Trial Outcomes & Findings for Ixazomib Citrate and Lenalidomide After Stem Cell Transplant in Treating Patients With Newly Diagnosed Multiple Myeloma (NCT NCT01718743)
NCT ID: NCT01718743
Last Updated: 2025-01-28
Results Overview
Monitored using the method of Thall et al. Estimated using the Kaplan-Meier method. Log-rank test will be performed to test the difference in time-to-event distributions between patient groups. Cox proportional hazards model will be used to include multiple covariates in the time-to-event analysis.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
64 participants
Primary outcome timeframe
Time from autologous stem cell transplant (ASCT) to time of clinical progression or death or the time of last contact, assessed up to 30 days after completion of study treatment
Results posted on
2025-01-28
Participant Flow
64 participants were enrolled in the study between December 3, 2012 and May 13, 2015
Participants with the following conditions were excluded from the study: grade 2 or higher peripheral neuropathy; major surgery or radiotherapy within 14 days of starting on the study; central nervous system involvement; treatment with modulators of CYP1A2 and CYP3A enzyme activity; and cardiovascular complications or ongoing systemic infections.
Participant milestones
| Measure |
Treatment (Ixazomib Citrate, Lenalidomide)
Beginning 60-180 days post-transplant, participants receive ixazomib citrate PO on days 1, 8, and 15 and lenalidomide PO on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Ixazomib Citrate: Given PO
Lenalidomide: Given PO
Questionnaire Administration: Ancillary studies
|
|---|---|
|
Overall Study
STARTED
|
64
|
|
Overall Study
COMPLETED
|
19
|
|
Overall Study
NOT COMPLETED
|
45
|
Reasons for withdrawal
| Measure |
Treatment (Ixazomib Citrate, Lenalidomide)
Beginning 60-180 days post-transplant, participants receive ixazomib citrate PO on days 1, 8, and 15 and lenalidomide PO on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Ixazomib Citrate: Given PO
Lenalidomide: Given PO
Questionnaire Administration: Ancillary studies
|
|---|---|
|
Overall Study
Physician Decision
|
7
|
|
Overall Study
Withdrawal by Subject
|
14
|
|
Overall Study
Progressive Disease
|
22
|
|
Overall Study
Toxicity
|
1
|
|
Overall Study
Malignancy
|
1
|
Baseline Characteristics
Ixazomib Citrate and Lenalidomide After Stem Cell Transplant in Treating Patients With Newly Diagnosed Multiple Myeloma
Baseline characteristics by cohort
| Measure |
Treatment (Ixazomib Citrate, Lenalidomide)
n=64 Participants
Beginning 60-180 days post-transplant, participants receive ixazomib citrate PO on days 1, 8, and 15 and lenalidomide PO on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Ixazomib Citrate: Given PO
Lenalidomide: Given PO
Questionnaire Administration: Ancillary studies
|
|---|---|
|
Age, Customized
Between 18-59
|
23 participants
n=5 Participants
|
|
Age, Customized
>= 60
|
41 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
42 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
61 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 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
|
8 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
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
64 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Time from autologous stem cell transplant (ASCT) to time of clinical progression or death or the time of last contact, assessed up to 30 days after completion of study treatmentPopulation: The upper bound of the 95% CI has not been reached.
Monitored using the method of Thall et al. Estimated using the Kaplan-Meier method. Log-rank test will be performed to test the difference in time-to-event distributions between patient groups. Cox proportional hazards model will be used to include multiple covariates in the time-to-event analysis.
Outcome measures
| Measure |
Treatment (Ixazomib Citrate, Lenalidomide)
n=64 Participants
Beginning 60-180 days post-transplant, participants receive ixazomib citrate PO on days 1, 8, and 15 and lenalidomide PO on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Ixazomib Citrate: Given PO
Lenalidomide: Given PO
Questionnaire Administration: Ancillary studies
|
|---|---|
|
Progression-free Survival
|
73.3 Months
Interval 59.9 to
The upper bound of the 95% CI has not been reached.
|
SECONDARY outcome
Timeframe: through out study treatment and up to 30 days after completion of study treatment, up to 119 monthsEstimated along with 95% confidence intervals.
Outcome measures
| Measure |
Treatment (Ixazomib Citrate, Lenalidomide)
n=64 Participants
Beginning 60-180 days post-transplant, participants receive ixazomib citrate PO on days 1, 8, and 15 and lenalidomide PO on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Ixazomib Citrate: Given PO
Lenalidomide: Given PO
Questionnaire Administration: Ancillary studies
|
|---|---|
|
Best Response Rate (Stringent Complete Response [sCR]/Near Complete Response [nCR]/Very Good Partial Response [VGPR]/Partial Response [PR])
|
98.4 percentage of participants
Interval 91.5 to 100.0
|
SECONDARY outcome
Timeframe: throughout study treatment and up to 30 days after completion of study treatment, up to 119 monthsToxicity data will be summarized by frequency tables.
