Trial Outcomes & Findings for Bendamustine Hydrochloride, Lenalidomide, and Dexamethasone in Treating Patients With Relapsed Multiple Myeloma (NCT NCT01049945)
NCT ID: NCT01049945
Last Updated: 2020-02-11
Results Overview
The Maximum Tolerated Dose (MTD) is the dose level below that at which a dose limiting toxicity (DLT) is observed in ≥ 33% (i.e., ≥ 2 of 6) subjects in a cohort. A dose limiting toxicity is defined as one of the following adverse events in the Common Terminology Criteria for Adverse Events (CTCAE) v 3.0 deemed at least possibly related to treatment: * Grade 2 neuropathy with pain * Any grade 3 Non-Hematologic toxicity * Any grade Non-Hematologic event requiring a dose reduction in cycle 1 or delaying the next cycle by \>14 days. * Grade 4 neutropenia * Febrile neutropenia * Grade 4 thrombocytopenia * Grade 3 thrombocytopenia associated with bleeding * Any Hematologic event requiring a dose reduction in cycle 1 or a delay in the next cycle of treatment by \>14 days. We are reporting the results of this endpoint as the number of DLTs per dose level.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
70 participants
Primary outcome timeframe
One cycle of treatment
Results posted on
2020-02-11
Participant Flow
Participant milestones
| Measure |
Phase I, Dose Level 1
Bendamustine 50 mg/m\^2 IV day 1 Lenalidomide 15 mg PO days 1-21 Dexamethasone 40 mg PO or IV days 1, 8, 15, 22 Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity
|
Phase I, Dose Level 2
Bendamustine 50 mg/m\^2 IV day 1 and 2 Lenalidomide 15 mg PO days 1-21 Dexamethasone 40 mg PO or IV days 1, 8, 15, 22 Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity
|
Phase I, Dose Level 3
Bendamustine 75 mg/m\^2 IV day 1 and 2 Lenalidomide 15 mg PO days 1-21 Dexamethasone 40 mg PO or IV days 1, 8, 15, 22 Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity
|
Phase I, Dose Level 4
Bendamustine 75 mg/m\^2 IV day 1 and 2 Lenalidomide 25 mg PO days 1-21 Dexamethasone 40 mg PO or IV days 1, 8, 15, 22 Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity
|
Phase I, Dose Level 5
Bendamustine 100 mg/m\^2 IV day 1 and 2 Lenalidomide 25 mg PO days 1-21 Dexamethasone 40 mg PO or IV days 1, 8, 15, 22 Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity
|
Phase II, Dose Level 4
Bendamustine 75 mg/m\^2 IV day 1 and 2 Lenalidomide 25 mg PO days 1-21 Dexamethasone 40 mg PO or IV days 1, 8, 15, 22 Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
6
|
3
|
6
|
3
|
49
|
|
Overall Study
COMPLETED
|
3
|
6
|
3
|
6
|
3
|
49
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Bendamustine Hydrochloride, Lenalidomide, and Dexamethasone in Treating Patients With Relapsed Multiple Myeloma
Baseline characteristics by cohort
| Measure |
Phase I
n=15 Participants
Participant demographics were analyzed according to their status for the Phase II Primary Endpoint. All participants registered to Dose Level 4 (the Maximum Tolerated Dose (MTD)) were eligible for the Phase II Primary Endpoint. This group included the 6 patients registered to Phase I, Dose Level 4 and the 49 participants registered to the Phase II portion. The demographic information for all other participants registered to Phase I (Dose Level 1, Dose Level 2, Dose Level 3, and Dose Level 5) were summarized together.
|
Maximum Tolerated Dose, Dose Level 4
n=55 Participants
Participant demographics were analyzed according to their status for the Phase II Primary Endpoint. All participants registered to Dose Level 4 (the Maximum Tolerated Dose (MTD)) were eligible for the Phase II Primary Endpoint. This group included the 6 patients registered to Phase I, Dose Level 4 and the 49 participants registered to the Phase II portion. The demographic information for all other participants registered to Phase I (Dose Level 1, Dose Level 2, Dose Level 3, and Dose Level 5) were summarized together.
|
Total
n=70 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63.5 years
n=5 Participants
|
61.9 years
n=7 Participants
|
62.3 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=5 Participants
|
55 participants
n=7 Participants
|
70 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: One cycle of treatmentPopulation: All participants registered to the Phase I portion of this study were evaluable for this endpoint.
The Maximum Tolerated Dose (MTD) is the dose level below that at which a dose limiting toxicity (DLT) is observed in ≥ 33% (i.e., ≥ 2 of 6) subjects in a cohort. A dose limiting toxicity is defined as one of the following adverse events in the Common Terminology Criteria for Adverse Events (CTCAE) v 3.0 deemed at least possibly related to treatment: * Grade 2 neuropathy with pain * Any grade 3 Non-Hematologic toxicity * Any grade Non-Hematologic event requiring a dose reduction in cycle 1 or delaying the next cycle by \>14 days. * Grade 4 neutropenia * Febrile neutropenia * Grade 4 thrombocytopenia * Grade 3 thrombocytopenia associated with bleeding * Any Hematologic event requiring a dose reduction in cycle 1 or a delay in the next cycle of treatment by \>14 days. We are reporting the results of this endpoint as the number of DLTs per dose level.
