Trial Outcomes & Findings for Cyclophosphamide, Carfilzomib, Thalidomide, and Dexamethasone in Treating Patients With Newly Diagnosed Active Multiple Myeloma (NCT NCT01057225)
NCT ID: NCT01057225
Last Updated: 2017-12-12
Results Overview
To establish the maximum tolerated dose of carfilzomib given in combination with oral cyclophosphamide and thalidomide and dexamethasone. For this protocol, dose-limiting toxicity (DLT) will be defined as an adverse event attributed (definitely, probably, possibly) in the first or second cycle for patients enrolled to Dose Levels -1 and 0 and in the first cycle only for patients enrolled to Dose Levels 1 and 2. We are reporting the number of DLTs
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
64 participants
Primary outcome timeframe
From baseline to end of active treatment, up to 12 28-day cycles.
Results posted on
2017-12-12
Participant Flow
Participant milestones
| Measure |
Phase I: Dose Level -1
Patients receive:
Oral 300 mg/m\^2 cyclophosphamide on days 1, 8, and 15;
Oral 40 mg dexamethasone on days 1, 8, 15, and 22;
Oral 100 mg thalidomide on days 1-28.
Patients also recieve 15 mg/m\^2 carfilzomib IV on days 1, 2, 8, 9, 15, and 16 in cycle 1, and 20 mg/m\^2 on days 1, 2, 8, 9, 15, and 16 in subsequent cycles.
|
Phase I: Dose Level 0
Patients receive:
Oral 300 mg/m\^2 cyclophosphamide on days 1, 8, and 15;
Oral 40 mg dexamethasone on days 1, 8, 15, and 22;
Oral 100 mg thalidomide on days 1-28.
Patients also recieve 20 mg/m\^2 carfilzomib IV on days 1, 2, 8, 9, 15, and 16 in cycle 1, and 27 mg/m\^2 on days 1, 2, 8, 9, 15, and 16 in subsequent cycles.
|
Phase I: Dose Level 1
Patients receive:
Oral 300 mg/m\^2 cyclophosphamide on days 1, 8, and 15;
Oral 40 mg dexamethasone on days 1, 8, 15, and 22;
Oral 100 mg thalidomide on days 1-28.
Patients also recieve 20 mg/m\^2 carfilzomib IV on days 1, 2, 8, 9, 15, and 16 in cycle 1, and 36 mg/m\^2 on days 1, 2, 8, 9, 15, and 16 in subsequent cycles.
|
Phase I: Dose Level 2
Patients receive:
Oral 300 mg/m\^2 cyclophosphamide on days 1, 8, and 15;
Oral 40 mg dexamethasone on days 1, 8, 15, and 22;
Oral 100 mg thalidomide on days 1-28.
Patients also recieve 20 mg/m\^2 carfilzomib IV on days 1, 2, 8, 9, 15, and 16 in cycle 1, and 45 mg/m\^2 on days 1, 2, 8, 9, 15, and 16 in subsequent cycles.
|
Phase II: Dose Level 0
Patients receive:
Oral 300 mg/m\^2 cyclophosphamide on days 1, 8, and 15;
Oral 40 mg dexamethasone on days 1, 8, 15, and 22;
Oral 100 mg thalidomide on days 1-28.
Patients also recieve 20 mg/m\^2 carfilzomib IV on days 1, 2, 8, 9, 15, and 16 in cycle 1, and 27 mg/m\^2 on days 1, 2, 8, 9, 15, and 16 in subsequent cycles.
|
Phase II: Dose Level 1
Patients receive:
Oral 300 mg/m\^2 cyclophosphamide on days 1, 8, and 15;
Oral 40 mg dexamethasone on days 1, 8, 15, and 22;
Oral 100 mg thalidomide on days 1-28.
Patients also recieve 20 mg/m\^2 carfilzomib IV on days 1, 2, 8, 9, 15, and 16 in cycle 1, and 36 mg/m\^2 on days 1, 2, 8, 9, 15, and 16 in subsequent cycles.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
6
|
7
|
22
|
23
|
|
Overall Study
COMPLETED
|
3
|
3
|
6
|
7
|
22
|
23
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Cyclophosphamide, Carfilzomib, Thalidomide, and Dexamethasone in Treating Patients With Newly Diagnosed Active Multiple Myeloma
Baseline characteristics by cohort
| Measure |
All Treated Patients
n=64 Participants
Patients receive carfilzomib IV on days 1, 2, 8, 9, 15, and 16; oral cyclophosphamide on days 1, 8, and 15; oral dexamethasone on days 1, 8, 15, and 22; and oral thalidomide on days 1-28.
|
|---|---|
|
Age, Continuous
|
62.5 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
34 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
54 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
64 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From baseline to end of active treatment, up to 12 28-day cycles.Population: All patients registered to a dose escalation Phase I group were analyzed for this endpoint.
To establish the maximum tolerated dose of carfilzomib given in combination with oral cyclophosphamide and thalidomide and dexamethasone. For this protocol, dose-limiting toxicity (DLT) will be defined as an adverse event attributed (definitely, probably, possibly) in the first or second cycle for patients enrolled to Dose Levels -1 and 0 and in the first cycle only for patients enrolled to Dose Levels 1 and 2. We are reporting the number of DLTs
Outcome measures
| Measure |
Phase I: Dose Level -1
n=3 Participants
Patients receive:
Oral 300 mg/m\^2 cyclophosphamide on days 1, 8, and 15; Oral 40 mg dexamethasone on days 1, 8, 15, and 22; Oral 100 mg thalidomide on days 1-28.
Patients also recieve 15 mg/m\^2 carfilzomib IV on days 1, 2, 8, 9, 15, and 16 in cycle 1, and 20 mg/m\^2 on days 1, 2, 8, 9, 15, and 16 in subsequent cycles.
|
Phase I: Dose Level 0
n=3 Participants
Patients receive:
Oral 300 mg/m\^2 cyclophosphamide on days 1, 8, and 15; Oral 40 mg dexamethasone on days 1, 8, 15, and 22; Oral 100 mg thalidomide on days 1-28.