Outcome measures
| Measure |
Treatment (Ixazomib Citrate, Lenalidomide)
n=64 Participants
Beginning 60-180 days post-transplant, participants receive ixazomib citrate PO on days 1, 8, and 15 and lenalidomide PO on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Ixazomib Citrate: Given PO
Lenalidomide: Given PO
Questionnaire Administration: Ancillary studies
|
|---|---|
|
Treatment-related Unmanageable Toxicities, Including Grade 3 Non-hematologic Effects, or Grade 4 Hematologic Effects
Serious AE-Lung Infections
|
12 Participants
|
|
Treatment-related Unmanageable Toxicities, Including Grade 3 Non-hematologic Effects, or Grade 4 Hematologic Effects
Serious AE-Treatment-related secondary malignancy
|
9 Participants
|
|
Treatment-related Unmanageable Toxicities, Including Grade 3 Non-hematologic Effects, or Grade 4 Hematologic Effects
Serious AE-Respiratory Disorders including respiratory failures
|
8 Participants
|
|
Treatment-related Unmanageable Toxicities, Including Grade 3 Non-hematologic Effects, or Grade 4 Hematologic Effects
Serious AE-other infections
|
5 Participants
|
SECONDARY outcome
Timeframe: through out study treatment and up to 30 days after completion of study treatment, up to 119 monthsCount of participants
Outcome measures
| Measure |
Treatment (Ixazomib Citrate, Lenalidomide)
n=64 Participants
Beginning 60-180 days post-transplant, participants receive ixazomib citrate PO on days 1, 8, and 15 and lenalidomide PO on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Ixazomib Citrate: Given PO
Lenalidomide: Given PO
Questionnaire Administration: Ancillary studies
|
|---|---|
|
Number of Participants Incidence of New Primary Malignancy
|
9 Participants
|
SECONDARY outcome
Timeframe: through out study treatment and up to 30 days after completion of study treatment, up to 119 monthsEstimated using the Kaplan-Meier method. Cox proportional hazards model will be used to include multiple covariates. Log-rank test will be performed to test the difference in time-to-event distributions between patient groups. Cox proportional hazards model will be used to include multiple covariates in the time-to-event analysis.
Outcome measures
| Measure |
Treatment (Ixazomib Citrate, Lenalidomide)
n=64 Participants
Beginning 60-180 days post-transplant, participants receive ixazomib citrate PO on days 1, 8, and 15 and lenalidomide PO on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Ixazomib Citrate: Given PO
Lenalidomide: Given PO
Questionnaire Administration: Ancillary studies
|
|---|---|
|
Overall Survival
|
NA months
The median OS time is the time point (from transplant) at which the probability of survival is 50%. If you look at the KM curve below for OS, the curve is going down overtime but has not reached the horizontal line for probability=0.5. The median OS time has not been reached. The 95% CI is not estimable.
|
SECONDARY outcome
Timeframe: through out study treatment and up to 30 days after completion of study treatment, up to 119 monthsAnalyzed with descriptive analysis. The MDASI-MM scores measure the how severe the symptoms are, so higher scores are considered to be worse patient outcomes. Five subscales are derived from the 26 questions of the MDASI-MM questionnaire: 1. mean core (13 MDASI core symptom items), ranges from 0 to 130. 2. mean severity (13 MDASI core plus 7 MM-specific items), ranges from 0 to 200. 3. mean interference (6 interference items), ranges from 0 to 60. 4. mean WAW (interference with work, general activity, and walking), ranges from 0 to 30. 5. mean REM (interference with relations with people, enjoyment of life, and mood), ranges from 0 to 30. has context menu
Outcome measures
| Measure |
Treatment (Ixazomib Citrate, Lenalidomide)
n=59 Participants
Beginning 60-180 days post-transplant, participants receive ixazomib citrate PO on days 1, 8, and 15 and lenalidomide PO on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Ixazomib Citrate: Given PO
Lenalidomide: Given PO
Questionnaire Administration: Ancillary studies
|
|---|---|
|
M. D. Anderson Symptom Inventory (MDASI)-Myeloma Symptom Evaluation
Core Score at Cycle 1
|
1.13 scores on a scale
Standard Deviation 1.35
|
|
M. D. Anderson Symptom Inventory (MDASI)-Myeloma Symptom Evaluation
Severity Score at Cycle 1
|
1.01 scores on a scale
Standard Deviation 1.27
|
|
M. D. Anderson Symptom Inventory (MDASI)-Myeloma Symptom Evaluation
Interference Score at Cycle 1
|
0.97 scores on a scale
Standard Deviation 1.52
|
|
M. D. Anderson Symptom Inventory (MDASI)-Myeloma Symptom Evaluation
WAW Score at Cycle 1
|
1.12 scores on a scale
Standard Deviation 1.67
|
|
M. D. Anderson Symptom Inventory (MDASI)-Myeloma Symptom Evaluation
REM Score at Cycle 1
|
0.81 scores on a scale
Standard Deviation 1.54
|
Adverse Events
Treatment (Ixazomib Citrate, Lenalidomide)
Serious events: 33 serious events
Other events: 64 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment (Ixazomib Citrate, Lenalidomide)
n=64 participants at risk
Beginning 60-180 days post-transplant, patients receive ixazomib citrate PO on days 1, 8, and 15 and lenalidomide PO on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Ixazomib Citrate: Given PO
Lenalidomide: Given PO
Questionnaire Administration: Ancillary studies
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Lung infection
|
18.8%
12/64 • through out study treatment and up to 30 days after completion of study treatment, up to 119 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic, and mediastinal disorders, including respiratory failure
|
12.5%
8/64 • through out study treatment and up to 30 days after completion of study treatment, up to 119 months
|
|
Infections and infestations
Infections and infestations
|
7.8%
5/64 • through out study treatment and up to 30 days after completion of study treatment, up to 119 months
