Trial Outcomes & Findings for A Study of Thalidomide Plus Dexamethasone (Thal-Dex) Versus DOXIL plusThalidomide Plus Dexamethasone (DOXIL -Thal-Dex) in Patients With Newly Diagnosed Multiple Myeloma (NCT NCT00097981)
NCT ID: NCT00097981
Last Updated: 2017-04-07
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
225 participants
Primary outcome timeframe
From Cycle 2 until 28 days following completion of treatment
Results posted on
2017-04-07
Participant Flow
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.
Participant milestones
| Measure |
Thalidomide + Dexamethasone
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 + Thalidomide + Dexamethasone
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 Study
STARTED
|
113
|
112
|
|
Overall Study
Received Study Medication
|
110
|
106
|
|
Overall Study
COMPLETED
|
7
|
12
|
|
Overall Study
NOT COMPLETED
|
106
|
100
|
Reasons for withdrawal
| Measure |
Thalidomide + Dexamethasone
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 + Thalidomide + Dexamethasone
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 Study
Adverse Event
|
31
|
44
|
|
Overall Study
Withdrawal by Subject
|
10
|
8
|
|
Overall Study
Protocol Violation
|
1
|
1
|
|
Overall Study
Death
|
2
|
4
|
|
Overall Study
Physician Decision
|
7
|
1
|
|
Overall Study
Disease Progression
|
8
|
2
|
|
Overall Study
Transplant planned
|
28
|
27
|
|
Overall Study
Other
|
19
|
13
|
Baseline Characteristics
A Study of Thalidomide Plus Dexamethasone (Thal-Dex) Versus DOXIL plusThalidomide Plus Dexamethasone (DOXIL -Thal-Dex) in Patients With Newly Diagnosed Multiple Myeloma
Baseline characteristics by cohort
| Measure |
Thalidomide + Dexamethasone
n=113 Participants
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 + Thalidomide + Dexamethasone
n=112 Participants
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
n=225 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60.29 years
STANDARD_DEVIATION 10.31 • n=99 Participants
|
60.62 years
STANDARD_DEVIATION 10.79 • n=107 Participants
|
60.45 years
STANDARD_DEVIATION 10.53 • n=206 Participants
|
|
Sex: Female, Male
Female
|
51 Participants
n=99 Participants
|
44 Participants
n=107 Participants
|
95 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
62 Participants
n=99 Participants
|
68 Participants
n=107 Participants
|
130 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: From Cycle 2 until 28 days following completion of treatmentPopulation: Intent-to-treat: Participants who were randomized to receive the treatment.
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.
Outcome measures
| Measure |
Thalidomide + Dexamethasone
n=113 Participants
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 + Thalidomide + Dexamethasone
n=112 Participants
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.
|
|---|---|---|
|
Complete Response Rate: Number of Participants Who Achieved a Complete Response
|
5 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: From Cycle 2 until 28 days following completion of treatmentPopulation: Intent-to-treat: Participants who were randomized to receive the treatment.
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.
Outcome measures
| Measure |
Thalidomide + Dexamethasone
n=113 Participants
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 + Thalidomide + Dexamethasone
n=112 Participants
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 Response: Number of Participants Who Achieved a Complete Response (CR) or Partial Response (PR)
|
81 Participants
|
76 Participants
|
SECONDARY outcome
Timeframe: From Cycle 2 until 28 days following completion of treatmentPopulation: Intent-to-treat: Participants who were randomized to receive the treatment.
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.
Outcome measures
| Measure |
Thalidomide + Dexamethasone
n=113 Participants
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 + Thalidomide + Dexamethasone
n=112 Participants
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.
|
|---|---|---|
|
Time to 1st Response
|
44 Days
Interval 37.0 to 58.0
|
58 Days
Interval 44.0 to 60.0
|
SECONDARY outcome
Timeframe: From randomization until death or as assessed up to 2 years post last participant last treatment visitPopulation: Intent-to-treat: Participants who were randomized to receive the treatment.
Time to progression is the interval between the date of randomization until disease progression or death due to progression.
Outcome measures
| Measure |
Thalidomide + Dexamethasone
n=113 Participants
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 + Thalidomide + Dexamethasone
n=112 Participants
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.
|
|---|---|---|
|
Time to Progression
|
584 Days
Interval 347.0 to
Upper limit of 95% CI was not estimable due to insufficient number of events observed by end of study.
|
408 Days
Interval 350.0 to 597.0
|
SECONDARY outcome
Timeframe: From randomization until death or as assessed up to 2 years post last participant last treatment visitPopulation: Intent-to-treat: Participants who were randomized to receive the treatment.
