Trial Outcomes & Findings for Thalidomide and Prednisone After Autologous Stem Cell Transplantation Multiple Myeloma (NCT NCT00049673)
NCT ID: NCT00049673
Last Updated: 2023-09-13
Results Overview
Number of patients died from any cause during the study.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
332 participants
Primary outcome timeframe
9 years
Results posted on
2023-09-13
Participant Flow
Participant milestones
| Measure |
Prednisone
Patients receive oral thalidomide daily and oral prednisone every other day for 4 years in the absence of disease progression or unacceptable toxicity.
prednisone: Given orally
thalidomide: Given orally
|
Observation
Patients undergo observation.
|
|---|---|---|
|
Overall Study
STARTED
|
166
|
166
|
|
Overall Study
COMPLETED
|
165
|
163
|
|
Overall Study
NOT COMPLETED
|
1
|
3
|
Reasons for withdrawal
| Measure |
Prednisone
Patients receive oral thalidomide daily and oral prednisone every other day for 4 years in the absence of disease progression or unacceptable toxicity.
prednisone: Given orally
thalidomide: Given orally
|
Observation
Patients undergo observation.
|
|---|---|---|
|
Overall Study
No receive treatment/lost to follow-up
|
1
|
3
|
Baseline Characteristics
Thalidomide and Prednisone After Autologous Stem Cell Transplantation Multiple Myeloma
Baseline characteristics by cohort
| Measure |
Prednisone
n=166 Participants
Patients receive oral thalidomide daily and oral prednisone every other day for 4 years in the absence of disease progression or unacceptable toxicity.
prednisone: Given orally
thalidomide: Given orally
|
Observation
n=166 Participants
Patients undergo observation.
|
Total
n=332 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Age < 60
|
102 Participants
n=93 Participants
|
103 Participants
n=4 Participants
|
205 Participants
n=27 Participants
|
|
Age, Customized
Age > or = 60
|
64 Participants
n=93 Participants
|
63 Participants
n=4 Participants
|
127 Participants
n=27 Participants
|
|
Sex: Female, Male
Female
|
58 Participants
n=93 Participants
|
56 Participants
n=4 Participants
|
114 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
108 Participants
n=93 Participants
|
110 Participants
n=4 Participants
|
218 Participants
n=27 Participants
|
|
Region of Enrollment
Canada
|
162 participants
n=93 Participants
|
162 participants
n=4 Participants
|
324 participants
n=27 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=93 Participants
|
4 participants
n=4 Participants
|
8 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 9 yearsPopulation: Intention-to-treat population
Number of patients died from any cause during the study.
Outcome measures
| Measure |
Prednisone
n=166 Participants
Patients receive oral thalidomide daily and oral prednisone every other day for 4 years in the absence of disease progression or unacceptable toxicity.
prednisone: Given orally
thalidomide: Given orally
|
Observation
n=166 Participants
Patients undergo observation.
|
|---|---|---|
|
Overall Survival
Death
|
50 Participants
|
61 Participants
|
|
Overall Survival
Alive
|
116 Participants
|
105 Participants
|
SECONDARY outcome
Timeframe: 9 yearsPopulation: Intention-to-treat
Number of patients with disease progression or death
Outcome measures
| Measure |
Prednisone
n=166 Participants
Patients receive oral thalidomide daily and oral prednisone every other day for 4 years in the absence of disease progression or unacceptable toxicity.
prednisone: Given orally
thalidomide: Given orally
|
Observation
n=166 Participants
Patients undergo observation.
|
|---|---|---|
|
Disease Progression-free Survival
Disease progression
|
100 Participants
|
127 Participants
|
|
Disease Progression-free Survival
Without progression
|
66 Participants
|
39 Participants
|
Adverse Events
Prednisone
Serious events: 5 serious events
Other events: 165 other events
Deaths: 50 deaths
Observation
Serious events: 2 serious events
Other events: 158 other events
Deaths: 61 deaths
Serious adverse events
| Measure |
Prednisone
n=165 participants at risk
Patients receive oral thalidomide daily and oral prednisone every other day for 4 years in the absence of disease progression or unacceptable toxicity.
prednisone: Given orally
thalidomide: Given orally
|
Observation
n=163 participants at risk
Patients undergo observation.