Patients also recieve 20 mg/m\^2 carfilzomib IV on days 1, 2, 8, 9, 15, and 16 in cycle 1, and 27 mg/m\^2 on days 1, 2, 8, 9, 15, and 16 in subsequent cycles.
|
Phase I: Dose Level 1
n=6 Participants
Patients receive:
Oral 300 mg/m\^2 cyclophosphamide on days 1, 8, and 15; Oral 40 mg dexamethasone on days 1, 8, 15, and 22; Oral 100 mg thalidomide on days 1-28.
Patients also recieve 20 mg/m\^2 carfilzomib IV on days 1, 2, 8, 9, 15, and 16 in cycle 1, and 36 mg/m\^2 on days 1, 2, 8, 9, 15, and 16 in subsequent cycles.
|
Phase I: Dose Level 2
n=7 Participants
Patients receive:
Oral 300 mg/m\^2 cyclophosphamide on days 1, 8, and 15; Oral 40 mg dexamethasone on days 1, 8, 15, and 22; Oral 100 mg thalidomide on days 1-28.
Patients also recieve 20 mg/m\^2 carfilzomib IV on days 1, 2, 8, 9, 15, and 16 in cycle 1, and 45 mg/m\^2 on days 1, 2, 8, 9, 15, and 16 in subsequent cycles.
|
|---|---|---|---|---|
|
Maximum Tolerated Dose (Phase I)
|
0 participants
|
0 participants
|
0 participants
|
3 participants
|
PRIMARY outcome
Timeframe: Following the first 4 cycles of treatment (28 day cycles)Population: All enrolled patients who began treatment were evaluated for safety and response.
The proportion of patients who have at least a confirmed very good partial response will be calculated by taking the number of patients with a very good partial response or a complete response divided by the total number of patients. A complete response is defined as: * Negative immunofixation of the serum and urine * If at on study, only the measurable non-bone marrow parameter was FLC, normalization of FLC ratio * \< 5% plasma cells in bone marrow * Disappearance of any soft tissue plasmacytomas A very good partial response is defined as: * Serum and urine M-component detectable by immunofixation but not on electrophoresis or * If at on study, serum measurable, ≥ 90% or greater reduction in serum Mcomponent * Urine M-component \<100 mg per 24 hour
Outcome measures
| Measure |
Phase I: Dose Level -1
n=64 Participants
Patients receive:
Oral 300 mg/m\^2 cyclophosphamide on days 1, 8, and 15; Oral 40 mg dexamethasone on days 1, 8, 15, and 22; Oral 100 mg thalidomide on days 1-28.
Patients also recieve 15 mg/m\^2 carfilzomib IV on days 1, 2, 8, 9, 15, and 16 in cycle 1, and 20 mg/m\^2 on days 1, 2, 8, 9, 15, and 16 in subsequent cycles.
|
Phase I: Dose Level 0
Patients receive:
Oral 300 mg/m\^2 cyclophosphamide on days 1, 8, and 15; Oral 40 mg dexamethasone on days 1, 8, 15, and 22; Oral 100 mg thalidomide on days 1-28.
Patients also recieve 20 mg/m\^2 carfilzomib IV on days 1, 2, 8, 9, 15, and 16 in cycle 1, and 27 mg/m\^2 on days 1, 2, 8, 9, 15, and 16 in subsequent cycles.
|
Phase I: Dose Level 1
Patients receive:
Oral 300 mg/m\^2 cyclophosphamide on days 1, 8, and 15; Oral 40 mg dexamethasone on days 1, 8, 15, and 22; Oral 100 mg thalidomide on days 1-28.
Patients also recieve 20 mg/m\^2 carfilzomib IV on days 1, 2, 8, 9, 15, and 16 in cycle 1, and 36 mg/m\^2 on days 1, 2, 8, 9, 15, and 16 in subsequent cycles.
|
Phase I: Dose Level 2
Patients receive:
Oral 300 mg/m\^2 cyclophosphamide on days 1, 8, and 15; Oral 40 mg dexamethasone on days 1, 8, 15, and 22; Oral 100 mg thalidomide on days 1-28.
Patients also recieve 20 mg/m\^2 carfilzomib IV on days 1, 2, 8, 9, 15, and 16 in cycle 1, and 45 mg/m\^2 on days 1, 2, 8, 9, 15, and 16 in subsequent cycles.
|
|---|---|---|---|---|
|
Percentage of Patients Who Have at Least a Confirmed Very Good Partial Response (Phase II)
|
91 percentage of participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From baseline to progression or death up to 3 yearsPopulation: All of the 64 participants that were eligible and began treatment were evaluated.
PFS was defined as the time from registration to progression or death due to any cause. Progression was defined as any one or more of the following: • Increase of 25% from lowest confirmed response in: Serum M-component (absolute increase must be ≥ 0.5 g/dl)c Urine M-component (absolute increase must be ≥ 200 mg/24 hour) If at on study, only the measurable non-bone marrow parameter was FLC, the difference between involved and uninvolved FLC levels (absolute increase must be \>10 mg/dl) Bone marrow plasma cell percentage (absolute % must be 10%)d Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas • Development of hypercalcemia (corrected serum calcium \>11.5 mg/dl) that can be attributed solely to the plasma cell proliferative disorder
Outcome measures
| Measure |
Phase I: Dose Level -1
n=64 Participants
Patients receive:
Oral 300 mg/m\^2 cyclophosphamide on days 1, 8, and 15; Oral 40 mg dexamethasone on days 1, 8, 15, and 22; Oral 100 mg thalidomide on days 1-28.
Patients also recieve 15 mg/m\^2 carfilzomib IV on days 1, 2, 8, 9, 15, and 16 in cycle 1, and 20 mg/m\^2 on days 1, 2, 8, 9, 15, and 16 in subsequent cycles.
|
Phase I: Dose Level 0
Patients receive:
Oral 300 mg/m\^2 cyclophosphamide on days 1, 8, and 15; Oral 40 mg dexamethasone on days 1, 8, 15, and 22; Oral 100 mg thalidomide on days 1-28.