Outcome measures
| Measure |
Thalidomide + Dexamethasone
n=113 Participants
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 + Thalidomide + Dexamethasone
n=112 Participants
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 Survival: Number of Participants Died Due to Any Cause
|
21 Participants
|
22 Participants
|
SECONDARY outcome
Timeframe: From randomization until death or as assessed up to 2 years post last participant last treatment visitPopulation: Intent-to-treat: Participants who were randomized to receive the treatment.
Outcome measures
| Measure |
Thalidomide + Dexamethasone
n=113 Participants
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 + Thalidomide + Dexamethasone
n=112 Participants
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.
|
|---|---|---|
|
Transplantation: Number of Participants Who Underwent Transplantation (Peripheral Stem Cell / Bone Marrow)
|
30 Participants
|
28 Participants
|
SECONDARY outcome
Timeframe: From randomization until death or as assessed up to 2 years post last participant last treatment visitPopulation: Intent-to-treat: Participants who were randomized to receive the treatment and who underwent transplantation.
Engraftment is the process of transplanted stem cells reproducing new cells.
Outcome measures
| Measure |
Thalidomide + Dexamethasone
n=30 Participants
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 + Thalidomide + Dexamethasone
n=28 Participants
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.
|
|---|---|---|
|
Engraftment: Number of Participants Who Underwent Engraftment
|
25 Participants
|
25 Participants
|
Adverse Events
Thalidomide + Dexamethasone
Serious events: 48 serious events
Other events: 110 other events
Deaths: 0 deaths
DOXIL + Thalidomide + Dexamethasone
Serious events: 53 serious events
Other events: 104 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Thalidomide + Dexamethasone
n=110 participants at risk
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 + Thalidomide + Dexamethasone
n=106 participants at risk
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.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
1.8%
2/110 • 2 years
|
2.8%
3/106 • 2 years
|
|
Blood and lymphatic system disorders
Coagulopathy
|
0.91%
1/110 • 2 years
|
1.9%
2/106 • 2 years
|
|
Blood and lymphatic system disorders
Disseminated Intravascular Coagulation
|
0.00%
0/110 • 2 years
|
0.94%
1/106 • 2 years
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
0.91%
1/110 • 2 years
|
0.94%
1/106 • 2 years
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/110 • 2 years
|
1.9%
2/106 • 2 years
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/110 • 2 years
|
0.94%
1/106 • 2 years
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.91%
1/110 • 2 years
|
1.9%
2/106 • 2 years
|
|
Cardiac disorders
Acute Myocardial Infarction
|
0.91%
1/110 • 2 years
|
0.00%
0/106 • 2 years
|
|
Cardiac disorders
Angina Pectoris
|
0.91%
1/110 • 2 years
|
0.94%
1/106 • 2 years
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/110 • 2 years
|
0.94%
1/106 • 2 years
|
|
Cardiac disorders
Atrial Fibrillation
|
2.7%
3/110 • 2 years
|
2.8%
3/106 • 2 years
|
|
Cardiac disorders
Bundle Branch Block Right
|
0.91%
1/110 • 2 years
|
0.00%
0/106 • 2 years
|
|
Cardiac disorders
Cardiac Arrest
|
0.91%
1/110 • 2 years
|
0.00%
0/106 • 2 years
|
|
Cardiac disorders
Cardiac Failure Congestive
|
0.91%
1/110 • 2 years
|
2.8%
3/106 • 2 years
|
|
Cardiac disorders
Cardio-Respiratory Arrest
|
0.00%
0/110 • 2 years
|
0.94%
1/106 • 2 years
|
|
Cardiac disorders
