Trial Outcomes & Findings for Ixazomib With Cyclophosphamide and Dexamethasone in Patients With Previously Untreated Symptomatic Multiple Myeloma or Light Chain Amyloidosis (NCT NCT01864018)
NCT ID: NCT01864018
Last Updated: 2025-07-24
Results Overview
Will be defined as the dose level below the lowest dose that induces dose-limiting toxicity in at least 1/3 of patients, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
87 participants
Primary outcome timeframe
At 28 days
Results posted on
2025-07-24
Participant Flow
The phase I participants are grouped with the phase II, cohort A participants because they were grouped in the published manuscript
Participant milestones
| Measure |
Phase I/II, Cohort A
Patients with Multiple Myeloma\>
\> INDUCTION THERAPY: Patients receive ixazomib citrate PO on days 1, 8, and 15 and cyclophosphamide PO and dexamethasone PO on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.\>
\>\>
\>
\>\> MAINTENANCE THERAPY: Patients receive ixazomib citrate PO on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.\>
\>\>
\>
\>\> Cyclophosphamide: Given PO\>
\>\>
\>
\>\> Dexamethasone: Given PO\>
\>\>
\>
\>\> Ixazomib Citrate: Given PO\>
\>\>
\>
\>\> Laboratory Biomarker Analysis: Correlative studies\>
\>\>
\>
\>\> Pharmacological Study: Correlative studies\>
\>\>
\>
\>\> Quality-of-Life Assessment: Ancillary studies\>
\>\>
\>
\>\> Questionnaire Administration: Ancillary studies
|
Phase II, Cohort B
Patients with biopsy proven light chain amyloidosis with organ involvement\> requiring therapy\>
\> INDUCTION THERAPY: Patients receive ixazomib citrate PO on days 1, 8, and 15 and cyclophosphamide PO and dexamethasone PO on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.\>
\>\>
\>
\>\> MAINTENANCE THERAPY: Patients receive ixazomib citrate PO on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.\>
\>\>
\>
\>\> Cyclophosphamide: Given PO\>
\>\>
\>
\>\> Dexamethasone: Given PO\>
\>\>
\>
\>\> Ixazomib Citrate: Given PO\>
\>\>
\>
\>\> Laboratory Biomarker Analysis: Correlative studies\>
\>\>
\>
\>\> Pharmacological Study: Correlative studies\>
\>\>
\>
\>\> Quality-of-Life Assessment: Ancillary studies\>
\>\>
\>
\>\> Questionnaire Administration: Ancillary studies
|
|---|---|---|
|
Overall Study
STARTED
|
51
|
36
|
|
Overall Study
Accrued During Phase I
|
10
|
0
|
|
Overall Study
Accrued During Phase II
|
41
|
36
|
|
Overall Study
COMPLETED
|
48
|
35
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
Reasons for withdrawal
| Measure |
Phase I/II, Cohort A
Patients with Multiple Myeloma\>
\> INDUCTION THERAPY: Patients receive ixazomib citrate PO on days 1, 8, and 15 and cyclophosphamide PO and dexamethasone PO on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.\>
\>\>
\>
\>\> MAINTENANCE THERAPY: Patients receive ixazomib citrate PO on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.\>
\>\>
\>
\>\> Cyclophosphamide: Given PO\>
\>\>
\>
\>\> Dexamethasone: Given PO\>
\>\>
\>
\>\> Ixazomib Citrate: Given PO\>
\>\>
\>
\>\> Laboratory Biomarker Analysis: Correlative studies\>
\>\>
\>
\>\> Pharmacological Study: Correlative studies\>
\>\>
\>
\>\> Quality-of-Life Assessment: Ancillary studies\>
\>\>
\>
\>\> Questionnaire Administration: Ancillary studies
|
Phase II, Cohort B
Patients with biopsy proven light chain amyloidosis with organ involvement\> requiring therapy\>
\> INDUCTION THERAPY: Patients receive ixazomib citrate PO on days 1, 8, and 15 and cyclophosphamide PO and dexamethasone PO on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.\>
\>\>
\>
\>\> MAINTENANCE THERAPY: Patients receive ixazomib citrate PO on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.\>
\>\>
\>
\>\> Cyclophosphamide: Given PO\>
\>\>
\>
\>\> Dexamethasone: Given PO\>
\>\>
\>
\>\> Ixazomib Citrate: Given PO\>
\>\>
\>
\>\> Laboratory Biomarker Analysis: Correlative studies\>
\>\>
\>
\>\> Pharmacological Study: Correlative studies\>
\>\>
\>
\>\> Quality-of-Life Assessment: Ancillary studies\>
\>\>
\>
\>\> Questionnaire Administration: Ancillary studies
|
|---|---|---|
|
Overall Study
Ineligible
|
3
|
1
|
Baseline Characteristics
Ixazomib With Cyclophosphamide and Dexamethasone in Patients With Previously Untreated Symptomatic Multiple Myeloma or Light Chain Amyloidosis
Baseline characteristics by cohort
| Measure |
Phase I/II, Cohort A
n=48 Participants
Patients with multiple myeloma\>
\> INDUCTION THERAPY: Patients receive ixazomib citrate PO on days 1, 8, and 15 and cyclophosphamide PO and dexamethasone PO on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.\>
