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The Effect of Ixazomib on the Latent HIV Reservoir

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02946047
Recruitment Status : Completed
First Posted : October 26, 2016
Results First Posted : January 6, 2022
Last Update Posted : January 6, 2022
Sponsor:
Collaborator:
Takeda
Information provided by (Responsible Party):
Nathan W. Cummins, M.D., Mayo Clinic

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Sequential Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Human Immunodeficiency Virus (HIV)
Interventions Drug: Ixazomib 1 MG
Drug: Ixazomib 2 MG
Drug: Ixazomib 3 MG
Drug: Ixazomib 4 MG
Enrollment 17
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Ixazomib 1 mg Ixazomib 2 mg Ixazomib 3 mg Ixazomib 4 mg
Hide Arm/Group Description

Cohort A: Patients will receive ixazomib 1mg 3 times monthly for 12 weeks, then weekly for 12 weeks.

Ixazomib 1 MG: 1 mg on days 1, 8 and 15 for three 28 days cycles, then be reviewed by DSMB and based upon their recommendation patients will receive ixazomib once weekly for 12 weeks or ixazomib 1 mg on days 1, 8 and 15 for three 28 days cycles. Visits 3-15 will have a window of ± 3 days.

Cohort B: Patients will receive ixazomib 2mg 3 times monthly for 12 weeks, then weekly for 12 weeks.

Ixazomib 2 MG: 2mg on days 1, 8 and 15 for three 28 days cycles, then be reviewed by DSMB and based upon their recommendation patients will receive ixazomib once weekly for 12 weeks or ixazomib 2 mg on days 1, 8 and 15 for three 28 days cycles. Visits 3-15 will have a window of ± 3 days.

Cohort C: Patients will receive ixazomib 3 mg 3 times monthly for 12 weeks, then weekly for 12 weeks.

Ixazomib 3 MG: 3 mg on days 1, 8 and 15 for three 28 days cycles, then be reviewed by DSMB and based upon their recommendation patients will receive ixazomib once weekly for 12 weeks or ixazomib 3 mg on days 1, 8 and 15 for three 28 days cycles. Visits 3-15 will have a window of ± 3 days.

Cohort D: Patients will receive ixazomib 4mg 3 times monthly for 12 weeks, then weekly for 12 weeks.

Ixazomib 4 MG: 4 mg on days 1, 8 and 15 for three 28 days cycles, then be reviewed by DSMB and based upon their recommendation patients will receive ixazomib once weekly for 12 weeks or ixazomib 4 mg on days 1, 8 and 15 for three 28 days cycles. Visits 3-15 will have a window of ± 3 days.

Period Title: Overall Study
Started 4 3 3 7
Completed 3 3 3 7
Not Completed 1 0 0 0
Reason Not Completed
Adverse Event             1             0             0             0
Arm/Group Title Ixazomib 1 mg Ixazomib 2 mg Ixazomib 3 mg Ixazomib 4 mg Total
Hide Arm/Group Description

Cohort A: Patients will receive ixazomib 1mg 3 times monthly for 12 weeks, then weekly for 12 weeks.

Ixazomib 1 MG: 1 mg on days 1, 8 and 15 for three 28 days cycles, then be reviewed by DSMB and based upon their recommendation patients will receive ixazomib once weekly for 12 weeks or ixazomib 1 mg on days 1, 8 and 15 for three 28 days cycles. Visits 3-15 will have a window of ± 3 days.

Cohort B: Patients will receive ixazomib 2mg 3 times monthly for 12 weeks, then weekly for 12 weeks.

Ixazomib 2 MG: 2mg on days 1, 8 and 15 for three 28 days cycles, then be reviewed by DSMB and based upon their recommendation patients will receive ixazomib once weekly for 12 weeks or ixazomib 2 mg on days 1, 8 and 15 for three 28 days cycles. Visits 3-15 will have a window of ± 3 days.

Cohort C: Patients will receive ixazomib 3 mg 3 times monthly for 12 weeks, then weekly for 12 weeks.

Ixazomib 3 MG: 3 mg on days 1, 8 and 15 for three 28 days cycles, then be reviewed by DSMB and based upon their recommendation patients will receive ixazomib once weekly for 12 weeks or ixazomib 3 mg on days 1, 8 and 15 for three 28 days cycles. Visits 3-15 will have a window of ± 3 days.

