Trial Outcomes & Findings for Safety and Efficacy Study of Single Weekly Bortezomib in Newly Diagnosed Multiple Myeloma (NCT NCT01090921)
NCT ID: NCT01090921
Last Updated: 2020-09-09
Results Overview
To evaluate the response rate for weekly administered bortezomib + dexamethasone in patients with newly diagnosed multiple myeloma who are ineligible for transplant or who are eligible but wish to postpone autologous stem cell transplant.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
50 participants
Primary outcome timeframe
Data was collected for each subject for the duration of the participation in the study, which was an average of 4.8 cycles.
Results posted on
2020-09-09
Participant Flow
Participant milestones
| Measure |
Bortezomib and Dexamethasone
Bortezomib is administered at a dose of 1.6mg/m2 IV push over 3 to 5 seconds. Treatment is administered once a week for four weeks followed by one week off. This 5 week period is considered a treatment cycle. Dexamethasone is also administered at a dose of 40mg daily on day of and day after each dose of Bortezomib, with a dose reduction to 20mg on the same schedule if the patient cannot tolerate the higher dose of dexamethasone. The study duration for a given subject will be approximately 30 weeks.
Bortezomib: Bortezomib will be administered at a dose of 1.6 mg/m2 IV push. Treatment will be administered once a week for four weeks followed by one week off. This 5 week period is considered a treatment cycle.
Dexamethasone will also be administered at a dose of 40mg on the day of and day after each dose of bortezomib, with a dose reduction to 20mg on the same schedule if the patient cannot tolerate the higher dose of dexamethasone.
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|---|---|
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Overall Study
STARTED
|
50
|
|
Overall Study
COMPLETED
|
23
|
|
Overall Study
NOT COMPLETED
|
27
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Efficacy Study of Single Weekly Bortezomib in Newly Diagnosed Multiple Myeloma
Baseline characteristics by cohort
| Measure |
Bortezomib and Dexamethasone
n=50 Participants
Bortezomib is administered at a dose of 1.6mg/m2 IV push over 3 to 5 seconds. Treatment is administered once a week for four weeks followed by one week off. This 5 week period is considered a treatment cycle. Dexamethasone is also administered at a dose of 40mg daily on day of and day after each dose of Bortezomib, with a dose reduction to 20mg on the same schedule if the patient cannot tolerate the higher dose of dexamethasone. The study duration for a given subject will be approximately 30 weeks.
Bortezomib: Bortezomib will be administered at a dose of 1.6 mg/m2 IV push. Treatment will be administered once a week for four weeks followed by one week off. This 5 week period is considered a treatment cycle.
Dexamethasone will also be administered at a dose of 40mg on the day of and day after each dose of bortezomib, with a dose reduction to 20mg on the same schedule if the patient cannot tolerate the higher dose of dexamethasone.
|
|---|---|
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Age, Customized
Age
|
70.9 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
50 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
50 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
50 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Data was collected for each subject for the duration of the participation in the study, which was an average of 4.8 cycles.To evaluate the response rate for weekly administered bortezomib + dexamethasone in patients with newly diagnosed multiple myeloma who are ineligible for transplant or who are eligible but wish to postpone autologous stem cell transplant.
Outcome measures
| Measure |
Bortezomib and Dexamethasone
n=50 Participants
Bortezomib is administered at a dose of 1.6mg/m2 IV push over 3 to 5 seconds. Treatment is administered once a week for four weeks followed by one week off. This 5 week period is considered a treatment cycle. Dexamethasone is also administered at a dose of 40mg daily on day of and day after each dose of Bortezomib, with a dose reduction to 20mg on the same schedule if the patient cannot tolerate the higher dose of dexamethasone. The study duration for a given subject will be approximately 30 weeks.
Bortezomib: Bortezomib will be administered at a dose of 1.6 mg/m2 IV push. Treatment will be administered once a week for four weeks followed by one week off. This 5 week period is considered a treatment cycle.
Dexamethasone will also be administered at a dose of 40mg on the day of and day after each dose of bortezomib, with a dose reduction to 20mg on the same schedule if the patient cannot tolerate the higher dose of dexamethasone.
|
|---|---|
|
Number of Participants at Each Response Category (Stable Disease, Minimal Response, Partial Response, Very Good Partial Response, Near Complete Response/Complete Resonse)
Complete Response/ near Complete Response
|
6 Participants
|
|
Number of Participants at Each Response Category (Stable Disease, Minimal Response, Partial Response, Very Good Partial Response, Near Complete Response/Complete Resonse)
Very Good Partial Response
|
13 Participants
|
|
Number of Participants at Each Response Category (Stable Disease, Minimal Response, Partial Response, Very Good Partial Response, Near Complete Response/Complete Resonse)
Partial Response
|
15 Participants
|
|
Number of Participants at Each Response Category (Stable Disease, Minimal Response, Partial Response, Very Good Partial Response, Near Complete Response/Complete Resonse)
Minimal Response
|
5 Participants
|
|
Number of Participants at Each Response Category (Stable Disease, Minimal Response, Partial Response, Very Good Partial Response, Near Complete Response/Complete Resonse)
Stable Disease
|
4 Participants
|
|
Number of Participants at Each Response Category (Stable Disease, Minimal Response, Partial Response, Very Good Partial Response, Near Complete Response/Complete Resonse)
Unevaluable
|
7 Participants
|
SECONDARY outcome
Timeframe: Data was collected for each subject for the duration of the participation in the study, which was an average of 4.8 cycles.To evaluate the toxicity (safety and tolerability) of weekly bortezomib + dexamethasone in patients with newly diagnosed multiple myeloma who are ineligible for transplant or who are eligible but wish to postpone autologous stem cell transplant.