Outcome measures
| Measure |
Phase I, Dose Level 1
n=3 Participants
Bendamustine 50 mg/m\^2 IV day 1 Lenalidomide 15 mg PO days 1-21 Dexamethasone 40 mg PO or IV days 1, 8, 15, 22 Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity
|
Phase I, Dose Level 2
n=6 Participants
Bendamustine 50 mg/m\^2 IV day 1 and 2 Lenalidomide 15 mg PO days 1-21 Dexamethasone 40 mg PO or IV days 1, 8, 15, 22 Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity
|
Phase I, Dose Level 3
n=3 Participants
Bendamustine 75 mg/m\^2 IV day 1 and 2 Lenalidomide 15 mg PO days 1-21 Dexamethasone 40 mg PO or IV days 1, 8, 15, 22 Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity
|
Phase I, Dose Level 4
n=6 Participants
Bendamustine 75 mg/m\^2 IV day 1 and 2 Lenalidomide 25 mg PO days 1-21 Dexamethasone 40 mg PO or IV days 1, 8, 15, 22 Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity
|
Phase I, Dose Level 5
n=3 Participants
Bendamustine 100 mg/m\^2 IV day 1 and 2 Lenalidomide 25 mg PO days 1-21 Dexamethasone 40 mg PO or IV days 1, 8, 15, 22 Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity
|
|---|---|---|---|---|---|
|
Dose Limiting Toxicity of Bendamustine Hydrochloride and Lenalidomide in Combination With Dexamethasone (Phase I)
|
0 Dose Limiting Toxic Events
|
1 Dose Limiting Toxic Events
|
0 Dose Limiting Toxic Events
|
0 Dose Limiting Toxic Events
|
2 Dose Limiting Toxic Events
|
PRIMARY outcome
Timeframe: Up to 6 cycles of treatmentPopulation: All participants registered to Dose Level 4 (the Maximum Tolerated Dose (MTD)) were eligible for the Phase II Primary Endpoint. This group included the 6 patients registered to Phase I, Dose Level 4 and the 49 participants registered to the Phase II portion.
Complete response (CR) \- Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and \<5% plasma cells in bone marrow. Stringent complete response (sCR) - A CR plus normal FLC ratio and no clonal cells in bone marrow Near complete response (nCR) A CR, with the persistence of original monoclonal protein Very good partial response (VGPR) \- Serum and urine M-component detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-component plus urine M-component \<100 mg per 24 h Partial response (PR) * ≥50% reduction of serum M-protein and reduction in 24-h urinary M-protein by ≥90% or to \<200 mg per 24 h. * a ≥50% decrease in the difference between involved and uninvolved FLC levels * or a ≥50% reduction in plasma cells is required in place of M-protein, if ≥30% at baseline.
Outcome measures
| Measure |
Phase I, Dose Level 1
n=55 Participants
Bendamustine 50 mg/m\^2 IV day 1 Lenalidomide 15 mg PO days 1-21 Dexamethasone 40 mg PO or IV days 1, 8, 15, 22 Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity
|
Phase I, Dose Level 2
Bendamustine 50 mg/m\^2 IV day 1 and 2 Lenalidomide 15 mg PO days 1-21 Dexamethasone 40 mg PO or IV days 1, 8, 15, 22 Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity
|
Phase I, Dose Level 3
Bendamustine 75 mg/m\^2 IV day 1 and 2 Lenalidomide 15 mg PO days 1-21 Dexamethasone 40 mg PO or IV days 1, 8, 15, 22 Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity
|
Phase I, Dose Level 4
Bendamustine 75 mg/m\^2 IV day 1 and 2 Lenalidomide 25 mg PO days 1-21 Dexamethasone 40 mg PO or IV days 1, 8, 15, 22 Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity
|
Phase I, Dose Level 5
Bendamustine 100 mg/m\^2 IV day 1 and 2 Lenalidomide 25 mg PO days 1-21 Dexamethasone 40 mg PO or IV days 1, 8, 15, 22 Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity
|
|---|---|---|---|---|---|
|
Confirmed Response Rate (Dose Level 4) Reported as the Percentage of Patients Achieving a Confirmed Response (sCR, CR, VGPR, or PR).
|
44 percentage of participants
Interval 30.0 to 58.0
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 2 years from study completionDOR is the time from the date the patient's objective status is first noted to be PR or better to the earliest date of progression (PD=Increase of \> 25% from lowest response value in Serum/Urine M-component) is documented. Treatment response was assessed using the International Myeloma Working Group uniform criteria. Complete response (CR)=Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and \<5% plasma cells in bone marrow. Stringent complete response (sCR)=A CR plus normal FLC ratio and no clonal cells in bone marrow. Near complete response (nCR)=A CR, with the persistence of original monoclonal protein. Very good partial response (VGPR) =Serum and urine M-component detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-component plus urine M-component \<100 mg per 24 h, Partial response (PR)=≥50% reduction of serum M-protein and reduction in 24-h urinary M-protein by ≥90% or to \<200 mg per 24 h.
