Trial Outcomes & Findings for Ixazomib Citrate in Treating Patients With Chronic Graft-versus-Host Disease (NCT NCT02513498)
NCT ID: NCT02513498
Last Updated: 2019-02-06
Results Overview
According to National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.0
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
50 participants
Primary outcome timeframe
Up to 30 days following completion of study treatment
Results posted on
2019-02-06
Participant Flow
Participant milestones
| Measure |
Treatment (Ixazomib Citrate)
Patients receive ixazomib citrate PO once weekly on days 1, 8, and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients with complete response, partial response, or stable disease may receive an additional 6 courses of ixazomib citrate.
|
|---|---|
|
Overall Study
STARTED
|
50
|
|
Overall Study
COMPLETED
|
26
|
|
Overall Study
NOT COMPLETED
|
24
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Ixazomib Citrate in Treating Patients With Chronic Graft-versus-Host Disease
Baseline characteristics by cohort
| Measure |
Treatment (Ixazomib Citrate)
n=50 Participants
Patients receive ixazomib citrate PO once weekly on days 1, 8, and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients with complete response, partial response, or stable disease may receive an additional 6 courses of ixazomib citrate.
|
|---|---|
|
Age, Continuous
|
58 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
38 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
42 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
3 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
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
43 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
|
Primary Disease
Acute leukemia (ALL/AML)
|
26 Participants
n=5 Participants
|
|
Primary Disease
Chronic leukemia (CML/CLL)
|
6 Participants
n=5 Participants
|
|
Primary Disease
Lymphoma (NHL/HD)
|
9 Participants
n=5 Participants
|
|
Primary Disease
Myeloma
|
2 Participants
n=5 Participants
|
|
Primary Disease
MDS/Myeloproliferative neoplasm
|
4 Participants
n=5 Participants
|
|
Primary Disease
Other
|
3 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 30 days following completion of study treatmentAccording to National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.0
Outcome measures
| Measure |
Treatment (Ixazomib Citrate)
n=50 Participants
Patients receive ixazomib citrate PO once weekly on days 1, 8, and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients with complete response, partial response, or stable disease may receive an additional 6 courses of ixazomib citrate.
|
Response Evaluated by NIH
Participants who receive ixazomib citrate
|
|---|---|---|
|
Incidence of Adverse Events
Serious Adverse Events
|
19 participants
|
—
|
|
Incidence of Adverse Events
Non-Serious Adverse Events
|
18 participants
|
—
|
PRIMARY outcome
Timeframe: 6 monthsKaplan-Meier estimate assessed at 6 months for probability of treatment failure, defined as addition of a line of systemic immune-suppressive therapy, recurrent malignancy, or death.
Outcome measures
| Measure |
Treatment (Ixazomib Citrate)
n=50 Participants
Patients receive ixazomib citrate PO once weekly on days 1, 8, and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients with complete response, partial response, or stable disease may receive an additional 6 courses of ixazomib citrate.
|
Response Evaluated by NIH
Participants who receive ixazomib citrate
|
|---|---|---|
|
Probability of Treatment Failure at 6 Months
|
.28 Treatment failure probability
|
—
|
SECONDARY outcome
Timeframe: Up to 6 monthsPopulation: Response to study drug too minimal to justify time and expense to perform biologic studies.
The biologic impact of proteasome inhibition in the treatment of chronic GVHD will be assessed.
Outcome measures
| Measure |
Treatment (Ixazomib Citrate)
n=50 Participants
Patients receive ixazomib citrate PO once weekly on days 1, 8, and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients with complete response, partial response, or stable disease may receive an additional 6 courses of ixazomib citrate.
|
Response Evaluated by NIH
Participants who receive ixazomib citrate
|
|---|---|---|
|
Biologic Studies
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Participants who could be evaluated for response (not missing data)
Response will be determined by both clinician-defined, as well as separately calculated according to the proposed response definitions of the NIH Consensus Conference.