\>\>
\>
\>\> MAINTENANCE THERAPY: Patients receive ixazomib citrate PO on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.\>
\>\>
\>
\>\> Cyclophosphamide: Given PO\>
\>\>
\>
\>\> Dexamethasone: Given PO\>
\>\>
\>
\>\> Ixazomib Citrate: Given PO\>
\>\>
\>
\>\> Laboratory Biomarker Analysis: Correlative studies\>
\>\>
\>
\>\> Pharmacological Study: Correlative studies\>
\>\>
\>
\>\> Quality-of-Life Assessment: Ancillary studies\>
\>\>
\>
\>\> Questionnaire Administration: Ancillary studies
|
Phase II, Cohort B
n=35 Participants
Patients with biopsy proven light chain amyloidosis with organ involvement\> requiring therapy\>
\> INDUCTION THERAPY: Patients receive ixazomib citrate PO on days 1, 8, and 15 and cyclophosphamide PO and dexamethasone PO on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.\>
\>\>
\>
\>\> MAINTENANCE THERAPY: Patients receive ixazomib citrate PO on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.\>
\>\>
\>
\>\> Cyclophosphamide: Given PO\>
\>\>
\>
\>\> Dexamethasone: Given PO\>
\>\>
\>
\>\> Ixazomib Citrate: Given PO\>
\>\>
\>
\>\> Laboratory Biomarker Analysis: Correlative studies\>
\>\>
\>
\>\> Pharmacological Study: Correlative studies\>
\>\>
\>
\>\> Quality-of-Life Assessment: Ancillary studies\>
\>\>
\>
\>\> Questionnaire Administration: Ancillary studies
|
Total
n=83 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64.5 years
n=5 Participants
|
67 years
n=7 Participants
|
65 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
46 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
81 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
48 participants
n=5 Participants
|
35 participants
n=7 Participants
|
83 participants
n=5 Participants
|
|
ECOG Performance Status
0
|
25 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
ECOG Performance Status
1
|
19 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
ECOG Performance Status
2
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At 28 daysPopulation: The 10 patients accrued to the phase I portion of the study were analyzed to determine the maximum tolerated dose of ixazomib with cyclophosphamide and dexamethasone
Will be defined as the dose level below the lowest dose that induces dose-limiting toxicity in at least 1/3 of patients, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0.
Outcome measures
| Measure |
Treatment (Ixazomib Citrate, Cyclophosphamide, Dexamethasone)
n=10 Participants
INDUCTION THERAPY: Patients receive ixazomib citrate PO on days 1, 8, and 15 and cyclophosphamide PO and dexamethasone PO on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.\> \>\>
\>
\>\> MAINTENANCE THERAPY: Patients receive ixazomib citrate PO on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.\>
\>\>
\>
\>\> Cyclophosphamide: Given PO\>
\>\>
\>
\>\> Dexamethasone: Given PO\>
\>\>
\>
\>\> Ixazomib Citrate: Given PO\>
\>\>
\>
\>\> Laboratory Biomarker Analysis: Correlative studies\>
\>\>
\>
\>\> Pharmacological Study: Correlative studies\>
\>\>
\>
\>\> Quality-of-Life Assessment: Ancillary studies\>
\>\>
\>
\>\> Questionnaire Administration: Ancillary studies
|
Phase II, Cohort B
Patients with biopsy proven light chain amyloidosis with organ involvement\> requiring therapy\>
\> INDUCTION THERAPY: Patients receive ixazomib citrate PO on days 1, 8, and 15 and cyclophosphamide PO and dexamethasone PO on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.\>
\>\>
\>
\>\> MAINTENANCE THERAPY: Patients receive ixazomib citrate PO on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.\>
\>\>
\>
\>\> Cyclophosphamide: Given PO\>
\>\>
\>
\>\> Dexamethasone: Given PO\>
\>\>
\>
\>\> Ixazomib Citrate: Given PO\>
\>\>
\>
\>\> Laboratory Biomarker Analysis: Correlative studies\>
\>\>
\>
\>\> Pharmacological Study: Correlative studies\>
\>\>
\>
\>\> Quality-of-Life Assessment: Ancillary studies\>
\>\>
\>
\>\> Questionnaire Administration: Ancillary studies
|
|---|---|---|
|
Maximum Tolerated (MTD) Dose of Cyclophosphamide With Ixazomib and Dexamethasone (Phase I)
MTD of ixazomib
|
4 mg weekly
|
—
|
|
Maximum Tolerated (MTD) Dose of Cyclophosphamide With Ixazomib and Dexamethasone (Phase I)
MTD of dexamethasone
|
40 mg weekly
|
—
|
PRIMARY outcome
Timeframe: Up to 48 weeksPopulation: Includes only eligible patients in phase II, cohort A
The percentage of successes will be estimated by the number of successes divided by the total number of evaluable patients. Exact binomial 95% confidence intervals for the true success proportion will be calculated.
