Trial Outcomes & Findings for Bortezomib Based Consolidation in Multiple Myeloma Patients Completing Stem Cell Transplant (NCT NCT01706666)
NCT ID: NCT01706666
Last Updated: 2018-09-17
Results Overview
Estimated by the number of sCRs divided by the total number of evaluable patients in each arm. Exact binomial confidence intervals for the true sCR rate will be calculated by arm. Stringent complete response (sCR) is defined as a complete response plus normal serum free light chain ratio and the absence of clonal cells in bone marrow by flow cytometry.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
3 participants
Primary outcome timeframe
24 months
Results posted on
2018-09-17
Participant Flow
Participant milestones
| Measure |
Arm A
Patients receive bortezomib SC on days 1 and 15 of courses 1-12 and day 1 of courses 13-24.
|
Arm B
Patients receive bortezomib SC as in Arm A, cyclophosphamide PO on days 1 and 15 of courses 1-12 and day 1 of courses 13-24, and dexamethasone PO on days 1 and 15 of courses 1-12 and day 1 of courses 13-24.
|
Arm C
Patients receive bortezomib SC as in Arm A and lenalidomide PO QD on days 1-28.
|
|---|---|---|---|
|
Overall Study
STARTED
|
1
|
1
|
1
|
|
Overall Study
COMPLETED
|
1
|
1
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Bortezomib Based Consolidation in Multiple Myeloma Patients Completing Stem Cell Transplant
Baseline characteristics by cohort
| Measure |
Arm A
n=1 Participants
Patients receive bortezomib SC on days 1 and 15 of courses 1-12 and day 1 of courses 13-24.
|
Arm B
n=1 Participants
Patients receive bortezomib SC as in Arm A, cyclophosphamide PO on days 1 and 15 of courses 1-12 and day 1 of courses 13-24, and dexamethasone PO on days 1 and 15 of courses 1-12 and day 1 of courses 13-24.
|
Arm C
n=1 Participants
Patients receive bortezomib SC as in Arm A and lenalidomide PO QD on days 1-28.
|
Total
n=3 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
54 Years
n=5 Participants
|
45 Years
n=7 Participants
|
50 Years
n=5 Participants
|
50 Years
n=4 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
3 participants
n=4 Participants
|
|
Had Prior Treatment
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
3 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 24 monthsEstimated by the number of sCRs divided by the total number of evaluable patients in each arm. Exact binomial confidence intervals for the true sCR rate will be calculated by arm. Stringent complete response (sCR) is defined as a complete response plus normal serum free light chain ratio and the absence of clonal cells in bone marrow by flow cytometry.
Outcome measures
| Measure |
Arm A
n=1 Participants
Patients receive bortezomib SC on days 1 and 15 of courses 1-12 and day 1 of courses 13-24.
|
Arm B
n=1 Participants
Patients receive bortezomib SC as in Arm A, cyclophosphamide PO on days 1 and 15 of courses 1-12 and day 1 of courses 13-24, and dexamethasone PO on days 1 and 15 of courses 1-12 and day 1 of courses 13-24.
|
Arm C
n=1 Participants
Patients receive bortezomib SC as in Arm A and lenalidomide PO QD on days 1-28.
|
|---|---|---|---|
|
Proportion of Patients Experiencing a Stringent Complete Response (sCR) After 12 Cycles, 24 Months
|
100 percentage of participants
|
0 percentage of participants
|
100 percentage of participants
|
SECONDARY outcome
Timeframe: From registration to death due to any cause, assessed up to 3 yearsPopulation: All patients are still alive
The distribution of survival time will be estimated by arm using the method of Kaplan-Meier.
Outcome measures
| Measure |
Arm A
n=1 Participants
Patients receive bortezomib SC on days 1 and 15 of courses 1-12 and day 1 of courses 13-24.
|
Arm B
n=1 Participants
Patients receive bortezomib SC as in Arm A, cyclophosphamide PO on days 1 and 15 of courses 1-12 and day 1 of courses 13-24, and dexamethasone PO on days 1 and 15 of courses 1-12 and day 1 of courses 13-24.
|
Arm C
n=1 Participants
Patients receive bortezomib SC as in Arm A and lenalidomide PO QD on days 1-28.
|
|---|---|---|---|
|
Survival Time
|
NA Months to death
No Deaths
|
NA Months to death
No Deaths
|
NA Months to death
No Deaths
|
SECONDARY outcome
Timeframe: From registration to the earliest date of documentation of disease progression or death due to any cause, assessed up to 3 yearsThe distribution of progression-free survival will be estimated by arm using the method of Kaplan-Meier.