|
|
General disorders
Treatment-related secondary malignancy
|
14.1%
9/64 • through out study treatment and up to 30 days after completion of study treatment, up to 119 months
|
|
General disorders
Sepsis
|
4.7%
3/64 • through out study treatment and up to 30 days after completion of study treatment, up to 119 months
|
|
Blood and lymphatic system disorders
Neoplasms benign, malignant, and unspecified (inclcysts and ployps)
|
4.7%
3/64 • through out study treatment and up to 30 days after completion of study treatment, up to 119 months
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory infection
|
3.1%
2/64 • through out study treatment and up to 30 days after completion of study treatment, up to 119 months
|
|
Renal and urinary disorders
Acute kidney inury
|
1.6%
1/64 • through out study treatment and up to 30 days after completion of study treatment, up to 119 months
|
|
General disorders
Dehydration
|
1.6%
1/64 • through out study treatment and up to 30 days after completion of study treatment, up to 119 months
|
|
Gastrointestinal disorders
Pancreatitis
|
1.6%
1/64 • through out study treatment and up to 30 days after completion of study treatment, up to 119 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.6%
1/64 • through out study treatment and up to 30 days after completion of study treatment, up to 119 months
|
|
Infections and infestations
Urinary tract infection
|
1.6%
1/64 • through out study treatment and up to 30 days after completion of study treatment, up to 119 months
|
|
Renal and urinary disorders
Urinary retention
|
1.6%
1/64 • through out study treatment and up to 30 days after completion of study treatment, up to 119 months
|
|
General disorders
Fever
|
1.6%
1/64 • through out study treatment and up to 30 days after completion of study treatment, up to 119 months
|
|
Gastrointestinal disorders
Diarrhea
|
1.6%
1/64 • through out study treatment and up to 30 days after completion of study treatment, up to 119 months
|
|
Blood and lymphatic system disorders
Thromboembolic event
|
1.6%
1/64 • through out study treatment and up to 30 days after completion of study treatment, up to 119 months
|
|
Nervous system disorders
Nervous system disorders
|
1.6%
1/64 • through out study treatment and up to 30 days after completion of study treatment, up to 119 months
|
|
General disorders
Non-cardiac chest pain
|
1.6%
1/64 • through out study treatment and up to 30 days after completion of study treatment, up to 119 months
|
|
General disorders
Syncope
|
1.6%
1/64 • through out study treatment and up to 30 days after completion of study treatment, up to 119 months
|
Other adverse events
| Measure |
Treatment (Ixazomib Citrate, Lenalidomide)
n=64 participants at risk
Beginning 60-180 days post-transplant, patients receive ixazomib citrate PO on days 1, 8, and 15 and lenalidomide PO on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Ixazomib Citrate: Given PO
Lenalidomide: Given PO
Questionnaire Administration: Ancillary studies
|
|---|---|
|
Skin and subcutaneous tissue disorders
Edema limbs
|
57.8%
37/64 • Number of events 104 • through out study treatment and up to 30 days after completion of study treatment, up to 119 months
|
|
Skin and subcutaneous tissue disorders
Edema trunk
|
1.6%
1/64 • Number of events 1 • through out study treatment and up to 30 days after completion of study treatment, up to 119 months
|
|
General disorders
Abdomial pain
|
7.8%
5/64 • Number of events 6 • through out study treatment and up to 30 days after completion of study treatment, up to 119 months
|
|
Nervous system disorders
Agitation
|
1.6%
1/64 • Number of events 1 • through out study treatment and up to 30 days after completion of study treatment, up to 119 months
|
|
General disorders
Alanine aminotransferase increased
|
54.7%
35/64 • Number of events 135 • through out study treatment and up to 30 days after completion of study treatment, up to 119 months
|
|
General disorders
Alkaline phosphatase increased
|
32.8%
21/64 • Number of events 56 • through out study treatment and up to 30 days after completion of study treatment, up to 119 months
|
|
General disorders
Allergic reaction
|
1.6%
1/64 • Number of events 1 • through out study treatment and up to 30 days after completion of study treatment, up to 119 months
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
3.1%
2/64 • Number of events 2 • through out study treatment and up to 30 days after completion of study treatment, up to 119 months
|
|
Blood and lymphatic system disorders
Anemia
|
42.2%
27/64 • Number of events 126 • through out study treatment and up to 30 days after completion of study treatment, up to 119 months
|
|
Musculoskeletal and connective tissue disorders
Ankle fracture
|
1.6%
1/64 • Number of events 1 • through out study treatment and up to 30 days after completion of study treatment, up to 119 months
|
|
General disorders
Anorexia
|
3.1%
2/64 • Number of events 2 • through out study treatment and up to 30 days after completion of study treatment, up to 119 months
|
|
Nervous system disorders
Anxiety
|
3.1%
2/64 • Number of events 3 • through out study treatment and up to 30 days after completion of study treatment, up to 119 months
|
|
General disorders
Arthralgia
|
10.9%
7/64 • Number of events 13 • through out study treatment and up to 30 days after completion of study treatment, up to 119 months
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
3.1%
2/64 • Number of events 3 • through out study treatment and up to 30 days after completion of study treatment, up to 119 months
|
|
General disorders
Aspartate aminotransferase increased
|
59.4%
38/64 • Number of events 146 • through out study treatment and up to 30 days after completion of study treatment, up to 119 months
|
|
Cardiac disorders
Atrial fibrillation
|
1.6%