Outcome measures
| Measure |
Treatment (Ixazomib Citrate)
n=42 Participants
Patients receive ixazomib citrate PO once weekly on days 1, 8, and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients with complete response, partial response, or stable disease may receive an additional 6 courses of ixazomib citrate.
|
Response Evaluated by NIH
n=43 Participants
Participants who receive ixazomib citrate
|
|---|---|---|
|
Complete Response (CR) Rate
Progressive
|
3 Participants
|
2 Participants
|
|
Complete Response (CR) Rate
Partial Response
|
16 Participants
|
17 Participants
|
|
Complete Response (CR) Rate
Mixed Response
|
4 Participants
|
10 Participants
|
|
Complete Response (CR) Rate
Unchanged
|
9 Participants
|
4 Participants
|
|
Complete Response (CR) Rate
Failed
|
10 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: 1 yearKaplan-Meier estimate assessed at 1 year for probability of non-relapse mortality, defined as death in the absence of primary malignancy relapse after transplant.
Outcome measures
| Measure |
Treatment (Ixazomib Citrate)
n=50 Participants
Patients receive ixazomib citrate PO once weekly on days 1, 8, and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients with complete response, partial response, or stable disease may receive an additional 6 courses of ixazomib citrate.
|
Response Evaluated by NIH
Participants who receive ixazomib citrate
|
|---|---|---|
|
Probability of Non-relapse Mortality at 1 Year
|
0.1 non-relapse mortality probability
|
—
|
SECONDARY outcome
Timeframe: 1 yearDefined as hematologic relapse or any unplanned intervention to prevent progression of disease in patients with evidence (molecular, cytogenetic, flow cytometric, radiographic) of malignant disease after transplantation.
Outcome measures
| Measure |
Treatment (Ixazomib Citrate)
n=50 Participants
Patients receive ixazomib citrate PO once weekly on days 1, 8, and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients with complete response, partial response, or stable disease may receive an additional 6 courses of ixazomib citrate.
|
Response Evaluated by NIH
Participants who receive ixazomib citrate
|
|---|---|---|
|
Cumulative Incidence of Primary Malignancy Relapse
|
1 Participants
|
—
|
SECONDARY outcome
Timeframe: 1 yearKaplan-Meier estimate assessed at 1 year for failure-free survival, defined as the absence of death from any cause, relapse or addition of secondary immune suppressive agents.
Outcome measures
| Measure |
Treatment (Ixazomib Citrate)
n=50 Participants
Patients receive ixazomib citrate PO once weekly on days 1, 8, and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients with complete response, partial response, or stable disease may receive an additional 6 courses of ixazomib citrate.
|
Response Evaluated by NIH
Participants who receive ixazomib citrate
|
|---|---|---|
|
Probability of Failure-free Survival at 1 Year
|
0.57 probability of failure-free survival
|
—
|
SECONDARY outcome
Timeframe: 1 yearThe incidence of complete discontinuation of all systemic immune-suppressive therapies will be determined at 1 year.
Outcome measures
| Measure |
Treatment (Ixazomib Citrate)
n=50 Participants
Patients receive ixazomib citrate PO once weekly on days 1, 8, and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients with complete response, partial response, or stable disease may receive an additional 6 courses of ixazomib citrate.
|
Response Evaluated by NIH
Participants who receive ixazomib citrate
|
|---|---|---|
|
Incidence of Discontinuation of All Systemic Immune Suppressive Therapies
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Participants with missing response data are counted as failures; primarily missing due to failure to collect data in patients who stopped study drug but did not experience treatment failure.
ORR at 6 months will be determined by both clinician-defined categories of complete response and partial response, as well as separately calculated according to the proposed response definitions of the NIH Consensus Conference.
Outcome measures
| Measure |
Treatment (Ixazomib Citrate)
n=50 Participants
Patients receive ixazomib citrate PO once weekly on days 1, 8, and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients with complete response, partial response, or stable disease may receive an additional 6 courses of ixazomib citrate.
|
Response Evaluated by NIH
Participants who receive ixazomib citrate
|
|---|---|---|
|
Overall Response Rate (ORR) (Complete Response + Partial Response)
Physician impression ORR
|
16 participants
|
—
|
|
Overall Response Rate (ORR) (Complete Response + Partial Response)
NIH ORR
|
17 participants
|
—
|
SECONDARY outcome
Timeframe: 1 yearKaplan-Meier estimate assessed at 1 year for overall survival, defined as absence of death from any cause.