Outcome measures
| Measure |
Treatment (Ixazomib Citrate, Cyclophosphamide, Dexamethasone)
n=48 Participants
INDUCTION THERAPY: Patients receive ixazomib citrate PO on days 1, 8, and 15 and cyclophosphamide PO and dexamethasone PO on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.\> \>\>
\>
\>\> MAINTENANCE THERAPY: Patients receive ixazomib citrate PO on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.\>
\>\>
\>
\>\> Cyclophosphamide: Given PO\>
\>\>
\>
\>\> Dexamethasone: Given PO\>
\>\>
\>
\>\> Ixazomib Citrate: Given PO\>
\>\>
\>
\>\> Laboratory Biomarker Analysis: Correlative studies\>
\>\>
\>
\>\> Pharmacological Study: Correlative studies\>
\>\>
\>
\>\> Quality-of-Life Assessment: Ancillary studies\>
\>\>
\>
\>\> Questionnaire Administration: Ancillary studies
|
Phase II, Cohort B
Patients with biopsy proven light chain amyloidosis with organ involvement\> requiring therapy\>
\> INDUCTION THERAPY: Patients receive ixazomib citrate PO on days 1, 8, and 15 and cyclophosphamide PO and dexamethasone PO on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.\>
\>\>
\>
\>\> MAINTENANCE THERAPY: Patients receive ixazomib citrate PO on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.\>
\>\>
\>
\>\> Cyclophosphamide: Given PO\>
\>\>
\>
\>\> Dexamethasone: Given PO\>
\>\>
\>
\>\> Ixazomib Citrate: Given PO\>
\>\>
\>
\>\> Laboratory Biomarker Analysis: Correlative studies\>
\>\>
\>
\>\> Pharmacological Study: Correlative studies\>
\>\>
\>
\>\> Quality-of-Life Assessment: Ancillary studies\>
\>\>
\>
\>\> Questionnaire Administration: Ancillary studies
|
|---|---|---|
|
Percentage of Patients With Complete Response or Very Good Partial Response (Phase II, Cohort A)
|
35 percentage of participants
Interval 22.0 to 50.0
|
—
|
PRIMARY outcome
Timeframe: Up to 48 weeksPopulation: Includes only patients with biopsy proven light chain amyloidosis with organ involvement\>\> requiring therapy at baseline
The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. Exact binomial 95% confidence intervals for the true success proportion will be calculated.
Outcome measures
| Measure |
Treatment (Ixazomib Citrate, Cyclophosphamide, Dexamethasone)
n=35 Participants
INDUCTION THERAPY: Patients receive ixazomib citrate PO on days 1, 8, and 15 and cyclophosphamide PO and dexamethasone PO on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.\> \>\>
\>
\>\> MAINTENANCE THERAPY: Patients receive ixazomib citrate PO on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.\>
\>\>
\>
\>\> Cyclophosphamide: Given PO\>
\>\>
\>
\>\> Dexamethasone: Given PO\>
\>\>
\>
\>\> Ixazomib Citrate: Given PO\>
\>\>
\>
\>\> Laboratory Biomarker Analysis: Correlative studies\>
\>\>
\>
\>\> Pharmacological Study: Correlative studies\>
\>\>
\>
\>\> Quality-of-Life Assessment: Ancillary studies\>
\>\>
\>
\>\> Questionnaire Administration: Ancillary studies
|
Phase II, Cohort B
Patients with biopsy proven light chain amyloidosis with organ involvement\> requiring therapy\>
\> INDUCTION THERAPY: Patients receive ixazomib citrate PO on days 1, 8, and 15 and cyclophosphamide PO and dexamethasone PO on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.\>
\>\>
\>
\>\> MAINTENANCE THERAPY: Patients receive ixazomib citrate PO on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.\>
\>\>
\>
\>\> Cyclophosphamide: Given PO\>
\>\>
\>
\>\> Dexamethasone: Given PO\>
\>\>
\>
\>\> Ixazomib Citrate: Given PO\>
\>\>
\>
\>\> Laboratory Biomarker Analysis: Correlative studies\>
\>\>
\>
\>\> Pharmacological Study: Correlative studies\>
\>\>
\>
\>\> Quality-of-Life Assessment: Ancillary studies\>
\>\>
\>
\>\> Questionnaire Administration: Ancillary studies
|
|---|---|---|
|
Rate of Complete Response, Very Good Partial Response, or Partial Response (Phase II, Cohort B)
|
63 percentage of participants
Interval 45.0 to 79.0
|
—
|
PRIMARY outcome
Timeframe: At 28 daysPopulation: The 10 patients accrued to the phase I portion of the study were analyzed to determine the maximum tolerated dose of ixazomib with cyclophosphamide and dexamethasone
Will be defined as the dose level below the lowest dose that induces dose-limiting toxicity in at least 1/3 of patients, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0.