Patients also recieve 20 mg/m\^2 carfilzomib IV on days 1, 2, 8, 9, 15, and 16 in cycle 1, and 27 mg/m\^2 on days 1, 2, 8, 9, 15, and 16 in subsequent cycles.
|
Phase I: Dose Level 1
Patients receive:
Oral 300 mg/m\^2 cyclophosphamide on days 1, 8, and 15; Oral 40 mg dexamethasone on days 1, 8, 15, and 22; Oral 100 mg thalidomide on days 1-28.
Patients also recieve 20 mg/m\^2 carfilzomib IV on days 1, 2, 8, 9, 15, and 16 in cycle 1, and 36 mg/m\^2 on days 1, 2, 8, 9, 15, and 16 in subsequent cycles.
|
Phase I: Dose Level 2
Patients receive:
Oral 300 mg/m\^2 cyclophosphamide on days 1, 8, and 15; Oral 40 mg dexamethasone on days 1, 8, 15, and 22; Oral 100 mg thalidomide on days 1-28.
Patients also recieve 20 mg/m\^2 carfilzomib IV on days 1, 2, 8, 9, 15, and 16 in cycle 1, and 45 mg/m\^2 on days 1, 2, 8, 9, 15, and 16 in subsequent cycles.
|
|---|---|---|---|---|
|
Progression-free Survival (Phase II)
|
NA months
The median and 95% confidence interval for the progression free survival could not be estimated due to too few events.
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From baseline to end of active treatmentPopulation: All enrolled patients who began treatment were evaluated for safety and response.
The time from the date of registration to the date at which the patient is removed from treatment due to progression, adverse events, or refusal. If the patient is considered to be a major treatment violation or is taken off study as a non-protocol failure, the patient will be censored on the date they were removed from treatment. The distribution of time to treatment failure will be estimated using the method of Kaplan-Meier
Outcome measures
| Measure |
Phase I: Dose Level -1
n=64 Participants
Patients receive:
Oral 300 mg/m\^2 cyclophosphamide on days 1, 8, and 15; Oral 40 mg dexamethasone on days 1, 8, 15, and 22; Oral 100 mg thalidomide on days 1-28.
Patients also recieve 15 mg/m\^2 carfilzomib IV on days 1, 2, 8, 9, 15, and 16 in cycle 1, and 20 mg/m\^2 on days 1, 2, 8, 9, 15, and 16 in subsequent cycles.
|
Phase I: Dose Level 0
Patients receive:
Oral 300 mg/m\^2 cyclophosphamide on days 1, 8, and 15; Oral 40 mg dexamethasone on days 1, 8, 15, and 22; Oral 100 mg thalidomide on days 1-28.
Patients also recieve 20 mg/m\^2 carfilzomib IV on days 1, 2, 8, 9, 15, and 16 in cycle 1, and 27 mg/m\^2 on days 1, 2, 8, 9, 15, and 16 in subsequent cycles.
|
Phase I: Dose Level 1
Patients receive:
Oral 300 mg/m\^2 cyclophosphamide on days 1, 8, and 15; Oral 40 mg dexamethasone on days 1, 8, 15, and 22; Oral 100 mg thalidomide on days 1-28.
Patients also recieve 20 mg/m\^2 carfilzomib IV on days 1, 2, 8, 9, 15, and 16 in cycle 1, and 36 mg/m\^2 on days 1, 2, 8, 9, 15, and 16 in subsequent cycles.
|
Phase I: Dose Level 2
Patients receive:
Oral 300 mg/m\^2 cyclophosphamide on days 1, 8, and 15; Oral 40 mg dexamethasone on days 1, 8, 15, and 22; Oral 100 mg thalidomide on days 1-28.
Patients also recieve 20 mg/m\^2 carfilzomib IV on days 1, 2, 8, 9, 15, and 16 in cycle 1, and 45 mg/m\^2 on days 1, 2, 8, 9, 15, and 16 in subsequent cycles.
|
|---|---|---|---|---|
|
Time to Treatment Failure
|
NA months
The median and 95% confidence interval for the time to treatment failure could not be estimated due to too few treatment failures.
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Following the first 4 courses of treatmentPopulation: Of the 64 patients that began protocol treatment, stem cell harvesting was attempted on 42 patients.
For patients going on to stem cell collection, the total number of CD34 positive cells collected per collection, days to platelets over 20,000 without transfusion and ANC over 1000 will be recorded. If a patient fails to collect adequate stem cells for transplant, this will be recorded as such. The number of patients with successful stem cell mobilization are reported.
Outcome measures
| Measure |
Phase I: Dose Level -1
n=42 Participants
Patients receive:
Oral 300 mg/m\^2 cyclophosphamide on days 1, 8, and 15; Oral 40 mg dexamethasone on days 1, 8, 15, and 22; Oral 100 mg thalidomide on days 1-28.
Patients also recieve 15 mg/m\^2 carfilzomib IV on days 1, 2, 8, 9, 15, and 16 in cycle 1, and 20 mg/m\^2 on days 1, 2, 8, 9, 15, and 16 in subsequent cycles.
|
Phase I: Dose Level 0
Patients receive:
Oral 300 mg/m\^2 cyclophosphamide on days 1, 8, and 15; Oral 40 mg dexamethasone on days 1, 8, 15, and 22; Oral 100 mg thalidomide on days 1-28.
Patients also recieve 20 mg/m\^2 carfilzomib IV on days 1, 2, 8, 9, 15, and 16 in cycle 1, and 27 mg/m\^2 on days 1, 2, 8, 9, 15, and 16 in subsequent cycles.
|
Phase I: Dose Level 1
Patients receive:
Oral 300 mg/m\^2 cyclophosphamide on days 1, 8, and 15; Oral 40 mg dexamethasone on days 1, 8, 15, and 22; Oral 100 mg thalidomide on days 1-28.