Outcome measures
| Measure |
Treatment (Ixazomib Citrate)
n=50 Participants
Patients receive ixazomib citrate PO once weekly on days 1, 8, and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients with complete response, partial response, or stable disease may receive an additional 6 courses of ixazomib citrate.
|
Response Evaluated by NIH
Participants who receive ixazomib citrate
|
|---|---|---|
|
Probability of Overall Survival at 1 Year
|
.9 probability of overall survival
|
—
|
SECONDARY outcome
Timeframe: 1 yearTreatment success will be estimated at 1 year with a composite outcome of complete resolution of all reversible chronic graft-versus-host disease (GVHD) manifestations, discontinuation of all systemic immune suppressive agents, and freedom from death or primary malignancy relapse after transplant.
Outcome measures
| Measure |
Treatment (Ixazomib Citrate)
n=50 Participants
Patients receive ixazomib citrate PO once weekly on days 1, 8, and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients with complete response, partial response, or stable disease may receive an additional 6 courses of ixazomib citrate.
|
Response Evaluated by NIH
Participants who receive ixazomib citrate
|
|---|---|---|
|
Treatment Success
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: 1 yearAddition of therapy after ixazomib constitutes failure, could occur at any time from baseline to 12mo.
Outcome measures
| Measure |
Treatment (Ixazomib Citrate)
n=50 Participants
Patients receive ixazomib citrate PO once weekly on days 1, 8, and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients with complete response, partial response, or stable disease may receive an additional 6 courses of ixazomib citrate.
|
Response Evaluated by NIH
Participants who receive ixazomib citrate
|
|---|---|---|
|
Use of Additional Systemic Immune Suppressive Therapies
|
21 Participants
|
—
|
SECONDARY outcome
Timeframe: 1 yearPopulation: 25 of 50 participants were evaluable at 12mo due to missing patient survey data
SF-36 subscales have min=0 and max=100; results given are actual scores at 12mo, with higher scores indicating higher quality of life.
Outcome measures
| Measure |
Treatment (Ixazomib Citrate)
n=25 Participants
Patients receive ixazomib citrate PO once weekly on days 1, 8, and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients with complete response, partial response, or stable disease may receive an additional 6 courses of ixazomib citrate.
|
Response Evaluated by NIH
Participants who receive ixazomib citrate
|
|---|---|---|
|
Symptoms as Measured by Patient Self-report--Short Form-36 (SF-36)
norm-based physical functioning
|
44.4 units on a scale
Interval 25.5 to 57.0
|
—
|
|
Symptoms as Measured by Patient Self-report--Short Form-36 (SF-36)
norm-based role-physical score
|
37.3 units on a scale
Interval 27.5 to 56.9
|
—
|
|
Symptoms as Measured by Patient Self-report--Short Form-36 (SF-36)
norm-based bodily pain score
|
46.1 units on a scale
Interval 29.2 to 62.1
|
—
|
|
Symptoms as Measured by Patient Self-report--Short Form-36 (SF-36)
norm-based general health score
|
36.2 units on a scale
Interval 25.8 to 57.7
|
—
|
|
Symptoms as Measured by Patient Self-report--Short Form-36 (SF-36)
norm-based vitality score
|
49 units on a scale
Interval 27.1 to 70.8
|
—
|
|
Symptoms as Measured by Patient Self-report--Short Form-36 (SF-36)
norm-based social functioning score
|
51.4 units on a scale
Interval 29.6 to 56.8
|
—
|
|
Symptoms as Measured by Patient Self-report--Short Form-36 (SF-36)
norm-based role-emotional score
|
48.1 units on a scale
Interval 28.7 to 55.9
|
—
|
|
Symptoms as Measured by Patient Self-report--Short Form-36 (SF-36)
norm-based mental health score
|
52.8 units on a scale
Interval 27.5 to 64.1
|
—
|
|
Symptoms as Measured by Patient Self-report--Short Form-36 (SF-36)
standardized physical component score
|
39.7 units on a scale
Interval 27.1 to 54.8
|
—
|
|
Symptoms as Measured by Patient Self-report--Short Form-36 (SF-36)
standardized mental component score
|
53.8 units on a scale
Interval 32.7 to 63.0
|
—
|
SECONDARY outcome
Timeframe: 1 yearPopulation: 25 of 50 participants were evaluable at 12mo due to missing patient survey data
FACT-BMT subscales have various min/max, see below; results given are actual 12mo scores, with higher scores indicating better functioning. FACT physical well-being (0-28) FACT social/family well-being (0-28) FACT emotional well-being (0-24) FACT functional well-being (0-28) FACT Bone Marrow Transplant (BMT) subscale (0-40) FACT trial outcome index (0-96) FACT-General (G) (0-108) FACT-BMT total (0-148)
Outcome measures
| Measure |
Treatment (Ixazomib Citrate)
n=25 Participants
Patients receive ixazomib citrate PO once weekly on days 1, 8, and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients with complete response, partial response, or stable disease may receive an additional 6 courses of ixazomib citrate.
