Trial Outcomes & Findings for Ixazomib and Dexamethasone Versus Ixazomib, Dexamethasone and Lenalidomide, Randomized With NFKB2 Rearrangement (NCT NCT02765854)
NCT ID: NCT02765854
Last Updated: 2025-06-26
Results Overview
Comparison to a historical control: The overall response rate (ORR) of each arm at 4 cycles (112 days) is compared to the historical RR of 30%. Arm A or Arm C is designed to detect an improved RR of 60% vs. 30% using Simon's 2-stage Optimum design with a power of at least 90% and an alpha error of 5%., respectively. For Arm B will achieve a power of at least 80% at the significance level of 0.05 to claim that Arm B has equivalent RR as the historical RR of 30% assuming an equivalence tolerance of +/- 20% when the true RR of Arm B is approximately 30%. Response Rate is defined by Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
70 participants
Primary outcome timeframe
112 days
Results posted on
2025-06-26
Participant Flow
Participant milestones
| Measure |
Arm B (Ixazomib and Dexamethasone)
MUTATED NFKB2 REARRANGEMENT: Patients receive ixazomib and dexamethasone as in arm A.
Dexamethasone: Given PO
Ixazomib: Given PO
|
Arm C (Ixazomib, Dexamethasone, Lenalidomide)
MUTATED NFKB2 REARRANGEMENT: Patients receive ixazomib and dexamethasone as in arm A and lenalidomide PO daily on days 1-21.
Dexamethasone: Given PO
Ixazomib: Given PO
Lenalidomide: Given PO
|
Arm A (Ixazomib and Dexamethasone)
UNMUTATED NFKB2 REARRANGEMENT: Patients receive ixazomib and dexamethasone.
Dexamethasone: Given PO
Ixazomib: Given PO
|
|---|---|---|---|
|
Overall Study
STARTED
|
22
|
21
|
27
|
|
Overall Study
COMPLETED
|
22
|
21
|
27
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Ixazomib and Dexamethasone Versus Ixazomib, Dexamethasone and Lenalidomide, Randomized With NFKB2 Rearrangement
Baseline characteristics by cohort
| Measure |
Arm B (Ixazomib and Dexamethasone)
n=22 Participants
MUTATED NFKB2 REARRANGEMENT: Patients receive ixazomib and dexamethasone as in arm A.
Dexamethasone: Given PO
Ixazomib: Given PO
|
Arm C (Ixazomib, Dexamethasone, Lenalidomide)
n=21 Participants
MUTATED NFKB2 REARRANGEMENT: Patients receive ixazomib and dexamethasone as in arm A and lenalidomide PO daily on days 1-21.
Dexamethasone: Given PO
Ixazomib: Given PO
Lenalidomide: Given PO
|
Arm A (Ixazomib and Dexamethasone)
n=27 Participants
UNMUTATED NFKB2 REARRANGEMENT: Patients receive ixazomib and dexamethasone.
Dexamethasone: Given PO
Ixazomib: Given PO
|
Total
n=70 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
26 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
15 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
44 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
40 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
9 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
38 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
22 participants
n=5 Participants
|
21 participants
n=7 Participants
|
27 participants
n=5 Participants
|
70 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 112 daysComparison to a historical control: The overall response rate (ORR) of each arm at 4 cycles (112 days) is compared to the historical RR of 30%. Arm A or Arm C is designed to detect an improved RR of 60% vs. 30% using Simon's 2-stage Optimum design with a power of at least 90% and an alpha error of 5%., respectively. For Arm B will achieve a power of at least 80% at the significance level of 0.05 to claim that Arm B has equivalent RR as the historical RR of 30% assuming an equivalence tolerance of +/- 20% when the true RR of Arm B is approximately 30%. Response Rate is defined by Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Outcome measures
| Measure |
Arm B (Ixazomib and Dexamethasone)
n=22 Participants
MUTATED NFKB2 REARRANGEMENT: Patients receive ixazomib and dexamethasone as in arm A.
