  6/110 (5.45%)  2/106 (1.89%) 
Neutropenia * 1  4/110 (3.64%)  21/106 (19.81%) 
Thrombocytopenia * 1  6/110 (5.45%)  1/106 (0.94%) 
Endocrine disorders     
Cushingoid * 1  5/110 (4.55%)  7/106 (6.60%) 
Eye disorders     
Vision Blurred * 1  9/110 (8.18%)  16/106 (15.09%) 
Gastrointestinal disorders     
Abdominal Pain * 1  4/110 (3.64%)  6/106 (5.66%) 
Constipation * 1  45/110 (40.91%)  48/106 (45.28%) 
Diarrhoea * 1  15/110 (13.64%)  16/106 (15.09%) 
Dry Mouth * 1  3/110 (2.73%)  7/106 (6.60%) 
Dyspepsia * 1  10/110 (9.09%)  6/106 (5.66%) 
Dysphagia * 1  3/110 (2.73%)  7/106 (6.60%) 
Gastrooesophageal Reflux Disease * 1  5/110 (4.55%)  8/106 (7.55%) 
Nausea * 1  26/110 (23.64%)  39/106 (36.79%) 
Stomatitis * 1  4/110 (3.64%)  14/106 (13.21%) 
Vomiting * 1  13/110 (11.82%)  15/106 (14.15%) 
General disorders     
Asthenia * 1  19/110 (17.27%)  13/106 (12.26%) 
Fatigue * 1  58/110 (52.73%)  58/106 (54.72%) 
Mucosal Inflammation * 1  4/110 (3.64%)  20/106 (18.87%) 
Oedema * 1  12/110 (10.91%)  16/106 (15.09%) 
Oedema Peripheral * 1  53/110 (48.18%)  60/106 (56.60%) 
Pyrexia * 1  14/110 (12.73%)  16/106 (15.09%) 
Infections and infestations     
Candidiasis * 1  3/110 (2.73%)  9/106 (8.49%) 
Oral Candidiasis * 1  2/110 (1.82%)  7/106 (6.60%) 
Upper Respiratory Tract Infection * 1  9/110 (8.18%)  14/106 (13.21%) 
Investigations     
International Normalised Ratio Increased * 1  7/110 (6.36%)  8/106 (7.55%) 
Weight Decreased * 1  9/110 (8.18%)  9/106 (8.49%) 
Weight Increased * 1  7/110 (6.36%)  5/106 (4.72%) 
Metabolism and nutrition disorders     
Anorexia * 1  12/110 (10.91%)  16/106 (15.09%) 
Decreased Appetite * 1  9/110 (8.18%)  10/106 (9.43%) 
Dehydration * 1  10/110 (9.09%)  10/106 (9.43%) 
Diabetes Mellitus * 1  7/110 (6.36%)  4/106 (3.77%) 
Hyperglycaemia * 1  19/110 (17.27%)  18/106 (16.98%) 
Hypocalcaemia * 1  10/110 (9.09%)  10/106 (9.43%) 
Hypokalaemia * 1  13/110 (11.82%)  11/106 (10.38%) 
Hyponatraemia * 1  6/110 (5.45%)  4/106 (3.77%) 
Musculoskeletal and connective tissue disorders     
Arthralgia * 1  16/110 (14.55%)  15/106 (14.15%) 
Back Pain * 1  16/110 (14.55%)  16/106 (15.09%) 
Bone Pain * 1  5/110 (4.55%)  9/106 (8.49%) 
Joint Swelling * 1  3/110 (2.73%)  6/106 (5.66%) 
Muscle Spasms * 1  9/110 (8.18%)  4/106 (3.77%) 
Muscular Weakness * 1  12/110 (10.91%)  10/106 (9.43%) 
Musculoskeletal Chest Pain * 1  9/110 (8.18%)  4/106 (3.77%) 
Myalgia * 1  9/110 (8.18%)  6/106 (5.66%) 
Pain in Extremity * 1  14/110 (12.73%)  13/106 (12.26%) 
Nervous system disorders     
Dizziness * 1  27/110 (24.55%)  23/106 (21.70%) 
Dysgeusia * 1  10/110 (9.09%)  16/106 (15.09%) 
Headache * 1  18/110 (16.36%)  4/106 (3.77%) 
Hypoaesthesia * 1  16/110 (14.55%)  14/106 (13.21%) 
Neuropathy * 1  13/110 (11.82%)  15/106 (14.15%) 
Neuropathy Peripheral * 1  22/110 (20.00%)  17/106 (16.04%) 
Paraesthesia * 1  16/110 (14.55%)  13/106 (12.26%) 
Peripheral Sensory Neuropathy * 1  14/110 (12.73%)  12/106 (11.32%) 
Somnolence * 1  13/110 (11.82%)  2/106 (1.89%) 
Tremor * 1  20/110 (18.18%)  22/106 (20.75%) 
Psychiatric disorders     
Anxiety * 1  16/110 (14.55%)  16/106 (15.09%) 
Confusional State * 1  8/110 (7.27%)  4/106 (3.77%) 
Depression * 1  15/110 (13.64%)  15/106 (14.15%) 
Insomnia * 1  24/110 (21.82%)  16/106 (15.09%) 
Respiratory, thoracic and mediastinal disorders     
Cough * 1  11/110 (10.00%)  10/106 (9.43%) 
Dyspnoea * 1  22/110 (20.00%)  24/106 (22.64%) 
Dyspnoea Exertional * 1  5/110 (4.55%)  6/106 (5.66%) 
Epistaxis * 1  3/110 (2.73%)  6/106 (5.66%) 
Pharyngolaryngeal Pain * 1  5/110 (4.55%)  8/106 (7.55%) 
Skin and subcutaneous tissue disorders     
Alopecia * 1  3/110 (2.73%)  7/106 (6.60%) 
Dry Skin * 1  3/110 (2.73%)  11/106 (10.38%) 
Erythema * 1  7/110 (6.36%)  7/106 (6.60%) 
Palmar-Plantar Erythrodysaesthesia Syndrome * 1  3/110 (2.73%)  39/106 (36.79%) 
Rash * 1  20/110 (18.18%)  20/106 (18.87%) 
Vascular disorders     
Deep Vein Thrombosis * 1  4/110 (3.64%)  10/106 (9.43%) 
Hypertension * 1  2/110 (1.82%)  9/106 (8.49%) 
Hypotension * 1  5/110 (4.55%)  6/106 (5.66%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA Version 8.1
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.
Results Point of Contact
Name/Title: Medical Director
Organization: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Phone: 1 215 325-5329
Responsible Party: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier: NCT00097981     History of Changes
Other Study ID Numbers: CR004579
DO04-23-006 ( Other Identifier: Johnson & Johnson Pharmaceutical Research and Development, L.L.C. )
First Submitted: December 1, 2004
First Posted: December 2, 2004
Results First Submitted: October 2, 2008
Results First Posted: November 27, 2008
Last Update Posted: April 7, 2017