Cohort D: Patients will receive ixazomib 4mg 3 times monthly for 12 weeks, then weekly for 12 weeks.

Ixazomib 4 MG: 4 mg on days 1, 8 and 15 for three 28 days cycles, then be reviewed by DSMB and based upon their recommendation patients will receive ixazomib once weekly for 12 weeks or ixazomib 4 mg on days 1, 8 and 15 for three 28 days cycles. Visits 3-15 will have a window of ± 3 days.

Total of all reporting groups
Overall Number of Baseline Participants 4 3 3 7 17
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 4 participants 3 participants 3 participants 7 participants 17 participants
54.1
(49.9 to 58.2)
49.3
(40.9 to 52.3)
51.0
(39.3 to 53.5)
49.0
(41.2 to 52.0)
51.0
(45.1 to 55.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 3 participants 3 participants 7 participants 17 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
1
  14.3%
1
   5.9%
Male
4
 100.0%
3
 100.0%
3
 100.0%
6
  85.7%
16
  94.1%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants
0
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 4 participants 3 participants 3 participants 7 participants 17 participants
4 3 3 3 7
1.Primary Outcome
Title Incidence of Treatment-Emergent Adverse Events
Hide Description Number of treatment-emergent adverse events experienced by subjects as defined by NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Time Frame 7 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ixazomib 1 mg Ixazomib 2 mg Ixazomib 3 mg Ixazomib 4 mg
Hide Arm/Group Description:

Cohort A: Patients will receive ixazomib 1mg 3 times monthly for 12 weeks, then weekly for 12 weeks.

Ixazomib 1 MG: 1 mg on days 1, 8 and 15 for three 28 days cycles, then be reviewed by DSMB and based upon their recommendation patients will receive ixazomib once weekly for 12 weeks or ixazomib 1 mg on days 1, 8 and 15 for three 28 days cycles. Visits 3-15 will have a window of ± 3 days.

Cohort B: Patients will receive ixazomib 2mg 3 times monthly for 12 weeks, then weekly for 12 weeks.

Ixazomib 2 MG: 2mg on days 1, 8 and 15 for three 28 days cycles, then be reviewed by DSMB and based upon their recommendation patients will receive ixazomib once weekly for 12 weeks or ixazomib 2 mg on days 1, 8 and 15 for three 28 days cycles. Visits 3-15 will have a window of ± 3 days.

Cohort C: Patients will receive ixazomib 3 mg 3 times monthly for 12 weeks, then weekly for 12 weeks.

Ixazomib 3 MG: 3 mg on days 1, 8 and 15 for three 28 days cycles, then be reviewed by DSMB and based upon their recommendation patients will receive ixazomib once weekly for 12 weeks or ixazomib 3 mg on days 1, 8 and 15 for three 28 days cycles. Visits 3-15 will have a window of ± 3 days.

Cohort D: Patients will receive ixazomib 4mg 3 times monthly for 12 weeks, then weekly for 12 weeks.

Ixazomib 4 MG: 4 mg on days 1, 8 and 15 for three 28 days cycles, then be reviewed by DSMB and based upon their recommendation patients will receive ixazomib once weekly for 12 weeks or ixazomib 4 mg on days 1, 8 and 15 for three 28 days cycles. Visits 3-15 will have a window of ± 3 days.

Overall Number of Participants Analyzed 4 3 3 7
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
2.Secondary Outcome
Title Cell Associated HIV DNA in CD4 T Cell Subsets
Hide Description HIV copies per million CD4 T cells
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
24 week data for 1 participant in the Ixazomib 1 mg arms was not collected or analyzed
Arm/Group Title Ixazomib 1 mg Ixazomib 2 mg Ixazomib 3 mg Ixazomib 4 mg
Hide Arm/Group Description:

Cohort A: Patients will receive ixazomib 1mg 3 times monthly for 12 weeks, then weekly for 12 weeks.

Ixazomib 1 MG: 1 mg on days 1, 8 and 15 for three 28 days cycles, then be reviewed by DSMB and based upon their recommendation patients will receive ixazomib once weekly for 12 weeks or ixazomib 1 mg on days 1, 8 and 15 for three 28 days cycles. Visits 3-15 will have a window of ± 3 days.

