Trial Outcomes & Findings for Phase I: Melphalan, Bendamustine and Carfilzomib for Autologous Transplant in Multiple Myeloma (NCT NCT02148913)
NCT ID: NCT02148913
Last Updated: 2024-07-26
Results Overview
An absence of neutrophil engraftment by Day +22, absence of platelet engraftment by Day +35, and any grade 4 GI toxicity or any \>/= grade 3 non-hematologic toxicity as defined by the common toxicity criteria, which is deemed by the DSMB as probably related to the study protocol.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
18 participants
Primary outcome timeframe
Assessed daily (while inpatient) through clinical and laboratory examinations up to 90 days.
Results posted on
2024-07-26
Participant Flow
This study was conducted using a standard 3+3 phase I design. If dose-limiting toxicity (DLT) occurred in 1 out of 3 patients, 3 additional patients were enrolled at that same dose level. Dose escalation was permitted if DLT did not occur in more than 0 out of 3, or 1 out of 6 patients
Participant milestones
| Measure |
Cohort 1: Carfilzomib 15 mg/m2
Carfilzomib 15 mg/m2 on days -2, -1, +5, and +6 IV over 10 minutes.
Cohort 1: Carfilzomib 15 mg/m2: Carfilzomib 20 mg/m2 on days -29, -28, -22, -21, -15, and -14 Bendamustine 120 mg/m2 on day -2 and 100 mg/m2 day -1 Melphalan 100 mg/m2 on day -2 and day -1 Carfilzomib 15 mg/m2 on day -2, -1, + 5 and +6
|
Cohort 2: Carfilzomib 20 mg/m2
Carfilzomib 20 mg/m2 on days -2, -1, +5, and +6 IV over 10 minutes.
Cohort 2: Carfilzomib 20 mg/m2: Carfilzomib 20 mg/m2 on days -29, -28, -22, -21, -15, and -14 Bendamustine 120 mg/m2 on day -2 and 100 mg/m2 day -1 Melphalan 100 mg/m2 on day -2 and day -1 Carfilzomib 20 mg/m2 on day -2, -1, + 5 and +6
|
Cohort 2b: Carfilzomib 20 mg/m2
Carfilzomib 20 mg/m2 on days -2, -1 and +5 IV over 10 minutes.
Cohort 2b: Carfilzomib 20 mg/m2: Carfilzomib 20 mg/m2 on days -29, -28, -22, -21, -15, and -14 Bendamustine 120 mg/m2 on day -2 and 100 mg/m2 day -1 Melphalan 140 mg/m2 on day -1 Carfilzomib 20 mg/m2 on day -2, -1 and + 5
|
Cohort 3: Carfilzomib 27mgm2
Carfilzomib 27 mg/m2 on days -2, -1 and +5 IV over 10 minutes.
Cohort 3b: Carfilzomib 27 mg/m2: Carfilzomib 20 mg/m2 on days -29, -28, -22, -21, -15, and -14 Bendamustine 120 mg/m2 on day -2 and 100 mg/m2 day -1 Melphalan 140 mg/m2 on day -1 Carfilzomib 27 mg/m2 on day -2, -1 and + 5
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
3
|
9
|
|
Overall Study
COMPLETED
|
3
|
2
|
3
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
0
|
0
|
Reasons for withdrawal
| Measure |
Cohort 1: Carfilzomib 15 mg/m2
Carfilzomib 15 mg/m2 on days -2, -1, +5, and +6 IV over 10 minutes.
Cohort 1: Carfilzomib 15 mg/m2: Carfilzomib 20 mg/m2 on days -29, -28, -22, -21, -15, and -14 Bendamustine 120 mg/m2 on day -2 and 100 mg/m2 day -1 Melphalan 100 mg/m2 on day -2 and day -1 Carfilzomib 15 mg/m2 on day -2, -1, + 5 and +6
|
Cohort 2: Carfilzomib 20 mg/m2
Carfilzomib 20 mg/m2 on days -2, -1, +5, and +6 IV over 10 minutes.
Cohort 2: Carfilzomib 20 mg/m2: Carfilzomib 20 mg/m2 on days -29, -28, -22, -21, -15, and -14 Bendamustine 120 mg/m2 on day -2 and 100 mg/m2 day -1 Melphalan 100 mg/m2 on day -2 and day -1 Carfilzomib 20 mg/m2 on day -2, -1, + 5 and +6
|
Cohort 2b: Carfilzomib 20 mg/m2
Carfilzomib 20 mg/m2 on days -2, -1 and +5 IV over 10 minutes.
Cohort 2b: Carfilzomib 20 mg/m2: Carfilzomib 20 mg/m2 on days -29, -28, -22, -21, -15, and -14 Bendamustine 120 mg/m2 on day -2 and 100 mg/m2 day -1 Melphalan 140 mg/m2 on day -1 Carfilzomib 20 mg/m2 on day -2, -1 and + 5
|
Cohort 3: Carfilzomib 27mgm2
Carfilzomib 27 mg/m2 on days -2, -1 and +5 IV over 10 minutes.
Cohort 3b: Carfilzomib 27 mg/m2: Carfilzomib 20 mg/m2 on days -29, -28, -22, -21, -15, and -14 Bendamustine 120 mg/m2 on day -2 and 100 mg/m2 day -1 Melphalan 140 mg/m2 on day -1 Carfilzomib 27 mg/m2 on day -2, -1 and + 5
|
|---|---|---|---|---|
|
Overall Study
Death
|
0
|
1
|
0
|
0
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Cohort 1: Carfilzomib 15 mg/m2
n=3 Participants
Carfilzomib 15 mg/m2 on days -2, -1, +5, and +6 IV over 10 minutes.
Cohort 1: Carfilzomib 15 mg/m2: Carfilzomib 20 mg/m2 on days -29, -28, -22, -21, -15, and -14 Bendamustine 120 mg/m2 on day -2 and 100 mg/m2 day -1 Melphalan 100 mg/m2 on day -2 and day -1 Carfilzomib 15 mg/m2 on day -2, -1, + 5 and +6
|
Cohort 2: Carfilzomib 20 mg/m2
n=3 Participants
Carfilzomib 20 mg/m2 on days -2, -1, +5, and +6 IV over 10 minutes.
Cohort 2: Carfilzomib 20 mg/m2: Carfilzomib 20 mg/m2 on days -29, -28, -22, -21, -15, and -14 Bendamustine 120 mg/m2 on day -2 and 100 mg/m2 day -1 Melphalan 100 mg/m2 on day -2 and day -1 Carfilzomib 20 mg/m2 on day -2, -1, + 5 and +6
|
Cohort 2b: Carfilzomib 20 mg/m2
n=3 Participants
Carfilzomib 20 mg/m2 on days -2, -1 and +5 IV over 10 minutes.
Cohort 2b: Carfilzomib 20 mg/m2: Carfilzomib 20 mg/m2 on days -29, -28, -22, -21, -15, and -14 Bendamustine 120 mg/m2 on day -2 and 100 mg/m2 day -1 Melphalan 140 mg/m2 on day -1 Carfilzomib 20 mg/m2 on day -2, -1 and + 5
|
Cohort 3: Carfilzomib 27mgm2
n=9 Participants
Carfilzomib 27 mg/m2 on days -2, -1 and +5 IV over 10 minutes.
Cohort 3b: Carfilzomib 27 mg/m2: Carfilzomib 20 mg/m2 on days -29, -28, -22, -21, -15, and -14 Bendamustine 120 mg/m2 on day -2 and 100 mg/m2 day -1 Melphalan 140 mg/m2 on day -1 Carfilzomib 27 mg/m2 on day -2, -1 and + 5
|
Total
n=18 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=18 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=3 Participants
|
2 Participants
n=3 Participants
|
2 Participants
n=3 Participants
|
7 Participants
n=9 Participants
|
14 Participants
n=18 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=3 Participants
|
1 Participants
n=3 Participants
|
1 Participants
n=3 Participants
|
2 Participants
n=9 Participants
|
4 Participants
n=18 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=3 Participants
|
2 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
3 Participants
n=9 Participants
|
7 Participants
n=18 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=3 Participants
|
1 Participants
n=3 Participants
|
3 Participants
n=3 Participants
|
6 Participants
n=9 Participants
|
11 Participants
n=18 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
3 participants
n=3 Participants
|
3 participants
n=3 Participants
|
3 participants
n=3 Participants
|
9 participants
n=9 Participants
|
18 participants
n=18 Participants
|
PRIMARY outcome
Timeframe: Assessed daily (while inpatient) through clinical and laboratory examinations up to 90 days.An absence of neutrophil engraftment by Day +22, absence of platelet engraftment by Day +35, and any grade 4 GI toxicity or any \>/= grade 3 non-hematologic toxicity as defined by the common toxicity criteria, which is deemed by the DSMB as probably related to the study protocol.
Outcome measures
| Measure |
Cohort 1: Carfilzomib 15 mg/m2
n=3 Participants
Carfilzomib 15 mg/m2 on days -2, -1, +5, and +6 IV over 10 minutes.