|
|---|---|---|
|
Cardiac disorders
Sinus bradycardia
|
0.61%
1/165 • 9 years
|
0.00%
0/163 • 9 years
|
|
Gastrointestinal disorders
Colitis
|
0.61%
1/165 • 9 years
|
0.00%
0/163 • 9 years
|
|
Immune system disorders
Other
|
0.61%
1/165 • 9 years
|
0.61%
1/163 • 9 years
|
|
Nervous system disorders
Syncope
|
0.61%
1/165 • 9 years
|
0.00%
0/163 • 9 years
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/165 • 9 years
|
0.61%
1/163 • 9 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.61%
1/165 • 9 years
|
0.00%
0/163 • 9 years
|
Other adverse events
| Measure |
Prednisone
n=165 participants at risk
Patients receive oral thalidomide daily and oral prednisone every other day for 4 years in the absence of disease progression or unacceptable toxicity.
prednisone: Given orally
thalidomide: Given orally
|
Observation
n=163 participants at risk
Patients undergo observation.
|
|---|---|---|
|
Nervous system disorders
Neuropathy-sensory
|
89.1%
147/165 • 9 years
|
43.6%
71/163 • 9 years
|
|
Nervous system disorders
Depressed conscious.
|
17.6%
29/165 • 9 years
|
3.1%
5/163 • 9 years
|
|
Nervous system disorders
Tremor
|
20.0%
33/165 • 9 years
|
1.2%
2/163 • 9 years
|
|
Nervous system disorders
Headache
|
14.5%
24/165 • 9 years
|
11.7%
19/163 • 9 years
|
|
Nervous system disorders
Neuropathic pain
|
9.7%
16/165 • 9 years
|
7.4%
12/163 • 9 years
|
|
Psychiatric disorders
Anxiety
|
38.2%
63/165 • 9 years
|
13.5%
22/163 • 9 years
|
|
Psychiatric disorders
Confusion
|
10.3%
17/165 • 9 years
|
1.2%
2/163 • 9 years
|
|
Psychiatric disorders
Insomnia
|
41.8%
69/165 • 9 years
|
27.0%
44/163 • 9 years
|
|
Psychiatric disorders
Depression
|
17.0%
28/165 • 9 years
|
16.6%
27/163 • 9 years
|
|
Renal and urinary disorders
Urine frequency/urgency
|
8.5%
14/165 • 9 years
|
7.4%
12/163 • 9 years
|
|
Reproductive system and breast disorders
Erectile impotence
|
6.7%
11/165 • 9 years
|
2.5%
4/163 • 9 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
31.5%
52/165 • 9 years
|
23.3%
38/163 • 9 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
41.8%
69/165 • 9 years
|
20.2%
33/163 • 9 years
|
|
Respiratory, thoracic and mediastinal disorders
Other
|
7.9%
13/165 • 9 years
|
4.3%
7/163 • 9 years
|
|
Skin and subcutaneous tissue disorders
Sweating
|
16.4%
27/165 • 9 years
|
7.4%
12/163 • 9 years
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
17.0%
28/165 • 9 years
|
10.4%
17/163 • 9 years
|
|
Skin and subcutaneous tissue disorders
Nail changes
|
5.5%
9/165 • 9 years
|
3.1%
5/163 • 9 years
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
10.9%
18/165 • 9 years
|
9.8%
16/163 • 9 years
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
36.4%
60/165 • 9 years
|
23.9%
39/163 • 9 years
|
|
Skin and subcutaneous tissue disorders
Other
|
8.5%
14/165 • 9 years
|
6.7%
11/163 • 9 years
|
|
Vascular disorders
Hypertension
|
16.4%
27/165 • 9 years
|
8.0%
13/163 • 9 years
|
|
Vascular disorders
Thrombosis/embolism
|
7.3%
12/165 • 9 years
|
0.61%
1/163 • 9 years
|
|
Vascular disorders
Hot flashes/ flushes
|
9.1%
15/165 • 9 years
|
3.7%
6/163 • 9 years
|
|
Vascular disorders
Flushing
|
5.5%
9/165 • 9 years
|
0.61%
1/163 • 9 years
|
|
Cardiac disorders
Edema
|
43.6%
72/165 • 9 years
|
17.8%
29/163 • 9 years
|
|
Ear and labyrinth disorders