1/64 • Number of events 1 • through out study treatment and up to 30 days after completion of study treatment, up to 119 months
|
|
General disorders
Back Pain
|
34.4%
22/64 • Number of events 41 • through out study treatment and up to 30 days after completion of study treatment, up to 119 months
|
|
Infections and infestations
Bladder infection
|
1.6%
1/64 • Number of events 1 • through out study treatment and up to 30 days after completion of study treatment, up to 119 months
|
|
General disorders
Bloating
|
6.2%
4/64 • Number of events 5 • through out study treatment and up to 30 days after completion of study treatment, up to 119 months
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders
|
31.2%
20/64 • Number of events 22 • through out study treatment and up to 30 days after completion of study treatment, up to 119 months
|
|
General disorders
Blood bilirubin increased
|
31.2%
20/64 • Number of events 228 • through out study treatment and up to 30 days after completion of study treatment, up to 119 months
|
|
Nervous system disorders
Blurred vision
|
50.0%
32/64 • Number of events 114 • through out study treatment and up to 30 days after completion of study treatment, up to 119 months
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
6.2%
4/64 • Number of events 5 • through out study treatment and up to 30 days after completion of study treatment, up to 119 months
|
|
General disorders
Breast pain
|
1.6%
1/64 • Number of events 1 • through out study treatment and up to 30 days after completion of study treatment, up to 119 months
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial infection
|
4.7%
3/64 • Number of events 4 • through out study treatment and up to 30 days after completion of study treatment, up to 119 months
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
1.6%
1/64 • Number of events 1 • through out study treatment and up to 30 days after completion of study treatment, up to 119 months
|
|
Cardiac disorders
Cardiac disorders
|
6.2%
4/64 • Number of events 5 • through out study treatment and up to 30 days after completion of study treatment, up to 119 months
|
|
General disorders
Cataract
|
1.6%
1/64 • Number of events 1 • through out study treatment and up to 30 days after completion of study treatment, up to 119 months
|
|
General disorders
Chest pain
|
4.7%
3/64 • Number of events 5 • through out study treatment and up to 30 days after completion of study treatment, up to 119 months
|
|
General disorders
Chills
|
1.6%
1/64 • Number of events 1 • through out study treatment and up to 30 days after completion of study treatment, up to 119 months
|
|
Renal and urinary disorders
Chronic kidney disease
|
1.6%
1/64 • Number of events 1 • through out study treatment and up to 30 days after completion of study treatment, up to 119 months
|
|
Nervous system disorders
Concentration impairment
|
1.6%
1/64 • Number of events 1 • through out study treatment and up to 30 days after completion of study treatment, up to 119 months
|
|
Nervous system disorders
Confusion
|
1.6%
1/64 • Number of events 3 • through out study treatment and up to 30 days after completion of study treatment, up to 119 months
|
|
Infections and infestations
Conjunctivitis
|
3.1%
2/64 • Number of events 2 • through out study treatment and up to 30 days after completion of study treatment, up to 119 months
|
|
Gastrointestinal disorders
Constipation
|
68.8%
44/64 • Number of events 258 • through out study treatment and up to 30 days after completion of study treatment, up to 119 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
35.9%
23/64 • Number of events 40 • through out study treatment and up to 30 days after completion of study treatment, up to 119 months
|
|
General disorders
Creatinine increased
|
45.3%
29/64 • Number of events 172 • through out study treatment and up to 30 days after completion of study treatment, up to 119 months
|
|
General disorders
Dehydration
|
3.1%
2/64 • Number of events 3 • through out study treatment and up to 30 days after completion of study treatment, up to 119 months
|
|
Nervous system disorders
Depression
|
6.2%
4/64 • Number of events 4 • through out study treatment and up to 30 days after completion of study treatment, up to 119 months
|
|
Gastrointestinal disorders
Diarrhea
|
82.8%
53/64 • Number of events 635 • through out study treatment and up to 30 days after completion of study treatment, up to 119 months
|
|
Nervous system disorders
Dizziness
|
51.6%
33/64 • Number of events 168 • through out study treatment and up to 30 days after completion of study treatment, up to 119 months
|
|
General disorders
Dry eye
|
48.4%
31/64 • Number of events 86 • through out study treatment and up to 30 days after completion of study treatment, up to 119 months
|
|
General disorders
Dry mouth
|
18.8%
12/64 • Number of events 19 • through out study treatment and up to 30 days after completion of study treatment, up to 119 months
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
14.1%
9/64 • Number of events 14 • through out study treatment and up to 30 days after completion of study treatment, up to 119 months
|
|
General disorders
Dysgeusia
|
4.7%
3/64 • Number of events 3 • through out study treatment and up to 30 days after completion of study treatment, up to 119 months
|
|
General disorders
Dyspepsia
|
3.1%
2/64 • Number of events 3 • through out study treatment and up to 30 days after completion of study treatment, up to 119 months
|
|
Respiratory, thoracic and mediastinal disorders
Dysphagia
|
1.6%
1/64 • Number of events 1 • through out study treatment and up to 30 days after completion of study treatment, up to 119 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
56.2%
36/64 • Number of events 131 • through out study treatment and up to 30 days after completion of study treatment, up to 119 months
|