Coronary Artery Disease
|
0.00%
0/110 • 2 years
|
0.94%
1/106 • 2 years
|
|
Cardiac disorders
Myocardial Infarction
|
1.8%
2/110 • 2 years
|
0.94%
1/106 • 2 years
|
|
Cardiac disorders
Supraventricular Tachycardia
|
0.00%
0/110 • 2 years
|
2.8%
3/106 • 2 years
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.91%
1/110 • 2 years
|
0.00%
0/106 • 2 years
|
|
Gastrointestinal disorders
Constipation
|
0.91%
1/110 • 2 years
|
0.00%
0/106 • 2 years
|
|
Gastrointestinal disorders
Duodenal Ulcer Haemorrhage
|
0.00%
0/110 • 2 years
|
0.94%
1/106 • 2 years
|
|
Gastrointestinal disorders
Gastrointestinal Haemorrhage
|
0.91%
1/110 • 2 years
|
1.9%
2/106 • 2 years
|
|
Gastrointestinal disorders
Gastrooesophageal Reflux Disease
|
0.91%
1/110 • 2 years
|
0.00%
0/106 • 2 years
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/110 • 2 years
|
0.94%
1/106 • 2 years
|
|
Gastrointestinal disorders
Intestinal Obstruction
|
0.00%
0/110 • 2 years
|
0.94%
1/106 • 2 years
|
|
Gastrointestinal disorders
Large Intestine Perforation
|
0.91%
1/110 • 2 years
|
0.00%
0/106 • 2 years
|
|
Gastrointestinal disorders
Nausea
|
0.91%
1/110 • 2 years
|
0.00%
0/106 • 2 years
|
|
Gastrointestinal disorders
Pancreatitis
|
0.91%
1/110 • 2 years
|
0.94%
1/106 • 2 years
|
|
Gastrointestinal disorders
Small Intestinal Obstruction
|
0.91%
1/110 • 2 years
|
0.00%
0/106 • 2 years
|
|
Gastrointestinal disorders
Stomatitis
|
0.91%
1/110 • 2 years
|
0.00%
0/106 • 2 years
|
|
Gastrointestinal disorders
Tongue Disorder
|
0.91%
1/110 • 2 years
|
0.00%
0/106 • 2 years
|
|
Gastrointestinal disorders
Vomiting
|
0.91%
1/110 • 2 years
|
0.00%
0/106 • 2 years
|
|
General disorders
Asthenia
|
2.7%
3/110 • 2 years
|
2.8%
3/106 • 2 years
|
|
General disorders
Chest Pain
|
0.00%
0/110 • 2 years
|
0.94%
1/106 • 2 years
|
|
General disorders
Chills
|
0.91%
1/110 • 2 years
|
0.00%
0/106 • 2 years
|
|
General disorders
Disease Progression
|
0.00%
0/110 • 2 years
|
0.94%
1/106 • 2 years
|
|
General disorders
Fatigue
|
0.91%
1/110 • 2 years
|
0.94%
1/106 • 2 years
|
|
General disorders
Mass
|
0.91%
1/110 • 2 years
|
0.00%
0/106 • 2 years
|
|
General disorders
Mucosal Inflammation
|
0.00%
0/110 • 2 years
|
0.94%
1/106 • 2 years
|
|
General disorders
Non-Cardiac Chest Pain
|
0.91%
1/110 • 2 years
|
0.00%
0/106 • 2 years
|
|
General disorders
Oedema
|
0.91%
1/110 • 2 years
|
0.00%
0/106 • 2 years
|
|
General disorders
Oedema Peripheral
|
0.00%
0/110 • 2 years
|
0.94%
1/106 • 2 years
|
|
General disorders
Pyrexia
|
0.91%
1/110 • 2 years
|
3.8%
4/106 • 2 years
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/110 • 2 years
|
0.94%
1/106 • 2 years
|
|
Infections and infestations
Abscess
|
0.91%
1/110 • 2 years
|
0.00%
0/106 • 2 years
|
|
Infections and infestations
Appendicitis
|
0.91%
1/110 • 2 years
|
0.00%
0/106 • 2 years
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/110 • 2 years
|
1.9%
2/106 • 2 years
|
|
Infections and infestations
Bacterial Infection
|
0.00%
0/110 • 2 years
|
0.94%
1/106 • 2 years
|
|
Infections and infestations
Catheter Related Infection
|
0.00%
0/110 • 2 years
|
0.94%
1/106 • 2 years
|
|
Infections and infestations
Cellulitis
|
0.00%
0/110 • 2 years
|
0.94%
1/106 • 2 years
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/110 • 2 years
|
0.94%
1/106 • 2 years
|
|
Infections and infestations
Endocarditis Enterococcal
|
0.91%
1/110 • 2 years
|
0.00%
0/106 • 2 years
|
|
Infections and infestations
Fungal Infection
|
0.00%
0/110 • 2 years
|
0.94%
1/106 • 2 years
|
|
Infections and infestations
Infection
|
0.00%
0/110 • 2 years
|
0.94%
1/106 • 2 years
|
|