Patients also recieve 20 mg/m\^2 carfilzomib IV on days 1, 2, 8, 9, 15, and 16 in cycle 1, and 36 mg/m\^2 on days 1, 2, 8, 9, 15, and 16 in subsequent cycles.
|
Phase I: Dose Level 2
Patients receive:
Oral 300 mg/m\^2 cyclophosphamide on days 1, 8, and 15; Oral 40 mg dexamethasone on days 1, 8, 15, and 22; Oral 100 mg thalidomide on days 1-28.
Patients also recieve 20 mg/m\^2 carfilzomib IV on days 1, 2, 8, 9, 15, and 16 in cycle 1, and 45 mg/m\^2 on days 1, 2, 8, 9, 15, and 16 in subsequent cycles.
|
|---|---|---|---|---|
|
Stem Cell Collection and Engraftment (Phase II)
|
42 participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Following the first 4 courses of treatmentIn patients continuing beyond 4 cycles the ability to induce complete response will be evaluated at completion of planned therapy.
Outcome measures
| Measure |
Phase I: Dose Level -1
n=3 Participants
Patients receive:
Oral 300 mg/m\^2 cyclophosphamide on days 1, 8, and 15; Oral 40 mg dexamethasone on days 1, 8, 15, and 22; Oral 100 mg thalidomide on days 1-28.
Patients also recieve 15 mg/m\^2 carfilzomib IV on days 1, 2, 8, 9, 15, and 16 in cycle 1, and 20 mg/m\^2 on days 1, 2, 8, 9, 15, and 16 in subsequent cycles.
|
Phase I: Dose Level 0
n=25 Participants
Patients receive:
Oral 300 mg/m\^2 cyclophosphamide on days 1, 8, and 15; Oral 40 mg dexamethasone on days 1, 8, 15, and 22; Oral 100 mg thalidomide on days 1-28.
Patients also recieve 20 mg/m\^2 carfilzomib IV on days 1, 2, 8, 9, 15, and 16 in cycle 1, and 27 mg/m\^2 on days 1, 2, 8, 9, 15, and 16 in subsequent cycles.
|
Phase I: Dose Level 1
n=29 Participants
Patients receive:
Oral 300 mg/m\^2 cyclophosphamide on days 1, 8, and 15; Oral 40 mg dexamethasone on days 1, 8, 15, and 22; Oral 100 mg thalidomide on days 1-28.
Patients also recieve 20 mg/m\^2 carfilzomib IV on days 1, 2, 8, 9, 15, and 16 in cycle 1, and 36 mg/m\^2 on days 1, 2, 8, 9, 15, and 16 in subsequent cycles.
|
Phase I: Dose Level 2
n=7 Participants
Patients receive:
Oral 300 mg/m\^2 cyclophosphamide on days 1, 8, and 15; Oral 40 mg dexamethasone on days 1, 8, 15, and 22; Oral 100 mg thalidomide on days 1-28.
Patients also recieve 20 mg/m\^2 carfilzomib IV on days 1, 2, 8, 9, 15, and 16 in cycle 1, and 45 mg/m\^2 on days 1, 2, 8, 9, 15, and 16 in subsequent cycles.
|
|---|---|---|---|---|
|
Complete Response (Phase II)
|
0 participants
|
2 participants
|
3 participants
|
0 participants
|
SECONDARY outcome
Timeframe: From baseline to deathSurvival time is defined as the time from registration to death due to any cause. The distribution of survival time will be estimated using the method of Kaplan-Meier
Outcome measures
| Measure |
Phase I: Dose Level -1
n=64 Participants
Patients receive:
Oral 300 mg/m\^2 cyclophosphamide on days 1, 8, and 15; Oral 40 mg dexamethasone on days 1, 8, 15, and 22; Oral 100 mg thalidomide on days 1-28.
Patients also recieve 15 mg/m\^2 carfilzomib IV on days 1, 2, 8, 9, 15, and 16 in cycle 1, and 20 mg/m\^2 on days 1, 2, 8, 9, 15, and 16 in subsequent cycles.
|
Phase I: Dose Level 0
Patients receive:
Oral 300 mg/m\^2 cyclophosphamide on days 1, 8, and 15; Oral 40 mg dexamethasone on days 1, 8, 15, and 22; Oral 100 mg thalidomide on days 1-28.
Patients also recieve 20 mg/m\^2 carfilzomib IV on days 1, 2, 8, 9, 15, and 16 in cycle 1, and 27 mg/m\^2 on days 1, 2, 8, 9, 15, and 16 in subsequent cycles.
|
Phase I: Dose Level 1
Patients receive:
Oral 300 mg/m\^2 cyclophosphamide on days 1, 8, and 15; Oral 40 mg dexamethasone on days 1, 8, 15, and 22; Oral 100 mg thalidomide on days 1-28.
Patients also recieve 20 mg/m\^2 carfilzomib IV on days 1, 2, 8, 9, 15, and 16 in cycle 1, and 36 mg/m\^2 on days 1, 2, 8, 9, 15, and 16 in subsequent cycles.
|
Phase I: Dose Level 2
Patients receive:
Oral 300 mg/m\^2 cyclophosphamide on days 1, 8, and 15; Oral 40 mg dexamethasone on days 1, 8, 15, and 22; Oral 100 mg thalidomide on days 1-28.
Patients also recieve 20 mg/m\^2 carfilzomib IV on days 1, 2, 8, 9, 15, and 16 in cycle 1, and 45 mg/m\^2 on days 1, 2, 8, 9, 15, and 16 in subsequent cycles.
|
|---|---|---|---|---|
|
Survival Time (Phase II)
|
NA months
The median and 95% confidence interval for the survival time could not be estimated due to too few deaths.
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: All of the 64 participants that were eligible and began treatment were evaluated.
Progression-free survival time is defined as the time from registration to the earliest date of documentation of disease progression. If a patient dies without a documentation of disease progression the patient will be considered to have had disease progression at the time of their death. If the patient is declared to be a major treatment violation, the patient will be censored on the date the treatment violation was declared to have occurred. In the case of a patient starting treatment and then never returning for any evaluations, the patient will be censored for progression 1 day post-registration. This is reported as the percentage of patients alive and progression free at the 12 month mark.