Cohort B: Patients will receive ixazomib 2mg 3 times monthly for 12 weeks, then weekly for 12 weeks.

Ixazomib 2 MG: 2mg on days 1, 8 and 15 for three 28 days cycles, then be reviewed by DSMB and based upon their recommendation patients will receive ixazomib once weekly for 12 weeks or ixazomib 2 mg on days 1, 8 and 15 for three 28 days cycles. Visits 3-15 will have a window of ± 3 days.

Cohort C: Patients will receive ixazomib 3 mg 3 times monthly for 12 weeks, then weekly for 12 weeks.

Ixazomib 3 MG: 3 mg on days 1, 8 and 15 for three 28 days cycles, then be reviewed by DSMB and based upon their recommendation patients will receive ixazomib once weekly for 12 weeks or ixazomib 3 mg on days 1, 8 and 15 for three 28 days cycles. Visits 3-15 will have a window of ± 3 days.

Cohort D: Patients will receive ixazomib 4mg 3 times monthly for 12 weeks, then weekly for 12 weeks.

Ixazomib 4 MG: 4 mg on days 1, 8 and 15 for three 28 days cycles, then be reviewed by DSMB and based upon their recommendation patients will receive ixazomib once weekly for 12 weeks or ixazomib 4 mg on days 1, 8 and 15 for three 28 days cycles. Visits 3-15 will have a window of ± 3 days.

Overall Number of Participants Analyzed 4 3 3 7
Median (Inter-Quartile Range)
Unit of Measure: copies per million
Baseline Number Analyzed 4 participants 3 participants 3 participants 7 participants
378
(208 to 837)
626
(54 to 1385)
664.8
(130 to 1014)
416
(39 to 988)
24 weeks Number Analyzed 3 participants 3 participants 3 participants 7 participants
394
(137 to 812)
425
(45 to 1715)
624
(98 to 1125)
481
(24 to 846)
3.Secondary Outcome
Title Culturable HIV by Quantitative Viral Outgrowth Assay
Hide Description Infectious units per million CD4 T cells
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
24 week data for 1 participant in the Ixazomib 1 mg arms was not collected or analyzed
Arm/Group Title Ixazomib 1 mg Ixazomib 2 mg Ixazomib 3 mg Ixazomib 4 mg
Hide Arm/Group Description:

Cohort A: Patients will receive ixazomib 1mg 3 times monthly for 12 weeks, then weekly for 12 weeks.

Ixazomib 1 MG: 1 mg on days 1, 8 and 15 for three 28 days cycles, then be reviewed by DSMB and based upon their recommendation patients will receive ixazomib once weekly for 12 weeks or ixazomib 1 mg on days 1, 8 and 15 for three 28 days cycles. Visits 3-15 will have a window of ± 3 days.

Cohort B: Patients will receive ixazomib 2mg 3 times monthly for 12 weeks, then weekly for 12 weeks.

Ixazomib 2 MG: 2mg on days 1, 8 and 15 for three 28 days cycles, then be reviewed by DSMB and based upon their recommendation patients will receive ixazomib once weekly for 12 weeks or ixazomib 2 mg on days 1, 8 and 15 for three 28 days cycles. Visits 3-15 will have a window of ± 3 days.

Cohort C: Patients will receive ixazomib 3 mg 3 times monthly for 12 weeks, then weekly for 12 weeks.

Ixazomib 3 MG: 3 mg on days 1, 8 and 15 for three 28 days cycles, then be reviewed by DSMB and based upon their recommendation patients will receive ixazomib once weekly for 12 weeks or ixazomib 3 mg on days 1, 8 and 15 for three 28 days cycles. Visits 3-15 will have a window of ± 3 days.

Cohort D: Patients will receive ixazomib 4mg 3 times monthly for 12 weeks, then weekly for 12 weeks.

Ixazomib 4 MG: 4 mg on days 1, 8 and 15 for three 28 days cycles, then be reviewed by DSMB and based upon their recommendation patients will receive ixazomib once weekly for 12 weeks or ixazomib 4 mg on days 1, 8 and 15 for three 28 days cycles. Visits 3-15 will have a window of ± 3 days.

