Trial Outcomes & Findings for Bortezomib and Thalidomide in Treating Patients With Newly Diagnosed Stage II or Stage III Multiple Myeloma (NCT NCT00287872)
NCT ID: NCT00287872
Last Updated: 2018-03-01
Results Overview
Clinical evaluations of disease response were determined with each cycle. Bone marrow biopsies were done at baseline and at study termination. Clinical responses were defined by the International Myeloma Working Group criteria: Stringent Complete Response (SCR), CR and normal free light chain ratio and no clonal cells in bone marrow; Complete Response (CR), Negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤ 5% plasma cells in bone marrow; Very Good Partial Response (VGPR), Serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥ 90% reduction in serum M-protein and urine M-protein level \< 100 mg/24 hours; Partial Response (PR), ≥ 50% reduction of serum M-Protein and reduction in urinary M-protein by ≥ 90% or to \< 200 mg/24 hours. Objective response is defined as a best overall response of SCR, CR, VGPR, or PR.
COMPLETED
PHASE2
30 participants
1-6 months
2018-03-01
Participant Flow
Participant milestones
| Measure |
Bortezomib and Thalidomide
The patients will receive Bortezomib on days 1, 4, 8 and 11 of each 21 day cycle in combination with daily oral Thalidomide.
bortezomib
thalidomide
|
|---|---|
|
Overall Study
STARTED
|
30
|
|
Overall Study
COMPLETED
|
30
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Bortezomib and Thalidomide in Treating Patients With Newly Diagnosed Stage II or Stage III Multiple Myeloma
Baseline characteristics by cohort
| Measure |
Bortezomib and Thalidomide
n=30 Participants
The patients will receive Bortezomib on days 1, 4, 8 and 11 of each 21 day cycle in combination with daily oral Thalidomide.
bortezomib
thalidomide
|
|---|---|
|
Age, Continuous
|
58.4 years
STANDARD_DEVIATION 9.9 • n=99 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
24 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
6 Participants
n=99 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
30 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 1-6 monthsClinical evaluations of disease response were determined with each cycle. Bone marrow biopsies were done at baseline and at study termination. Clinical responses were defined by the International Myeloma Working Group criteria: Stringent Complete Response (SCR), CR and normal free light chain ratio and no clonal cells in bone marrow; Complete Response (CR), Negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤ 5% plasma cells in bone marrow; Very Good Partial Response (VGPR), Serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥ 90% reduction in serum M-protein and urine M-protein level \< 100 mg/24 hours; Partial Response (PR), ≥ 50% reduction of serum M-Protein and reduction in urinary M-protein by ≥ 90% or to \< 200 mg/24 hours. Objective response is defined as a best overall response of SCR, CR, VGPR, or PR.
Outcome measures
| Measure |
Bortezomib and Thalidomide
n=27 Participants
The patients will receive Bortezomib on days 1, 4, 8 and 11 of each 21 day cycle in combination with daily oral Thalidomide.
bortezomib
thalidomide
|
|---|---|
|
Clinical Response to Treatment
|
81.5 percentage of participants
Interval 62.0 to 94.0
|
SECONDARY outcome
Timeframe: 1-6 monthsNeuropathy was monitored using Total Neuropathy Score reduced (TNSr).
Outcome measures
| Measure |
Bortezomib and Thalidomide
n=27 Participants
The patients will receive Bortezomib on days 1, 4, 8 and 11 of each 21 day cycle in combination with daily oral Thalidomide.
bortezomib
thalidomide
|
|---|---|
|
Peripheral Motor and Sensory Neuropathy (Grade 2 and Higher)
|
19 participants
|
SECONDARY outcome
Timeframe: 1-6 monthsPopulation: Analysis not completed as the information was not relevant since no patients went on to transplant.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1-6 monthsOutcome measures
| Measure |
Bortezomib and Thalidomide
n=22 Participants
The patients will receive Bortezomib on days 1, 4, 8 and 11 of each 21 day cycle in combination with daily oral Thalidomide.
bortezomib
thalidomide
|
|---|---|
|
The Time to Response
|
2 months
Interval 0.5 to 5.8
|
SECONDARY outcome
Timeframe: 0-6 monthsPopulation: Analysis not done on subject population.
Outcome measures
Outcome data not reported
Adverse Events
Bortezomib and Thalidomide
Serious adverse events
| Measure |
Bortezomib and Thalidomide
n=30 participants at risk
The patients will receive Bortezomib on days 1, 4, 8 and 11 of each 21 day cycle in combination with daily oral Thalidomide.
bortezomib
thalidomide
|
|---|---|
|
Gastrointestinal disorders
dehydration
|
6.7%
2/30 • Number of events 2
|
|
Gastrointestinal disorders
nausea & vomiting
|
6.7%
2/30 • Number of events 2
|
|
Renal and urinary disorders
renal failure
|
3.3%
1/30 • Number of events 1
|
|
Infections and infestations
neutropenic fever
|
3.3%
1/30 • Number of events 1
|
|
Infections and infestations
pneumonia
|
10.0%
3/30 • Number of events 3
|
|
Metabolism and nutrition disorders
hyperkalemia
|
3.3%
1/30 • Number of events 1
|
Other adverse events
| Measure |
Bortezomib and Thalidomide
n=30 participants at risk
The patients will receive Bortezomib on days 1, 4, 8 and 11 of each 21 day cycle in combination with daily oral Thalidomide.
bortezomib
thalidomide
|
|---|---|
|
Nervous system disorders
peripheral neuropathy
|
83.3%
25/30 • Number of events 75
|
|
Cardiac disorders
hypotension
|
20.0%
6/30 • Number of events 7
|
|
General disorders
fatigue
|
73.3%
22/30 • Number of events 48
|
|
Gastrointestinal disorders
constipation
|
63.3%
19/30 • Number of events 40
|
|
Gastrointestinal disorders
diarrhoea
|
50.0%
15/30 • Number of events 29
|
Additional Information
Dr. Ivan Borrello
The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place