Dexamethasone: Given PO
Ixazomib: Given PO
|
Arm C (Ixazomib, Dexamethasone, Lenalidomide)
n=21 Participants
MUTATED NFKB2 REARRANGEMENT: Patients receive ixazomib and dexamethasone as in arm A and lenalidomide PO daily on days 1-21.
Dexamethasone: Given PO
Ixazomib: Given PO
Lenalidomide: Given PO
|
Arm A (Ixazomib and Dexamethasone)
n=27 Participants
UNMUTATED NFKB2 REARRANGEMENT: Patients receive ixazomib and dexamethasone.
Dexamethasone: Given PO
Ixazomib: Given PO
|
|---|---|---|---|
|
The Primary Objective of the Study is to Test Whether the NFKB2 Rearrangement Can Guide the Selection of Treatment (Ixazomib Plus Dexamethasone (Id) or Ixazomib Plus Lenalidomide and Dexamethasone (IRd)) by Conducting the 3 Following Comparisons
Yes: Response Achieved at Four Cycles
|
8 Participants
|
14 Participants
|
16 Participants
|
|
The Primary Objective of the Study is to Test Whether the NFKB2 Rearrangement Can Guide the Selection of Treatment (Ixazomib Plus Dexamethasone (Id) or Ixazomib Plus Lenalidomide and Dexamethasone (IRd)) by Conducting the 3 Following Comparisons
No: Response Achieved at Four Cycles
|
14 Participants
|
7 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: Up to 30 monthsKaplan-Meier curves will be used for the time to treatment failure according to the Arm of treatment utilized. Kaplan-Meyer curve analysis was performed to evaluate the time to treatment failure comparison.
Outcome measures
| Measure |
Arm B (Ixazomib and Dexamethasone)
n=22 Participants
MUTATED NFKB2 REARRANGEMENT: Patients receive ixazomib and dexamethasone as in arm A.
Dexamethasone: Given PO
Ixazomib: Given PO
|
Arm C (Ixazomib, Dexamethasone, Lenalidomide)
n=21 Participants
MUTATED NFKB2 REARRANGEMENT: Patients receive ixazomib and dexamethasone as in arm A and lenalidomide PO daily on days 1-21.
Dexamethasone: Given PO
Ixazomib: Given PO
Lenalidomide: Given PO
|
Arm A (Ixazomib and Dexamethasone)
n=27 Participants
UNMUTATED NFKB2 REARRANGEMENT: Patients receive ixazomib and dexamethasone.
Dexamethasone: Given PO
Ixazomib: Given PO
|
|---|---|---|---|
|
Time to Treatment Failure
12 Months
|
0.353 Months
Interval 0.142 to 0.575
|
0.312 Months
Interval 0.103 to 0.551
|
0.729 Months
Interval 0.512 to 0.861
|
|
Time to Treatment Failure
6 Months
|
0.495 Months
Interval 0.259 to 0.693
|
0.683 Months
Interval 0.419 to 0.847
|
0.729 Months
Interval 0.512 to 0.861
|
|
Time to Treatment Failure
18 Months
|
0.283 Months
Interval 0.095 to 0.508
|
0.312 Months
Interval 0.103 to 0.551
|
0.663 Months
Interval 0.425 to 0.821
|
|
Time to Treatment Failure
24 Months
|
0.141 Months
Interval 0.024 to 0.357
|
0.156 Months
Interval 0.026 to 0.388
|
0.505 Months
Interval 0.249 to 0.715
|
|
Time to Treatment Failure
30 Months
|
0.141 Months
Interval 0.024 to 0.357
|
0.078 Months
Interval 0.005 to 0.294
|
0.421 Months
Interval 0.176 to 0.65
|
SECONDARY outcome
Timeframe: At baseline and month 12To determine the prevalence of NFKB2 rearrangement according to the type of previous therapies received in all patients screened in the study.