Infections and infestations
Oesophageal Candidiasis
|
0.00%
0/110 • 2 years
|
0.94%
1/106 • 2 years
|
|
Infections and infestations
Pneumonia
|
4.5%
5/110 • 2 years
|
6.6%
7/106 • 2 years
|
|
Infections and infestations
Pneumonia Pneumococcal
|
0.91%
1/110 • 2 years
|
0.00%
0/106 • 2 years
|
|
Infections and infestations
Pneumonia Staphylococcal
|
0.91%
1/110 • 2 years
|
0.00%
0/106 • 2 years
|
|
Infections and infestations
Sepsis
|
2.7%
3/110 • 2 years
|
1.9%
2/106 • 2 years
|
|
Infections and infestations
Staphylococcal Infection
|
0.91%
1/110 • 2 years
|
0.00%
0/106 • 2 years
|
|
Infections and infestations
Urinary Tract Infection
|
0.91%
1/110 • 2 years
|
0.00%
0/106 • 2 years
|
|
Infections and infestations
Urosepsis
|
0.00%
0/110 • 2 years
|
0.94%
1/106 • 2 years
|
|
Injury, poisoning and procedural complications
Accidental Overdose
|
0.00%
0/110 • 2 years
|
0.94%
1/106 • 2 years
|
|
Injury, poisoning and procedural complications
Compression Fracture
|
0.91%
1/110 • 2 years
|
0.00%
0/106 • 2 years
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/110 • 2 years
|
0.94%
1/106 • 2 years
|
|
Injury, poisoning and procedural complications
Hip Fracture
|
0.00%
0/110 • 2 years
|
0.94%
1/106 • 2 years
|
|
Injury, poisoning and procedural complications
Spinal Compression Fracture
|
0.91%
1/110 • 2 years
|
0.00%
0/106 • 2 years
|
|
Investigations
Ejection Fraction Decreased
|
0.00%
0/110 • 2 years
|
0.94%
1/106 • 2 years
|
|
Investigations
International Normalised Ratio Increased
|
0.91%
1/110 • 2 years
|
0.94%
1/106 • 2 years
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/110 • 2 years
|
0.94%
1/106 • 2 years
|
|
Metabolism and nutrition disorders
Dehydration
|
3.6%
4/110 • 2 years
|
2.8%
3/106 • 2 years
|
|
Metabolism and nutrition disorders
Diabetes Mellitus
|
0.91%
1/110 • 2 years
|
0.00%
0/106 • 2 years
|
|
Metabolism and nutrition disorders
Diabetic Ketoacidosis
|
0.00%
0/110 • 2 years
|
0.94%
1/106 • 2 years
|
|
Metabolism and nutrition disorders
Electrolyte Imbalance
|
0.91%
1/110 • 2 years
|
0.00%
0/106 • 2 years
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
6.4%
7/110 • 2 years
|
0.94%
1/106 • 2 years
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.91%
1/110 • 2 years
|
0.94%
1/106 • 2 years
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.91%
1/110 • 2 years
|
0.94%
1/106 • 2 years
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.91%
1/110 • 2 years
|
0.94%
1/106 • 2 years
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.91%
1/110 • 2 years
|
0.94%
1/106 • 2 years
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
1.8%
2/110 • 2 years
|
0.94%
1/106 • 2 years
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
0.00%
0/110 • 2 years
|
0.94%
1/106 • 2 years
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.91%
1/110 • 2 years
|
0.00%
0/106 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/110 • 2 years
|
0.94%
1/106 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/110 • 2 years
|
0.94%
1/106 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Joint Effusion
|
0.00%
0/110 • 2 years
|
0.94%
1/106 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Myopathy Steroid
|
0.91%
1/110 • 2 years
|
0.94%
1/106 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
0.00%
0/110 • 2 years
|
0.94%
1/106 • 2 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Multiple Myeloma
|
0.00%
0/110 • 2 years
|
0.94%
1/106 • 2 years
|
|
Nervous system disorders
Cerebral Haemorrhage
|
0.00%
0/110 • 2 years
|
0.94%
1/106 • 2 years
|
|
Nervous system disorders
Cerebrovascular Accident