Outcome measures
| Measure |
Treatment (Ixazomib Citrate, Cyclophosphamide, Dexamethasone)
n=10 Participants
INDUCTION THERAPY: Patients receive ixazomib citrate PO on days 1, 8, and 15 and cyclophosphamide PO and dexamethasone PO on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.\> \>\>
\>
\>\> MAINTENANCE THERAPY: Patients receive ixazomib citrate PO on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.\>
\>\>
\>
\>\> Cyclophosphamide: Given PO\>
\>\>
\>
\>\> Dexamethasone: Given PO\>
\>\>
\>
\>\> Ixazomib Citrate: Given PO\>
\>\>
\>
\>\> Laboratory Biomarker Analysis: Correlative studies\>
\>\>
\>
\>\> Pharmacological Study: Correlative studies\>
\>\>
\>
\>\> Quality-of-Life Assessment: Ancillary studies\>
\>\>
\>
\>\> Questionnaire Administration: Ancillary studies
|
Phase II, Cohort B
Patients with biopsy proven light chain amyloidosis with organ involvement\> requiring therapy\>
\> INDUCTION THERAPY: Patients receive ixazomib citrate PO on days 1, 8, and 15 and cyclophosphamide PO and dexamethasone PO on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.\>
\>\>
\>
\>\> MAINTENANCE THERAPY: Patients receive ixazomib citrate PO on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.\>
\>\>
\>
\>\> Cyclophosphamide: Given PO\>
\>\>
\>
\>\> Dexamethasone: Given PO\>
\>\>
\>
\>\> Ixazomib Citrate: Given PO\>
\>\>
\>
\>\> Laboratory Biomarker Analysis: Correlative studies\>
\>\>
\>
\>\> Pharmacological Study: Correlative studies\>
\>\>
\>
\>\> Quality-of-Life Assessment: Ancillary studies\>
\>\>
\>
\>\> Questionnaire Administration: Ancillary studies
|
|---|---|---|
|
Maximum Tolerated (MTD) Dose of Cyclophosphamide (Phase I)
|
400 mg/m² weekly
|
—
|
SECONDARY outcome
Timeframe: Up to 5 yearsThe maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine patterns. Additionally, the relationship of the adverse event(s) to the study treatment will be taken into consideration. Adverse events will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0. A grade 3 event is one that is severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL.
Outcome measures
| Measure |
Treatment (Ixazomib Citrate, Cyclophosphamide, Dexamethasone)
n=48 Participants
INDUCTION THERAPY: Patients receive ixazomib citrate PO on days 1, 8, and 15 and cyclophosphamide PO and dexamethasone PO on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.\> \>\>
\>
\>\> MAINTENANCE THERAPY: Patients receive ixazomib citrate PO on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.\>
\>\>
\>
\>\> Cyclophosphamide: Given PO\>
\>\>
\>
\>\> Dexamethasone: Given PO\>
\>\>
\>
\>\> Ixazomib Citrate: Given PO\>
\>\>
\>
\>\> Laboratory Biomarker Analysis: Correlative studies\>
\>\>
\>
\>\> Pharmacological Study: Correlative studies\>
\>\>
\>
\>\> Quality-of-Life Assessment: Ancillary studies\>
\>\>
\>
\>\> Questionnaire Administration: Ancillary studies
|
Phase II, Cohort B
n=35 Participants
Patients with biopsy proven light chain amyloidosis with organ involvement\> requiring therapy\>
\> INDUCTION THERAPY: Patients receive ixazomib citrate PO on days 1, 8, and 15 and cyclophosphamide PO and dexamethasone PO on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.\>
\>\>
\>
\>\> MAINTENANCE THERAPY: Patients receive ixazomib citrate PO on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.\>
\>\>
\>
\>\> Cyclophosphamide: Given PO\>
\>\>
\>
\>\> Dexamethasone: Given PO\>
\>\>
\>
\>\> Ixazomib Citrate: Given PO\>
\>\>
\>
\>\> Laboratory Biomarker Analysis: Correlative studies\>
\>\>
\>
\>\> Pharmacological Study: Correlative studies\>
\>\>
\>
\>\> Quality-of-Life Assessment: Ancillary studies\>
\>\>
\>
\>\> Questionnaire Administration: Ancillary studies
|
|---|---|---|
|
Number of Patients Experiencing a Grade 3 or Greater Adverse Event at Least Possibly Related to Treatment as Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
|
36 Participants
|
16 Participants
|
SECONDARY outcome
Timeframe: Time from registration to the earliest date of documentation of disease progression or death due to any cause, assessed up to 5 yearsThe distribution of PFS will be estimated using the method of Kaplan Meier.