Outcome measures
| Measure |
Phase I: Dose Level -1
n=64 Participants
Patients receive:
Oral 300 mg/m\^2 cyclophosphamide on days 1, 8, and 15; Oral 40 mg dexamethasone on days 1, 8, 15, and 22; Oral 100 mg thalidomide on days 1-28.
Patients also recieve 15 mg/m\^2 carfilzomib IV on days 1, 2, 8, 9, 15, and 16 in cycle 1, and 20 mg/m\^2 on days 1, 2, 8, 9, 15, and 16 in subsequent cycles.
|
Phase I: Dose Level 0
Patients receive:
Oral 300 mg/m\^2 cyclophosphamide on days 1, 8, and 15; Oral 40 mg dexamethasone on days 1, 8, 15, and 22; Oral 100 mg thalidomide on days 1-28.
Patients also recieve 20 mg/m\^2 carfilzomib IV on days 1, 2, 8, 9, 15, and 16 in cycle 1, and 27 mg/m\^2 on days 1, 2, 8, 9, 15, and 16 in subsequent cycles.
|
Phase I: Dose Level 1
Patients receive:
Oral 300 mg/m\^2 cyclophosphamide on days 1, 8, and 15; Oral 40 mg dexamethasone on days 1, 8, 15, and 22; Oral 100 mg thalidomide on days 1-28.
Patients also recieve 20 mg/m\^2 carfilzomib IV on days 1, 2, 8, 9, 15, and 16 in cycle 1, and 36 mg/m\^2 on days 1, 2, 8, 9, 15, and 16 in subsequent cycles.
|
Phase I: Dose Level 2
Patients receive:
Oral 300 mg/m\^2 cyclophosphamide on days 1, 8, and 15; Oral 40 mg dexamethasone on days 1, 8, 15, and 22; Oral 100 mg thalidomide on days 1-28.
Patients also recieve 20 mg/m\^2 carfilzomib IV on days 1, 2, 8, 9, 15, and 16 in cycle 1, and 45 mg/m\^2 on days 1, 2, 8, 9, 15, and 16 in subsequent cycles.
|
|---|---|---|---|---|
|
Progression Free Survival (12 Month)
|
85 percentage of participants at 12 months
Interval 71.0 to 93.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 24 monthsPopulation: All of the 64 participants that were eligible and began treatment were evaluated.
Progression-free survival time is defined as the time from registration to the earliest date of documentation of disease progression. If a patient dies without a documentation of disease progression the patient will be considered to have had disease progression at the time of their death. If the patient is declared to be a major treatment violation, the patient will be censored on the date the treatment violation was declared to have occurred. In the case of a patient starting treatment and then never returning for any evaluations, the patient will be censored for progression 1 day post-registration. This is reported as the percentage of patients alive and progression free at the 24 month mark.
Outcome measures
| Measure |
Phase I: Dose Level -1
n=64 Participants
Patients receive:
Oral 300 mg/m\^2 cyclophosphamide on days 1, 8, and 15; Oral 40 mg dexamethasone on days 1, 8, 15, and 22; Oral 100 mg thalidomide on days 1-28.
Patients also recieve 15 mg/m\^2 carfilzomib IV on days 1, 2, 8, 9, 15, and 16 in cycle 1, and 20 mg/m\^2 on days 1, 2, 8, 9, 15, and 16 in subsequent cycles.
|
Phase I: Dose Level 0
Patients receive:
Oral 300 mg/m\^2 cyclophosphamide on days 1, 8, and 15; Oral 40 mg dexamethasone on days 1, 8, 15, and 22; Oral 100 mg thalidomide on days 1-28.
Patients also recieve 20 mg/m\^2 carfilzomib IV on days 1, 2, 8, 9, 15, and 16 in cycle 1, and 27 mg/m\^2 on days 1, 2, 8, 9, 15, and 16 in subsequent cycles.
|
Phase I: Dose Level 1
Patients receive:
Oral 300 mg/m\^2 cyclophosphamide on days 1, 8, and 15; Oral 40 mg dexamethasone on days 1, 8, 15, and 22; Oral 100 mg thalidomide on days 1-28.
Patients also recieve 20 mg/m\^2 carfilzomib IV on days 1, 2, 8, 9, 15, and 16 in cycle 1, and 36 mg/m\^2 on days 1, 2, 8, 9, 15, and 16 in subsequent cycles.
|
Phase I: Dose Level 2
Patients receive:
Oral 300 mg/m\^2 cyclophosphamide on days 1, 8, and 15; Oral 40 mg dexamethasone on days 1, 8, 15, and 22; Oral 100 mg thalidomide on days 1-28.
Patients also recieve 20 mg/m\^2 carfilzomib IV on days 1, 2, 8, 9, 15, and 16 in cycle 1, and 45 mg/m\^2 on days 1, 2, 8, 9, 15, and 16 in subsequent cycles.
|
|---|---|---|---|---|
|
Progession Free Survival (24 Month)
|
76 percentage of participants at 24 months
Interval 59.0 to 87.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From baseline to deathPopulation: All of the 64 participants that were eligible and began treatment were evaluated.
12 Month Overall survival is defined as the proportion of patients to still be alive after 12 months.
Outcome measures
| Measure |
Phase I: Dose Level -1
n=64 Participants
Patients receive:
Oral 300 mg/m\^2 cyclophosphamide on days 1, 8, and 15; Oral 40 mg dexamethasone on days 1, 8, 15, and 22; Oral 100 mg thalidomide on days 1-28.
Patients also recieve 15 mg/m\^2 carfilzomib IV on days 1, 2, 8, 9, 15, and 16 in cycle 1, and 20 mg/m\^2 on days 1, 2, 8, 9, 15, and 16 in subsequent cycles.
|
Phase I: Dose Level 0
Patients receive:
Oral 300 mg/m\^2 cyclophosphamide on days 1, 8, and 15; Oral 40 mg dexamethasone on days 1, 8, 15, and 22; Oral 100 mg thalidomide on days 1-28.