Cohort 1: Carfilzomib 15 mg/m2: Carfilzomib 20 mg/m2 on days -29, -28, -22, -21, -15, and -14 Bendamustine 120 mg/m2 on day -2 and 100 mg/m2 day -1 Melphalan 100 mg/m2 on day -2 and day -1 Carfilzomib 15 mg/m2 on day -2, -1, + 5 and +6
|
Cohort 2: Carfilzomib 20 mg/m2
n=3 Participants
Carfilzomib 20 mg/m2 on days -2, -1, +5, and +6 IV over 10 minutes.
Cohort 2: Carfilzomib 20 mg/m2: Carfilzomib 20 mg/m2 on days -29, -28, -22, -21, -15, and -14 Bendamustine 120 mg/m2 on day -2 and 100 mg/m2 day -1 Melphalan 100 mg/m2 on day -2 and day -1 Carfilzomib 20 mg/m2 on day -2, -1, + 5 and +6
|
Cohort 2b: Carfilzomib 20 mg/m2
n=3 Participants
Carfilzomib 20 mg/m2 on days -2, -1 and +5 IV over 10 minutes.
Cohort 2b: Carfilzomib 20 mg/m2: Carfilzomib 20 mg/m2 on days -29, -28, -22, -21, -15, and -14 Bendamustine 120 mg/m2 on day -2 and 100 mg/m2 day -1 Melphalan 140 mg/m2 on day -1 Carfilzomib 20 mg/m2 on day -2, -1 and + 5
|
Cohort 3: Carfilzomib 27mgm2
n=9 Participants
Carfilzomib 27 mg/m2 on days -2, -1 and +5 IV over 10 minutes.
Cohort 3b: Carfilzomib 27 mg/m2: Carfilzomib 20 mg/m2 on days -29, -28, -22, -21, -15, and -14 Bendamustine 120 mg/m2 on day -2 and 100 mg/m2 day -1 Melphalan 140 mg/m2 on day -1 Carfilzomib 27 mg/m2 on day -2, -1 and + 5
|
|---|---|---|---|---|
|
Absence of Dose Limiting Toxicity
|
3 Participants
|
1 Participants
|
3 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: Assessed daily (while inpatient) through clinical and laboratory examinations up to 90 days.Engraftment of Neutrophils: ANC recovery is defined as an absolute neutrophil count (ANC) of ≥ 0.5 x 109/L for three consecutive laboratory values obtained on different days. The day used as neutrophil engraftment is the date of the first of three laboratory values. Graft Failure: Graft failure includes failure to achieve neutrophil engraftment by day 22.
Outcome measures
| Measure |
Cohort 1: Carfilzomib 15 mg/m2
n=3 Participants
Carfilzomib 15 mg/m2 on days -2, -1, +5, and +6 IV over 10 minutes.
Cohort 1: Carfilzomib 15 mg/m2: Carfilzomib 20 mg/m2 on days -29, -28, -22, -21, -15, and -14 Bendamustine 120 mg/m2 on day -2 and 100 mg/m2 day -1 Melphalan 100 mg/m2 on day -2 and day -1 Carfilzomib 15 mg/m2 on day -2, -1, + 5 and +6
|
Cohort 2: Carfilzomib 20 mg/m2
n=3 Participants
Carfilzomib 20 mg/m2 on days -2, -1, +5, and +6 IV over 10 minutes.
Cohort 2: Carfilzomib 20 mg/m2: Carfilzomib 20 mg/m2 on days -29, -28, -22, -21, -15, and -14 Bendamustine 120 mg/m2 on day -2 and 100 mg/m2 day -1 Melphalan 100 mg/m2 on day -2 and day -1 Carfilzomib 20 mg/m2 on day -2, -1, + 5 and +6
|
Cohort 2b: Carfilzomib 20 mg/m2
n=3 Participants
Carfilzomib 20 mg/m2 on days -2, -1 and +5 IV over 10 minutes.
Cohort 2b: Carfilzomib 20 mg/m2: Carfilzomib 20 mg/m2 on days -29, -28, -22, -21, -15, and -14 Bendamustine 120 mg/m2 on day -2 and 100 mg/m2 day -1 Melphalan 140 mg/m2 on day -1 Carfilzomib 20 mg/m2 on day -2, -1 and + 5
|
Cohort 3: Carfilzomib 27mgm2
n=9 Participants
Carfilzomib 27 mg/m2 on days -2, -1 and +5 IV over 10 minutes.
Cohort 3b: Carfilzomib 27 mg/m2: Carfilzomib 20 mg/m2 on days -29, -28, -22, -21, -15, and -14 Bendamustine 120 mg/m2 on day -2 and 100 mg/m2 day -1 Melphalan 140 mg/m2 on day -1 Carfilzomib 27 mg/m2 on day -2, -1 and + 5
|
|---|---|---|---|---|
|
Neutrophil Engraftment
|
11.33 days
Standard Deviation 0.58
|
12.67 days
Standard Deviation 2.08
|
12 days
Standard Deviation 0
|
12.11 days
Standard Deviation 0.78
|
SECONDARY outcome
Timeframe: Assessed daily (while inpatient) through clinical and laboratory examinations up to 90 days.Engraftment of Platelets: Platelet engraftment is defined as a platelet count ≥ 20 x 109/L for 3 consecutive measurements obtained on different days. The patient must not have received a platelet infusion for seven consecutive days prior to the first day being considered. The day used as platelet engraftment is the date of the first of three laboratory values.
Outcome measures
| Measure |
Cohort 1: Carfilzomib 15 mg/m2
n=3 Participants
Carfilzomib 15 mg/m2 on days -2, -1, +5, and +6 IV over 10 minutes.
Cohort 1: Carfilzomib 15 mg/m2: Carfilzomib 20 mg/m2 on days -29, -28, -22, -21, -15, and -14 Bendamustine 120 mg/m2 on day -2 and 100 mg/m2 day -1 Melphalan 100 mg/m2 on day -2 and day -1 Carfilzomib 15 mg/m2 on day -2, -1, + 5 and +6
|
Cohort 2: Carfilzomib 20 mg/m2
n=2 Participants
Carfilzomib 20 mg/m2 on days -2, -1, +5, and +6 IV over 10 minutes.
Cohort 2: Carfilzomib 20 mg/m2: Carfilzomib 20 mg/m2 on days -29, -28, -22, -21, -15, and -14 Bendamustine 120 mg/m2 on day -2 and 100 mg/m2 day -1 Melphalan 100 mg/m2 on day -2 and day -1 Carfilzomib 20 mg/m2 on day -2, -1, + 5 and +6
|
Cohort 2b: Carfilzomib 20 mg/m2
n=3 Participants
Carfilzomib 20 mg/m2 on days -2, -1 and +5 IV over 10 minutes.
Cohort 2b: Carfilzomib 20 mg/m2: Carfilzomib 20 mg/m2 on days -29, -28, -22, -21, -15, and -14 Bendamustine 120 mg/m2 on day -2 and 100 mg/m2 day -1 Melphalan 140 mg/m2 on day -1 Carfilzomib 20 mg/m2 on day -2, -1 and + 5
|
Cohort 3: Carfilzomib 27mgm2
n=9 Participants
Carfilzomib 27 mg/m2 on days -2, -1 and +5 IV over 10 minutes.
Cohort 3b: Carfilzomib 27 mg/m2: Carfilzomib 20 mg/m2 on days -29, -28, -22, -21, -15, and -14 Bendamustine 120 mg/m2 on day -2 and 100 mg/m2 day -1 Melphalan 140 mg/m2 on day -1 Carfilzomib 27 mg/m2 on day -2, -1 and + 5
|
|---|---|---|---|---|
|
Platelet Engraftment
|
17 days
Standard Deviation 2.65
|
15.5 days
Standard Deviation 0.71
|
15.67 days
Standard Deviation 3.51
|
15.89 days
Standard Deviation 1.96
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Disease assessment at day +100, +180, and +365 (+/- 7 days).Find the response rate of the combination of melphalan, bendamustine, and carfilzomib as a conditioning regimen in patients with multiple myeloma undergoing autologous transplantation.
Outcome measures
| Measure |
Cohort 1: Carfilzomib 15 mg/m2
n=3 Participants
Carfilzomib 15 mg/m2 on days -2, -1, +5, and +6 IV over 10 minutes.
Cohort 1: Carfilzomib 15 mg/m2: Carfilzomib 20 mg/m2 on days -29, -28, -22, -21, -15, and -14 Bendamustine 120 mg/m2 on day -2 and 100 mg/m2 day -1 Melphalan 100 mg/m2 on day -2 and day -1 Carfilzomib 15 mg/m2 on day -2, -1, + 5 and +6
|
Cohort 2: Carfilzomib 20 mg/m2
n=2 Participants
Carfilzomib 20 mg/m2 on days -2, -1, +5, and +6 IV over 10 minutes.
Cohort 2: Carfilzomib 20 mg/m2: Carfilzomib 20 mg/m2 on days -29, -28, -22, -21, -15, and -14 Bendamustine 120 mg/m2 on day -2 and 100 mg/m2 day -1 Melphalan 100 mg/m2 on day -2 and day -1 Carfilzomib 20 mg/m2 on day -2, -1, + 5 and +6
|
Cohort 2b: Carfilzomib 20 mg/m2
n=3 Participants
Carfilzomib 20 mg/m2 on days -2, -1 and +5 IV over 10 minutes.