Outcome measures
| Measure |
Treatment (Ixazomib Citrate, Cyclophosphamide, Dexamethasone)
n=48 Participants
INDUCTION THERAPY: Patients receive ixazomib citrate PO on days 1, 8, and 15 and cyclophosphamide PO and dexamethasone PO on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.\> \>\>
\>
\>\> MAINTENANCE THERAPY: Patients receive ixazomib citrate PO on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.\>
\>\>
\>
\>\> Cyclophosphamide: Given PO\>
\>\>
\>
\>\> Dexamethasone: Given PO\>
\>\>
\>
\>\> Ixazomib Citrate: Given PO\>
\>\>
\>
\>\> Laboratory Biomarker Analysis: Correlative studies\>
\>\>
\>
\>\> Pharmacological Study: Correlative studies\>
\>\>
\>
\>\> Quality-of-Life Assessment: Ancillary studies\>
\>\>
\>
\>\> Questionnaire Administration: Ancillary studies
|
Phase II, Cohort B
n=35 Participants
Patients with biopsy proven light chain amyloidosis with organ involvement\> requiring therapy\>
\> INDUCTION THERAPY: Patients receive ixazomib citrate PO on days 1, 8, and 15 and cyclophosphamide PO and dexamethasone PO on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.\>
\>\>
\>
\>\> MAINTENANCE THERAPY: Patients receive ixazomib citrate PO on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.\>
\>\>
\>
\>\> Cyclophosphamide: Given PO\>
\>\>
\>
\>\> Dexamethasone: Given PO\>
\>\>
\>
\>\> Ixazomib Citrate: Given PO\>
\>\>
\>
\>\> Laboratory Biomarker Analysis: Correlative studies\>
\>\>
\>
\>\> Pharmacological Study: Correlative studies\>
\>\>
\>
\>\> Quality-of-Life Assessment: Ancillary studies\>
\>\>
\>
\>\> Questionnaire Administration: Ancillary studies
|
|---|---|---|
|
Progression-free Survival (PFS)
|
NA months
Interval 31.3 to
Median and upper 95% CI PFS was not reached due to the low number of progressions (11)
|
NA months
Interval 39.6 to
Median and upper 95% CI PFS was not reached due to the low number of progressions (5)
|
SECONDARY outcome
Timeframe: Time from registration to death due to any cause, assessed up to 5 yearsThe distribution of survival time will be estimated using the method of Kaplan-Meier.
Outcome measures
| Measure |
Treatment (Ixazomib Citrate, Cyclophosphamide, Dexamethasone)
n=48 Participants
INDUCTION THERAPY: Patients receive ixazomib citrate PO on days 1, 8, and 15 and cyclophosphamide PO and dexamethasone PO on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.\> \>\>
\>
\>\> MAINTENANCE THERAPY: Patients receive ixazomib citrate PO on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.\>
\>\>
\>
\>\> Cyclophosphamide: Given PO\>
\>\>
\>
\>\> Dexamethasone: Given PO\>
\>\>
\>
\>\> Ixazomib Citrate: Given PO\>
\>\>
\>
\>\> Laboratory Biomarker Analysis: Correlative studies\>
\>\>
\>
\>\> Pharmacological Study: Correlative studies\>
\>\>
\>
\>\> Quality-of-Life Assessment: Ancillary studies\>
\>\>
\>
\>\> Questionnaire Administration: Ancillary studies
|
Phase II, Cohort B
n=35 Participants
Patients with biopsy proven light chain amyloidosis with organ involvement\> requiring therapy\>
\> INDUCTION THERAPY: Patients receive ixazomib citrate PO on days 1, 8, and 15 and cyclophosphamide PO and dexamethasone PO on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.\>
\>\>
\>
\>\> MAINTENANCE THERAPY: Patients receive ixazomib citrate PO on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.\>
\>\>
\>
\>\> Cyclophosphamide: Given PO\>
\>\>
\>
\>\> Dexamethasone: Given PO\>
\>\>
\>
\>\> Ixazomib Citrate: Given PO\>
\>\>
\>
\>\> Laboratory Biomarker Analysis: Correlative studies\>
\>\>
\>
\>\> Pharmacological Study: Correlative studies\>
\>\>
\>
\>\> Quality-of-Life Assessment: Ancillary studies\>
\>\>
\>
\>\> Questionnaire Administration: Ancillary studies
|
|---|---|---|
|
Survival Time
|
NA months
Median and 95% CI PFS was not reached due to the low number of deaths (2)
|
NA months
Median and 95% CI PFS was not reached due to the low number of deaths (7)
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Post-dose, 1 and 4 hours on day 1, pre-dose on days 8, 15, and 22, and day 1 of course 2Will be estimated using noncompartmental analysis methods. The plasma PK parameters calculated for individual plasma ixazomib concentration-time data will include, but are not limited to: peak concentration, time to first maximum plasma concentration, and area under the curve. PK parameters will be summarized using descriptive statistics.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 5 yearsPatients will be evaluated by overall score at each time point and changes over time will be calculated. These measures will be correlated with outcome using Fisher's exact test and Kaplan-Meier methods where appropriate.