|
Response Evaluated by NIH
Participants who receive ixazomib citrate
|
|---|---|---|
|
Symptoms as Measured by Patient Self-report--Functional Assessment of Chronic Illness Therapy (FACT)
trial outcome index
|
72 units on a scale
Interval 38.8 to 89.0
|
—
|
|
Symptoms as Measured by Patient Self-report--Functional Assessment of Chronic Illness Therapy (FACT)
physical well-being
|
23 units on a scale
Interval 7.0 to 28.0
|
—
|
|
Symptoms as Measured by Patient Self-report--Functional Assessment of Chronic Illness Therapy (FACT)
social/family well-being
|
23.7 units on a scale
Interval 12.0 to 28.0
|
—
|
|
Symptoms as Measured by Patient Self-report--Functional Assessment of Chronic Illness Therapy (FACT)
emotional well-being
|
21 units on a scale
Interval 10.0 to 24.0
|
—
|
|
Symptoms as Measured by Patient Self-report--Functional Assessment of Chronic Illness Therapy (FACT)
functional well-being
|
18 units on a scale
Interval 5.8 to 28.0
|
—
|
|
Symptoms as Measured by Patient Self-report--Functional Assessment of Chronic Illness Therapy (FACT)
BMT subscale
|
32 units on a scale
Interval 16.0 to 36.0
|
—
|
|
Symptoms as Measured by Patient Self-report--Functional Assessment of Chronic Illness Therapy (FACT)
FACT-G
|
84.7 units on a scale
Interval 55.8 to 105.0
|
—
|
|
Symptoms as Measured by Patient Self-report--Functional Assessment of Chronic Illness Therapy (FACT)
FACT-BMT total
|
114.1 units on a scale
Interval 75.0 to 140.0
|
—
|
SECONDARY outcome
Timeframe: 1 yearPopulation: 25 of 50 participants were evaluable at 12mo due to missing patient survey data
HAP subscales have min=0 and max=94; results given are actual 12mo scores, with higher scores indicating better functioning. Maximum Activity Score (MAS) is highest item number answered still doing. Represents highest oxygen demanding activity that respondent still performs. Adjusted Activity Score (AAS) is MAS minus total number of stopped doing responses below MAS. A measure of usual daily activities. Modified AAS is MAS minus total number of stopped doing responses below MAS but not penalized for not doing activities not permitted post transplant. The following items are not counted against the score:11,15,19,20,22,25,34,41,42,47,49,50,52,53,54,57,72,73,77,78.
Outcome measures
| Measure |
Treatment (Ixazomib Citrate)
n=25 Participants
Patients receive ixazomib citrate PO once weekly on days 1, 8, and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients with complete response, partial response, or stable disease may receive an additional 6 courses of ixazomib citrate.
|
Response Evaluated by NIH
Participants who receive ixazomib citrate
|
|---|---|---|
|
Symptoms as Measured by Patient Self-report--Human Activities Profile (HAP)
maximum activity score
|
74 units on a scale
Interval 28.0 to 91.0
|
—
|
|
Symptoms as Measured by Patient Self-report--Human Activities Profile (HAP)
adjusted activity score
|
70 units on a scale
Interval 24.0 to 88.0
|
—
|
|
Symptoms as Measured by Patient Self-report--Human Activities Profile (HAP)
modified adjusted activity score
|
70 units on a scale
Interval 24.0 to 88.0
|
—
|
SECONDARY outcome
Timeframe: 1 yearPopulation: 25 of 50 participants were evaluable at 12mo due to missing patient survey data
Lee symptom scale (LSS) has subscales with min=0, max=100; results given are 12mo scores, with higher numbers indicating higher symptom burden.