|
Skin and subcutaneous tissue disorders
Edema face
|
1.6%
1/64 • Number of events 1 • through out study treatment and up to 30 days after completion of study treatment, up to 119 months
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
1.6%
1/64 • Number of events 1 • through out study treatment and up to 30 days after completion of study treatment, up to 119 months
|
|
General disorders
Eye disorders
|
7.8%
5/64 • Number of events 6 • through out study treatment and up to 30 days after completion of study treatment, up to 119 months
|
|
Nervous system disorders
Eyelid function disorder
|
1.6%
1/64 • Number of events 1 • through out study treatment and up to 30 days after completion of study treatment, up to 119 months
|
|
General disorders
Fall
|
12.5%
8/64 • Number of events 10 • through out study treatment and up to 30 days after completion of study treatment, up to 119 months
|
|
General disorders
Fatigue
|
93.8%
60/64 • Number of events 442 • through out study treatment and up to 30 days after completion of study treatment, up to 119 months
|
|
General disorders
Fever
|
57.8%
37/64 • Number of events 103 • through out study treatment and up to 30 days after completion of study treatment, up to 119 months
|
|
Musculoskeletal and connective tissue disorders
Fibrosis deep connective tissue
|
1.6%
1/64 • Number of events 1 • through out study treatment and up to 30 days after completion of study treatment, up to 119 months
|
|
Gastrointestinal disorders
Flatulence
|
1.6%
1/64 • Number of events 1 • through out study treatment and up to 30 days after completion of study treatment, up to 119 months
|
|
General disorders
Flu like symptoms
|
12.5%
8/64 • Number of events 12 • through out study treatment and up to 30 days after completion of study treatment, up to 119 months
|
|
Vascular disorders
Flushing
|
1.6%
1/64 • Number of events 1 • through out study treatment and up to 30 days after completion of study treatment, up to 119 months
|
|
Musculoskeletal and connective tissue disorders
Fracture
|
3.1%
2/64 • Number of events 5 • through out study treatment and up to 30 days after completion of study treatment, up to 119 months
|
|
Musculoskeletal and connective tissue disorders
Gait disturbance
|
1.6%
1/64 • Number of events 2 • through out study treatment and up to 30 days after completion of study treatment, up to 119 months
|
|
Gastrointestinal disorders
Gastritis
|
1.6%
1/64 • Number of events 1 • through out study treatment and up to 30 days after completion of study treatment, up to 119 months
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
3.1%
2/64 • Number of events 2 • through out study treatment and up to 30 days after completion of study treatment, up to 119 months
|
|
Gastrointestinal disorders
Gastrointestinal disorders
|
10.9%
7/64 • Number of events 9 • through out study treatment and up to 30 days after completion of study treatment, up to 119 months
|
|
General disorders
General disorders and administration site conditions
|
3.1%
2/64 • Number of events 3 • through out study treatment and up to 30 days after completion of study treatment, up to 119 months
|
|
Nervous system disorders
Hallucinations
|
1.6%
1/64 • Number of events 1 • through out study treatment and up to 30 days after completion of study treatment, up to 119 months
|
|
Nervous system disorders
Headache
|
21.9%
14/64 • Number of events 20 • through out study treatment and up to 30 days after completion of study treatment, up to 119 months
|
|
Nervous system disorders
Hearing impaired
|
4.7%
3/64 • Number of events 4 • through out study treatment and up to 30 days after completion of study treatment, up to 119 months
|
|
Renal and urinary disorders
Hematuria
|
1.6%
1/64 • Number of events 1 • through out study treatment and up to 30 days after completion of study treatment, up to 119 months
|
|
Vascular disorders
Hot flashes
|
1.6%
1/64 • Number of events 1 • through out study treatment and up to 30 days after completion of study treatment, up to 119 months
|
|
General disorders
Hypercalcemia
|
25.0%
16/64 • Number of events 39 • through out study treatment and up to 30 days after completion of study treatment, up to 119 months
|
|
General disorders
Hyperglycemia
|
67.2%
43/64 • Number of events 352 • through out study treatment and up to 30 days after completion of study treatment, up to 119 months
|
|
General disorders
Hyperkalemia
|
20.3%
13/64 • Number of events 26 • through out study treatment and up to 30 days after completion of study treatment, up to 119 months
|
|
General disorders
Hypermagnesemia
|
3.1%
2/64 • Number of events 2 • through out study treatment and up to 30 days after completion of study treatment, up to 119 months
|
|
General disorders
Hypernatremia
|
7.8%
5/64 • Number of events 6 • through out study treatment and up to 30 days after completion of study treatment, up to 119 months
|
|
General disorders
Hypertension
|
4.7%
3/64 • Number of events 3 • through out study treatment and up to 30 days after completion of study treatment, up to 119 months
|
|
General disorders
Hyperuricemia
|
18.8%
12/64 • Number of events 24 • through out study treatment and up to 30 days after completion of study treatment, up to 119 months
|
|
General disorders
Hypoalbuminemia
|
50.0%
32/64 • Number of events 85 • through out study treatment and up to 30 days after completion of study treatment, up to 119 months
|
|
General disorders
Hypocalcemia
|
48.4%
31/64 • Number of events 130 • through out study treatment and up to 30 days after completion of study treatment, up to 119 months
|
|
General disorders
Hypoglycemia
|
37.5%
24/64 • Number of events 79 • through out study treatment and up to 30 days after completion of study treatment, up to 119 months
|
|
General disorders
Hypokalemia
|
43.8%