|
0.00%
0/110 • 2 years
|
0.94%
1/106 • 2 years
|
|
Nervous system disorders
Grand Mal Convulsion
|
0.00%
0/110 • 2 years
|
0.94%
1/106 • 2 years
|
|
Nervous system disorders
Hemiparesis
|
0.00%
0/110 • 2 years
|
0.94%
1/106 • 2 years
|
|
Nervous system disorders
Sleep Apnoea Syndrome
|
0.00%
0/110 • 2 years
|
0.94%
1/106 • 2 years
|
|
Nervous system disorders
Syncope
|
3.6%
4/110 • 2 years
|
4.7%
5/106 • 2 years
|
|
Nervous system disorders
Tremor
|
0.91%
1/110 • 2 years
|
0.00%
0/106 • 2 years
|
|
Psychiatric disorders
Anxiety
|
0.91%
1/110 • 2 years
|
0.00%
0/106 • 2 years
|
|
Psychiatric disorders
Psychotic Disorder
|
0.00%
0/110 • 2 years
|
0.94%
1/106 • 2 years
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/110 • 2 years
|
0.94%
1/106 • 2 years
|
|
Renal and urinary disorders
Polyuria
|
0.91%
1/110 • 2 years
|
0.00%
0/106 • 2 years
|
|
Renal and urinary disorders
Renal Failure
|
4.5%
5/110 • 2 years
|
2.8%
3/106 • 2 years
|
|
Renal and urinary disorders
Renal Failure Acute
|
0.91%
1/110 • 2 years
|
1.9%
2/106 • 2 years
|
|
Reproductive system and breast disorders
Vaginal Haemorrhage
|
0.91%
1/110 • 2 years
|
0.00%
0/106 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Distress Syndrome
|
0.00%
0/110 • 2 years
|
0.94%
1/106 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.91%
1/110 • 2 years
|
0.00%
0/106 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.91%
1/110 • 2 years
|
0.00%
0/106 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Airways Disease Exacerbated
|
0.91%
1/110 • 2 years
|
0.00%
0/106 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease
|
0.00%
0/110 • 2 years
|
0.94%
1/106 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Cryptogenic Organising Pneumonia
|
0.00%
0/110 • 2 years
|
0.94%
1/106 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.8%
2/110 • 2 years
|
0.94%
1/106 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/110 • 2 years
|
1.9%
2/106 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial Lung Disease
|
0.00%
0/110 • 2 years
|
0.94%
1/106 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.91%
1/110 • 2 years
|
0.00%
0/106 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/110 • 2 years
|
0.94%
1/106 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
5.5%
6/110 • 2 years
|
3.8%
4/106 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Hypertension
|
0.00%
0/110 • 2 years
|
0.94%
1/106 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Distress
|
0.91%
1/110 • 2 years
|
0.00%
0/106 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
0.00%
0/110 • 2 years
|
2.8%
3/106 • 2 years
|
|
Skin and subcutaneous tissue disorders
Decubitus Ulcer
|
0.00%
0/110 • 2 years
|
0.94%
1/106 • 2 years
|
|
Skin and subcutaneous tissue disorders
Stevens-Johnson Syndrome
|
0.91%
1/110 • 2 years
|
0.00%
0/106 • 2 years
|
|
Surgical and medical procedures
Arthrectomy
|
0.91%
1/110 • 2 years
|
0.00%
0/106 • 2 years
|
|
Vascular disorders
Deep Vein Thrombosis
|
4.5%
5/110 • 2 years
|
3.8%
4/106 • 2 years
|
|
Vascular disorders
Haematoma
|
0.91%
1/110 • 2 years
|
0.00%
0/106 • 2 years
|
|
Vascular disorders
Haemorrhage
|
0.00%
0/110 • 2 years
|
0.94%
1/106 • 2 years
|
|
Vascular disorders
Hypertension
|
1.8%
2/110 • 2 years
|
0.94%
1/106 • 2 years
|
|
Vascular disorders
Hypotension
|
1.8%
2/110 • 2 years
|
0.94%
1/106 • 2 years
|
|
Vascular disorders
Orthostatic Hypotension
|
0.91%
1/110 • 2 years
|
0.00%
0/106 • 2 years
|
|
Vascular disorders
Shock
|
0.00%
0/110 • 2 years
|
0.94%
1/106 • 2 years
|
|
Vascular disorders
Thrombophlebitis
|
0.00%
0/110 • 2 years