Outcome measures
| Measure |
Phase I, Dose Level 1
n=55 Participants
Bendamustine 50 mg/m\^2 IV day 1 Lenalidomide 15 mg PO days 1-21 Dexamethasone 40 mg PO or IV days 1, 8, 15, 22 Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity
|
Phase I, Dose Level 2
Bendamustine 50 mg/m\^2 IV day 1 and 2 Lenalidomide 15 mg PO days 1-21 Dexamethasone 40 mg PO or IV days 1, 8, 15, 22 Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity
|
Phase I, Dose Level 3
Bendamustine 75 mg/m\^2 IV day 1 and 2 Lenalidomide 15 mg PO days 1-21 Dexamethasone 40 mg PO or IV days 1, 8, 15, 22 Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity
|
Phase I, Dose Level 4
Bendamustine 75 mg/m\^2 IV day 1 and 2 Lenalidomide 25 mg PO days 1-21 Dexamethasone 40 mg PO or IV days 1, 8, 15, 22 Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity
|
Phase I, Dose Level 5
Bendamustine 100 mg/m\^2 IV day 1 and 2 Lenalidomide 25 mg PO days 1-21 Dexamethasone 40 mg PO or IV days 1, 8, 15, 22 Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity
|
|---|---|---|---|---|---|
|
Duration of Response (DOR) (Phase II)
|
24.4 months
Interval 10.8 to 29.0
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 2 years from study completionThe event-free survival time is defined as the time from registration to disease progression (PD=Increase of \> 25% from lowest response value in Serum/Urine M-component) while receiving bendamustine, lenalidomide, and dexamethasone, death due to any cause, or subsequent treatment for multiple myeloma. The distribution of event-free survival will be estimated using the method of Kaplan-Meier. Treatment response was assessed using the International Myeloma Working Group uniform criteria.
Outcome measures
| Measure |
Phase I, Dose Level 1
n=55 Participants
Bendamustine 50 mg/m\^2 IV day 1 Lenalidomide 15 mg PO days 1-21 Dexamethasone 40 mg PO or IV days 1, 8, 15, 22 Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity
|
Phase I, Dose Level 2
Bendamustine 50 mg/m\^2 IV day 1 and 2 Lenalidomide 15 mg PO days 1-21 Dexamethasone 40 mg PO or IV days 1, 8, 15, 22 Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity
|
Phase I, Dose Level 3
Bendamustine 75 mg/m\^2 IV day 1 and 2 Lenalidomide 15 mg PO days 1-21 Dexamethasone 40 mg PO or IV days 1, 8, 15, 22 Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity
|
Phase I, Dose Level 4
Bendamustine 75 mg/m\^2 IV day 1 and 2 Lenalidomide 25 mg PO days 1-21 Dexamethasone 40 mg PO or IV days 1, 8, 15, 22 Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity
|
Phase I, Dose Level 5
Bendamustine 100 mg/m\^2 IV day 1 and 2 Lenalidomide 25 mg PO days 1-21 Dexamethasone 40 mg PO or IV days 1, 8, 15, 22 Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity
|
|---|---|---|---|---|---|
|
Event Free Survival (Phase II)
|
5.6 months
Interval 3.2 to 9.1
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 2 years from study completionThe progression-free survival time is defined as the time from registration to disease progression (PD=Increase of \> 25% from lowest response value in Serum/Urine M-component) while receiving bendamustine, lenalidomide, and dexamethasone or death due to any cause, whichever comes first. The distribution of progression-free survival will be estimated using the method of Kaplan-Meier. Treatment response was assessed using the International Myeloma Working Group uniform criteria.
Outcome measures
| Measure |
Phase I, Dose Level 1
n=55 Participants
Bendamustine 50 mg/m\^2 IV day 1 Lenalidomide 15 mg PO days 1-21 Dexamethasone 40 mg PO or IV days 1, 8, 15, 22 Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity
|
Phase I, Dose Level 2
Bendamustine 50 mg/m\^2 IV day 1 and 2 Lenalidomide 15 mg PO days 1-21 Dexamethasone 40 mg PO or IV days 1, 8, 15, 22 Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity
|
Phase I, Dose Level 3
Bendamustine 75 mg/m\^2 IV day 1 and 2 Lenalidomide 15 mg PO days 1-21 Dexamethasone 40 mg PO or IV days 1, 8, 15, 22 Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity
|
Phase I, Dose Level 4
Bendamustine 75 mg/m\^2 IV day 1 and 2 Lenalidomide 25 mg PO days 1-21 Dexamethasone 40 mg PO or IV days 1, 8, 15, 22 Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity
|
Phase I, Dose Level 5
Bendamustine 100 mg/m\^2 IV day 1 and 2 Lenalidomide 25 mg PO days 1-21 Dexamethasone 40 mg PO or IV days 1, 8, 15, 22 Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity
|
|---|---|---|---|---|---|
|
Progression Free Survival (Phase II)
|
11.8 months
Interval 3.5 to 13.8
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: at 6 monthsThe overall survival time is defined as the time from registration to death due to any cause. The distribution of overall survival will be estimated using the method of Kaplan-Meier. The overall survival rate at 6 months is defined as the percentage of participants who are alive at 6 months.