Overall Number of Participants Analyzed 4 3 3 7
Median (Inter-Quartile Range)
Unit of Measure: units per million
Baseline Number Analyzed 4 participants 3 participants 3 participants 7 participants
0.49
(0.15 to 1.23)
0.30
(0.14 to 1.60)
0.62
(0.30 to 2.12)
1.54
(0.15 to 2.95)
24 weeks Number Analyzed 3 participants 3 participants 3 participants 7 participants
0.30
(0.30 to 0.66)
0.48
(0.10 to 0.65)
0.82
(0.81 to 1.07)
1.31
(0.10 to 2.58)
4.Secondary Outcome
Title Absolute CD4 T Cell Count
Hide Description Cells per microliter
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
24 week data for 1 participant in the Ixazomib 1 mg arms was not collected or analyzed
Arm/Group Title Ixazomib 1 mg Ixazomib 2 mg Ixazomib 3 mg Ixazomib 4 mg
Hide Arm/Group Description:

Cohort A: Patients will receive ixazomib 1mg 3 times monthly for 12 weeks, then weekly for 12 weeks.

Ixazomib 1 MG: 1 mg on days 1, 8 and 15 for three 28 days cycles, then be reviewed by DSMB and based upon their recommendation patients will receive ixazomib once weekly for 12 weeks or ixazomib 1 mg on days 1, 8 and 15 for three 28 days cycles. Visits 3-15 will have a window of ± 3 days.

Cohort B: Patients will receive ixazomib 2mg 3 times monthly for 12 weeks, then weekly for 12 weeks.

Ixazomib 2 MG: 2mg on days 1, 8 and 15 for three 28 days cycles, then be reviewed by DSMB and based upon their recommendation patients will receive ixazomib once weekly for 12 weeks or ixazomib 2 mg on days 1, 8 and 15 for three 28 days cycles. Visits 3-15 will have a window of ± 3 days.

Cohort C: Patients will receive ixazomib 3 mg 3 times monthly for 12 weeks, then weekly for 12 weeks.

Ixazomib 3 MG: 3 mg on days 1, 8 and 15 for three 28 days cycles, then be reviewed by DSMB and based upon their recommendation patients will receive ixazomib once weekly for 12 weeks or ixazomib 3 mg on days 1, 8 and 15 for three 28 days cycles. Visits 3-15 will have a window of ± 3 days.

Cohort D: Patients will receive ixazomib 4mg 3 times monthly for 12 weeks, then weekly for 12 weeks.

Ixazomib 4 MG: 4 mg on days 1, 8 and 15 for three 28 days cycles, then be reviewed by DSMB and based upon their recommendation patients will receive ixazomib once weekly for 12 weeks or ixazomib 4 mg on days 1, 8 and 15 for three 28 days cycles. Visits 3-15 will have a window of ± 3 days.

Overall Number of Participants Analyzed 4 3 3 7
Median (Inter-Quartile Range)
Unit of Measure: cells/mmˆ(3)
Baseline Number Analyzed 4 participants 3 participants 3 participants 7 participants
724
(676 to 830)
914
(790 to 968)
1130
(1029 to 1240)
735
(680 to 770)
24 weeks Number Analyzed 3 participants 3 participants 3 participants 7 participants
714
(696 to 735)
809
(771 to 813)
765
(676 to 825)
632
(548 to 768)
5.Secondary Outcome
Title Absolute CD8 T Cell Count
Hide Description Cells per microliter
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
24 week data for 1 participant in the Ixazomib 1 mg arms was not collected or analyzed
Arm/Group Title Ixazomib 1 mg Ixazomib 2 mg Ixazomib 3 mg Ixazomib 4 mg
Hide Arm/Group Description:

Cohort A: Patients will receive ixazomib 1mg 3 times monthly for 12 weeks, then weekly for 12 weeks.

Ixazomib 1 MG: 1 mg on days 1, 8 and 15 for three 28 days cycles, then be reviewed by DSMB and based upon their recommendation patients will receive ixazomib once weekly for 12 weeks or ixazomib 1 mg on days 1, 8 and 15 for three 28 days cycles. Visits 3-15 will have a window of ± 3 days.

Cohort B: Patients will receive ixazomib 2mg 3 times monthly for 12 weeks, then weekly for 12 weeks.

Ixazomib 2 MG: 2mg on days 1, 8 and 15 for three 28 days cycles, then be reviewed by DSMB and based upon their recommendation patients will receive ixazomib once weekly for 12 weeks or ixazomib 2 mg on days 1, 8 and 15 for three 28 days cycles. Visits 3-15 will have a window of ± 3 days.