Outcome measures
| Measure |
Arm B (Ixazomib and Dexamethasone)
n=22 Participants
MUTATED NFKB2 REARRANGEMENT: Patients receive ixazomib and dexamethasone as in arm A.
Dexamethasone: Given PO
Ixazomib: Given PO
|
Arm C (Ixazomib, Dexamethasone, Lenalidomide)
n=21 Participants
MUTATED NFKB2 REARRANGEMENT: Patients receive ixazomib and dexamethasone as in arm A and lenalidomide PO daily on days 1-21.
Dexamethasone: Given PO
Ixazomib: Given PO
Lenalidomide: Given PO
|
Arm A (Ixazomib and Dexamethasone)
n=27 Participants
UNMUTATED NFKB2 REARRANGEMENT: Patients receive ixazomib and dexamethasone.
Dexamethasone: Given PO
Ixazomib: Given PO
|
|---|---|---|---|
|
Prevalence of NFKB2 Rearrangement in Relapsed/Refractory Multiple Myeloma Patients Screened in the Study.
|
22 Participants
|
21 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: At baseline and at 12 monthsDetermine percentage of patients with response at 8 cycles of treatment
Outcome measures
| Measure |
Arm B (Ixazomib and Dexamethasone)
n=22 Participants
MUTATED NFKB2 REARRANGEMENT: Patients receive ixazomib and dexamethasone as in arm A.
Dexamethasone: Given PO
Ixazomib: Given PO
|
Arm C (Ixazomib, Dexamethasone, Lenalidomide)
n=21 Participants
MUTATED NFKB2 REARRANGEMENT: Patients receive ixazomib and dexamethasone as in arm A and lenalidomide PO daily on days 1-21.
Dexamethasone: Given PO
Ixazomib: Given PO
Lenalidomide: Given PO
|
Arm A (Ixazomib and Dexamethasone)
n=27 Participants
UNMUTATED NFKB2 REARRANGEMENT: Patients receive ixazomib and dexamethasone.
Dexamethasone: Given PO
Ixazomib: Given PO
|
|---|---|---|---|
|
Percentage of Patients With Response at Baseline and at 12 Months
Baseline
|
31 percentage of participants
|
42 percentage of participants
|
37 percentage of participants
|
|
Percentage of Patients With Response at Baseline and at 12 Months
Month 12
|
35 percentage of participants
|
35 percentage of participants
|
73 percentage of participants
|
SECONDARY outcome
Timeframe: 30 days post-treatment, up to a total of 1 yearToxicity information recorded will include the type, severity, and the probable association with the study regimen. Tables will be constructed to summarize the observed incidence by severity and type of toxicity. Additional safety analyses may be performed to most clearly enumerate rates of toxicities and to further define the safety profile of Id or IRd combinations. Treatment-emergent events will be tabulated.
Outcome measures
| Measure |
Arm B (Ixazomib and Dexamethasone)
n=22 Participants
MUTATED NFKB2 REARRANGEMENT: Patients receive ixazomib and dexamethasone as in arm A.
Dexamethasone: Given PO
Ixazomib: Given PO
|
Arm C (Ixazomib, Dexamethasone, Lenalidomide)
n=21 Participants
MUTATED NFKB2 REARRANGEMENT: Patients receive ixazomib and dexamethasone as in arm A and lenalidomide PO daily on days 1-21.
Dexamethasone: Given PO
Ixazomib: Given PO
Lenalidomide: Given PO
|
Arm A (Ixazomib and Dexamethasone)
n=27 Participants
UNMUTATED NFKB2 REARRANGEMENT: Patients receive ixazomib and dexamethasone.