Outcome measures
| Measure |
Phase I, Dose Level 1
n=55 Participants
Bendamustine 50 mg/m\^2 IV day 1 Lenalidomide 15 mg PO days 1-21 Dexamethasone 40 mg PO or IV days 1, 8, 15, 22 Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity
|
Phase I, Dose Level 2
Bendamustine 50 mg/m\^2 IV day 1 and 2 Lenalidomide 15 mg PO days 1-21 Dexamethasone 40 mg PO or IV days 1, 8, 15, 22 Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity
|
Phase I, Dose Level 3
Bendamustine 75 mg/m\^2 IV day 1 and 2 Lenalidomide 15 mg PO days 1-21 Dexamethasone 40 mg PO or IV days 1, 8, 15, 22 Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity
|
Phase I, Dose Level 4
Bendamustine 75 mg/m\^2 IV day 1 and 2 Lenalidomide 25 mg PO days 1-21 Dexamethasone 40 mg PO or IV days 1, 8, 15, 22 Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity
|
Phase I, Dose Level 5
Bendamustine 100 mg/m\^2 IV day 1 and 2 Lenalidomide 25 mg PO days 1-21 Dexamethasone 40 mg PO or IV days 1, 8, 15, 22 Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity
|
|---|---|---|---|---|---|
|
Overall Survival (Phase II)
|
87 percentage of participants
Interval 77.0 to 97.0
|
—
|
—
|
—
|
—
|
Adverse Events
Phase I, Dose Level 1
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Phase I, Dose Level 2
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
Phase I, Dose Level 3
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
Phase I, Dose Level 4
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
Phase I, Dose Level 5
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Phase II, Dose Level 4
Serious events: 24 serious events
Other events: 49 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Phase I, Dose Level 1
n=3 participants at risk
Bendamustine 50 mg/m\^2 IV day 1 Lenalidomide 15 mg PO days 1-21 Dexamethasone 40 mg PO or IV days 1, 8, 15, 22 Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity
|
Phase I, Dose Level 2
n=6 participants at risk
Bendamustine 50 mg/m\^2 IV day 1 and 2 Lenalidomide 15 mg PO days 1-21 Dexamethasone 40 mg PO or IV days 1, 8, 15, 22 Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity
|
Phase I, Dose Level 3
n=3 participants at risk
Bendamustine 75 mg/m\^2 IV day 1 and 2 Lenalidomide 15 mg PO days 1-21 Dexamethasone 40 mg PO or IV days 1, 8, 15, 22 Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity
|
Phase I, Dose Level 4
n=6 participants at risk
Bendamustine 75 mg/m\^2 IV day 1 and 2 Lenalidomide 25 mg PO days 1-21 Dexamethasone 40 mg PO or IV days 1, 8, 15, 22 Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity
|
Phase I, Dose Level 5
n=3 participants at risk
Bendamustine 100 mg/m\^2 IV day 1 and 2 Lenalidomide 25 mg PO days 1-21 Dexamethasone 40 mg PO or IV days 1, 8, 15, 22 Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity
|
Phase II, Dose Level 4
n=49 participants at risk
Bendamustine 75 mg/m\^2 IV day 1 and 2 Lenalidomide 25 mg PO days 1-21 Dexamethasone 40 mg PO or IV days 1, 8, 15, 22 Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity
|
|---|---|---|---|---|---|---|
|
Infections and infestations
Herpes Zoster
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
2.0%
1/49 • Number of events 1
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
4.1%
2/49 • Number of events 2
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/3
|
0.00%
0/6
|
33.3%
1/3 • Number of events 1
|
0.00%
0/6
|
33.3%
1/3 • Number of events 1
|
2.0%
1/49 • Number of events 1
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
2.0%
1/49 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
4.1%
2/49 • Number of events 2
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
2.0%
1/49 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
2.0%
1/49 • Number of events 1
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
2.0%
1/49 • Number of events 1
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
0.00%
0/49
|
|
General disorders
Chest pain
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
2.0%
1/49 • Number of events 1
|
|
General disorders
Disease progression
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
6.1%
3/49 • Number of events 3
|
|
General disorders
Fatigue
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
2.0%
1/49 • Number of events 1
|
|
General disorders
Fever
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
4.1%
2/49 • Number of events 2
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
2.0%
1/49 • Number of events 1
|
|
Infections and infestations
Appendicitis
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
2.0%
1/49 • Number of events 1
|
|
Infections and infestations
Bronchitis
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
2.0%
1/49 • Number of events 1
|
|
Infections and infestations
Opportunistic infection
|
0.00%
0/3
|
0.00%
0/6
|
33.3%
1/3 • Number of events 1
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/49
|
|
Infections and infestations
Pneumonia
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
12.2%
6/49 • Number of events 6
|
|
Infections and infestations
Upper respiratory infection
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
33.3%
1/3 • Number of events 1
|
0.00%
0/49
|
|
Investigations
Creatinine increased
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
0.00%
0/49
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
33.3%
1/3 • Number of events 1
|
4.1%
2/49 • Number of events 2
|
|
Investigations
Platelet count decreased
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
4.1%
2/49 • Number of events 2
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
4.1%
2/49 • Number of events 2
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
2.0%
1/49 • Number of events 1
|
|
Metabolism and nutrition disorders
