Trial Outcomes & Findings for Subcutaneous (SC) Bortezomib-Regimens for Patients With RR MM Failing Prior IV Bortezomib-Containing Regimens (NCT NCT01695330)
NCT ID: NCT01695330
Last Updated: 2017-01-16
Results Overview
Definition of incidence: the number of participants enrolled in the study experiencing treatment-emergent peripheral neuropathy. Emergence of peripheral neuropathy is determined via neurological assessment conducted on Day 1 and Day 11 of each treatment cycle as well as during the End of Study visit. Definition of severity: the severity of any treatment-emergent peripheral neuropathy experienced by a patient on-study. Peripheral neuropathy severity is determined via neurological assessment conducted on Day 1 and Day 11 of each treatment cycle as well as the End of Study visit and is graded on a 0-4 scale based on CTCAE criteria. Incidence of Peripheral Neuropathy Definition: the number of participants enrolled in the study experiencing treatment-emergent peripheral neuropathy. Emergence of peripheral neuropathy is determined via neurological assessment conducted on Day 1 and Day 11 of each treatment cycle as well as during the End of Study visit.
TERMINATED
PHASE2
5 participants
Subjects eligible for this study will receive treatment with study drug for a maximum of eight 28 day treatment cycles.
2017-01-16
Participant Flow
Patients with MM who received treatment with a SC bortezomib-containing combination
Participant milestones
| Measure |
Subcutaneous Bortezomib
patients with MM who received treatment with a SC bortezomib-containing combination. The patients were required to have received a prior IV bortezomib containing combination regimen that differs from the SC bortezomib-containing treatment.
|
This is one-arm study.
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|---|---|---|
|
Overall Study
STARTED
|
52
|
0
|
|
Overall Study
COMPLETED
|
5
|
0
|
|
Overall Study
NOT COMPLETED
|
47
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Subcutaneous (SC) Bortezomib-Regimens for Patients With RR MM Failing Prior IV Bortezomib-Containing Regimens
Baseline characteristics by cohort
| Measure |
Subcutaneous Bortezomib
n=5 Participants
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
|
Age, Continuous
|
62 years
STANDARD_DEVIATION 5.1 • n=5 Participants
|
|
Gender
Female
|
3 Participants
n=5 Participants
|
|
Gender
Male
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=5 Participants
|
|
The patients were required to have received a prior IV bortezomib containing combination regimen tha
|
5 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Subjects eligible for this study will receive treatment with study drug for a maximum of eight 28 day treatment cycles.Definition of incidence: the number of participants enrolled in the study experiencing treatment-emergent peripheral neuropathy. Emergence of peripheral neuropathy is determined via neurological assessment conducted on Day 1 and Day 11 of each treatment cycle as well as during the End of Study visit. Definition of severity: the severity of any treatment-emergent peripheral neuropathy experienced by a patient on-study. Peripheral neuropathy severity is determined via neurological assessment conducted on Day 1 and Day 11 of each treatment cycle as well as the End of Study visit and is graded on a 0-4 scale based on CTCAE criteria. Incidence of Peripheral Neuropathy Definition: the number of participants enrolled in the study experiencing treatment-emergent peripheral neuropathy. Emergence of peripheral neuropathy is determined via neurological assessment conducted on Day 1 and Day 11 of each treatment cycle as well as during the End of Study visit.
Outcome measures
| Measure |
Subcutaneous Bortezomib
n=5 Participants
Patients with MM who received treatment with a SC bortezomib-containing combination
|
|---|---|
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The Primary Objective of This Study Will be to Investigate the Incidence and Severity of Peripheral Neuropathy Caused by a Prior Intravenous VELCADE-containing Regimen in Comparison to That Caused by a Subcutaneous VELCADE-containing Regimen.
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5 Participants
|
SECONDARY outcome
Timeframe: Subjects eligible for this study will receive treatment with study drug for a maximum of eight 28 day treatment cycles.Compare overall response rate \[combined CR + very good partial response (VGPR) + PR + MR\] and disease parameters \[time to progression, -progression free survival, -time to first response, -duration of response, -overall survival\] following treatment with a SC bortezomib-containing combination regimen for MM patients who have demonstrated progressive disease form a prior or different IV bortezomib-containing combination regimen. Determine incidence and severity of injection-site reactions with CS administration of bortezomib by number of patients with injection site reaction specific adverse events.
Outcome measures
Outcome data not reported
Adverse Events
Subcutaneous Bortezomib
Serious adverse events
| Measure |
Subcutaneous Bortezomib
n=5 participants at risk
Bortezomib was administered SC at a dose of 1.0 mg/m2. Doses were administered on days 1, 4, 8, and 11 of a 28-day cycle. When administered subcutaneously, sites for each injection (thigh or abdomen) were rotated and reported. All other drugs used in combination with the SC bortezomib were recorded in the Case Report Forms along with their corresponding doses and schedules.
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|---|---|
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Immune system disorders
Gr3 Neturopenia
|
40.0%
2/5 • Number of events 2
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Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place