Dexamethasone: Given PO
Ixazomib: Given PO
|
|---|---|---|---|
|
Incidence of Adverse Events
Lymphopenia
|
0 participants
|
0 participants
|
1 participants
|
|
Incidence of Adverse Events
Neutropenic Fever
|
0 participants
|
1 participants
|
0 participants
|
|
Incidence of Adverse Events
Ari
|
1 participants
|
0 participants
|
0 participants
|
|
Incidence of Adverse Events
Cardiopulmonary Arrest, Presumed
|
0 participants
|
0 participants
|
1 participants
|
|
Incidence of Adverse Events
Colitis
|
0 participants
|
1 participants
|
4 participants
|
|
Incidence of Adverse Events
Fatigue
|
1 participants
|
0 participants
|
1 participants
|
|
Incidence of Adverse Events
Gastrointestinal Bleed
|
0 participants
|
0 participants
|
1 participants
|
|
Incidence of Adverse Events
Hepatitis
|
0 participants
|
0 participants
|
1 participants
|
|
Incidence of Adverse Events
Hypophosphatemia
|
0 participants
|
1 participants
|
0 participants
|
|
Incidence of Adverse Events
Supraventricular Tachycardia
|
0 participants
|
1 participants
|
0 participants
|
|
Incidence of Adverse Events
Urinary Tract Infection
|
1 participants
|
0 participants
|
1 participants
|
|
Incidence of Adverse Events
Neuropathy
|
0 participants
|
3 participants
|
2 participants
|
|
Incidence of Adverse Events
Nausea And Vomiting
|
0 participants
|
0 participants
|
1 participants
|
|
Incidence of Adverse Events
Agitation
|
0 participants
|
0 participants
|
1 participants
|
|
Incidence of Adverse Events
Altered Mental Status
|
0 participants
|
0 participants
|
1 participants
|
|
Incidence of Adverse Events
Anemia
|
1 participants
|
1 participants
|
1 participants
|
|
Incidence of Adverse Events
Anxiety
|
0 participants
|
1 participants
|
0 participants
|
|
Incidence of Adverse Events
Bone Pain
|
4 participants
|
1 participants
|
0 participants
|
|
Incidence of Adverse Events
Bp195/90
|
0 participants
|
0 participants
|
1 participants
|
|
Incidence of Adverse Events
Cellulitis
|
1 participants
|
0 participants
|
0 participants
|
|
Incidence of Adverse Events
Conjunctivitis
|
4 participants
|
0 participants
|
2 participants
|
|
Incidence of Adverse Events
Constipation
|
0 participants
|
1 participants
|
0 participants
|
|
Incidence of Adverse Events
Death-Multisystem Organ Failure
|
0 participants
|
0 participants
|
1 participants
|
|
Incidence of Adverse Events
Dehydration
|
0 participants
|
1 participants
|
0 participants
|
|
Incidence of Adverse Events
Diarrhea
|
0 participants
|
1 participants
|
2 participants
|
|
Incidence of Adverse Events
Dress Syndrome
|
0 participants
|
1 participants
|
0 participants
|
|
Incidence of Adverse Events
Dysphagia
|
0 participants
|
0 participants
|
2 participants
|
|
Incidence of Adverse Events
Ecchymosis
|
1 participants
|
0 participants
|
0 participants
|
|
Incidence of Adverse Events
Edema
|
0 participants
|
0 participants
|
1 participants
|
|
Incidence of Adverse Events
Generalized Weakness
|
0 participants
|
0 participants
|
1 participants
|
|
Incidence of Adverse Events
Hernia
|
0 participants
|
1 participants
|
0 participants
|
|
Incidence of Adverse Events
Hyperglycemia
|
0 participants
|
2 participants
|
0 participants
|