|
0.94%
1/106 • 2 years
|
Other adverse events
| Measure |
Thalidomide + Dexamethasone
n=110 participants at risk
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 + Thalidomide + Dexamethasone
n=106 participants at risk
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.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
19.1%
21/110 • 2 years
|
29.2%
31/106 • 2 years
|
|
Blood and lymphatic system disorders
Leukopenia
|
5.5%
6/110 • 2 years
|
1.9%
2/106 • 2 years
|
|
Blood and lymphatic system disorders
Neutropenia
|
3.6%
4/110 • 2 years
|
19.8%
21/106 • 2 years
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
5.5%
6/110 • 2 years
|
0.94%
1/106 • 2 years
|
|
Endocrine disorders
Cushingoid
|
4.5%
5/110 • 2 years
|
6.6%
7/106 • 2 years
|
|
Eye disorders
Vision Blurred
|
8.2%
9/110 • 2 years
|
15.1%
16/106 • 2 years
|
|
Gastrointestinal disorders
Abdominal Pain
|
3.6%
4/110 • 2 years
|
5.7%
6/106 • 2 years
|
|
Gastrointestinal disorders
Constipation
|
40.9%
45/110 • 2 years
|
45.3%
48/106 • 2 years
|
|
Gastrointestinal disorders
Diarrhoea
|
13.6%
15/110 • 2 years
|
15.1%
16/106 • 2 years
|
|
Gastrointestinal disorders
Dry Mouth
|
2.7%
3/110 • 2 years
|
6.6%
7/106 • 2 years
|
|
Gastrointestinal disorders
Dyspepsia
|
9.1%
10/110 • 2 years
|
5.7%
6/106 • 2 years
|
|
Gastrointestinal disorders
Dysphagia
|
2.7%
3/110 • 2 years
|
6.6%
7/106 • 2 years
|
|
Gastrointestinal disorders
Gastrooesophageal Reflux Disease
|
4.5%
5/110 • 2 years
|
7.5%
8/106 • 2 years
|
|
Gastrointestinal disorders
Nausea
|
23.6%
26/110 • 2 years
|
36.8%
39/106 • 2 years
|
|
Gastrointestinal disorders
Stomatitis
|
3.6%
4/110 • 2 years
|
13.2%
14/106 • 2 years
|
|
Gastrointestinal disorders
Vomiting
|
11.8%
13/110 • 2 years
|
14.2%
15/106 • 2 years
|
|
General disorders
Asthenia
|
17.3%
19/110 • 2 years
|
12.3%
13/106 • 2 years
|
|
General disorders
Fatigue
|
52.7%
58/110 • 2 years
|
54.7%
58/106 • 2 years
|
|
General disorders
Mucosal Inflammation
|
3.6%
4/110 • 2 years
|
18.9%
20/106 • 2 years
|
|
General disorders
Oedema
|
10.9%
12/110 • 2 years
|
15.1%
16/106 • 2 years
|
|
General disorders
Oedema Peripheral
|
48.2%
53/110 • 2 years
|
56.6%
60/106 • 2 years
|
|
General disorders
Pyrexia
|
12.7%
14/110 • 2 years
|
15.1%
16/106 • 2 years
|
|
Infections and infestations
Candidiasis
|
2.7%
3/110 • 2 years
|
8.5%
9/106 • 2 years
|
|
Infections and infestations
Oral Candidiasis
|
1.8%
2/110 • 2 years
|
6.6%
7/106 • 2 years
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
8.2%
9/110 • 2 years
|
13.2%
14/106 • 2 years
|
|
Investigations
International Normalised Ratio Increased
|
6.4%
7/110 • 2 years
|
7.5%
8/106 • 2 years
|
|
Investigations
Weight Decreased
|
8.2%
9/110 • 2 years
|
8.5%
9/106 • 2 years
|
|
Investigations
Weight Increased
|
6.4%
7/110 • 2 years
|
4.7%
5/106 • 2 years
|
|
Metabolism and nutrition disorders
Anorexia
|
10.9%
12/110 • 2 years
|
15.1%
16/106 • 2 years
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
8.2%
9/110 • 2 years
|
9.4%
10/106 • 2 years
|
|
Metabolism and nutrition disorders
Dehydration
|
9.1%
10/110 • 2 years
|
9.4%
10/106 • 2 years
|
|
Metabolism and nutrition disorders
Diabetes Mellitus
|
6.4%
7/110 • 2 years
|
3.8%
4/106 • 2 years
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
17.3%
19/110 • 2 years
|
17.0%
18/106 • 2 years
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
9.1%
10/110 • 2 years
|
9.4%
10/106 • 2 years
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
11.8%
13/110 • 2 years
|
10.4%
11/106 • 2 years
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
5.5%