Outcome measures
Outcome data not reported
Adverse Events
Phase I/II, Cohort A
Serious events: 16 serious events
Other events: 48 other events
Deaths: 2 deaths
Phase II, Cohort B
Serious events: 15 serious events
Other events: 35 other events
Deaths: 7 deaths
Serious adverse events
| Measure |
Phase I/II, Cohort A
n=48 participants at risk
Questionnaire Administration: Ancillary studies
|
Phase II, Cohort B
n=35 participants at risk
Questionnaire Administration: Ancillary studies
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
2.1%
1/48 • Number of events 1 • 5 years
|
0.00%
0/35 • 5 years
|
|
Cardiac disorders
Atrial fibrillation
|
2.1%
1/48 • Number of events 1 • 5 years
|
8.6%
3/35 • Number of events 3 • 5 years
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/48 • 5 years
|
2.9%
1/35 • Number of events 1 • 5 years
|
|
Cardiac disorders
Chest pain - cardiac
|
0.00%
0/48 • 5 years
|
2.9%
1/35 • Number of events 1 • 5 years
|
|
Cardiac disorders
Heart failure
|
0.00%
0/48 • 5 years
|
8.6%
3/35 • Number of events 3 • 5 years
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/48 • 5 years
|
2.9%
1/35 • Number of events 1 • 5 years
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/48 • 5 years
|
2.9%
1/35 • Number of events 1 • 5 years
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/48 • 5 years
|
2.9%
1/35 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
Diarrhea
|
2.1%
1/48 • Number of events 1 • 5 years
|
0.00%
0/35 • 5 years
|
|
Gastrointestinal disorders
Gastric hemorrhage
|
2.1%
1/48 • Number of events 1 • 5 years
|
0.00%
0/35 • 5 years
|
|
Gastrointestinal disorders
Pancreatitis
|
2.1%
1/48 • Number of events 1 • 5 years
|
0.00%
0/35 • 5 years
|
|
General disorders
Death NOS
|
0.00%
0/48 • 5 years
|
2.9%
1/35 • Number of events 1 • 5 years
|
|
General disorders
Fatigue
|
2.1%
1/48 • Number of events 1 • 5 years
|
0.00%
0/35 • 5 years
|
|
Hepatobiliary disorders
Cholecystitis
|
2.1%
1/48 • Number of events 1 • 5 years
|
0.00%
0/35 • 5 years
|
|
Immune system disorders
Allergic reaction
|
0.00%
0/48 • 5 years
|
2.9%
1/35 • Number of events 1 • 5 years
|
|
Infections and infestations
Infections and infestations - Oth spec
|
0.00%
0/48 • 5 years
|
2.9%
1/35 • Number of events 1 • 5 years
|
|
Infections and infestations
Lung infection
|
0.00%
0/48 • 5 years
|
8.6%
3/35 • Number of events 3 • 5 years
|
|
Infections and infestations
Skin infection
|
0.00%
0/48 • 5 years
|
2.9%
1/35 • Number of events 1 • 5 years
|
|
Infections and infestations
Upper respiratory infection
|
2.1%
1/48 • Number of events 1 • 5 years
|
0.00%
0/35 • 5 years
|
|
Infections and infestations
Urinary tract infection
|
2.1%
1/48 • Number of events 1 • 5 years
|
2.9%
1/35 • Number of events 1 • 5 years
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
0.00%
0/48 • 5 years
|
2.9%
1/35 • Number of events 1 • 5 years
|
|
Investigations
Alanine aminotransferase increased
|
2.1%
1/48 • Number of events 1 • 5 years
|
0.00%
0/35 • 5 years
|
|
Investigations
Alkaline phosphatase increased
|
0.00%
0/48 • 5 years
|
2.9%
1/35 • Number of events 1 • 5 years
|
|
Investigations
Aspartate aminotransferase increased
|
2.1%
1/48 • Number of events 1 • 5 years
|
0.00%
0/35 • 5 years
|
|
Investigations
Blood bilirubin increased
|
2.1%
1/48 • Number of events 1 • 5 years
|
0.00%
0/35 • 5 years
|
|
Investigations
Lymphocyte count decreased
|
10.4%
5/48 • Number of events 5 • 5 years
|
0.00%
0/35 • 5 years
|
|
Investigations
Neutrophil count decreased
|
4.2%
2/48 • Number of events 2 • 5 years
|
0.00%
0/35 • 5 years
|
|
Investigations
Platelet count decreased
|
2.1%
1/48 • Number of events 2 • 5 years
|
5.7%
2/35 • Number of events 2 • 5 years
|
|
Investigations
Weight gain
|
2.1%
1/48 • Number of events 12 • 5 years
|
0.00%
0/35 • 5 years
|
|
Investigations
White blood cell decreased
|
4.2%
2/48 • Number of events 2 • 5 years
|
2.9%
1/35 • Number of events 1 • 5 years
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
4.2%
2/48 • Number of events 3 • 5 years
|
2.9%
1/35 • Number of events 1 • 5 years
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/48 • 5 years
|
2.9%
1/35 • Number of events 1 • 5 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
2.1%
1/48 • Number of events 1 • 5 years
|
0.00%
0/35 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.1%
1/48 • Number of events 1 • 5 years
|
0.00%
0/35 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
2.1%
1/48 • Number of events 1 • 5 years
|
0.00%
0/35 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
0.00%
0/48 • 5 years
|
2.9%
1/35 • Number of events 1 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
2.1%
1/48 • Number of events 1 • 5 years