Cohort 2b: Carfilzomib 20 mg/m2: Carfilzomib 20 mg/m2 on days -29, -28, -22, -21, -15, and -14 Bendamustine 120 mg/m2 on day -2 and 100 mg/m2 day -1 Melphalan 140 mg/m2 on day -1 Carfilzomib 20 mg/m2 on day -2, -1 and + 5
|
Cohort 3: Carfilzomib 27mgm2
n=9 Participants
Carfilzomib 27 mg/m2 on days -2, -1 and +5 IV over 10 minutes.
Cohort 3b: Carfilzomib 27 mg/m2: Carfilzomib 20 mg/m2 on days -29, -28, -22, -21, -15, and -14 Bendamustine 120 mg/m2 on day -2 and 100 mg/m2 day -1 Melphalan 140 mg/m2 on day -1 Carfilzomib 27 mg/m2 on day -2, -1 and + 5
|
|---|---|---|---|---|
|
Response Rate
partial response
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
|
Response Rate
complete response
|
1 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
|
Response Rate
very good partial response
|
2 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Response Rate
progressive disease
|
0 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
Adverse Events
Cohort 1: Carfilzomib 15 mg/m2
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort 2: Carfilzomib 20 mg/m2
Serious events: 2 serious events
Other events: 3 other events
Deaths: 1 deaths
Cohort 2b: Carfilzomib 20 mg/m2
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort 3: Carfilzomib 27mgm2
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort 1: Carfilzomib 15 mg/m2
n=3 participants at risk
Carfilzomib 15 mg/m2 on days -2, -1, +5, and +6 IV over 10 minutes.
Cohort 1: Carfilzomib 15 mg/m2: Carfilzomib 20 mg/m2 on days -29, -28, -22, -21, -15, and -14 Bendamustine 120 mg/m2 on day -2 and 100 mg/m2 day -1 Melphalan 100 mg/m2 on day -2 and day -1 Carfilzomib 15 mg/m2 on day -2, -1, + 5 and +6
|
Cohort 2: Carfilzomib 20 mg/m2
n=3 participants at risk
Carfilzomib 20 mg/m2 on days -2, -1, +5, and +6 IV over 10 minutes.
Cohort 2: Carfilzomib 20 mg/m2: Carfilzomib 20 mg/m2 on days -29, -28, -22, -21, -15, and -14 Bendamustine 120 mg/m2 on day -2 and 100 mg/m2 day -1 Melphalan 100 mg/m2 on day -2 and day -1 Carfilzomib 20 mg/m2 on day -2, -1, + 5 and +6
|
Cohort 2b: Carfilzomib 20 mg/m2
n=3 participants at risk
Carfilzomib 20 mg/m2 on days -2, -1 and +5 IV over 10 minutes.
Cohort 2b: Carfilzomib 20 mg/m2: Carfilzomib 20 mg/m2 on days -29, -28, -22, -21, -15, and -14 Bendamustine 120 mg/m2 on day -2 and 100 mg/m2 day -1 Melphalan 140 mg/m2 on day -1 Carfilzomib 20 mg/m2 on day -2, -1 and + 5
|
Cohort 3: Carfilzomib 27mgm2
n=9 participants at risk
Carfilzomib 27 mg/m2 on days -2, -1 and +5 IV over 10 minutes.
Cohort 3b: Carfilzomib 27 mg/m2: Carfilzomib 20 mg/m2 on days -29, -28, -22, -21, -15, and -14 Bendamustine 120 mg/m2 on day -2 and 100 mg/m2 day -1 Melphalan 140 mg/m2 on day -1 Carfilzomib 27 mg/m2 on day -2, -1 and + 5
|
|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Distress
|
0.00%
0/3 • CBC, CMP, BUN, creatinine labs, and LFT were then measured at least weekly until day +100. Daily physical examination, including toxicity assessments were conducted until discharge and then weekly until day +100. Disease assessments were conducted at day +100, +180, and +365 (+/- 7 days).
CTCAE v4.0
|
33.3%
1/3 • Number of events 1 • CBC, CMP, BUN, creatinine labs, and LFT were then measured at least weekly until day +100. Daily physical examination, including toxicity assessments were conducted until discharge and then weekly until day +100. Disease assessments were conducted at day +100, +180, and +365 (+/- 7 days).
CTCAE v4.0
|
0.00%
0/3 • CBC, CMP, BUN, creatinine labs, and LFT were then measured at least weekly until day +100. Daily physical examination, including toxicity assessments were conducted until discharge and then weekly until day +100. Disease assessments were conducted at day +100, +180, and +365 (+/- 7 days).
CTCAE v4.0
|
0.00%
0/9 • CBC, CMP, BUN, creatinine labs, and LFT were then measured at least weekly until day +100. Daily physical examination, including toxicity assessments were conducted until discharge and then weekly until day +100. Disease assessments were conducted at day +100, +180, and +365 (+/- 7 days).
CTCAE v4.0
|
|
Infections and infestations
Septic Shock
|
0.00%
0/3 • CBC, CMP, BUN, creatinine labs, and LFT were then measured at least weekly until day +100. Daily physical examination, including toxicity assessments were conducted until discharge and then weekly until day +100. Disease assessments were conducted at day +100, +180, and +365 (+/- 7 days).
CTCAE v4.0
|
33.3%
1/3 • Number of events 1 • CBC, CMP, BUN, creatinine labs, and LFT were then measured at least weekly until day +100. Daily physical examination, including toxicity assessments were conducted until discharge and then weekly until day +100. Disease assessments were conducted at day +100, +180, and +365 (+/- 7 days).
CTCAE v4.0
|
0.00%
0/3 • CBC, CMP, BUN, creatinine labs, and LFT were then measured at least weekly until day +100. Daily physical examination, including toxicity assessments were conducted until discharge and then weekly until day +100. Disease assessments were conducted at day +100, +180, and +365 (+/- 7 days).
CTCAE v4.0
|
0.00%
0/9 • CBC, CMP, BUN, creatinine labs, and LFT were then measured at least weekly until day +100. Daily physical examination, including toxicity assessments were conducted until discharge and then weekly until day +100. Disease assessments were conducted at day +100, +180, and +365 (+/- 7 days).
CTCAE v4.0
|
Other adverse events
| Measure |
Cohort 1: Carfilzomib 15 mg/m2
n=3 participants at risk
Carfilzomib 15 mg/m2 on days -2, -1, +5, and +6 IV over 10 minutes.
Cohort 1: Carfilzomib 15 mg/m2: Carfilzomib 20 mg/m2 on days -29, -28, -22, -21, -15, and -14 Bendamustine 120 mg/m2 on day -2 and 100 mg/m2 day -1 Melphalan 100 mg/m2 on day -2 and day -1 Carfilzomib 15 mg/m2 on day -2, -1, + 5 and +6
|
Cohort 2: Carfilzomib 20 mg/m2
n=3 participants at risk
Carfilzomib 20 mg/m2 on days -2, -1, +5, and +6 IV over 10 minutes.
Cohort 2: Carfilzomib 20 mg/m2: Carfilzomib 20 mg/m2 on days -29, -28, -22, -21, -15, and -14 Bendamustine 120 mg/m2 on day -2 and 100 mg/m2 day -1 Melphalan 100 mg/m2 on day -2 and day -1 Carfilzomib 20 mg/m2 on day -2, -1, + 5 and +6
|
Cohort 2b: Carfilzomib 20 mg/m2
n=3 participants at risk
Carfilzomib 20 mg/m2 on days -2, -1 and +5 IV over 10 minutes.
Cohort 2b: Carfilzomib 20 mg/m2: Carfilzomib 20 mg/m2 on days -29, -28, -22, -21, -15, and -14 Bendamustine 120 mg/m2 on day -2 and 100 mg/m2 day -1 Melphalan 140 mg/m2 on day -1 Carfilzomib 20 mg/m2 on day -2, -1 and + 5
|
Cohort 3: Carfilzomib 27mgm2
n=9 participants at risk
Carfilzomib 27 mg/m2 on days -2, -1 and +5 IV over 10 minutes.
Cohort 3b: Carfilzomib 27 mg/m2: Carfilzomib 20 mg/m2 on days -29, -28, -22, -21, -15, and -14 Bendamustine 120 mg/m2 on day -2 and 100 mg/m2 day -1 Melphalan 140 mg/m2 on day -1 Carfilzomib 27 mg/m2 on day -2, -1 and + 5
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
66.7%
2/3 • Number of events 2 • CBC, CMP, BUN, creatinine labs, and LFT were then measured at least weekly until day +100. Daily physical examination, including toxicity assessments were conducted until discharge and then weekly until day +100. Disease assessments were conducted at day +100, +180, and +365 (+/- 7 days).
CTCAE v4.0
|
33.3%
1/3 • Number of events 1 • CBC, CMP, BUN, creatinine labs, and LFT were then measured at least weekly until day +100. Daily physical examination, including toxicity assessments were conducted until discharge and then weekly until day +100. Disease assessments were conducted at day +100, +180, and +365 (+/- 7 days).
CTCAE v4.0
|
66.7%
2/3 • Number of events 2 • CBC, CMP, BUN, creatinine labs, and LFT were then measured at least weekly until day +100. Daily physical examination, including toxicity assessments were conducted until discharge and then weekly until day +100. Disease assessments were conducted at day +100, +180, and +365 (+/- 7 days).