6/110 • 2 years
|
3.8%
4/106 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
14.5%
16/110 • 2 years
|
14.2%
15/106 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
14.5%
16/110 • 2 years
|
15.1%
16/106 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
4.5%
5/110 • 2 years
|
8.5%
9/106 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Joint Swelling
|
2.7%
3/110 • 2 years
|
5.7%
6/106 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
8.2%
9/110 • 2 years
|
3.8%
4/106 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Muscular Weakness
|
10.9%
12/110 • 2 years
|
9.4%
10/106 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Chest Pain
|
8.2%
9/110 • 2 years
|
3.8%
4/106 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
8.2%
9/110 • 2 years
|
5.7%
6/106 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
12.7%
14/110 • 2 years
|
12.3%
13/106 • 2 years
|
|
Nervous system disorders
Dizziness
|
24.5%
27/110 • 2 years
|
21.7%
23/106 • 2 years
|
|
Nervous system disorders
Dysgeusia
|
9.1%
10/110 • 2 years
|
15.1%
16/106 • 2 years
|
|
Nervous system disorders
Headache
|
16.4%
18/110 • 2 years
|
3.8%
4/106 • 2 years
|
|
Nervous system disorders
Hypoaesthesia
|
14.5%
16/110 • 2 years
|
13.2%
14/106 • 2 years
|
|
Nervous system disorders
Neuropathy
|
11.8%
13/110 • 2 years
|
14.2%
15/106 • 2 years
|
|
Nervous system disorders
Neuropathy Peripheral
|
20.0%
22/110 • 2 years
|
16.0%
17/106 • 2 years
|
|
Nervous system disorders
Paraesthesia
|
14.5%
16/110 • 2 years
|
12.3%
13/106 • 2 years
|
|
Nervous system disorders
Peripheral Sensory Neuropathy
|
12.7%
14/110 • 2 years
|
11.3%
12/106 • 2 years
|
|
Nervous system disorders
Somnolence
|
11.8%
13/110 • 2 years
|
1.9%
2/106 • 2 years
|
|
Nervous system disorders
Tremor
|
18.2%
20/110 • 2 years
|
20.8%
22/106 • 2 years
|
|
Psychiatric disorders
Anxiety
|
14.5%
16/110 • 2 years
|
15.1%
16/106 • 2 years
|
|
Psychiatric disorders
Confusional State
|
7.3%
8/110 • 2 years
|
3.8%
4/106 • 2 years
|
|
Psychiatric disorders
Depression
|
13.6%
15/110 • 2 years
|
14.2%
15/106 • 2 years
|
|
Psychiatric disorders
Insomnia
|
21.8%
24/110 • 2 years
|
15.1%
16/106 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.0%
11/110 • 2 years
|
9.4%
10/106 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
20.0%
22/110 • 2 years
|
22.6%
24/106 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea Exertional
|
4.5%
5/110 • 2 years
|
5.7%
6/106 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
2.7%
3/110 • 2 years
|
5.7%
6/106 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal Pain
|
4.5%
5/110 • 2 years
|
7.5%
8/106 • 2 years
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
2.7%
3/110 • 2 years
|
6.6%
7/106 • 2 years
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
2.7%
3/110 • 2 years
|
10.4%
11/106 • 2 years
|
|
Skin and subcutaneous tissue disorders
Erythema
|
6.4%
7/110 • 2 years
|
6.6%
7/106 • 2 years
|
|
Skin and subcutaneous tissue disorders
Palmar-Plantar Erythrodysaesthesia Syndrome
|
2.7%
3/110 • 2 years
|
36.8%
39/106 • 2 years
|
|
Skin and subcutaneous tissue disorders
Rash
|
18.2%
20/110 • 2 years
|
18.9%
20/106 • 2 years
|
|
Vascular disorders
Deep Vein Thrombosis
|
3.6%
4/110 • 2 years
|
9.4%
10/106 • 2 years
|
|
Vascular disorders
Hypertension
|
1.8%
2/110 • 2 years
|
8.5%
9/106 • 2 years
|
|
Vascular disorders
Hypotension
|
4.5%
5/110 • 2 years
|
5.7%
6/106 • 2 years
|
Additional Information
Medical Director
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Phone: 1 215 325-5329
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60