Patients also recieve 20 mg/m\^2 carfilzomib IV on days 1, 2, 8, 9, 15, and 16 in cycle 1, and 27 mg/m\^2 on days 1, 2, 8, 9, 15, and 16 in subsequent cycles.
|
Phase I: Dose Level 1
Patients receive:
Oral 300 mg/m\^2 cyclophosphamide on days 1, 8, and 15; Oral 40 mg dexamethasone on days 1, 8, 15, and 22; Oral 100 mg thalidomide on days 1-28.
Patients also recieve 20 mg/m\^2 carfilzomib IV on days 1, 2, 8, 9, 15, and 16 in cycle 1, and 36 mg/m\^2 on days 1, 2, 8, 9, 15, and 16 in subsequent cycles.
|
Phase I: Dose Level 2
Patients receive:
Oral 300 mg/m\^2 cyclophosphamide on days 1, 8, and 15; Oral 40 mg dexamethasone on days 1, 8, 15, and 22; Oral 100 mg thalidomide on days 1-28.
Patients also recieve 20 mg/m\^2 carfilzomib IV on days 1, 2, 8, 9, 15, and 16 in cycle 1, and 45 mg/m\^2 on days 1, 2, 8, 9, 15, and 16 in subsequent cycles.
|
|---|---|---|---|---|
|
Overall Survival (12 Month)
|
96 percentage of patients
Interval 86.0 to 99.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From baseline to deathPopulation: All of the 64 participants that were eligible and began treatment were evaluated.
24 Month Overall survival is defined as the proportion of patients to still be alive after 24 months.
Outcome measures
| Measure |
Phase I: Dose Level -1
n=64 Participants
Patients receive:
Oral 300 mg/m\^2 cyclophosphamide on days 1, 8, and 15; Oral 40 mg dexamethasone on days 1, 8, 15, and 22; Oral 100 mg thalidomide on days 1-28.
Patients also recieve 15 mg/m\^2 carfilzomib IV on days 1, 2, 8, 9, 15, and 16 in cycle 1, and 20 mg/m\^2 on days 1, 2, 8, 9, 15, and 16 in subsequent cycles.
|
Phase I: Dose Level 0
Patients receive:
Oral 300 mg/m\^2 cyclophosphamide on days 1, 8, and 15; Oral 40 mg dexamethasone on days 1, 8, 15, and 22; Oral 100 mg thalidomide on days 1-28.
Patients also recieve 20 mg/m\^2 carfilzomib IV on days 1, 2, 8, 9, 15, and 16 in cycle 1, and 27 mg/m\^2 on days 1, 2, 8, 9, 15, and 16 in subsequent cycles.
|
Phase I: Dose Level 1
Patients receive:
Oral 300 mg/m\^2 cyclophosphamide on days 1, 8, and 15; Oral 40 mg dexamethasone on days 1, 8, 15, and 22; Oral 100 mg thalidomide on days 1-28.
Patients also recieve 20 mg/m\^2 carfilzomib IV on days 1, 2, 8, 9, 15, and 16 in cycle 1, and 36 mg/m\^2 on days 1, 2, 8, 9, 15, and 16 in subsequent cycles.
|
Phase I: Dose Level 2
Patients receive:
Oral 300 mg/m\^2 cyclophosphamide on days 1, 8, and 15; Oral 40 mg dexamethasone on days 1, 8, 15, and 22; Oral 100 mg thalidomide on days 1-28.
Patients also recieve 20 mg/m\^2 carfilzomib IV on days 1, 2, 8, 9, 15, and 16 in cycle 1, and 45 mg/m\^2 on days 1, 2, 8, 9, 15, and 16 in subsequent cycles.
|
|---|---|---|---|---|
|
Overall Survival (24 Month)
|
96 percentage of patients
Interval 86.0 to 99.0
|
—
|
—
|
—
|
Adverse Events
All Treated Patients
Serious events: 30 serious events
Other events: 64 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
All Treated Patients
n=64 participants at risk
Patients receive carfilzomib IV on days 1, 2, 8, 9, 15, and 16; oral cyclophosphamide on days 1, 8, and 15; oral dexamethasone on days 1, 8, 15, and 22; and oral thalidomide on days 1-28.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
3.1%
2/64 • Number of events 2
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
1.6%
1/64 • Number of events 1
|
|
Cardiac disorders
Atrial fibrillation
|
1.6%
1/64 • Number of events 1
|
|
Cardiac disorders
Conduction disorder
|
1.6%
1/64 • Number of events 2
|
|
Cardiac disorders
Heart failure
|
4.7%
3/64 • Number of events 3
|
|
Cardiac disorders
Restrictive cardiomyopathy
|
1.6%
1/64 • Number of events 1
|
|
Cardiac disorders
Ventricular tachycardia
|
1.6%
1/64 • Number of events 2
|
|
Eye disorders
Eye disorders - Other, specify
|
1.6%
1/64 • Number of events 1
|
|
Gastrointestinal disorders
Lower gastrointestinal hemorrhage
|
1.6%
1/64 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
1.6%
1/64 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
1.6%
1/64 • Number of events 1
|
|
General disorders
Fatigue
|
3.1%
2/64 • Number of events 2
|
|
General disorders
Infusion related reaction
|
1.6%
1/64 • Number of events 1
|
|
General disorders
Multi-organ failure
|
1.6%
1/64 • Number of events 1
|
|
Immune system disorders
Immune system disorders - Other, specify
|
1.6%
1/64 • Number of events 1
|
|
Infections and infestations
Infections and infestations - Other, specify
|
1.6%
1/64 • Number of events 1
|
|
Infections and infestations
Lung infection
|
6.2%
4/64 • Number of events 4
|
|
Infections and infestations
Skin infection
|
1.6%
1/64 • Number of events 1
|
|
Infections and infestations
Urinary tract infection
|
1.6%
1/64 • Number of events 1
|
|
Infections and infestations
Wound infection
|
1.6%
1/64 • Number of events 1
|
|
Investigations
Alanine aminotransferase increased
|
6.2%
4/64 • Number of events 4
|
|
Investigations
Alkaline phosphatase increased
|
1.6%
1/64 • Number of events 1
|
|
Investigations
Aspartate aminotransferase increased
|
6.2%
4/64 • Number of events 4
|
|
Investigations
Creatinine increased
|
4.7%
3/64 • Number of events 4
|
|
Investigations
Lymphocyte count decreased
|
3.1%
2/64 • Number of events 5
|
|
Investigations
Neutrophil count decreased
|
4.7%
3/64 • Number of events 3
|
|
Investigations
Urine output decreased
|
1.6%
1/64 • Number of events 4
|
|
Investigations
White blood cell decreased
|
3.1%
2/64 • Number of events 2
|
|
Metabolism and nutrition disorders
Dehydration
|
1.6%
1/64 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