CTCAE v4.0
|
66.7%
6/9 • Number of events 6 • CBC, CMP, BUN, creatinine labs, and LFT were then measured at least weekly until day +100. Daily physical examination, including toxicity assessments were conducted until discharge and then weekly until day +100. Disease assessments were conducted at day +100, +180, and +365 (+/- 7 days).
CTCAE v4.0
|
|
Gastrointestinal disorders
Nausea
|
66.7%
2/3 • Number of events 2 • CBC, CMP, BUN, creatinine labs, and LFT were then measured at least weekly until day +100. Daily physical examination, including toxicity assessments were conducted until discharge and then weekly until day +100. Disease assessments were conducted at day +100, +180, and +365 (+/- 7 days).
CTCAE v4.0
|
66.7%
2/3 • Number of events 2 • CBC, CMP, BUN, creatinine labs, and LFT were then measured at least weekly until day +100. Daily physical examination, including toxicity assessments were conducted until discharge and then weekly until day +100. Disease assessments were conducted at day +100, +180, and +365 (+/- 7 days).
CTCAE v4.0
|
33.3%
1/3 • Number of events 1 • CBC, CMP, BUN, creatinine labs, and LFT were then measured at least weekly until day +100. Daily physical examination, including toxicity assessments were conducted until discharge and then weekly until day +100. Disease assessments were conducted at day +100, +180, and +365 (+/- 7 days).
CTCAE v4.0
|
0.00%
0/9 • CBC, CMP, BUN, creatinine labs, and LFT were then measured at least weekly until day +100. Daily physical examination, including toxicity assessments were conducted until discharge and then weekly until day +100. Disease assessments were conducted at day +100, +180, and +365 (+/- 7 days).
CTCAE v4.0
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
1/3 • Number of events 1 • CBC, CMP, BUN, creatinine labs, and LFT were then measured at least weekly until day +100. Daily physical examination, including toxicity assessments were conducted until discharge and then weekly until day +100. Disease assessments were conducted at day +100, +180, and +365 (+/- 7 days).
CTCAE v4.0
|
33.3%
1/3 • Number of events 1 • CBC, CMP, BUN, creatinine labs, and LFT were then measured at least weekly until day +100. Daily physical examination, including toxicity assessments were conducted until discharge and then weekly until day +100. Disease assessments were conducted at day +100, +180, and +365 (+/- 7 days).
CTCAE v4.0
|
33.3%
1/3 • Number of events 1 • CBC, CMP, BUN, creatinine labs, and LFT were then measured at least weekly until day +100. Daily physical examination, including toxicity assessments were conducted until discharge and then weekly until day +100. Disease assessments were conducted at day +100, +180, and +365 (+/- 7 days).
CTCAE v4.0
|
0.00%
0/9 • CBC, CMP, BUN, creatinine labs, and LFT were then measured at least weekly until day +100. Daily physical examination, including toxicity assessments were conducted until discharge and then weekly until day +100. Disease assessments were conducted at day +100, +180, and +365 (+/- 7 days).
CTCAE v4.0
|
|
Gastrointestinal disorders
dehydration
|
33.3%
1/3 • Number of events 1 • CBC, CMP, BUN, creatinine labs, and LFT were then measured at least weekly until day +100. Daily physical examination, including toxicity assessments were conducted until discharge and then weekly until day +100. Disease assessments were conducted at day +100, +180, and +365 (+/- 7 days).
CTCAE v4.0
|
0.00%
0/3 • CBC, CMP, BUN, creatinine labs, and LFT were then measured at least weekly until day +100. Daily physical examination, including toxicity assessments were conducted until discharge and then weekly until day +100. Disease assessments were conducted at day +100, +180, and +365 (+/- 7 days).
CTCAE v4.0
|
0.00%
0/3 • CBC, CMP, BUN, creatinine labs, and LFT were then measured at least weekly until day +100. Daily physical examination, including toxicity assessments were conducted until discharge and then weekly until day +100. Disease assessments were conducted at day +100, +180, and +365 (+/- 7 days).
CTCAE v4.0
|
0.00%
0/9 • CBC, CMP, BUN, creatinine labs, and LFT were then measured at least weekly until day +100. Daily physical examination, including toxicity assessments were conducted until discharge and then weekly until day +100. Disease assessments were conducted at day +100, +180, and +365 (+/- 7 days).
CTCAE v4.0
|
|
Gastrointestinal disorders
mucositis/esophagitis
|
66.7%
2/3 • Number of events 2 • CBC, CMP, BUN, creatinine labs, and LFT were then measured at least weekly until day +100. Daily physical examination, including toxicity assessments were conducted until discharge and then weekly until day +100. Disease assessments were conducted at day +100, +180, and +365 (+/- 7 days).
CTCAE v4.0
|
33.3%
1/3 • Number of events 1 • CBC, CMP, BUN, creatinine labs, and LFT were then measured at least weekly until day +100. Daily physical examination, including toxicity assessments were conducted until discharge and then weekly until day +100. Disease assessments were conducted at day +100, +180, and +365 (+/- 7 days).
CTCAE v4.0
|
33.3%
1/3 • Number of events 1 • CBC, CMP, BUN, creatinine labs, and LFT were then measured at least weekly until day +100. Daily physical examination, including toxicity assessments were conducted until discharge and then weekly until day +100. Disease assessments were conducted at day +100, +180, and +365 (+/- 7 days).
CTCAE v4.0
|
0.00%
0/9 • CBC, CMP, BUN, creatinine labs, and LFT were then measured at least weekly until day +100. Daily physical examination, including toxicity assessments were conducted until discharge and then weekly until day +100. Disease assessments were conducted at day +100, +180, and +365 (+/- 7 days).
CTCAE v4.0
|
|
Gastrointestinal disorders
enteritis
|
0.00%
0/3 • CBC, CMP, BUN, creatinine labs, and LFT were then measured at least weekly until day +100. Daily physical examination, including toxicity assessments were conducted until discharge and then weekly until day +100. Disease assessments were conducted at day +100, +180, and +365 (+/- 7 days).
CTCAE v4.0
|
33.3%
1/3 • Number of events 1 • CBC, CMP, BUN, creatinine labs, and LFT were then measured at least weekly until day +100. Daily physical examination, including toxicity assessments were conducted until discharge and then weekly until day +100. Disease assessments were conducted at day +100, +180, and +365 (+/- 7 days).
CTCAE v4.0
|
0.00%
0/3 • CBC, CMP, BUN, creatinine labs, and LFT were then measured at least weekly until day +100. Daily physical examination, including toxicity assessments were conducted until discharge and then weekly until day +100. Disease assessments were conducted at day +100, +180, and +365 (+/- 7 days).
CTCAE v4.0
|
11.1%
1/9 • Number of events 1 • CBC, CMP, BUN, creatinine labs, and LFT were then measured at least weekly until day +100. Daily physical examination, including toxicity assessments were conducted until discharge and then weekly until day +100. Disease assessments were conducted at day +100, +180, and +365 (+/- 7 days).
CTCAE v4.0
|
|
Gastrointestinal disorders
small bowel obstruction
|
0.00%
0/3 • CBC, CMP, BUN, creatinine labs, and LFT were then measured at least weekly until day +100. Daily physical examination, including toxicity assessments were conducted until discharge and then weekly until day +100. Disease assessments were conducted at day +100, +180, and +365 (+/- 7 days).
CTCAE v4.0
|
33.3%
1/3 • Number of events 1 • CBC, CMP, BUN, creatinine labs, and LFT were then measured at least weekly until day +100. Daily physical examination, including toxicity assessments were conducted until discharge and then weekly until day +100. Disease assessments were conducted at day +100, +180, and +365 (+/- 7 days).
CTCAE v4.0
|
0.00%
0/3 • CBC, CMP, BUN, creatinine labs, and LFT were then measured at least weekly until day +100. Daily physical examination, including toxicity assessments were conducted until discharge and then weekly until day +100. Disease assessments were conducted at day +100, +180, and +365 (+/- 7 days).
CTCAE v4.0
|
0.00%
0/9 • CBC, CMP, BUN, creatinine labs, and LFT were then measured at least weekly until day +100. Daily physical examination, including toxicity assessments were conducted until discharge and then weekly until day +100. Disease assessments were conducted at day +100, +180, and +365 (+/- 7 days).
CTCAE v4.0
|
|
Gastrointestinal disorders
partial ileus
|
0.00%
0/3 • CBC, CMP, BUN, creatinine labs, and LFT were then measured at least weekly until day +100. Daily physical examination, including toxicity assessments were conducted until discharge and then weekly until day +100. Disease assessments were conducted at day +100, +180, and +365 (+/- 7 days).
CTCAE v4.0
|
0.00%
0/3 • CBC, CMP, BUN, creatinine labs, and LFT were then measured at least weekly until day +100. Daily physical examination, including toxicity assessments were conducted until discharge and then weekly until day +100. Disease assessments were conducted at day +100, +180, and +365 (+/- 7 days).
CTCAE v4.0
|
33.3%
1/3 • Number of events 1 • CBC, CMP, BUN, creatinine labs, and LFT were then measured at least weekly until day +100. Daily physical examination, including toxicity assessments were conducted until discharge and then weekly until day +100. Disease assessments were conducted at day +100, +180, and +365 (+/- 7 days).