28/64 • Number of events 103 • through out study treatment and up to 30 days after completion of study treatment, up to 119 months
|
|
General disorders
Hypomagnesemia
|
59.4%
38/64 • Number of events 165 • through out study treatment and up to 30 days after completion of study treatment, up to 119 months
|
|
General disorders
Hyponatremia
|
7.8%
5/64 • Number of events 5 • through out study treatment and up to 30 days after completion of study treatment, up to 119 months
|
|
General disorders
Hypophosphatemia
|
7.8%
5/64 • Number of events 7 • through out study treatment and up to 30 days after completion of study treatment, up to 119 months
|
|
Vascular disorders
Hypotension
|
1.6%
1/64 • Number of events 2 • through out study treatment and up to 30 days after completion of study treatment, up to 119 months
|
|
General disorders
Infections and infestation
|
45.3%
29/64 • Number of events 41 • through out study treatment and up to 30 days after completion of study treatment, up to 119 months
|
|
General disorders
Injury, poisoning and procedural complications
|
1.6%
1/64 • Number of events 1 • through out study treatment and up to 30 days after completion of study treatment, up to 119 months
|
|
General disorders
INR increased
|
1.6%
1/64 • Number of events 1 • through out study treatment and up to 30 days after completion of study treatment, up to 119 months
|
|
Nervous system disorders
Insomnia
|
15.6%
10/64 • Number of events 13 • through out study treatment and up to 30 days after completion of study treatment, up to 119 months
|
|
General disorders
Investigations
|
43.8%
28/64 • Number of events 51 • through out study treatment and up to 30 days after completion of study treatment, up to 119 months
|
|
General disorders
Lethargy
|
1.6%
1/64 • Number of events 1 • through out study treatment and up to 30 days after completion of study treatment, up to 119 months
|
|
Blood and lymphatic system disorders
Leukemia secondary to oncology chemotherapy
|
1.6%
1/64 • Number of events 1 • through out study treatment and up to 30 days after completion of study treatment, up to 119 months
|
|
Infections and infestations
Lip Infection
|
1.6%
1/64 • Number of events 1 • through out study treatment and up to 30 days after completion of study treatment, up to 119 months
|
|
Infections and infestations
Lung infection
|
32.8%
21/64 • Number of events 30 • through out study treatment and up to 30 days after completion of study treatment, up to 119 months
|
|
Blood and lymphatic system disorders
Lymphocyte count decreased
|
34.4%
22/64 • Number of events 78 • through out study treatment and up to 30 days after completion of study treatment, up to 119 months
|
|
Nervous system disorders
Mania
|
1.6%
1/64 • Number of events 1 • through out study treatment and up to 30 days after completion of study treatment, up to 119 months
|
|
Nervous system disorders
Memory impairment
|
48.4%
31/64 • Number of events 65 • through out study treatment and up to 30 days after completion of study treatment, up to 119 months
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders
|
39.1%
25/64 • Number of events 182 • through out study treatment and up to 30 days after completion of study treatment, up to 119 months
|
|
Skin and subcutaneous tissue disorders
Mucositis oral
|
35.9%
23/64 • Number of events 81 • through out study treatment and up to 30 days after completion of study treatment, up to 119 months
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness left-sided
|
1.6%
1/64 • Number of events 2 • through out study treatment and up to 30 days after completion of study treatment, up to 119 months
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
1.6%
1/64 • Number of events 1 • through out study treatment and up to 30 days after completion of study treatment, up to 119 months
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness right-sided
|
1.6%
1/64 • Number of events 1 • through out study treatment and up to 30 days after completion of study treatment, up to 119 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder
|
25.0%
16/64 • Number of events 28 • through out study treatment and up to 30 days after completion of study treatment, up to 119 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
76.6%
49/64 • Number of events 209 • through out study treatment and up to 30 days after completion of study treatment, up to 119 months
|
|
Infections and infestations
Nail infection
|
1.6%
1/64 • Number of events 1 • through out study treatment and up to 30 days after completion of study treatment, up to 119 months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
18.8%
12/64 • Number of events 14 • through out study treatment and up to 30 days after completion of study treatment, up to 119 months
|
|
Gastrointestinal disorders
Nausea
|
81.2%
52/64 • Number of events 474 • through out study treatment and up to 30 days after completion of study treatment, up to 119 months
|
|
Nervous system disorders
Neck pain
|
3.1%
2/64 • Number of events 2 • through out study treatment and up to 30 days after completion of study treatment, up to 119 months
|
|
General disorders
Neoplasms benign, malignant and unspecified
|
1.6%
1/64 • Number of events 1 • through out study treatment and up to 30 days after completion of study treatment, up to 119 months
|
|
Nervous system disorders
Nervous system disorders
|
1.6%
1/64 • Number of events 1 • through out study treatment and up to 30 days after completion of study treatment, up to 119 months
|
|
Blood and lymphatic system disorders
Neutrophil count decreased
|
89.1%
57/64 • Number of events 814 • through out study treatment and up to 30 days after completion of study treatment, up to 119 months
|
|
Nervous system disorders
Non-cardiac chest pain
|
1.6%
1/64 • Number of events 1 • through out study treatment and up to 30 days after completion of study treatment, up to 119 months