1.6%
1/64 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
1.6%
1/64 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
3.1%
2/64 • Number of events 2
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
3.1%
2/64 • Number of events 2
|
|
Metabolism and nutrition disorders
Hypokalemia
|
4.7%
3/64 • Number of events 4
|
|
Metabolism and nutrition disorders
Hyponatremia
|
1.6%
1/64 • Number of events 2
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
4.7%
3/64 • Number of events 5
|
|
Metabolism and nutrition disorders
Tumor lysis syndrome
|
1.6%
1/64 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
3.1%
2/64 • Number of events 2
|
|
Nervous system disorders
Nervous system disorders - Other, specify
|
1.6%
1/64 • Number of events 1
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
1.6%
1/64 • Number of events 1
|
|
Nervous system disorders
Syncope
|
3.1%
2/64 • Number of events 2
|
|
Psychiatric disorders
Agitation
|
1.6%
1/64 • Number of events 1
|
|
Renal and urinary disorders
Acute kidney injury
|
3.1%
2/64 • Number of events 2
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, specify
|
1.6%
1/64 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Adult respiratory distress syndrome
|
1.6%
1/64 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
3.1%
2/64 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
1.6%
1/64 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
3.1%
2/64 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.6%
1/64 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
1.6%
1/64 • Number of events 1
|
|
Surgical and medical procedures
Surgical and medical procedures - Other, specify
|
1.6%
1/64 • Number of events 1
|
|
Vascular disorders
Hypertension
|
3.1%
2/64 • Number of events 2
|
|
Vascular disorders
Hypotension
|
3.1%
2/64 • Number of events 2
|
|
Vascular disorders
Thromboembolic event
|
6.2%
4/64 • Number of events 7
|
Other adverse events
| Measure |
All Treated Patients
n=64 participants at risk
Patients receive carfilzomib IV on days 1, 2, 8, 9, 15, and 16; oral cyclophosphamide on days 1, 8, and 15; oral dexamethasone on days 1, 8, 15, and 22; and oral thalidomide on days 1-28.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
42.2%
27/64 • Number of events 74
|
|
Blood and lymphatic system disorders
Leukocytosis
|
1.6%
1/64 • Number of events 1
|
|
Cardiac disorders
Chest pain - cardiac
|
3.1%
2/64 • Number of events 2
|
|
Cardiac disorders
Heart failure
|
1.6%
1/64 • Number of events 1
|
|
Cardiac disorders
Myocardial infarction
|
1.6%
1/64 • Number of events 1
|
|
Cardiac disorders
Palpitations
|
1.6%
1/64 • Number of events 1
|
|
Cardiac disorders
Paroxysmal atrial tachycardia
|
1.6%
1/64 • Number of events 1
|
|
Cardiac disorders
Sinus bradycardia
|
3.1%
2/64 • Number of events 2
|
|
Ear and labyrinth disorders
Hearing impaired
|
1.6%
1/64 • Number of events 4
|
|
Endocrine disorders
Cushingoid
|
1.6%
1/64 • Number of events 2
|
|
Eye disorders
Floaters
|
1.6%
1/64 • Number of events 4
|
|
Gastrointestinal disorders
Abdominal distension
|
3.1%
2/64 • Number of events 2
|
|
Gastrointestinal disorders
Abdominal pain
|
4.7%
3/64 • Number of events 5
|
|
Gastrointestinal disorders
Constipation
|
54.7%
35/64 • Number of events 106
|
|
Gastrointestinal disorders
Diarrhea
|
15.6%
10/64 • Number of events 17
|
|
Gastrointestinal disorders
Dry mouth
|
3.1%
2/64 • Number of events 5
|
|
Gastrointestinal disorders
Dyspepsia
|
1.6%
1/64 • Number of events 1
|
|
Gastrointestinal disorders
Esophageal pain
|
1.6%
1/64 • Number of events 1
|
|
Gastrointestinal disorders
Flatulence
|
1.6%
1/64 • Number of events 1
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
3.1%
2/64 • Number of events 3
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
4.7%
3/64 • Number of events 5
|
|
Gastrointestinal disorders
Mucositis oral
|
1.6%
1/64 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
20.3%
13/64 • Number of events 22
|
|
Gastrointestinal disorders
Vomiting
|
4.7%
3/64 • Number of events 4
|
|
General disorders
Chills
|
4.7%
3/64 • Number of events 3
|
|
General disorders
Edema limbs
|
23.4%
15/64 • Number of events 28
|
|
General disorders
Edema trunk
|
3.1%
2/64 • Number of events 2
|
|
General disorders
Fatigue
|
79.7%
51/64 • Number of events 159
|
|
General disorders
Fever
|
7.8%
5/64 • Number of events 5
|
|
General disorders
Gait disturbance
|
1.6%
1/64 • Number of events 1
|
|
General disorders
General disorders and administration site conditions - Other, specify
|
1.6%
1/64 • Number of events 2
|
|
General disorders
Irritability
|
3.1%
2/64 • Number of events 4
|
|
General disorders
Malaise
|
17.2%
11/64 • Number of events 34
|
|
General disorders
Pain
|
1.6%
1/64 • Number of events 1
|
|
Immune system disorders
Allergic reaction
|
1.6%
1/64 • Number of events 1
|
|
Infections and infestations
Lung infection
|
3.1%
2/64 • Number of events 2
|
|
Infections and infestations
Upper respiratory infection
|
4.7%
3/64 • Number of events 3
|
|
Infections and infestations
Urinary tract infection
|
3.1%
2/64 • Number of events 2
|
|
Investigations
Alanine aminotransferase increased
|
10.9%
7/64 • Number of events 12
|
|
Investigations
Alkaline phosphatase increased
|
14.1%
9/64 • Number of events 12
|
|
Investigations
Aspartate aminotransferase increased
|
12.5%
8/64 • Number of events 13
|
|
Investigations
Blood bilirubin increased
|
1.6%
1/64 • Number of events 2
|
|
Investigations
Creatinine increased
|
37.5%
24/64 • Number of events 54
|
|