CTCAE v4.0
|
0.00%
0/9 • CBC, CMP, BUN, creatinine labs, and LFT were then measured at least weekly until day +100. Daily physical examination, including toxicity assessments were conducted until discharge and then weekly until day +100. Disease assessments were conducted at day +100, +180, and +365 (+/- 7 days).
CTCAE v4.0
|
|
Gastrointestinal disorders
hematochezia
|
0.00%
0/3 • CBC, CMP, BUN, creatinine labs, and LFT were then measured at least weekly until day +100. Daily physical examination, including toxicity assessments were conducted until discharge and then weekly until day +100. Disease assessments were conducted at day +100, +180, and +365 (+/- 7 days).
CTCAE v4.0
|
0.00%
0/3 • CBC, CMP, BUN, creatinine labs, and LFT were then measured at least weekly until day +100. Daily physical examination, including toxicity assessments were conducted until discharge and then weekly until day +100. Disease assessments were conducted at day +100, +180, and +365 (+/- 7 days).
CTCAE v4.0
|
0.00%
0/3 • CBC, CMP, BUN, creatinine labs, and LFT were then measured at least weekly until day +100. Daily physical examination, including toxicity assessments were conducted until discharge and then weekly until day +100. Disease assessments were conducted at day +100, +180, and +365 (+/- 7 days).
CTCAE v4.0
|
11.1%
1/9 • Number of events 1 • CBC, CMP, BUN, creatinine labs, and LFT were then measured at least weekly until day +100. Daily physical examination, including toxicity assessments were conducted until discharge and then weekly until day +100. Disease assessments were conducted at day +100, +180, and +365 (+/- 7 days).
CTCAE v4.0
|
|
Gastrointestinal disorders
hemorrhoids
|
0.00%
0/3 • CBC, CMP, BUN, creatinine labs, and LFT were then measured at least weekly until day +100. Daily physical examination, including toxicity assessments were conducted until discharge and then weekly until day +100. Disease assessments were conducted at day +100, +180, and +365 (+/- 7 days).
CTCAE v4.0
|
0.00%
0/3 • CBC, CMP, BUN, creatinine labs, and LFT were then measured at least weekly until day +100. Daily physical examination, including toxicity assessments were conducted until discharge and then weekly until day +100. Disease assessments were conducted at day +100, +180, and +365 (+/- 7 days).
CTCAE v4.0
|
0.00%
0/3 • CBC, CMP, BUN, creatinine labs, and LFT were then measured at least weekly until day +100. Daily physical examination, including toxicity assessments were conducted until discharge and then weekly until day +100. Disease assessments were conducted at day +100, +180, and +365 (+/- 7 days).
CTCAE v4.0
|
11.1%
1/9 • Number of events 1 • CBC, CMP, BUN, creatinine labs, and LFT were then measured at least weekly until day +100. Daily physical examination, including toxicity assessments were conducted until discharge and then weekly until day +100. Disease assessments were conducted at day +100, +180, and +365 (+/- 7 days).
CTCAE v4.0
|
|
Investigations
hypophosphatemia
|
100.0%
3/3 • Number of events 3 • CBC, CMP, BUN, creatinine labs, and LFT were then measured at least weekly until day +100. Daily physical examination, including toxicity assessments were conducted until discharge and then weekly until day +100. Disease assessments were conducted at day +100, +180, and +365 (+/- 7 days).
CTCAE v4.0
|
66.7%
2/3 • Number of events 2 • CBC, CMP, BUN, creatinine labs, and LFT were then measured at least weekly until day +100. Daily physical examination, including toxicity assessments were conducted until discharge and then weekly until day +100. Disease assessments were conducted at day +100, +180, and +365 (+/- 7 days).
CTCAE v4.0
|
100.0%
3/3 • Number of events 3 • CBC, CMP, BUN, creatinine labs, and LFT were then measured at least weekly until day +100. Daily physical examination, including toxicity assessments were conducted until discharge and then weekly until day +100. Disease assessments were conducted at day +100, +180, and +365 (+/- 7 days).
CTCAE v4.0
|
0.00%
0/9 • CBC, CMP, BUN, creatinine labs, and LFT were then measured at least weekly until day +100. Daily physical examination, including toxicity assessments were conducted until discharge and then weekly until day +100. Disease assessments were conducted at day +100, +180, and +365 (+/- 7 days).
CTCAE v4.0
|
|
Investigations
hypocalcemia
|
0.00%
0/3 • CBC, CMP, BUN, creatinine labs, and LFT were then measured at least weekly until day +100. Daily physical examination, including toxicity assessments were conducted until discharge and then weekly until day +100. Disease assessments were conducted at day +100, +180, and +365 (+/- 7 days).
CTCAE v4.0
|
66.7%
2/3 • Number of events 2 • CBC, CMP, BUN, creatinine labs, and LFT were then measured at least weekly until day +100. Daily physical examination, including toxicity assessments were conducted until discharge and then weekly until day +100. Disease assessments were conducted at day +100, +180, and +365 (+/- 7 days).
CTCAE v4.0
|
0.00%
0/3 • CBC, CMP, BUN, creatinine labs, and LFT were then measured at least weekly until day +100. Daily physical examination, including toxicity assessments were conducted until discharge and then weekly until day +100. Disease assessments were conducted at day +100, +180, and +365 (+/- 7 days).
CTCAE v4.0
|
0.00%
0/9 • CBC, CMP, BUN, creatinine labs, and LFT were then measured at least weekly until day +100. Daily physical examination, including toxicity assessments were conducted until discharge and then weekly until day +100. Disease assessments were conducted at day +100, +180, and +365 (+/- 7 days).
CTCAE v4.0
|
|
Investigations
hypokalemia
|
0.00%
0/3 • CBC, CMP, BUN, creatinine labs, and LFT were then measured at least weekly until day +100. Daily physical examination, including toxicity assessments were conducted until discharge and then weekly until day +100. Disease assessments were conducted at day +100, +180, and +365 (+/- 7 days).
CTCAE v4.0
|
33.3%
1/3 • Number of events 1 • CBC, CMP, BUN, creatinine labs, and LFT were then measured at least weekly until day +100. Daily physical examination, including toxicity assessments were conducted until discharge and then weekly until day +100. Disease assessments were conducted at day +100, +180, and +365 (+/- 7 days).
CTCAE v4.0
|
33.3%
1/3 • Number of events 1 • CBC, CMP, BUN, creatinine labs, and LFT were then measured at least weekly until day +100. Daily physical examination, including toxicity assessments were conducted until discharge and then weekly until day +100. Disease assessments were conducted at day +100, +180, and +365 (+/- 7 days).
CTCAE v4.0
|
22.2%
2/9 • Number of events 2 • CBC, CMP, BUN, creatinine labs, and LFT were then measured at least weekly until day +100. Daily physical examination, including toxicity assessments were conducted until discharge and then weekly until day +100. Disease assessments were conducted at day +100, +180, and +365 (+/- 7 days).
CTCAE v4.0
|
|
Investigations
hypermagnesemia
|
0.00%
0/3 • CBC, CMP, BUN, creatinine labs, and LFT were then measured at least weekly until day +100. Daily physical examination, including toxicity assessments were conducted until discharge and then weekly until day +100. Disease assessments were conducted at day +100, +180, and +365 (+/- 7 days).
CTCAE v4.0
|
33.3%
1/3 • Number of events 1 • CBC, CMP, BUN, creatinine labs, and LFT were then measured at least weekly until day +100. Daily physical examination, including toxicity assessments were conducted until discharge and then weekly until day +100. Disease assessments were conducted at day +100, +180, and +365 (+/- 7 days).
CTCAE v4.0
|
0.00%
0/3 • CBC, CMP, BUN, creatinine labs, and LFT were then measured at least weekly until day +100. Daily physical examination, including toxicity assessments were conducted until discharge and then weekly until day +100. Disease assessments were conducted at day +100, +180, and +365 (+/- 7 days).
CTCAE v4.0
|
0.00%
0/9 • CBC, CMP, BUN, creatinine labs, and LFT were then measured at least weekly until day +100. Daily physical examination, including toxicity assessments were conducted until discharge and then weekly until day +100. Disease assessments were conducted at day +100, +180, and +365 (+/- 7 days).
CTCAE v4.0
|
|
Investigations
elevated ALT
|
0.00%
0/3 • CBC, CMP, BUN, creatinine labs, and LFT were then measured at least weekly until day +100. Daily physical examination, including toxicity assessments were conducted until discharge and then weekly until day +100. Disease assessments were conducted at day +100, +180, and +365 (+/- 7 days).
CTCAE v4.0
|
33.3%
1/3 • Number of events 1 • CBC, CMP, BUN, creatinine labs, and LFT were then measured at least weekly until day +100. Daily physical examination, including toxicity assessments were conducted until discharge and then weekly until day +100. Disease assessments were conducted at day +100, +180, and +365 (+/- 7 days).
CTCAE v4.0
|
33.3%
1/3 • Number of events 1 • CBC, CMP, BUN, creatinine labs, and LFT were then measured at least weekly until day +100. Daily physical examination, including toxicity assessments were conducted until discharge and then weekly until day +100. Disease assessments were conducted at day +100, +180, and +365 (+/- 7 days).