Cohort C: Patients will receive ixazomib 3 mg 3 times monthly for 12 weeks, then weekly for 12 weeks.

Ixazomib 3 MG: 3 mg on days 1, 8 and 15 for three 28 days cycles, then be reviewed by DSMB and based upon their recommendation patients will receive ixazomib once weekly for 12 weeks or ixazomib 3 mg on days 1, 8 and 15 for three 28 days cycles. Visits 3-15 will have a window of ± 3 days.

Cohort D: Patients will receive ixazomib 4mg 3 times monthly for 12 weeks, then weekly for 12 weeks.

Ixazomib 4 MG: 4 mg on days 1, 8 and 15 for three 28 days cycles, then be reviewed by DSMB and based upon their recommendation patients will receive ixazomib once weekly for 12 weeks or ixazomib 4 mg on days 1, 8 and 15 for three 28 days cycles. Visits 3-15 will have a window of ± 3 days.

Overall Number of Participants Analyzed 4 3 3 7
Median (Inter-Quartile Range)
Unit of Measure: cells/mmˆ(3)
Baseline Number Analyzed 4 participants 3 participants 3 participants 7 participants
508
(504 to 810)
803
(716 to 834)
1014
(868 to 1208)
573
(405 to 712)
24 weeks Number Analyzed 3 participants 3 participants 3 participants 7 participants
387
(337 to 428)
885
(624 to 888)
689
(573 to 723)
416
(332 to 486)
6.Secondary Outcome
Title CD4/CD8 Ratio
Hide Description CD4/CD8 T cell count ratio
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
24 week data for 1 participant in the Ixazomib 1 mg arms was not collected or analyzed
Arm/Group Title Ixazomib 1 mg Ixazomib 2 mg Ixazomib 3 mg Ixazomib 4 mg
Hide Arm/Group Description:

Cohort A: Patients will receive ixazomib 1mg 3 times monthly for 12 weeks, then weekly for 12 weeks.

Ixazomib 1 MG: 1 mg on days 1, 8 and 15 for three 28 days cycles, then be reviewed by DSMB and based upon their recommendation patients will receive ixazomib once weekly for 12 weeks or ixazomib 1 mg on days 1, 8 and 15 for three 28 days cycles. Visits 3-15 will have a window of ± 3 days.

Cohort B: Patients will receive ixazomib 2mg 3 times monthly for 12 weeks, then weekly for 12 weeks.

Ixazomib 2 MG: 2mg on days 1, 8 and 15 for three 28 days cycles, then be reviewed by DSMB and based upon their recommendation patients will receive ixazomib once weekly for 12 weeks or ixazomib 2 mg on days 1, 8 and 15 for three 28 days cycles. Visits 3-15 will have a window of ± 3 days.

Cohort C: Patients will receive ixazomib 3 mg 3 times monthly for 12 weeks, then weekly for 12 weeks.

Ixazomib 3 MG: 3 mg on days 1, 8 and 15 for three 28 days cycles, then be reviewed by DSMB and based upon their recommendation patients will receive ixazomib once weekly for 12 weeks or ixazomib 3 mg on days 1, 8 and 15 for three 28 days cycles. Visits 3-15 will have a window of ± 3 days.

Cohort D: Patients will receive ixazomib 4mg 3 times monthly for 12 weeks, then weekly for 12 weeks.

Ixazomib 4 MG: 4 mg on days 1, 8 and 15 for three 28 days cycles, then be reviewed by DSMB and based upon their recommendation patients will receive ixazomib once weekly for 12 weeks or ixazomib 4 mg on days 1, 8 and 15 for three 28 days cycles. Visits 3-15 will have a window of ± 3 days.