Serum calcium decreased
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
2.0%
1/49 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/3
|
0.00%
0/6
|
33.3%
1/3 • Number of events 1
|
0.00%
0/6
|
0.00%
0/3
|
2.0%
1/49 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
2.0%
1/49 • Number of events 1
|
|
Nervous system disorders
Ataxia
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/49
|
|
Nervous system disorders
CNS hemorrhage/bleeding
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
2.0%
1/49 • Number of events 1
|
|
Nervous system disorders
Ischemia cerebrovascular
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
2.0%
1/49 • Number of events 1
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
2.0%
1/49 • Number of events 1
|
|
Nervous system disorders
Seizure
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
0.00%
0/49
|
|
Nervous system disorders
Syncope
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
2.0%
1/49 • Number of events 1
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
2.0%
1/49 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
2.0%
1/49 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
2.0%
1/49 • Number of events 1
|
|
Vascular disorders
Hypotension
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
2.0%
1/49 • Number of events 1
|
|
Vascular disorders
Thrombosis
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
2.0%
1/49 • Number of events 1
|
Other adverse events
| Measure |
Phase I, Dose Level 1
n=3 participants at risk
Bendamustine 50 mg/m\^2 IV day 1 Lenalidomide 15 mg PO days 1-21 Dexamethasone 40 mg PO or IV days 1, 8, 15, 22 Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity
|
Phase I, Dose Level 2
n=6 participants at risk
Bendamustine 50 mg/m\^2 IV day 1 and 2 Lenalidomide 15 mg PO days 1-21 Dexamethasone 40 mg PO or IV days 1, 8, 15, 22 Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity
|
Phase I, Dose Level 3
n=3 participants at risk
Bendamustine 75 mg/m\^2 IV day 1 and 2 Lenalidomide 15 mg PO days 1-21 Dexamethasone 40 mg PO or IV days 1, 8, 15, 22 Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity
|
Phase I, Dose Level 4
n=6 participants at risk
Bendamustine 75 mg/m\^2 IV day 1 and 2 Lenalidomide 25 mg PO days 1-21 Dexamethasone 40 mg PO or IV days 1, 8, 15, 22 Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity
|
Phase I, Dose Level 5
n=3 participants at risk
Bendamustine 100 mg/m\^2 IV day 1 and 2 Lenalidomide 25 mg PO days 1-21 Dexamethasone 40 mg PO or IV days 1, 8, 15, 22 Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity
|
Phase II, Dose Level 4
n=49 participants at risk
Bendamustine 75 mg/m\^2 IV day 1 and 2 Lenalidomide 25 mg PO days 1-21 Dexamethasone 40 mg PO or IV days 1, 8, 15, 22 Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity
|
|---|---|---|---|---|---|---|
|
Infections and infestations
Bronchitis
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
4.1%
2/49 • Number of events 2
|
|
Infections and infestations
Colitis, infectious (e.g., Clostridium difficile)
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
2.0%
1/49 • Number of events 1
|
|
Infections and infestations
Gingival infection
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
4.1%
2/49 • Number of events 2
|
|
Infections and infestations
Mucosal infection
|
33.3%
1/3 • Number of events 1
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
4.1%
2/49 • Number of events 2
|
|
Infections and infestations
Nail infection
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/49
|
|
Infections and infestations
Opportunistic infection
|
0.00%
0/3
|
0.00%
0/6
|
33.3%
1/3 • Number of events 1
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/49
|
|
Infections and infestations
Otitis externa
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
33.3%
1/3 • Number of events 1
|
2.0%
1/49 • Number of events 1
|
|
Infections and infestations
Pneumonia
|
33.3%
1/3 • Number of events 1
|
0.00%
0/6
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
4.1%
2/49 • Number of events 2
|
|
Infections and infestations
Sinusitis
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
0.00%
0/6
|
33.3%
1/3 • Number of events 1
|
2.0%
1/49 • Number of events 1
|
|
Infections and infestations
Skin infection
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
16.7%
1/6 • Number of events 2
|
0.00%
0/3
|
2.0%
1/49 • Number of events 1
|
|
Infections and infestations
Upper aerodigestive tract infection
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/49
|
|
Infections and infestations
Upper respiratory infection
|
33.3%
1/3 • Number of events 1
|
50.0%
3/6 • Number of events 4
|
0.00%
0/3
|
66.7%
4/6 • Number of events 5
|
66.7%
2/3 • Number of events 2
|
20.4%
10/49 • Number of events 11
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
4.1%
2/49 • Number of events 2
|
|
Injury, poisoning and procedural complications
Bruising
|
33.3%
1/3 • Number of events 1
|
33.3%
2/6 • Number of events 2
|
0.00%
0/3
|
16.7%
1/6 • Number of events 2
|
0.00%
0/3
|
22.4%
11/49 • Number of events 12
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
2.0%
1/49 • Number of events 1
|
|
Investigations
Alkaline phosphatase increased
|
33.3%
1/3 • Number of events 1
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
2.0%
1/49 • Number of events 1
|
|
Investigations
Creatinine increased
|
0.00%
0/3
|
0.00%
0/6
|
33.3%
1/3 • Number of events 1
|
0.00%
0/6
|
0.00%
0/3
|
2.0%
1/49 • Number of events 1
|
|
Investigations
Leukocyte count decreased
|
66.7%
2/3 • Number of events 3
|
50.0%
3/6 • Number of events 3
|
100.0%
3/3 • Number of events 3
|
83.3%
5/6 • Number of events 5
|
100.0%
3/3 • Number of events 4
|
79.6%
39/49 • Number of events 39
|
|
Investigations