|
0.00%
0/35 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, mal, uncpec - Oth spec
|
0.00%
0/48 • 5 years
|
2.9%
1/35 • Number of events 1 • 5 years
|
|
Nervous system disorders
Leukoencephalopathy
|
2.1%
1/48 • Number of events 1 • 5 years
|
0.00%
0/35 • 5 years
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
2.1%
1/48 • Number of events 1 • 5 years
|
2.9%
1/35 • Number of events 1 • 5 years
|
|
Nervous system disorders
Stroke
|
0.00%
0/48 • 5 years
|
2.9%
1/35 • Number of events 1 • 5 years
|
|
Nervous system disorders
Syncope
|
0.00%
0/48 • 5 years
|
5.7%
2/35 • Number of events 2 • 5 years
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/48 • 5 years
|
2.9%
1/35 • Number of events 1 • 5 years
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.00%
0/48 • 5 years
|
2.9%
1/35 • Number of events 1 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial obstruction
|
0.00%
0/48 • 5 years
|
2.9%
1/35 • Number of events 1 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/48 • 5 years
|
5.7%
2/35 • Number of events 3 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
2.1%
1/48 • Number of events 1 • 5 years
|
0.00%
0/35 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/48 • 5 years
|
2.9%
1/35 • Number of events 1 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/48 • 5 years
|
2.9%
1/35 • Number of events 1 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Resp, thoracic, mediastinal - Oth spec
|
2.1%
1/48 • Number of events 1 • 5 years
|
0.00%
0/35 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
2.1%
1/48 • Number of events 1 • 5 years
|
0.00%
0/35 • 5 years
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
4.2%
2/48 • Number of events 2 • 5 years
|
0.00%
0/35 • 5 years
|
|
Vascular disorders
Hypotension
|
0.00%
0/48 • 5 years
|
2.9%
1/35 • Number of events 1 • 5 years
|
Other adverse events
| Measure |
Phase I/II, Cohort A
n=48 participants at risk
Questionnaire Administration: Ancillary studies
|
Phase II, Cohort B
n=35 participants at risk
Questionnaire Administration: Ancillary studies
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
29.2%
14/48 • Number of events 29 • 5 years
|
5.7%
2/35 • Number of events 3 • 5 years
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
2.1%
1/48 • Number of events 1 • 5 years
|
0.00%
0/35 • 5 years
|
|
Cardiac disorders
Chest pain - cardiac
|
0.00%
0/48 • 5 years
|
2.9%
1/35 • Number of events 2 • 5 years
|
|
Cardiac disorders
Heart failure
|
2.1%
1/48 • Number of events 5 • 5 years
|
0.00%
0/35 • 5 years
|
|
Ear and labyrinth disorders
Hearing impaired
|
2.1%
1/48 • Number of events 4 • 5 years
|
0.00%
0/35 • 5 years
|
|
Eye disorders
Cataract
|
2.1%
1/48 • Number of events 3 • 5 years
|
0.00%
0/35 • 5 years
|
|
Gastrointestinal disorders
Constipation
|
75.0%
36/48 • Number of events 179 • 5 years
|
71.4%
25/35 • Number of events 68 • 5 years
|
|
Gastrointestinal disorders
Diarrhea
|
60.4%
29/48 • Number of events 115 • 5 years
|
42.9%
15/35 • Number of events 48 • 5 years
|
|
Gastrointestinal disorders
Duodenal ulcer
|
2.1%
1/48 • Number of events 2 • 5 years
|
0.00%
0/35 • 5 years
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/48 • 5 years
|
2.9%
1/35 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
2.1%
1/48 • Number of events 2 • 5 years
|
2.9%
1/35 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Oth spec
|
4.2%
2/48 • Number of events 2 • 5 years
|
0.00%
0/35 • 5 years
|
|
Gastrointestinal disorders
Nausea
|
60.4%
29/48 • Number of events 138 • 5 years
|
62.9%
22/35 • Number of events 66 • 5 years
|
|
Gastrointestinal disorders
Vomiting
|
25.0%
12/48 • Number of events 17 • 5 years
|
17.1%
6/35 • Number of events 11 • 5 years
|
|
General disorders
Edema limbs
|
2.1%
1/48 • Number of events 2 • 5 years
|
17.1%
6/35 • Number of events 10 • 5 years
|
|
General disorders
Edema trunk
|
0.00%
0/48 • 5 years
|
2.9%
1/35 • Number of events 1 • 5 years
|
|
General disorders
Fatigue
|
97.9%
47/48 • Number of events 546 • 5 years
|
91.4%
32/35 • Number of events 221 • 5 years
|
|
General disorders
Pain
|
2.1%
1/48 • Number of events 4 • 5 years
|
0.00%
0/35 • 5 years
|
|
Infections and infestations
Infections and infestations - Oth spec
|
2.1%
1/48 • Number of events 1 • 5 years
|
0.00%
0/35 • 5 years
|
|
Infections and infestations
Lung infection
|
0.00%
0/48 • 5 years
|
2.9%
1/35 • Number of events 1 • 5 years
|
|
Infections and infestations
Sepsis
|
6.2%
3/48 • Number of events 4 • 5 years
|
0.00%
0/35 • 5 years
|
|
Infections and infestations
Upper respiratory infection
|
2.1%
1/48 • Number of events 1 • 5 years
|
0.00%
0/35 • 5 years
|
|
Investigations
Alkaline phosphatase increased
|
2.1%