Overall Number of Participants Analyzed 4 3 3 7
Median (Inter-Quartile Range)
Unit of Measure: ratio
Baseline Number Analyzed 4 participants 3 participants 3 participants 7 participants
1.45
(1.10 to 1.67)
1.14
(0.95 to 1.38)
1.28
(1.04 to 1.31)
1.58
(1.15 to 1.82)
24 weeks Number Analyzed 3 participants 3 participants 3 participants 7 participants
1.84
(1.64 to 2.24)
0.92
(0.87 to 1.57)
1.17
(1.01 to 1.42)
1.75
(1.42 to 2.09)
Time Frame Adverse events were collected from baseline to end of study for a total of approximately 7 months on all participatns.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Ixazomib 1 mg Ixazomib 2 mg Ixazomib 3 mg Ixazomib 4 mg
Hide Arm/Group Description

Cohort A: Patients will receive ixazomib 1mg 3 times monthly for 12 weeks, then weekly for 12 weeks.

Ixazomib 1 MG: 1 mg on days 1, 8 and 15 for three 28 days cycles, then be reviewed by DSMB and based upon their recommendation patients will receive ixazomib once weekly for 12 weeks or ixazomib 1 mg on days 1, 8 and 15 for three 28 days cycles. Visits 3-15 will have a window of ± 3 days.

Cohort B: Patients will receive ixazomib 2mg 3 times monthly for 12 weeks, then weekly for 12 weeks.

Ixazomib 2 MG: 2mg on days 1, 8 and 15 for three 28 days cycles, then be reviewed by DSMB and based upon their recommendation patients will receive ixazomib once weekly for 12 weeks or ixazomib 2 mg on days 1, 8 and 15 for three 28 days cycles. Visits 3-15 will have a window of ± 3 days.

Cohort C: Patients will receive ixazomib 3 mg 3 times monthly for 12 weeks, then weekly for 12 weeks.

Ixazomib 3 MG: 3 mg on days 1, 8 and 15 for three 28 days cycles, then be reviewed by DSMB and based upon their recommendation patients will receive ixazomib once weekly for 12 weeks or ixazomib 3 mg on days 1, 8 and 15 for three 28 days cycles. Visits 3-15 will have a window of ± 3 days.

Cohort D: Patients will receive ixazomib 4mg 3 times monthly for 12 weeks, then weekly for 12 weeks.

Ixazomib 4 MG: 4 mg on days 1, 8 and 15 for three 28 days cycles, then be reviewed by DSMB and based upon their recommendation patients will receive ixazomib once weekly for 12 weeks or ixazomib 4 mg on days 1, 8 and 15 for three 28 days cycles. Visits 3-15 will have a window of ± 3 days.

All-Cause Mortality
Ixazomib 1 mg Ixazomib 2 mg Ixazomib 3 mg Ixazomib 4 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/4 (0.00%)      0/3 (0.00%)      0/3 (0.00%)      0/7 (0.00%)    
Hide Serious Adverse Events
Ixazomib 1 mg Ixazomib 2 mg Ixazomib 3 mg Ixazomib 4 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/4 (0.00%)      0/3 (0.00%)      0/3 (0.00%)      0/7 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Ixazomib 1 mg Ixazomib 2 mg Ixazomib 3 mg Ixazomib 4 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/4 (75.00%)      2/3 (66.67%)      1/3 (33.33%)      1/7 (14.29%)    
Gastrointestinal disorders         
Constipation   1/4 (25.00%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/7 (0.00%)  0
Diarrhea   1/4 (25.00%)  1 0/3 (0.00%)  0 1/3 (33.33%)  1 1/7 (14.29%)  1
Nausea   0/4 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1 0/7 (0.00%)  0
General disorders         
Edema Limbs   0/4 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 0/7 (0.00%)  0
Fatigue   0/4 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1 0/7 (0.00%)  0
Infection   1/4 (25.00%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/7 (0.00%)  0
Nervous system disorders         
Peripheral motor neuropathy   0/4 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1 0/7 (0.00%)  0
Peripheral sensory neuropathy   0/4 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1 0/7 (0.00%)  0
Skin and subcutaneous tissue disorders         
Rash, maculopapular   0/4 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 1/7 (14.29%)  1
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Nathan Cummins
Organization: Mayo Clinic
Phone: 507-284-3747
EMail: Cummins.Nathan@mayo.edu
Layout table for additonal information
Responsible Party: Nathan W. Cummins, M.D., Mayo Clinic
ClinicalTrials.gov Identifier: NCT02946047    
Other Study ID Numbers: 16-001938
First Submitted: October 24, 2016
First Posted: October 26, 2016
Results First Submitted: December 8, 2021
Results First Posted: January 6, 2022
Last Update Posted: January 6, 2022