Lymphocyte count decreased
|
66.7%
2/3 • Number of events 3
|
83.3%
5/6 • Number of events 6
|
100.0%
3/3 • Number of events 3
|
100.0%
6/6 • Number of events 6
|
66.7%
2/3 • Number of events 2
|
85.7%
42/49 • Number of events 43
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/3
|
16.7%
1/6 • Number of events 2
|
100.0%
3/3 • Number of events 4
|
83.3%
5/6 • Number of events 7
|
100.0%
3/3 • Number of events 4
|
81.6%
40/49 • Number of events 48
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
2.0%
1/49 • Number of events 1
|
|
Cardiac disorders
Ventricular arrhythmia
|
33.3%
1/3 • Number of events 1
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/49
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
2.0%
1/49 • Number of events 1
|
|
Eye disorders
Cataract
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
2.0%
1/49 • Number of events 1
|
|
Eye disorders
Eye disorder
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/49
|
|
Eye disorders
Vision
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/49
|
|
Eye disorders
Watering eyes
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
2.0%
1/49 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain
|
33.3%
1/3 • Number of events 2
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
33.3%
2/6 • Number of events 2
|
33.3%
1/3 • Number of events 1
|
8.2%
4/49 • Number of events 5
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
0.00%
0/49
|
|
Gastrointestinal disorders
Constipation
|
33.3%
1/3 • Number of events 1
|
33.3%
2/6 • Number of events 2
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
33.3%
1/3 • Number of events 1
|
30.6%
15/49 • Number of events 15
|
|
Gastrointestinal disorders
Diarrhea
|
100.0%
3/3 • Number of events 3
|
33.3%
2/6 • Number of events 3
|
33.3%
1/3 • Number of events 1
|
83.3%
5/6 • Number of events 7
|
33.3%
1/3 • Number of events 1
|
49.0%
24/49 • Number of events 26
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
2.0%
1/49 • Number of events 1
|
|
Gastrointestinal disorders
Dyspepsia
|
33.3%
1/3 • Number of events 1
|
33.3%
2/6 • Number of events 2
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
33.3%
1/3 • Number of events 1
|
18.4%
9/49 • Number of events 10
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
8.2%
4/49 • Number of events 4
|
|
Gastrointestinal disorders
Flatulence
|
33.3%
1/3 • Number of events 1
|
16.7%
1/6 • Number of events 2
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
4.1%
2/49 • Number of events 3
|
|
Gastrointestinal disorders
Melena/GI bleeding
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
0.00%
0/49
|
|
Gastrointestinal disorders
Mucositis oral
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
16.7%
1/6 • Number of events 2
|
0.00%
0/3
|
4.1%
2/49 • Number of events 2
|
|
Gastrointestinal disorders
Nausea
|
66.7%
2/3 • Number of events 2
|
33.3%
2/6 • Number of events 2
|
0.00%
0/3
|
50.0%
3/6 • Number of events 3
|
33.3%
1/3 • Number of events 1
|
46.9%
23/49 • Number of events 23
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/49
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
0.00%
0/49
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
33.3%
1/3 • Number of events 1
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
4.1%
2/49 • Number of events 2
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
28.6%
14/49 • Number of events 14
|
|
General disorders
Chest pain
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
8.2%
4/49 • Number of events 4
|
|
General disorders
Chills
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
6.1%
3/49 • Number of events 3
|
|
General disorders
Edema limbs
|
33.3%
1/3 • Number of events 2
|
0.00%
0/6
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
14.3%
7/49 • Number of events 9
|
|
General disorders
Fatigue
|
100.0%
3/3 • Number of events 4
|
50.0%
3/6 • Number of events 4
|
0.00%
0/3
|
66.7%
4/6 • Number of events 4
|
66.7%
2/3 • Number of events 2
|
55.1%
27/49 • Number of events 30
|
|
General disorders
Fever
|
33.3%
1/3 • Number of events 1
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
22.4%
11/49 • Number of events 11
|
|
General disorders
Gait abnormal
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
2.0%
1/49 • Number of events 1
|
|
General disorders
Gait disturbance
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
2.0%
1/49 • Number of events 1
|
|
General disorders
Injection site reaction
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
4.1%
2/49 • Number of events 2
|
|
General disorders
Pain
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
2.0%
1/49 • Number of events 1
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/49
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
8.2%
4/49 • Number of events 4
|
|
Infections and infestations
Herpes Zoster
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
33.3%
1/3 • Number of events 1
|
0.00%
0/6
|
0.00%
0/3
|
14.3%
7/49 • Number of events 8
|
|
Musculoskeletal and connective tissue disorders
Leg Cramp
|
66.7%
2/3 • Number of events 3
|
0.00%
0/6
|
0.00%
0/3
|
33.3%
2/6 • Number of events 2
|
0.00%
0/3
|
16.3%
8/49 • Number of events 14
|
|
Blood and lymphatic system disorders
Anemia
|
33.3%
1/3 • Number of events 1
|
0.00%
0/6
|
33.3%
1/3 • Number of events 1
|
33.3%
2/6 • Number of events 2
|
33.3%
1/3 • Number of events 1
|
44.9%
22/49 • Number of events 25
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
2.0%
1/49 • Number of events 2
|
|
Cardiac disorders
Cardiac pain
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
2.0%
1/49 • Number of events 1
|
|
Cardiac disorders
Conduction disorder
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
2.0%
1/49 • Number of events 1
|
|