Outcome measures
| Measure |
Treatment (Ixazomib Citrate)
n=25 Participants
Patients receive ixazomib citrate PO once weekly on days 1, 8, and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients with complete response, partial response, or stable disease may receive an additional 6 courses of ixazomib citrate.
|
Response Evaluated by NIH
Participants who receive ixazomib citrate
|
|---|---|---|
|
Symptoms as Measured by Patient Self-report--Lee Chronic GVHD Symptom Scale
nutrition scale
|
0 units on a scale
Interval 0.0 to 25.0
|
—
|
|
Symptoms as Measured by Patient Self-report--Lee Chronic GVHD Symptom Scale
skin scale
|
15 units on a scale
Interval 0.0 to 45.0
|
—
|
|
Symptoms as Measured by Patient Self-report--Lee Chronic GVHD Symptom Scale
energy scale
|
25 units on a scale
Interval 0.0 to 87.5
|
—
|
|
Symptoms as Measured by Patient Self-report--Lee Chronic GVHD Symptom Scale
lung scale
|
10 units on a scale
Interval 0.0 to 60.0
|
—
|
|
Symptoms as Measured by Patient Self-report--Lee Chronic GVHD Symptom Scale
eye scale
|
50 units on a scale
Interval 0.0 to 100.0
|
—
|
|
Symptoms as Measured by Patient Self-report--Lee Chronic GVHD Symptom Scale
psychological scale
|
16.7 units on a scale
Interval 0.0 to 58.3
|
—
|
|
Symptoms as Measured by Patient Self-report--Lee Chronic GVHD Symptom Scale
mouth scale
|
0 units on a scale
Interval 0.0 to 37.5
|
—
|
|
Symptoms as Measured by Patient Self-report--Lee Chronic GVHD Symptom Scale
overall summary score
|
20.8 units on a scale
Interval 4.3 to 50.0
|
—
|
Adverse Events
Treatment (Ixazomib Citrate)
Serious events: 19 serious events
Other events: 18 other events
Deaths: 5 deaths
Serious adverse events
| Measure |
Treatment (Ixazomib Citrate)
n=50 participants at risk
Patients receive ixazomib citrate PO once weekly on days 1, 8, and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients with complete response, partial response, or stable disease may receive an additional 6 courses of ixazomib citrate.
|
|---|---|
|
General disorders
Death
|
2.0%
1/50 • Number of events 1 • 30 days after stopping study drug
|
|
Musculoskeletal and connective tissue disorders
Calcaneal fracture
|
2.0%
1/50 • Number of events 1 • 30 days after stopping study drug
|
|
Gastrointestinal disorders
Pancreatitis
|
2.0%
1/50 • Number of events 1 • 30 days after stopping study drug
|
|
Cardiac disorders
atrial fibrillation
|
2.0%
1/50 • Number of events 1 • 30 days after stopping study drug
|
|
Respiratory, thoracic and mediastinal disorders
pleural effusion
|
4.0%
2/50 • Number of events 2 • 30 days after stopping study drug
|
|
Respiratory, thoracic and mediastinal disorders
respiratory failure
|
2.0%
1/50 • Number of events 1 • 30 days after stopping study drug
|
|
Gastrointestinal disorders
vomiting, nausea, diarrhea
|
2.0%
1/50 • Number of events 1 • 30 days after stopping study drug
|
|
General disorders
chills/weakness
|
2.0%
1/50 • Number of events 1 • 30 days after stopping study drug
|
|
Respiratory, thoracic and mediastinal disorders
upper respiratory infection
|
2.0%
1/50 • Number of events 1 • 30 days after stopping study drug
|
|
Cardiac disorders
right bundle branch block
|
2.0%
1/50 • Number of events 1 • 30 days after stopping study drug
|
|
General disorders
flu-like symptoms
|
2.0%
1/50 • Number of events 1 • 30 days after stopping study drug
|
|
Respiratory, thoracic and mediastinal disorders
pneumonia
|
2.0%
1/50 • Number of events 1 • 30 days after stopping study drug
|
|
Infections and infestations
skin infection
|
2.0%
1/50 • Number of events 1 • 30 days after stopping study drug
|
|
Musculoskeletal and connective tissue disorders
avascular necrosis of hip
|
2.0%
1/50 • Number of events 1 • 30 days after stopping study drug
|
|
Gastrointestinal disorders
perforated colon
|
2.0%
1/50 • Number of events 1 • 30 days after stopping study drug
|
|
Eye disorders
periorbital cellulitis
|
2.0%
1/50 • Number of events 1 • 30 days after stopping study drug
|
|
Respiratory, thoracic and mediastinal disorders
dyspnea
|
2.0%