CTCAE v4.0
|
0.00%
0/9 • CBC, CMP, BUN, creatinine labs, and LFT were then measured at least weekly until day +100. Daily physical examination, including toxicity assessments were conducted until discharge and then weekly until day +100. Disease assessments were conducted at day +100, +180, and +365 (+/- 7 days).
CTCAE v4.0
|
|
Investigations
elevated AST
|
0.00%
0/3 • CBC, CMP, BUN, creatinine labs, and LFT were then measured at least weekly until day +100. Daily physical examination, including toxicity assessments were conducted until discharge and then weekly until day +100. Disease assessments were conducted at day +100, +180, and +365 (+/- 7 days).
CTCAE v4.0
|
33.3%
1/3 • Number of events 1 • CBC, CMP, BUN, creatinine labs, and LFT were then measured at least weekly until day +100. Daily physical examination, including toxicity assessments were conducted until discharge and then weekly until day +100. Disease assessments were conducted at day +100, +180, and +365 (+/- 7 days).
CTCAE v4.0
|
33.3%
1/3 • Number of events 1 • CBC, CMP, BUN, creatinine labs, and LFT were then measured at least weekly until day +100. Daily physical examination, including toxicity assessments were conducted until discharge and then weekly until day +100. Disease assessments were conducted at day +100, +180, and +365 (+/- 7 days).
CTCAE v4.0
|
0.00%
0/9 • CBC, CMP, BUN, creatinine labs, and LFT were then measured at least weekly until day +100. Daily physical examination, including toxicity assessments were conducted until discharge and then weekly until day +100. Disease assessments were conducted at day +100, +180, and +365 (+/- 7 days).
CTCAE v4.0
|
|
Investigations
elevated serum creatinine
|
0.00%
0/3 • CBC, CMP, BUN, creatinine labs, and LFT were then measured at least weekly until day +100. Daily physical examination, including toxicity assessments were conducted until discharge and then weekly until day +100. Disease assessments were conducted at day +100, +180, and +365 (+/- 7 days).
CTCAE v4.0
|
66.7%
2/3 • Number of events 2 • CBC, CMP, BUN, creatinine labs, and LFT were then measured at least weekly until day +100. Daily physical examination, including toxicity assessments were conducted until discharge and then weekly until day +100. Disease assessments were conducted at day +100, +180, and +365 (+/- 7 days).
CTCAE v4.0
|
33.3%
1/3 • Number of events 1 • CBC, CMP, BUN, creatinine labs, and LFT were then measured at least weekly until day +100. Daily physical examination, including toxicity assessments were conducted until discharge and then weekly until day +100. Disease assessments were conducted at day +100, +180, and +365 (+/- 7 days).
CTCAE v4.0
|
22.2%
2/9 • Number of events 2 • CBC, CMP, BUN, creatinine labs, and LFT were then measured at least weekly until day +100. Daily physical examination, including toxicity assessments were conducted until discharge and then weekly until day +100. Disease assessments were conducted at day +100, +180, and +365 (+/- 7 days).
CTCAE v4.0
|
|
Investigations
elevated bilirubin
|
0.00%
0/3 • CBC, CMP, BUN, creatinine labs, and LFT were then measured at least weekly until day +100. Daily physical examination, including toxicity assessments were conducted until discharge and then weekly until day +100. Disease assessments were conducted at day +100, +180, and +365 (+/- 7 days).
CTCAE v4.0
|
0.00%
0/3 • CBC, CMP, BUN, creatinine labs, and LFT were then measured at least weekly until day +100. Daily physical examination, including toxicity assessments were conducted until discharge and then weekly until day +100. Disease assessments were conducted at day +100, +180, and +365 (+/- 7 days).
CTCAE v4.0
|
33.3%
1/3 • Number of events 1 • CBC, CMP, BUN, creatinine labs, and LFT were then measured at least weekly until day +100. Daily physical examination, including toxicity assessments were conducted until discharge and then weekly until day +100. Disease assessments were conducted at day +100, +180, and +365 (+/- 7 days).
CTCAE v4.0
|
0.00%
0/9 • CBC, CMP, BUN, creatinine labs, and LFT were then measured at least weekly until day +100. Daily physical examination, including toxicity assessments were conducted until discharge and then weekly until day +100. Disease assessments were conducted at day +100, +180, and +365 (+/- 7 days).
CTCAE v4.0
|
|
Investigations
elevated alkaline phosphatase
|
0.00%
0/3 • CBC, CMP, BUN, creatinine labs, and LFT were then measured at least weekly until day +100. Daily physical examination, including toxicity assessments were conducted until discharge and then weekly until day +100. Disease assessments were conducted at day +100, +180, and +365 (+/- 7 days).
CTCAE v4.0
|
0.00%
0/3 • CBC, CMP, BUN, creatinine labs, and LFT were then measured at least weekly until day +100. Daily physical examination, including toxicity assessments were conducted until discharge and then weekly until day +100. Disease assessments were conducted at day +100, +180, and +365 (+/- 7 days).
CTCAE v4.0
|
33.3%
1/3 • Number of events 1 • CBC, CMP, BUN, creatinine labs, and LFT were then measured at least weekly until day +100. Daily physical examination, including toxicity assessments were conducted until discharge and then weekly until day +100. Disease assessments were conducted at day +100, +180, and +365 (+/- 7 days).
CTCAE v4.0
|
0.00%
0/9 • CBC, CMP, BUN, creatinine labs, and LFT were then measured at least weekly until day +100. Daily physical examination, including toxicity assessments were conducted until discharge and then weekly until day +100. Disease assessments were conducted at day +100, +180, and +365 (+/- 7 days).
CTCAE v4.0
|
|
Infections and infestations
febrile neutropenia
|
66.7%
2/3 • Number of events 2 • CBC, CMP, BUN, creatinine labs, and LFT were then measured at least weekly until day +100. Daily physical examination, including toxicity assessments were conducted until discharge and then weekly until day +100. Disease assessments were conducted at day +100, +180, and +365 (+/- 7 days).
CTCAE v4.0
|
66.7%
2/3 • Number of events 2 • CBC, CMP, BUN, creatinine labs, and LFT were then measured at least weekly until day +100. Daily physical examination, including toxicity assessments were conducted until discharge and then weekly until day +100. Disease assessments were conducted at day +100, +180, and +365 (+/- 7 days).
CTCAE v4.0
|
33.3%
1/3 • Number of events 1 • CBC, CMP, BUN, creatinine labs, and LFT were then measured at least weekly until day +100. Daily physical examination, including toxicity assessments were conducted until discharge and then weekly until day +100. Disease assessments were conducted at day +100, +180, and +365 (+/- 7 days).
CTCAE v4.0
|
44.4%
4/9 • Number of events 4 • CBC, CMP, BUN, creatinine labs, and LFT were then measured at least weekly until day +100. Daily physical examination, including toxicity assessments were conducted until discharge and then weekly until day +100. Disease assessments were conducted at day +100, +180, and +365 (+/- 7 days).
CTCAE v4.0
|
|
Infections and infestations
pneumonia
|
0.00%
0/3 • CBC, CMP, BUN, creatinine labs, and LFT were then measured at least weekly until day +100. Daily physical examination, including toxicity assessments were conducted until discharge and then weekly until day +100. Disease assessments were conducted at day +100, +180, and +365 (+/- 7 days).
CTCAE v4.0
|
33.3%
1/3 • Number of events 1 • CBC, CMP, BUN, creatinine labs, and LFT were then measured at least weekly until day +100. Daily physical examination, including toxicity assessments were conducted until discharge and then weekly until day +100. Disease assessments were conducted at day +100, +180, and +365 (+/- 7 days).
CTCAE v4.0
|
0.00%
0/3 • CBC, CMP, BUN, creatinine labs, and LFT were then measured at least weekly until day +100. Daily physical examination, including toxicity assessments were conducted until discharge and then weekly until day +100. Disease assessments were conducted at day +100, +180, and +365 (+/- 7 days).
CTCAE v4.0
|
0.00%
0/9 • CBC, CMP, BUN, creatinine labs, and LFT were then measured at least weekly until day +100. Daily physical examination, including toxicity assessments were conducted until discharge and then weekly until day +100. Disease assessments were conducted at day +100, +180, and +365 (+/- 7 days).
CTCAE v4.0
|
|
Infections and infestations
fever of unknown origin
|
0.00%
0/3 • CBC, CMP, BUN, creatinine labs, and LFT were then measured at least weekly until day +100. Daily physical examination, including toxicity assessments were conducted until discharge and then weekly until day +100. Disease assessments were conducted at day +100, +180, and +365 (+/- 7 days).
CTCAE v4.0
|
33.3%
1/3 • Number of events 1 • CBC, CMP, BUN, creatinine labs, and LFT were then measured at least weekly until day +100. Daily physical examination, including toxicity assessments were conducted until discharge and then weekly until day +100. Disease assessments were conducted at day +100, +180, and +365 (+/- 7 days).
CTCAE v4.0
|
0.00%
0/3 • CBC, CMP, BUN, creatinine labs, and LFT were then measured at least weekly until day +100. Daily physical examination, including toxicity assessments were conducted until discharge and then weekly until day +100. Disease assessments were conducted at day +100, +180, and +365 (+/- 7 days).