|
|
Nervous system disorders
Optic nerve disorder
|
1.6%
1/64 • Number of events 2 • through out study treatment and up to 30 days after completion of study treatment, up to 119 months
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
1.6%
1/64 • Number of events 1 • through out study treatment and up to 30 days after completion of study treatment, up to 119 months
|
|
Infections and infestations
Otitis media
|
3.1%
2/64 • Number of events 2 • through out study treatment and up to 30 days after completion of study treatment, up to 119 months
|
|
Nervous system disorders
Pain
|
42.2%
27/64 • Number of events 51 • through out study treatment and up to 30 days after completion of study treatment, up to 119 months
|
|
Nervous system disorders
Pain in extremity
|
10.9%
7/64 • Number of events 9 • through out study treatment and up to 30 days after completion of study treatment, up to 119 months
|
|
Gastrointestinal disorders
Pancreatitis
|
3.1%
2/64 • Number of events 2 • through out study treatment and up to 30 days after completion of study treatment, up to 119 months
|
|
Nervous system disorders
Paresthesia
|
17.2%
11/64 • Number of events 17 • through out study treatment and up to 30 days after completion of study treatment, up to 119 months
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
84.4%
54/64 • Number of events 221 • through out study treatment and up to 30 days after completion of study treatment, up to 119 months
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngitis
|
3.1%
2/64 • Number of events 3 • through out study treatment and up to 30 days after completion of study treatment, up to 119 months
|
|
Vascular disorders
Phlebitis infective
|
1.6%
1/64 • Number of events 2 • through out study treatment and up to 30 days after completion of study treatment, up to 119 months
|
|
Blood and lymphatic system disorders
Platelet count decreased
|
81.2%
52/64 • Number of events 284 • through out study treatment and up to 30 days after completion of study treatment, up to 119 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.6%
1/64 • Number of events 1 • through out study treatment and up to 30 days after completion of study treatment, up to 119 months
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
10.9%
7/64 • Number of events 9 • through out study treatment and up to 30 days after completion of study treatment, up to 119 months
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
4.7%
3/64 • Number of events 3 • through out study treatment and up to 30 days after completion of study treatment, up to 119 months
|
|
Infections and infestations
Prostate infection
|
1.6%
1/64 • Number of events 2 • through out study treatment and up to 30 days after completion of study treatment, up to 119 months
|
|
General disorders
Prostatic obstruction
|
1.6%
1/64 • Number of events 1 • through out study treatment and up to 30 days after completion of study treatment, up to 119 months
|
|
Renal and urinary disorders
Proteinuria
|
15.6%
10/64 • Number of events 11 • through out study treatment and up to 30 days after completion of study treatment, up to 119 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
21.9%
14/64 • Number of events 32 • through out study treatment and up to 30 days after completion of study treatment, up to 119 months
|
|
Nervous system disorders
Psychiatric disorders
|
1.6%
1/64 • Number of events 1 • through out study treatment and up to 30 days after completion of study treatment, up to 119 months
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
1.6%
1/64 • Number of events 2 • through out study treatment and up to 30 days after completion of study treatment, up to 119 months
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
31.2%
20/64 • Number of events 40 • through out study treatment and up to 30 days after completion of study treatment, up to 119 months
|
|
Renal and urinary disorders
Renal and urinary disorders
|
10.9%
7/64 • Number of events 9 • through out study treatment and up to 30 days after completion of study treatment, up to 119 months
|
|
Renal and urinary disorders
Renal calculi
|
1.6%
1/64 • Number of events 1 • through out study treatment and up to 30 days after completion of study treatment, up to 119 months
|
|
General disorders
Reproductive system and breast disorders
|
1.6%
1/64 • Number of events 1 • through out study treatment and up to 30 days after completion of study treatment, up to 119 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
4.7%
3/64 • Number of events 3 • through out study treatment and up to 30 days after completion of study treatment, up to 119 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders
|
18.8%
12/64 • Number of events 14 • through out study treatment and up to 30 days after completion of study treatment, up to 119 months
|
|
General disorders
Scleral disorder
|
1.6%
1/64 • Number of events 1 • through out study treatment and up to 30 days after completion of study treatment, up to 119 months
|
|
Blood and lymphatic system disorders
Sepsis
|
1.6%
1/64 • Number of events 1 • through out study treatment and up to 30 days after completion of study treatment, up to 119 months
|
|
Cardiac disorders
Sinus bradycardia
|
4.7%
3/64 • Number of events 4 • through out study treatment and up to 30 days after completion of study treatment, up to 119 months
|
|
Vascular disorders
Sinus disorder
|
1.6%
1/64 • Number of events 2 • through out study treatment and up to 30 days after completion of study treatment, up to 119 months
|
|
Respiratory, thoracic and mediastinal disorders
Sinusitis
|
25.0%
16/64 • Number of events 27 • through out study treatment and up to 30 days after completion of study treatment, up to 119 months
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders
|
29.7%