1/50 • Number of events 1 • 30 days after stopping study drug
|
|
General disorders
fever
|
6.0%
3/50 • Number of events 4 • 30 days after stopping study drug
|
|
Musculoskeletal and connective tissue disorders
osteonecrosis
|
2.0%
1/50 • Number of events 1 • 30 days after stopping study drug
|
|
Nervous system disorders
Progressive multifocal leukoencephalopathy
|
2.0%
1/50 • Number of events 1 • 30 days after stopping study drug
|
|
Skin and subcutaneous tissue disorders
leg ulcers/cellulitis
|
2.0%
1/50 • Number of events 1 • 30 days after stopping study drug
|
|
Cardiac disorders
pericardial effusion
|
2.0%
1/50 • Number of events 1 • 30 days after stopping study drug
|
|
Respiratory, thoracic and mediastinal disorders
acute bronchitis
|
2.0%
1/50 • Number of events 1 • 30 days after stopping study drug
|
|
Gastrointestinal disorders
nausea
|
2.0%
1/50 • Number of events 1 • 30 days after stopping study drug
|
|
Respiratory, thoracic and mediastinal disorders
pneumonitis
|
2.0%
1/50 • Number of events 1 • 30 days after stopping study drug
|
Other adverse events
| Measure |
Treatment (Ixazomib Citrate)
n=50 participants at risk
Patients receive ixazomib citrate PO once weekly on days 1, 8, and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients with complete response, partial response, or stable disease may receive an additional 6 courses of ixazomib citrate.
|
|---|---|
|
Investigations
amylase increased
|
2.0%
1/50 • Number of events 1 • 30 days after stopping study drug
|
|
Gastrointestinal disorders
constipation
|
2.0%
1/50 • Number of events 1 • 30 days after stopping study drug
|
|
Gastrointestinal disorders
diarrhea
|
2.0%
1/50 • Number of events 1 • 30 days after stopping study drug
|
|
General disorders
fatigue
|
2.0%
1/50 • Number of events 1 • 30 days after stopping study drug
|
|
Nervous system disorders
headache
|
2.0%
1/50 • Number of events 1 • 30 days after stopping study drug
|
|
Metabolism and nutrition disorders
hyperglycemia
|
2.0%
1/50 • Number of events 1 • 30 days after stopping study drug
|
|
Metabolism and nutrition disorders
hypertriglyceridemia
|
4.0%
2/50 • Number of events 3 • 30 days after stopping study drug
|
|
Metabolism and nutrition disorders
hyponatremia
|
2.0%
1/50 • Number of events 1 • 30 days after stopping study drug
|
|
Metabolism and nutrition disorders
hypophosphatemia
|
2.0%
1/50 • Number of events 1 • 30 days after stopping study drug
|
|
Infections and infestations
influenza a
|
2.0%
1/50 • Number of events 1 • 30 days after stopping study drug
|
|
Musculoskeletal and connective tissue disorders
leg pain
|
2.0%
1/50 • Number of events 1 • 30 days after stopping study drug
|
|
Investigations
lipase increased
|
2.0%
1/50 • Number of events 1 • 30 days after stopping study drug
|
|
Blood and lymphatic system disorders
lymphopenia
|
2.0%
1/50 • Number of events 1 • 30 days after stopping study drug
|
|
Musculoskeletal and connective tissue disorders
muscle weakness
|
2.0%
1/50 • Number of events 1 • 30 days after stopping study drug
|
|
Nervous system disorders
peripheral neuropathy
|
4.0%
2/50 • Number of events 2 • 30 days after stopping study drug
|
|
Ear and labyrinth disorders
otomastoiditis
|
2.0%
1/50 • Number of events 1 • 30 days after stopping study drug
|
|
Respiratory, thoracic and mediastinal disorders
pneumonia
|
2.0%
1/50 • Number of events 1 • 30 days after stopping study drug
|
|
Nervous system disorders
restlessness
|
2.0%
1/50 • Number of events 1 • 30 days after stopping study drug
|
|
Infections and infestations
skin infection
|
2.0%
1/50 • Number of events 2 • 30 days after stopping study drug
|
|
Blood and lymphatic system disorders
thrombocytopenia
|
6.0%
3/50 • Number of events 5 • 30 days after stopping study drug
|
|
Musculoskeletal and connective tissue disorders
worsening pain
|
2.0%
1/50 • Number of events 1 • 30 days after stopping study drug
|
|
Infections and infestations
wound infection
|
2.0%
1/50 • Number of events 1 • 30 days after stopping study drug
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place