1/48 • Number of events 3 • 5 years
|
2.9%
1/35 • Number of events 5 • 5 years
|
|
Investigations
CD4 lymphocytes decreased
|
10.4%
5/48 • Number of events 5 • 5 years
|
0.00%
0/35 • 5 years
|
|
Investigations
Creatinine increased
|
20.8%
10/48 • Number of events 25 • 5 years
|
42.9%
15/35 • Number of events 138 • 5 years
|
|
Investigations
Lymphocyte count decreased
|
87.5%
42/48 • Number of events 296 • 5 years
|
25.7%
9/35 • Number of events 40 • 5 years
|
|
Investigations
Lymphocyte count increased
|
10.4%
5/48 • Number of events 8 • 5 years
|
5.7%
2/35 • Number of events 2 • 5 years
|
|
Investigations
Neutrophil count decreased
|
60.4%
29/48 • Number of events 138 • 5 years
|
5.7%
2/35 • Number of events 3 • 5 years
|
|
Investigations
Platelet count decreased
|
64.6%
31/48 • Number of events 86 • 5 years
|
31.4%
11/35 • Number of events 25 • 5 years
|
|
Investigations
White blood cell decreased
|
87.5%
42/48 • Number of events 230 • 5 years
|
17.1%
6/35 • Number of events 8 • 5 years
|
|
Metabolism and nutrition disorders
Anorexia
|
4.2%
2/48 • Number of events 3 • 5 years
|
0.00%
0/35 • 5 years
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
8.3%
4/48 • Number of events 9 • 5 years
|
5.7%
2/35 • Number of events 3 • 5 years
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
0.00%
0/48 • 5 years
|
2.9%
1/35 • Number of events 3 • 5 years
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
0.00%
0/48 • 5 years
|
2.9%
1/35 • Number of events 1 • 5 years
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
2.1%
1/48 • Number of events 1 • 5 years
|
0.00%
0/35 • 5 years
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/48 • 5 years
|
2.9%
1/35 • Number of events 1 • 5 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/48 • 5 years
|
2.9%
1/35 • Number of events 1 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
2.1%
1/48 • Number of events 2 • 5 years
|
0.00%
0/35 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
2.1%
1/48 • Number of events 1 • 5 years
|
0.00%
0/35 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal, conn tissue - Oth spec
|
2.1%
1/48 • Number of events 1 • 5 years
|
0.00%
0/35 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
4.2%
2/48 • Number of events 7 • 5 years
|
0.00%
0/35 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, mal, uncpec - Oth spec
|
2.1%
1/48 • Number of events 1 • 5 years
|
0.00%
0/35 • 5 years
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/48 • 5 years
|
2.9%
1/35 • Number of events 1 • 5 years
|
|
Nervous system disorders
Headache
|
2.1%
1/48 • Number of events 1 • 5 years
|
0.00%
0/35 • 5 years
|
|
Nervous system disorders
Peripheral motor neuropathy
|
18.8%
9/48 • Number of events 24 • 5 years
|
8.6%
3/35 • Number of events 4 • 5 years
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
72.9%
35/48 • Number of events 361 • 5 years
|
54.3%
19/35 • Number of events 91 • 5 years
|
|
Psychiatric disorders
Agitation
|
2.1%
1/48 • Number of events 1 • 5 years
|
0.00%
0/35 • 5 years
|
|
Psychiatric disorders
Anxiety
|
2.1%
1/48 • Number of events 1 • 5 years
|
0.00%
0/35 • 5 years
|
|
Psychiatric disorders
Confusion
|
2.1%
1/48 • Number of events 1 • 5 years
|
0.00%
0/35 • 5 years
|
|
Psychiatric disorders
Insomnia
|
12.5%
6/48 • Number of events 10 • 5 years
|
22.9%
8/35 • Number of events 18 • 5 years
|
|
Psychiatric disorders
Libido decreased
|
2.1%
1/48 • Number of events 9 • 5 years
|
0.00%
0/35 • 5 years
|
|
Renal and urinary disorders
Hematuria
|
2.1%
1/48 • Number of events 1 • 5 years
|
2.9%
1/35 • Number of events 1 • 5 years
|
|
Renal and urinary disorders
Urinary frequency
|
0.00%
0/48 • 5 years
|
2.9%
1/35 • Number of events 1 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
2.1%
1/48 • Number of events 1 • 5 years
|
14.3%
5/35 • Number of events 10 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/48 • 5 years
|
2.9%
1/35 • Number of events 7 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
0.00%
0/48 • 5 years
|
2.9%
1/35 • Number of events 2 • 5 years
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
2.1%
1/48 • Number of events 1 • 5 years
|
0.00%
0/35 • 5 years
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
39.6%
19/48 • Number of events 34 • 5 years
|
31.4%
11/35 • Number of events 70 • 5 years
|
|
Vascular disorders
Hematoma
|
2.1%
1/48 • Number of events 1 • 5 years
|
0.00%
0/35 • 5 years
|
|
Vascular disorders
Hypotension
|
0.00%
0/48 • 5 years
|
2.9%
1/35 • Number of events 1 • 5 years
|
|
Vascular disorders
Thromboembolic event
|
2.1%
1/48 • Number of events 12 • 5 years
|
5.7%
2/35 • Number of events 7 • 5 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place