Cardiac disorders
Edema
|
33.3%
1/3 • Number of events 1
|
0.00%
0/6
|
0.00%
0/3
|
16.7%
1/6 • Number of events 2
|
0.00%
0/3
|
10.2%
5/49 • Number of events 5
|
|
Cardiac disorders
Palpitations
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
2.0%
1/49 • Number of events 1
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
33.3%
2/6 • Number of events 2
|
0.00%
0/3
|
8.2%
4/49 • Number of events 4
|
|
Investigations
Platelet count decreased
|
33.3%
1/3 • Number of events 2
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
66.7%
4/6 • Number of events 6
|
33.3%
1/3 • Number of events 1
|
65.3%
32/49 • Number of events 34
|
|
Investigations
Weight gain
|
33.3%
1/3 • Number of events 1
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/49
|
|
Investigations
Weight loss
|
0.00%
0/3
|
33.3%
2/6 • Number of events 2
|
0.00%
0/3
|
33.3%
2/6 • Number of events 2
|
33.3%
1/3 • Number of events 1
|
28.6%
14/49 • Number of events 14
|
|
Investigations
White blood cell decreased
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/49
|
|
Metabolism and nutrition disorders
Acidosis
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
2.0%
1/49 • Number of events 1
|
|
Metabolism and nutrition disorders
Anorexia
|
33.3%
1/3 • Number of events 1
|
0.00%
0/6
|
0.00%
0/3
|
33.3%
2/6 • Number of events 2
|
0.00%
0/3
|
14.3%
7/49 • Number of events 7
|
|
Metabolism and nutrition disorders
Blood bicarbonate decreased
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
2.0%
1/49 • Number of events 1
|
|
Metabolism and nutrition disorders
Blood uric acid increased
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
2.0%
1/49 • Number of events 1
|
|
Metabolism and nutrition disorders
Dehydration
|
33.3%
1/3 • Number of events 1
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/49
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
33.3%
1/3 • Number of events 2
|
33.3%
2/6 • Number of events 2
|
33.3%
1/3 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
12.2%
6/49 • Number of events 6
|
|
Metabolism and nutrition disorders
Hypokalemia
|
33.3%
1/3 • Number of events 1
|
0.00%
0/6
|
33.3%
1/3 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
33.3%
1/3 • Number of events 1
|
14.3%
7/49 • Number of events 7
|
|
Metabolism and nutrition disorders
Serum calcium decreased
|
0.00%
0/3
|
0.00%
0/6
|
33.3%
1/3 • Number of events 1
|
0.00%
0/6
|
0.00%
0/3
|
2.0%
1/49 • Number of events 1
|
|
Metabolism and nutrition disorders
Serum calcium increased
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
2.0%
1/49 • Number of events 1
|
|
Metabolism and nutrition disorders
Serum magnesium decreased
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
2.0%
1/49 • Number of events 1
|
|
Metabolism and nutrition disorders
Serum phosphate decreased
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
6.1%
3/49 • Number of events 3
|
|
Metabolism and nutrition disorders
Serum potassium decreased
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
4.1%
2/49 • Number of events 2
|
|
Metabolism and nutrition disorders
Serum sodium decreased
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
2.0%
1/49 • Number of events 1
|
|
Metabolism and nutrition disorders
Tumor lysis syndrome
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/49
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
33.3%
1/3 • Number of events 1
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
2.0%
1/49 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
100.0%
3/3 • Number of events 3
|
16.7%
1/6 • Number of events 1
|
33.3%
1/3 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
33.3%
1/3 • Number of events 1
|
20.4%
10/49 • Number of events 11
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal
|
33.3%
1/3 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/49
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
66.7%
2/3 • Number of events 2
|
16.7%
1/6 • Number of events 1
|
33.3%
1/3 • Number of events 1
|
33.3%
2/6 • Number of events 2
|
0.00%
0/3
|
38.8%
19/49 • Number of events 23
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
2.0%
1/49 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
66.7%
2/3 • Number of events 2
|
33.3%
2/6 • Number of events 2
|
0.00%
0/3
|
0.00%
0/6
|
33.3%
1/3 • Number of events 1
|
10.2%
5/49 • Number of events 6
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
4.1%
2/49 • Number of events 3
|
|
Nervous system disorders
Ataxia
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/49
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
16.3%
8/49 • Number of events 8
|
|
Nervous system disorders
Dysgeusia
|
33.3%
1/3 • Number of events 1
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
6.1%
3/49 • Number of events 3
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
2.0%
1/49 • Number of events 1
|
|
Nervous system disorders
Facial nerve disorder
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
2.0%
1/49 • Number of events 1
|
|
Nervous system disorders
Headache
|
33.3%
1/3 • Number of events 1
|
0.00%
0/6
|
33.3%
1/3 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
33.3%
1/3 • Number of events 1
|
16.3%
8/49 • Number of events 8
|
|
Nervous system disorders
Ischemia cerebrovascular
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
2.0%
1/49 • Number of events 1
|
|
Nervous system disorders
Peripheral motor neuropathy
|
33.3%
1/3 • Number of events 1
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/49
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
33.3%
1/3 • Number of events 1
|
50.0%
3/6 • Number of events 3
|
0.00%
0/3
|
33.3%
2/6 • Number of events 4
|
33.3%
1/3 • Number of events 1
|
28.6%
14/49 • Number of events 14
|
|
Nervous system disorders
Somnolence
|
0.00%