|
Incidence of Adverse Events
Hypertension
|
0 participants
|
1 participants
|
1 participants
|
|
Incidence of Adverse Events
Hyponatremia
|
0 participants
|
0 participants
|
1 participants
|
|
Incidence of Adverse Events
Insomnia
|
0 participants
|
0 participants
|
1 participants
|
|
Incidence of Adverse Events
Leucopenia
|
0 participants
|
1 participants
|
0 participants
|
|
Incidence of Adverse Events
Neutropenia
|
0 participants
|
2 participants
|
0 participants
|
|
Incidence of Adverse Events
Pancytopenia
|
0 participants
|
1 participants
|
0 participants
|
|
Incidence of Adverse Events
Pedestrian In Motor Vehicle Accident
|
0 participants
|
0 participants
|
1 participants
|
|
Incidence of Adverse Events
Pneumonia
|
3 participants
|
3 participants
|
6 participants
|
|
Incidence of Adverse Events
Rash
|
0 participants
|
1 participants
|
1 participants
|
|
Incidence of Adverse Events
Sepsis
|
0 participants
|
0 participants
|
1 participants
|
|
Incidence of Adverse Events
Sinus Tachycardia
|
0 participants
|
0 participants
|
1 participants
|
|
Incidence of Adverse Events
Thrombocytopenia
|
0 participants
|
6 participants
|
2 participants
|
|
Incidence of Adverse Events
Tremors
|
0 participants
|
1 participants
|
0 participants
|
|
Incidence of Adverse Events
Tumor Lysis Syndrome
|
0 participants
|
0 participants
|
1 participants
|
|
Incidence of Adverse Events
Upper Respiratory Infection
|
0 participants
|
0 participants
|
6 participants
|
Adverse Events
Arm A (Ixazomib and Dexamethasone)
Serious events: 20 serious events
Other events: 20 other events
Deaths: 1 deaths
Arm B (Ixazomib and Dexamethasone)
Serious events: 10 serious events
Other events: 10 other events
Deaths: 0 deaths
Arm C (Ixazomib, Dexamethasone, Lenalidomide)
Serious events: 10 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm A (Ixazomib and Dexamethasone)
n=27 participants at risk
UNMUTATED NFKB2 REARRANGEMENT: Patients receive ixazomib and dexamethasone.
Dexamethasone: Given PO
Ixazomib: Given PO
|
Arm B (Ixazomib and Dexamethasone)
n=22 participants at risk
MUTATED NFKB2 REARRANGEMENT: Patients receive ixazomib and dexamethasone as in arm A.
Dexamethasone: Given PO
Ixazomib: Given PO
|
Arm C (Ixazomib, Dexamethasone, Lenalidomide)
n=21 participants at risk
MUTATED NFKB2 REARRANGEMENT: Patients receive ixazomib and dexamethasone as in arm A and lenalidomide PO daily on days 1-21.
Dexamethasone: Given PO
Ixazomib: Given PO
Lenalidomide: Given PO
|
|---|---|---|---|
|
Cardiac disorders
Death
|
3.7%
1/27 • Number of events 1 • 1 year
|
0.00%
0/22 • 1 year
|
0.00%
0/21 • 1 year
|
|
Blood and lymphatic system disorders
Anemia
|
3.7%
1/27 • Number of events 1 • 1 year
|
4.5%
1/22 • Number of events 1 • 1 year
|
0.00%
0/21 • 1 year
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/27 • 1 year
|
4.5%
1/22 • Number of events 1 • 1 year
|
0.00%
0/21 • 1 year
|
|
Renal and urinary disorders
Acute Renal Failure
|
0.00%
0/27 • 1 year
|
4.5%
1/22 • Number of events 1 • 1 year
|
0.00%
0/21 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
0.00%
0/27 • 1 year
|
0.00%
0/22 • 1 year
|
4.8%
1/21 • Number of events 1 • 1 year
|
|
Vascular disorders