Outcome measures
| Measure |
Arm A
n=1 Participants
Patients receive bortezomib SC on days 1 and 15 of courses 1-12 and day 1 of courses 13-24.
|
Arm B
n=1 Participants
Patients receive bortezomib SC as in Arm A, cyclophosphamide PO on days 1 and 15 of courses 1-12 and day 1 of courses 13-24, and dexamethasone PO on days 1 and 15 of courses 1-12 and day 1 of courses 13-24.
|
Arm C
n=1 Participants
Patients receive bortezomib SC as in Arm A and lenalidomide PO QD on days 1-28.
|
|---|---|---|---|
|
Progression-free Survival
|
NA Months to Progression
No progressions
|
9.2 Months to Progression
|
NA Months to Progression
No progressions
|
Adverse Events
Arm A
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Arm B
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Arm C
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm A
n=1 participants at risk
Patients receive bortezomib SC on days 1 and 15 of courses 1-12 and day 1 of courses 13-24.
|
Arm B
n=1 participants at risk
Patients receive bortezomib SC as in Arm A, cyclophosphamide PO on days 1 and 15 of courses 1-12 and day 1 of courses 13-24, and dexamethasone PO on days 1 and 15 of courses 1-12 and day 1 of courses 13-24.
|
Arm C
n=1 participants at risk
Patients receive bortezomib SC as in Arm A and lenalidomide PO QD on days 1-28.
|
|---|---|---|---|
|
Investigations
Neutrophil count decreased
|
0.00%
0/1
|
0.00%
0/1
|
100.0%
1/1 • Number of events 1
|
|
Vascular disorders
Hypertension
|
100.0%
1/1 • Number of events 1
|
0.00%
0/1
|
0.00%
0/1
|
Other adverse events
| Measure |
Arm A
n=1 participants at risk
Patients receive bortezomib SC on days 1 and 15 of courses 1-12 and day 1 of courses 13-24.
|
Arm B
n=1 participants at risk
Patients receive bortezomib SC as in Arm A, cyclophosphamide PO on days 1 and 15 of courses 1-12 and day 1 of courses 13-24, and dexamethasone PO on days 1 and 15 of courses 1-12 and day 1 of courses 13-24.
|
Arm C
n=1 participants at risk
Patients receive bortezomib SC as in Arm A and lenalidomide PO QD on days 1-28.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
100.0%
1/1 • Number of events 5
|
100.0%
1/1 • Number of events 10
|
0.00%
0/1
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/1
|
0.00%
0/1
|
100.0%
1/1 • Number of events 10
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/1
|
100.0%
1/1 • Number of events 7
|
100.0%
1/1 • Number of events 2
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/1
|
100.0%
1/1 • Number of events 9
|
100.0%
1/1 • Number of events 2
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/1
|
0.00%
0/1
|
100.0%
1/1 • Number of events 1
|
|
General disorders
Fatigue
|
100.0%
1/1 • Number of events 1
|
100.0%
1/1 • Number of events 6
|
100.0%
1/1 • Number of events 13
|
|
General disorders
Injection site reaction
|
0.00%
0/1
|
100.0%
1/1 • Number of events 1
|
0.00%
0/1
|
|
General disorders
Malaise
|
100.0%
1/1 • Number of events 1
|
0.00%
0/1
|
0.00%
0/1
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/1
|
0.00%
0/1
|
100.0%
1/1 • Number of events 10
|
|
Investigations
Platelet count decreased
|
100.0%
1/1 • Number of events 1
|
0.00%
0/1
|
100.0%
1/1 • Number of events 10
|
|
Investigations
White blood cell decreased
|
0.00%
0/1
|
100.0%
1/1 • Number of events 5
|
100.0%
1/1 • Number of events 9
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
100.0%
1/1 • Number of events 1
|
0.00%
0/1
|
100.0%
1/1 • Number of events 1
|
|
Renal and urinary disorders
Cystitis noninfective
|
100.0%
1/1 • Number of events 1
|
0.00%
0/1
|
0.00%
0/1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/1
|
0.00%
0/1
|
100.0%
1/1 • Number of events 3
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place