CTCAE v4.0
|
0.00%
0/9 • CBC, CMP, BUN, creatinine labs, and LFT were then measured at least weekly until day +100. Daily physical examination, including toxicity assessments were conducted until discharge and then weekly until day +100. Disease assessments were conducted at day +100, +180, and +365 (+/- 7 days).
CTCAE v4.0
|
|
Infections and infestations
typhlitis
|
0.00%
0/3 • CBC, CMP, BUN, creatinine labs, and LFT were then measured at least weekly until day +100. Daily physical examination, including toxicity assessments were conducted until discharge and then weekly until day +100. Disease assessments were conducted at day +100, +180, and +365 (+/- 7 days).
CTCAE v4.0
|
0.00%
0/3 • CBC, CMP, BUN, creatinine labs, and LFT were then measured at least weekly until day +100. Daily physical examination, including toxicity assessments were conducted until discharge and then weekly until day +100. Disease assessments were conducted at day +100, +180, and +365 (+/- 7 days).
CTCAE v4.0
|
33.3%
1/3 • Number of events 1 • CBC, CMP, BUN, creatinine labs, and LFT were then measured at least weekly until day +100. Daily physical examination, including toxicity assessments were conducted until discharge and then weekly until day +100. Disease assessments were conducted at day +100, +180, and +365 (+/- 7 days).
CTCAE v4.0
|
0.00%
0/9 • CBC, CMP, BUN, creatinine labs, and LFT were then measured at least weekly until day +100. Daily physical examination, including toxicity assessments were conducted until discharge and then weekly until day +100. Disease assessments were conducted at day +100, +180, and +365 (+/- 7 days).
CTCAE v4.0
|
|
Infections and infestations
bacteremia
|
0.00%
0/3 • CBC, CMP, BUN, creatinine labs, and LFT were then measured at least weekly until day +100. Daily physical examination, including toxicity assessments were conducted until discharge and then weekly until day +100. Disease assessments were conducted at day +100, +180, and +365 (+/- 7 days).
CTCAE v4.0
|
0.00%
0/3 • CBC, CMP, BUN, creatinine labs, and LFT were then measured at least weekly until day +100. Daily physical examination, including toxicity assessments were conducted until discharge and then weekly until day +100. Disease assessments were conducted at day +100, +180, and +365 (+/- 7 days).
CTCAE v4.0
|
0.00%
0/3 • CBC, CMP, BUN, creatinine labs, and LFT were then measured at least weekly until day +100. Daily physical examination, including toxicity assessments were conducted until discharge and then weekly until day +100. Disease assessments were conducted at day +100, +180, and +365 (+/- 7 days).
CTCAE v4.0
|
11.1%
1/9 • Number of events 1 • CBC, CMP, BUN, creatinine labs, and LFT were then measured at least weekly until day +100. Daily physical examination, including toxicity assessments were conducted until discharge and then weekly until day +100. Disease assessments were conducted at day +100, +180, and +365 (+/- 7 days).
CTCAE v4.0
|
|
Cardiac disorders
elevated troponin T
|
0.00%
0/3 • CBC, CMP, BUN, creatinine labs, and LFT were then measured at least weekly until day +100. Daily physical examination, including toxicity assessments were conducted until discharge and then weekly until day +100. Disease assessments were conducted at day +100, +180, and +365 (+/- 7 days).
CTCAE v4.0
|
33.3%
1/3 • Number of events 1 • CBC, CMP, BUN, creatinine labs, and LFT were then measured at least weekly until day +100. Daily physical examination, including toxicity assessments were conducted until discharge and then weekly until day +100. Disease assessments were conducted at day +100, +180, and +365 (+/- 7 days).
CTCAE v4.0
|
0.00%
0/3 • CBC, CMP, BUN, creatinine labs, and LFT were then measured at least weekly until day +100. Daily physical examination, including toxicity assessments were conducted until discharge and then weekly until day +100. Disease assessments were conducted at day +100, +180, and +365 (+/- 7 days).
CTCAE v4.0
|
11.1%
1/9 • Number of events 1 • CBC, CMP, BUN, creatinine labs, and LFT were then measured at least weekly until day +100. Daily physical examination, including toxicity assessments were conducted until discharge and then weekly until day +100. Disease assessments were conducted at day +100, +180, and +365 (+/- 7 days).
CTCAE v4.0
|
|
Cardiac disorders
hypotension
|
0.00%
0/3 • CBC, CMP, BUN, creatinine labs, and LFT were then measured at least weekly until day +100. Daily physical examination, including toxicity assessments were conducted until discharge and then weekly until day +100. Disease assessments were conducted at day +100, +180, and +365 (+/- 7 days).
CTCAE v4.0
|
33.3%
1/3 • Number of events 1 • CBC, CMP, BUN, creatinine labs, and LFT were then measured at least weekly until day +100. Daily physical examination, including toxicity assessments were conducted until discharge and then weekly until day +100. Disease assessments were conducted at day +100, +180, and +365 (+/- 7 days).
CTCAE v4.0
|
33.3%
1/3 • Number of events 1 • CBC, CMP, BUN, creatinine labs, and LFT were then measured at least weekly until day +100. Daily physical examination, including toxicity assessments were conducted until discharge and then weekly until day +100. Disease assessments were conducted at day +100, +180, and +365 (+/- 7 days).
CTCAE v4.0
|
0.00%
0/9 • CBC, CMP, BUN, creatinine labs, and LFT were then measured at least weekly until day +100. Daily physical examination, including toxicity assessments were conducted until discharge and then weekly until day +100. Disease assessments were conducted at day +100, +180, and +365 (+/- 7 days).
CTCAE v4.0
|
|
Cardiac disorders
LV systolic dysfunction
|
0.00%
0/3 • CBC, CMP, BUN, creatinine labs, and LFT were then measured at least weekly until day +100. Daily physical examination, including toxicity assessments were conducted until discharge and then weekly until day +100. Disease assessments were conducted at day +100, +180, and +365 (+/- 7 days).
CTCAE v4.0
|
33.3%
1/3 • Number of events 1 • CBC, CMP, BUN, creatinine labs, and LFT were then measured at least weekly until day +100. Daily physical examination, including toxicity assessments were conducted until discharge and then weekly until day +100. Disease assessments were conducted at day +100, +180, and +365 (+/- 7 days).
CTCAE v4.0
|
0.00%
0/3 • CBC, CMP, BUN, creatinine labs, and LFT were then measured at least weekly until day +100. Daily physical examination, including toxicity assessments were conducted until discharge and then weekly until day +100. Disease assessments were conducted at day +100, +180, and +365 (+/- 7 days).
CTCAE v4.0
|
0.00%
0/9 • CBC, CMP, BUN, creatinine labs, and LFT were then measured at least weekly until day +100. Daily physical examination, including toxicity assessments were conducted until discharge and then weekly until day +100. Disease assessments were conducted at day +100, +180, and +365 (+/- 7 days).
CTCAE v4.0
|
|
Cardiac disorders
arrhythmia--a fib
|
0.00%
0/3 • CBC, CMP, BUN, creatinine labs, and LFT were then measured at least weekly until day +100. Daily physical examination, including toxicity assessments were conducted until discharge and then weekly until day +100. Disease assessments were conducted at day +100, +180, and +365 (+/- 7 days).
CTCAE v4.0
|
33.3%
1/3 • Number of events 1 • CBC, CMP, BUN, creatinine labs, and LFT were then measured at least weekly until day +100. Daily physical examination, including toxicity assessments were conducted until discharge and then weekly until day +100. Disease assessments were conducted at day +100, +180, and +365 (+/- 7 days).
CTCAE v4.0
|
0.00%
0/3 • CBC, CMP, BUN, creatinine labs, and LFT were then measured at least weekly until day +100. Daily physical examination, including toxicity assessments were conducted until discharge and then weekly until day +100. Disease assessments were conducted at day +100, +180, and +365 (+/- 7 days).
CTCAE v4.0
|
11.1%
1/9 • Number of events 1 • CBC, CMP, BUN, creatinine labs, and LFT were then measured at least weekly until day +100. Daily physical examination, including toxicity assessments were conducted until discharge and then weekly until day +100. Disease assessments were conducted at day +100, +180, and +365 (+/- 7 days).
CTCAE v4.0
|
|
Cardiac disorders
edema
|
0.00%
0/3 • CBC, CMP, BUN, creatinine labs, and LFT were then measured at least weekly until day +100. Daily physical examination, including toxicity assessments were conducted until discharge and then weekly until day +100. Disease assessments were conducted at day +100, +180, and +365 (+/- 7 days).
CTCAE v4.0
|
0.00%
0/3 • CBC, CMP, BUN, creatinine labs, and LFT were then measured at least weekly until day +100. Daily physical examination, including toxicity assessments were conducted until discharge and then weekly until day +100. Disease assessments were conducted at day +100, +180, and +365 (+/- 7 days).
CTCAE v4.0
|
66.7%
2/3 • Number of events 2 • CBC, CMP, BUN, creatinine labs, and LFT were then measured at least weekly until day +100. Daily physical examination, including toxicity assessments were conducted until discharge and then weekly until day +100. Disease assessments were conducted at day +100, +180, and +365 (+/- 7 days).
CTCAE v4.0
|
0.00%
0/9 • CBC, CMP, BUN, creatinine labs, and LFT were then measured at least weekly until day +100. Daily physical examination, including toxicity assessments were conducted until discharge and then weekly until day +100. Disease assessments were conducted at day +100, +180, and +365 (+/- 7 days).