Outcome measures
| Measure |
Bortezomib and Dexamethasone
n=50 Participants
Bortezomib is administered at a dose of 1.6mg/m2 IV push over 3 to 5 seconds. Treatment is administered once a week for four weeks followed by one week off. This 5 week period is considered a treatment cycle. Dexamethasone is also administered at a dose of 40mg daily on day of and day after each dose of Bortezomib, with a dose reduction to 20mg on the same schedule if the patient cannot tolerate the higher dose of dexamethasone. The study duration for a given subject will be approximately 30 weeks.
Bortezomib: Bortezomib will be administered at a dose of 1.6 mg/m2 IV push. Treatment will be administered once a week for four weeks followed by one week off. This 5 week period is considered a treatment cycle.
Dexamethasone will also be administered at a dose of 40mg on the day of and day after each dose of bortezomib, with a dose reduction to 20mg on the same schedule if the patient cannot tolerate the higher dose of dexamethasone.
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|---|---|
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Number of Participants With Dose Reductions in Bortezomib, Dexamethasone or Both
Bortezomib reductions
|
8 Participants
|
|
Number of Participants With Dose Reductions in Bortezomib, Dexamethasone or Both
Dexamethasone reductions
|
14 Participants
|
|
Number of Participants With Dose Reductions in Bortezomib, Dexamethasone or Both
Bortezomib and Dexamethasone reductions
|
4 Participants
|
Adverse Events
Bortezomib and Dexamethasone
Serious events: 28 serious events
Other events: 0 other events
Deaths: 6 deaths
Serious adverse events
| Measure |
Bortezomib and Dexamethasone
n=50 participants at risk
Bortezomib is administered at a dose of 1.6mg/m2 IV push over 3 to 5 seconds. Treatment is administered once a week for four weeks followed by one week off. This 5 week period is considered a treatment cycle. Dexamethasone is also administered at a dose of 40mg daily on day of and day after each dose of Bortezomib, with a dose reduction to 20mg on the same schedule if the patient cannot tolerate the higher dose of dexamethasone. The study duration for a given subject will be approximately 30 weeks.
Bortezomib: Bortezomib will be administered at a dose of 1.6 mg/m2 IV push. Treatment will be administered once a week for four weeks followed by one week off. This 5 week period is considered a treatment cycle.
Dexamethasone will also be administered at a dose of 40mg on the day of and day after each dose of bortezomib, with a dose reduction to 20mg on the same schedule if the patient cannot tolerate the higher dose of dexamethasone.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
4.0%
2/50 • Number of events 2 • Data was collected for each subject for the duration of the participation in the study, which was an average of 4.8 cycles.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
2.0%
1/50 • Number of events 1 • Data was collected for each subject for the duration of the participation in the study, which was an average of 4.8 cycles.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
18.0%
9/50 • Number of events 9 • Data was collected for each subject for the duration of the participation in the study, which was an average of 4.8 cycles.
|
|
Gastrointestinal disorders
Diarrhea
|
4.0%
2/50 • Number of events 2 • Data was collected for each subject for the duration of the participation in the study, which was an average of 4.8 cycles.
|
|
Gastrointestinal disorders
Constipation
|
4.0%
2/50 • Number of events 2 • Data was collected for each subject for the duration of the participation in the study, which was an average of 4.8 cycles.
|
|
Gastrointestinal disorders
Vomiting/Nausea
|
2.0%
1/50 • Number of events 1 • Data was collected for each subject for the duration of the participation in the study, which was an average of 4.8 cycles.
|
|
Renal and urinary disorders
Elevated creatinine
|
2.0%
1/50 • Number of events 1 • Data was collected for each subject for the duration of the participation in the study, which was an average of 4.8 cycles.
|
|
Renal and urinary disorders
Acute renal failure
|
4.0%
2/50 • Number of events 2 • Data was collected for each subject for the duration of the participation in the study, which was an average of 4.8 cycles.
|
|
General disorders
Asthenia
|
8.0%
4/50 • Number of events 4 • Data was collected for each subject for the duration of the participation in the study, which was an average of 4.8 cycles.
|
|
Endocrine disorders
Hyperglycemia
|
18.0%
9/50 • Number of events 9 • Data was collected for each subject for the duration of the participation in the study, which was an average of 4.8 cycles.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place