Investigations
Investigations - Other, specify
|
3.1%
2/64 • Number of events 5
|
|
Investigations
Lymphocyte count decreased
|
40.6%
26/64 • Number of events 112
|
|
Investigations
Lymphocyte count increased
|
6.2%
4/64 • Number of events 5
|
|
Investigations
Neutrophil count decreased
|
50.0%
32/64 • Number of events 95
|
|
Investigations
Platelet count decreased
|
46.9%
30/64 • Number of events 74
|
|
Investigations
Weight gain
|
1.6%
1/64 • Number of events 1
|
|
Investigations
White blood cell decreased
|
42.2%
27/64 • Number of events 76
|
|
Metabolism and nutrition disorders
Anorexia
|
9.4%
6/64 • Number of events 9
|
|
Metabolism and nutrition disorders
Dehydration
|
4.7%
3/64 • Number of events 3
|
|
Metabolism and nutrition disorders
Glucose intolerance
|
1.6%
1/64 • Number of events 2
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
1.6%
1/64 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
37.5%
24/64 • Number of events 79
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
6.2%
4/64 • Number of events 6
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
1.6%
1/64 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypernatremia
|
1.6%
1/64 • Number of events 2
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
3.1%
2/64 • Number of events 7
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
7.8%
5/64 • Number of events 7
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
6.2%
4/64 • Number of events 6
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
21.9%
14/64 • Number of events 30
|
|
Metabolism and nutrition disorders
Hypokalemia
|
15.6%
10/64 • Number of events 22
|
|
Metabolism and nutrition disorders
Hyponatremia
|
14.1%
9/64 • Number of events 12
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
14.1%
9/64 • Number of events 14
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other, specify
|
1.6%
1/64 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.6%
1/64 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.6%
1/64 • Number of events 8
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
1.6%
1/64 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
3.1%
2/64 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
1.6%
1/64 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify
|
3.1%
2/64 • Number of events 5
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
4.7%
3/64 • Number of events 6
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.2%
4/64 • Number of events 4
|
|
Nervous system disorders
Cognitive disturbance
|
1.6%
1/64 • Number of events 1
|
|
Nervous system disorders
Depressed level of consciousness
|
10.9%
7/64 • Number of events 8
|
|
Nervous system disorders
Dizziness
|
10.9%
7/64 • Number of events 12
|
|
Nervous system disorders
Dysgeusia
|
3.1%
2/64 • Number of events 3
|
|
Nervous system disorders
Headache
|
10.9%
7/64 • Number of events 13
|
|
Nervous system disorders
Lethargy
|
25.0%
16/64 • Number of events 22
|
|
Nervous system disorders
Memory impairment
|
1.6%
1/64 • Number of events 1
|
|
Nervous system disorders
Nervous system disorders - Other, specify
|
1.6%
1/64 • Number of events 3
|
|
Nervous system disorders
Peripheral motor neuropathy
|
7.8%
5/64 • Number of events 5
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
35.9%
23/64 • Number of events 65
|
|
Nervous system disorders
Seizure
|
1.6%
1/64 • Number of events 3
|
|
Nervous system disorders
Somnolence
|
20.3%
13/64 • Number of events 19
|
|
Nervous system disorders
Tremor
|
6.2%
4/64 • Number of events 11
|
|
Psychiatric disorders
Anxiety
|
7.8%
5/64 • Number of events 10
|
|
Psychiatric disorders
Delirium
|
1.6%
1/64 • Number of events 1
|
|
Psychiatric disorders
Depression
|
1.6%
1/64 • Number of events 4
|
|
Psychiatric disorders
Insomnia
|
6.2%
4/64 • Number of events 5
|
|
Psychiatric disorders
Psychiatric disorders - Other, specify
|
1.6%
1/64 • Number of events 1
|
|
Renal and urinary disorders
Acute kidney injury
|
1.6%
1/64 • Number of events 1
|
|
Renal and urinary disorders
Bladder spasm
|
1.6%
1/64 • Number of events 4
|
|
Renal and urinary disorders
Cystitis noninfective
|
1.6%
1/64 • Number of events 1
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, specify
|
3.1%
2/64 • Number of events 3
|
|
Renal and urinary disorders
Urinary frequency
|
1.6%
1/64 • Number of events 1
|
|
Renal and urinary disorders
Urinary incontinence
|
1.6%
1/64 • Number of events 1
|
|
Reproductive system and breast disorders
Genital edema
|
1.6%
1/64 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Apnea
|
1.6%
1/64 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.2%
4/64 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
20.3%
13/64 • Number of events 21
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
1.6%
1/64 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
1.6%
1/64 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
1.6%
1/64 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
1.6%
1/64 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
1.6%
1/64 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
1.6%
1/64 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
9.4%
6/64 • Number of events 8
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
1.6%
1/64 • Number of events 4
|
|
Vascular disorders
Hypertension
|
7.8%
5/64 • Number of events 19
|
|
Vascular disorders
Hypotension
|
1.6%
1/64 • Number of events 1
|
|
Vascular disorders
Thromboembolic event
|
1.6%
1/64 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place