CTCAE v4.0
|
|
Cardiac disorders
decreased EF
|
0.00%
0/3 • CBC, CMP, BUN, creatinine labs, and LFT were then measured at least weekly until day +100. Daily physical examination, including toxicity assessments were conducted until discharge and then weekly until day +100. Disease assessments were conducted at day +100, +180, and +365 (+/- 7 days).
CTCAE v4.0
|
0.00%
0/3 • CBC, CMP, BUN, creatinine labs, and LFT were then measured at least weekly until day +100. Daily physical examination, including toxicity assessments were conducted until discharge and then weekly until day +100. Disease assessments were conducted at day +100, +180, and +365 (+/- 7 days).
CTCAE v4.0
|
33.3%
1/3 • Number of events 1 • CBC, CMP, BUN, creatinine labs, and LFT were then measured at least weekly until day +100. Daily physical examination, including toxicity assessments were conducted until discharge and then weekly until day +100. Disease assessments were conducted at day +100, +180, and +365 (+/- 7 days).
CTCAE v4.0
|
0.00%
0/9 • CBC, CMP, BUN, creatinine labs, and LFT were then measured at least weekly until day +100. Daily physical examination, including toxicity assessments were conducted until discharge and then weekly until day +100. Disease assessments were conducted at day +100, +180, and +365 (+/- 7 days).
CTCAE v4.0
|
|
Cardiac disorders
AV block
|
0.00%
0/3 • CBC, CMP, BUN, creatinine labs, and LFT were then measured at least weekly until day +100. Daily physical examination, including toxicity assessments were conducted until discharge and then weekly until day +100. Disease assessments were conducted at day +100, +180, and +365 (+/- 7 days).
CTCAE v4.0
|
0.00%
0/3 • CBC, CMP, BUN, creatinine labs, and LFT were then measured at least weekly until day +100. Daily physical examination, including toxicity assessments were conducted until discharge and then weekly until day +100. Disease assessments were conducted at day +100, +180, and +365 (+/- 7 days).
CTCAE v4.0
|
0.00%
0/3 • CBC, CMP, BUN, creatinine labs, and LFT were then measured at least weekly until day +100. Daily physical examination, including toxicity assessments were conducted until discharge and then weekly until day +100. Disease assessments were conducted at day +100, +180, and +365 (+/- 7 days).
CTCAE v4.0
|
11.1%
1/9 • Number of events 1 • CBC, CMP, BUN, creatinine labs, and LFT were then measured at least weekly until day +100. Daily physical examination, including toxicity assessments were conducted until discharge and then weekly until day +100. Disease assessments were conducted at day +100, +180, and +365 (+/- 7 days).
CTCAE v4.0
|
|
Cardiac disorders
prolonged QTc interval
|
0.00%
0/3 • CBC, CMP, BUN, creatinine labs, and LFT were then measured at least weekly until day +100. Daily physical examination, including toxicity assessments were conducted until discharge and then weekly until day +100. Disease assessments were conducted at day +100, +180, and +365 (+/- 7 days).
CTCAE v4.0
|
0.00%
0/3 • CBC, CMP, BUN, creatinine labs, and LFT were then measured at least weekly until day +100. Daily physical examination, including toxicity assessments were conducted until discharge and then weekly until day +100. Disease assessments were conducted at day +100, +180, and +365 (+/- 7 days).
CTCAE v4.0
|
0.00%
0/3 • CBC, CMP, BUN, creatinine labs, and LFT were then measured at least weekly until day +100. Daily physical examination, including toxicity assessments were conducted until discharge and then weekly until day +100. Disease assessments were conducted at day +100, +180, and +365 (+/- 7 days).
CTCAE v4.0
|
11.1%
1/9 • Number of events 1 • CBC, CMP, BUN, creatinine labs, and LFT were then measured at least weekly until day +100. Daily physical examination, including toxicity assessments were conducted until discharge and then weekly until day +100. Disease assessments were conducted at day +100, +180, and +365 (+/- 7 days).
CTCAE v4.0
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.00%
0/3 • CBC, CMP, BUN, creatinine labs, and LFT were then measured at least weekly until day +100. Daily physical examination, including toxicity assessments were conducted until discharge and then weekly until day +100. Disease assessments were conducted at day +100, +180, and +365 (+/- 7 days).
CTCAE v4.0
|
33.3%
1/3 • Number of events 1 • CBC, CMP, BUN, creatinine labs, and LFT were then measured at least weekly until day +100. Daily physical examination, including toxicity assessments were conducted until discharge and then weekly until day +100. Disease assessments were conducted at day +100, +180, and +365 (+/- 7 days).
CTCAE v4.0
|
0.00%
0/3 • CBC, CMP, BUN, creatinine labs, and LFT were then measured at least weekly until day +100. Daily physical examination, including toxicity assessments were conducted until discharge and then weekly until day +100. Disease assessments were conducted at day +100, +180, and +365 (+/- 7 days).
CTCAE v4.0
|
0.00%
0/9 • CBC, CMP, BUN, creatinine labs, and LFT were then measured at least weekly until day +100. Daily physical examination, including toxicity assessments were conducted until discharge and then weekly until day +100. Disease assessments were conducted at day +100, +180, and +365 (+/- 7 days).
CTCAE v4.0
|
|
Respiratory, thoracic and mediastinal disorders
prolonged intubation
|
0.00%
0/3 • CBC, CMP, BUN, creatinine labs, and LFT were then measured at least weekly until day +100. Daily physical examination, including toxicity assessments were conducted until discharge and then weekly until day +100. Disease assessments were conducted at day +100, +180, and +365 (+/- 7 days).
CTCAE v4.0
|
33.3%
1/3 • Number of events 1 • CBC, CMP, BUN, creatinine labs, and LFT were then measured at least weekly until day +100. Daily physical examination, including toxicity assessments were conducted until discharge and then weekly until day +100. Disease assessments were conducted at day +100, +180, and +365 (+/- 7 days).
CTCAE v4.0
|
0.00%
0/3 • CBC, CMP, BUN, creatinine labs, and LFT were then measured at least weekly until day +100. Daily physical examination, including toxicity assessments were conducted until discharge and then weekly until day +100. Disease assessments were conducted at day +100, +180, and +365 (+/- 7 days).
CTCAE v4.0
|
0.00%
0/9 • CBC, CMP, BUN, creatinine labs, and LFT were then measured at least weekly until day +100. Daily physical examination, including toxicity assessments were conducted until discharge and then weekly until day +100. Disease assessments were conducted at day +100, +180, and +365 (+/- 7 days).
CTCAE v4.0
|
|
Respiratory, thoracic and mediastinal disorders
hypoxia
|
0.00%
0/3 • CBC, CMP, BUN, creatinine labs, and LFT were then measured at least weekly until day +100. Daily physical examination, including toxicity assessments were conducted until discharge and then weekly until day +100. Disease assessments were conducted at day +100, +180, and +365 (+/- 7 days).
CTCAE v4.0
|
0.00%
0/3 • CBC, CMP, BUN, creatinine labs, and LFT were then measured at least weekly until day +100. Daily physical examination, including toxicity assessments were conducted until discharge and then weekly until day +100. Disease assessments were conducted at day +100, +180, and +365 (+/- 7 days).
CTCAE v4.0
|
33.3%
1/3 • Number of events 1 • CBC, CMP, BUN, creatinine labs, and LFT were then measured at least weekly until day +100. Daily physical examination, including toxicity assessments were conducted until discharge and then weekly until day +100. Disease assessments were conducted at day +100, +180, and +365 (+/- 7 days).
CTCAE v4.0
|
11.1%
1/9 • Number of events 1 • CBC, CMP, BUN, creatinine labs, and LFT were then measured at least weekly until day +100. Daily physical examination, including toxicity assessments were conducted until discharge and then weekly until day +100. Disease assessments were conducted at day +100, +180, and +365 (+/- 7 days).
CTCAE v4.0
|
|
Endocrine disorders
Adrenal Insufficiency
|
0.00%
0/3 • CBC, CMP, BUN, creatinine labs, and LFT were then measured at least weekly until day +100. Daily physical examination, including toxicity assessments were conducted until discharge and then weekly until day +100. Disease assessments were conducted at day +100, +180, and +365 (+/- 7 days).
CTCAE v4.0
|
0.00%
0/3 • CBC, CMP, BUN, creatinine labs, and LFT were then measured at least weekly until day +100. Daily physical examination, including toxicity assessments were conducted until discharge and then weekly until day +100. Disease assessments were conducted at day +100, +180, and +365 (+/- 7 days).
CTCAE v4.0
|
33.3%
1/3 • Number of events 1 • CBC, CMP, BUN, creatinine labs, and LFT were then measured at least weekly until day +100. Daily physical examination, including toxicity assessments were conducted until discharge and then weekly until day +100. Disease assessments were conducted at day +100, +180, and +365 (+/- 7 days).
CTCAE v4.0
|
0.00%
0/9 • CBC, CMP, BUN, creatinine labs, and LFT were then measured at least weekly until day +100. Daily physical examination, including toxicity assessments were conducted until discharge and then weekly until day +100. Disease assessments were conducted at day +100, +180, and +365 (+/- 7 days).
CTCAE v4.0
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place