19/64 • Number of events 24 • through out study treatment and up to 30 days after completion of study treatment, up to 119 months
|
|
Skin and subcutaneous tissue disorders
Skin hypopigmentation
|
1.6%
1/64 • Number of events 1 • through out study treatment and up to 30 days after completion of study treatment, up to 119 months
|
|
Infections and infestations
Skin infection
|
7.8%
5/64 • Number of events 5 • through out study treatment and up to 30 days after completion of study treatment, up to 119 months
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
1.6%
1/64 • Number of events 1 • through out study treatment and up to 30 days after completion of study treatment, up to 119 months
|
|
Nervous system disorders
Somnolence
|
3.1%
2/64 • Number of events 6 • through out study treatment and up to 30 days after completion of study treatment, up to 119 months
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
12.5%
8/64 • Number of events 13 • through out study treatment and up to 30 days after completion of study treatment, up to 119 months
|
|
Musculoskeletal and connective tissue disorders
Spasticity
|
1.6%
1/64 • Number of events 1 • through out study treatment and up to 30 days after completion of study treatment, up to 119 months
|
|
Gastrointestinal disorders
Stomach pain
|
1.6%
1/64 • Number of events 1 • through out study treatment and up to 30 days after completion of study treatment, up to 119 months
|
|
Blood and lymphatic system disorders
Superficial thrombophlebitis
|
3.1%
2/64 • Number of events 2 • through out study treatment and up to 30 days after completion of study treatment, up to 119 months
|
|
Nervous system disorders
Syncope
|
1.6%
1/64 • Number of events 1 • through out study treatment and up to 30 days after completion of study treatment, up to 119 months
|
|
Blood and lymphatic system disorders
Thromboembolic event
|
6.2%
4/64 • Number of events 4 • through out study treatment and up to 30 days after completion of study treatment, up to 119 months
|
|
Nervous system disorders
Tinnitus
|
9.4%
6/64 • Number of events 9 • through out study treatment and up to 30 days after completion of study treatment, up to 119 months
|
|
General disorders
Tooth development disorder
|
1.6%
1/64 • Number of events 1 • through out study treatment and up to 30 days after completion of study treatment, up to 119 months
|
|
Infections and infestations
Tooth infection
|
1.6%
1/64 • Number of events 1 • through out study treatment and up to 30 days after completion of study treatment, up to 119 months
|
|
Infections and infestations
Toothache
|
6.2%
4/64 • Number of events 4 • through out study treatment and up to 30 days after completion of study treatment, up to 119 months
|
|
Nervous system disorders
Tremor
|
4.7%
3/64 • Number of events 3 • through out study treatment and up to 30 days after completion of study treatment, up to 119 months
|
|
Infections and infestations
Upper respiraotry infection
|
64.1%
41/64 • Number of events 102 • through out study treatment and up to 30 days after completion of study treatment, up to 119 months
|
|
Renal and urinary disorders
Urinary frequency
|
1.6%
1/64 • Number of events 1 • through out study treatment and up to 30 days after completion of study treatment, up to 119 months
|
|
Renal and urinary disorders
Urinary incontinence
|
3.1%
2/64 • Number of events 2 • through out study treatment and up to 30 days after completion of study treatment, up to 119 months
|
|
Renal and urinary disorders
Urinary retention
|
1.6%
1/64 • Number of events 1 • through out study treatment and up to 30 days after completion of study treatment, up to 119 months
|
|
Renal and urinary disorders
Urinary tract infection
|
21.9%
14/64 • Number of events 23 • through out study treatment and up to 30 days after completion of study treatment, up to 119 months
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
3.1%
2/64 • Number of events 2 • through out study treatment and up to 30 days after completion of study treatment, up to 119 months
|
|
Infections and infestations
Vaginal infection
|
1.6%
1/64 • Number of events 2 • through out study treatment and up to 30 days after completion of study treatment, up to 119 months
|
|
Vascular disorders
Vascular access complication
|
1.6%
1/64 • Number of events 1 • through out study treatment and up to 30 days after completion of study treatment, up to 119 months
|
|
General disorders
Voice alteration
|
1.6%
1/64 • Number of events 1 • through out study treatment and up to 30 days after completion of study treatment, up to 119 months
|
|
Nervous system disorders
Vomiting
|
64.1%
41/64 • Number of events 122 • through out study treatment and up to 30 days after completion of study treatment, up to 119 months
|
|
General disorders
Watering eyes
|
40.6%
26/64 • Number of events 76 • through out study treatment and up to 30 days after completion of study treatment, up to 119 months
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
1.6%
1/64 • Number of events 1 • through out study treatment and up to 30 days after completion of study treatment, up to 119 months
|
|
Blood and lymphatic system disorders
WBC decreased
|
87.5%
56/64 • Number of events 748 • through out study treatment and up to 30 days after completion of study treatment, up to 119 months
|
|
Skin and subcutaneous tissue disorders
Wound complication
|
1.6%
1/64 • Number of events 2 • through out study treatment and up to 30 days after completion of study treatment, up to 119 months
|
|
Infections and infestations
Wound infection
|
1.6%
1/64 • Number of events 1 • through out study treatment and up to 30 days after completion of study treatment, up to 119 months
|
Additional Information
Dr. Krina Patel
University of Texas M D Anderson Cancer Center
Phone: (713) 792-6662
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place