0/3
|
0.00%
0/6
|
33.3%
1/3 • Number of events 1
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/49
|
|
Nervous system disorders
Tremor
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
6.1%
3/49 • Number of events 3
|
|
Psychiatric disorders
Agitation
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
33.3%
1/3 • Number of events 1
|
2.0%
1/49 • Number of events 1
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
4.1%
2/49 • Number of events 2
|
|
Psychiatric disorders
Confusion
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
2.0%
1/49 • Number of events 1
|
|
Psychiatric disorders
Depression
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
33.3%
1/3 • Number of events 1
|
2.0%
1/49 • Number of events 1
|
|
Psychiatric disorders
Hallucinations
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
2.0%
1/49 • Number of events 1
|
|
Psychiatric disorders
Insomnia
|
66.7%
2/3 • Number of events 2
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
33.3%
2/6 • Number of events 2
|
0.00%
0/3
|
22.4%
11/49 • Number of events 11
|
|
Psychiatric disorders
Psychiatric disorders - Other, specify
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
2.0%
1/49 • Number of events 1
|
|
Renal and urinary disorders
Cystitis
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
2.0%
1/49 • Number of events 1
|
|
Renal and urinary disorders
Glomerular filtration rate decreased
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
2.0%
1/49 • Number of events 1
|
|
Renal and urinary disorders
Hematuria (absence of vaginal bleeding)
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
2.0%
1/49 • Number of events 1
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
2.0%
1/49 • Number of events 1
|
|
Renal and urinary disorders
Urinary frequency
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
2.0%
1/49 • Number of events 1
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/49
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
4.1%
2/49 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Apnea
|
33.3%
1/3 • Number of events 1
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/49
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
33.3%
1/3 • Number of events 1
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
33.3%
1/3 • Number of events 1
|
16.3%
8/49 • Number of events 8
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
66.7%
2/3 • Number of events 2
|
0.00%
0/6
|
33.3%
1/3 • Number of events 1
|
33.3%
2/6 • Number of events 2
|
66.7%
2/3 • Number of events 2
|
12.2%
6/49 • Number of events 6
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
33.3%
1/3 • Number of events 1
|
0.00%
0/6
|
0.00%
0/3
|
2.0%
1/49 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Hemoptysis
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
2.0%
1/49 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
2.0%
1/49 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
4.1%
2/49 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
2.0%
1/49 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
33.3%
1/3 • Number of events 1
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/49
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/3
|
0.00%
0/6
|
33.3%
1/3 • Number of events 1
|
0.00%
0/6
|
0.00%
0/3
|
2.0%
1/49 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
2.0%
1/49 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
33.3%
1/3 • Number of events 1
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
2.0%
1/49 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
2.0%
1/49 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
33.3%
1/3 • Number of events 1
|
0.00%
0/6
|
0.00%
0/3
|
4.1%
2/49 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
33.3%
1/3 • Number of events 1
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
4.1%
2/49 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
0.00%
0/3
|
0.00%
0/6
|
33.3%
1/3 • Number of events 1
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/49
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
2.0%
1/49 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
33.3%
1/3 • Number of events 1
|
0.00%
0/6
|
0.00%
0/3
|
6.1%
3/49 • Number of events 4
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
2.0%
1/49 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash desquamating
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/49
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
33.3%
1/3 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
33.3%
2/6 • Number of events 3
|
33.3%
1/3 • Number of events 1
|
20.4%
10/49 • Number of events 11
|
|
Skin and subcutaneous tissue disorders
Skin atrophy
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
2.0%
1/49 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Sweating
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
33.3%
1/3 • Number of events 1
|
2.0%
1/49 • Number of events 1
|
|
Vascular disorders
Flushing
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
2.0%
1/49 • Number of events 1
|
|
Vascular disorders
Hematoma
|
0.00%
0/3
|
0.00%
0/6
|
33.3%
1/3 • Number of events 1
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/49
|
|
Vascular disorders
Hypertension
|
33.3%
1/3 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
2.0%
1/49 • Number of events 1
|
|
Vascular disorders
Hypotension
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
4.1%
2/49 • Number of events 2
|
|
Vascular disorders
Phlebitis
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
2.0%
1/49 • Number of events 1
|
|
Vascular disorders
Thrombosis
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
8.2%
4/49 • Number of events 4
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place