Inner ear/hearing
|
15.2%
25/165 • 9 years
|
2.5%
4/163 • 9 years
|
|
Endocrine disorders
Cushingoid appearance
|
15.2%
25/165 • 9 years
|
0.00%
0/163 • 9 years
|
|
Eye disorders
Blurred vision
|
18.8%
31/165 • 9 years
|
3.1%
5/163 • 9 years
|
|
Eye disorders
Cataract
|
10.9%
18/165 • 9 years
|
0.61%
1/163 • 9 years
|
|
Gastrointestinal disorders
Constipation
|
58.8%
97/165 • 9 years
|
19.6%
32/163 • 9 years
|
|
Gastrointestinal disorders
Diarrhea
|
18.8%
31/165 • 9 years
|
22.1%
36/163 • 9 years
|
|
Gastrointestinal disorders
Mouth dryness
|
33.3%
55/165 • 9 years
|
3.1%
5/163 • 9 years
|
|
Gastrointestinal disorders
Dyspepsia/heartburn
|
24.8%
41/165 • 9 years
|
10.4%
17/163 • 9 years
|
|
Gastrointestinal disorders
Nausea
|
22.4%
37/165 • 9 years
|
17.2%
28/163 • 9 years
|
|
Gastrointestinal disorders
Stomatitis
|
8.5%
14/165 • 9 years
|
5.5%
9/163 • 9 years
|
|
Gastrointestinal disorders
Vomiting
|
9.7%
16/165 • 9 years
|
11.7%
19/163 • 9 years
|
|
Gastrointestinal disorders
Other
|
13.9%
23/165 • 9 years
|
3.7%
6/163 • 9 years
|
|
Gastrointestinal disorders
Abdominal pain
|
18.2%
30/165 • 9 years
|
14.7%
24/163 • 9 years
|
|
General disorders
Fatigue
|
72.7%
120/165 • 9 years
|
58.3%
95/163 • 9 years
|
|
General disorders
Other
|
17.0%
28/165 • 9 years
|
14.1%
23/163 • 9 years
|
|
General disorders
Chest pain
|
10.9%
18/165 • 9 years
|
4.3%
7/163 • 9 years
|
|
General disorders
Pain-Other
|
27.3%
45/165 • 9 years
|
13.5%
22/163 • 9 years
|
|
Immune system disorders
Allergic reaction
|
7.3%
12/165 • 9 years
|
3.7%
6/163 • 9 years
|
|
Immune system disorders
Fever
|
13.3%
22/165 • 9 years
|
9.8%
16/163 • 9 years
|
|
Immune system disorders
Other
|
12.1%
20/165 • 9 years
|
6.7%
11/163 • 9 years
|
|
Infections and infestations
Infection w/o neutropen
|
68.5%
113/165 • 9 years
|
54.0%
88/163 • 9 years
|
|
Infections and infestations
Infection-unknown ANC
|
6.7%
11/165 • 9 years
|
4.3%
7/163 • 9 years
|
|
Injury, poisoning and procedural complications
Bruising
|
8.5%
14/165 • 9 years
|
0.61%
1/163 • 9 years
|
|
Investigations
Hypercholesterolemia
|
9.1%
15/165 • 9 years
|
1.8%
3/163 • 9 years
|
|
Metabolism and nutrition disorders
Anorexia
|
9.7%
16/165 • 9 years
|
9.2%
15/163 • 9 years
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
19.4%
32/165 • 9 years
|
5.5%
9/163 • 9 years
|
|
Musculoskeletal and connective tissue disorders
Other
|
20.6%
34/165 • 9 years
|
13.5%
22/163 • 9 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
21.8%
36/165 • 9 years
|
24.5%
40/163 • 9 years
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
44.8%
74/165 • 9 years
|
31.3%
51/163 • 9 years
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
72.1%
119/165 • 9 years
|
74.2%
121/163 • 9 years
|
|
Nervous system disorders
Taste disturbance
|
9.1%
15/165 • 9 years
|
4.3%
7/163 • 9 years
|
|
Nervous system disorders
Dizziness
|
42.4%
70/165 • 9 years
|
9.2%
15/163 • 9 years
|
|
Nervous system disorders
Memory loss
|
11.5%
19/165 • 9 years
|
1.8%
3/163 • 9 years
|
|
Nervous system disorders
Neuropathy-motor
|
7.9%
13/165 • 9 years
|
2.5%
4/163 • 9 years
|
Additional Information
Director of Clinical Trials
Canadian Cancer Trials Group
Phone: 613-533-6340
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place