Hypertension
|
3.7%
1/27 • Number of events 1 • 1 year
|
0.00%
0/22 • 1 year
|
0.00%
0/21 • 1 year
|
|
Cardiac disorders
Cardiopulmonary Arrest
|
3.7%
1/27 • Number of events 1 • 1 year
|
0.00%
0/22 • 1 year
|
0.00%
0/21 • 1 year
|
|
Infections and infestations
cellulitis
|
0.00%
0/27 • 1 year
|
4.5%
1/22 • Number of events 1 • 1 year
|
0.00%
0/21 • 1 year
|
|
Gastrointestinal disorders
Colitis
|
7.4%
2/27 • Number of events 2 • 1 year
|
0.00%
0/22 • 1 year
|
4.8%
1/21 • Number of events 1 • 1 year
|
|
Eye disorders
Conjunctivtis
|
0.00%
0/27 • 1 year
|
18.2%
4/22 • Number of events 4 • 1 year
|
0.00%
0/21 • 1 year
|
|
General disorders
Death
|
3.7%
1/27 • Number of events 1 • 1 year
|
0.00%
0/22 • 1 year
|
0.00%
0/21 • 1 year
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/27 • 1 year
|
0.00%
0/22 • 1 year
|
4.8%
1/21 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Diarrhea
|
7.4%
2/27 • Number of events 2 • 1 year
|
0.00%
0/22 • 1 year
|
0.00%
0/21 • 1 year
|
|
General disorders
Dress Syndrome
|
0.00%
0/27 • 1 year
|
0.00%
0/22 • 1 year
|
4.8%
1/21 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Gastrointestinal Bleed
|
3.7%
1/27 • Number of events 1 • 1 year
|
0.00%
0/22 • 1 year
|
0.00%
0/21 • 1 year
|
|
Metabolism and nutrition disorders
Hyponatremia
|
3.7%
1/27 • Number of events 1 • 1 year
|
0.00%
0/22 • 1 year
|
0.00%
0/21 • 1 year
|
|
Psychiatric disorders
Insomnia
|
3.7%
1/27 • Number of events 1 • 1 year
|
0.00%
0/22 • 1 year
|
0.00%
0/21 • 1 year
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/27 • 1 year
|
0.00%
0/22 • 1 year
|
4.8%
1/21 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Nausea and Vomiting
|
3.7%
1/27 • Number of events 1 • 1 year
|
0.00%
0/22 • 1 year
|
0.00%
0/21 • 1 year
|
|
General disorders
MVA
|
3.7%
1/27 • Number of events 1 • 1 year
|
0.00%
0/22 • 1 year
|
0.00%
0/21 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
11.1%
3/27 • Number of events 3 • 1 year
|
4.5%
1/22 • Number of events 1 • 1 year
|
4.8%
1/21 • Number of events 1 • 1 year
|
|
Skin and subcutaneous tissue disorders
Rash
|
3.7%
1/27 • Number of events 1 • 1 year
|
0.00%
0/22 • 1 year
|
4.8%
1/21 • Number of events 1 • 1 year
|
|
Infections and infestations
Suspected Sepsis
|
3.7%
1/27 • Number of events 1 • 1 year
|
0.00%
0/22 • 1 year
|
0.00%
0/21 • 1 year
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
3.7%
1/27 • Number of events 1 • 1 year
|
0.00%
0/22 • 1 year
|
14.3%
3/21 • Number of events 3 • 1 year
|
|
Metabolism and nutrition disorders
Tumor Lysis Syndrome
|
3.7%
1/27 • Number of events 1 • 1 year
|
0.00%
0/22 • 1 year
|
0.00%
0/21 • 1 year
|
|
Renal and urinary disorders
Urinary Tract Infection
|
3.7%
1/27 • Number of events 1 • 1 year
|
4.5%
1/22 • Number of events 1 • 1 year
|
0.00%
0/21 • 1 year
|
Other adverse events
| Measure |
Arm A (Ixazomib and Dexamethasone)
n=27 participants at risk
UNMUTATED NFKB2 REARRANGEMENT: Patients receive ixazomib and dexamethasone.
Dexamethasone: Given PO
Ixazomib: Given PO
|
Arm B (Ixazomib and Dexamethasone)
n=22 participants at risk
MUTATED NFKB2 REARRANGEMENT: Patients receive ixazomib and dexamethasone as in arm A.
Dexamethasone: Given PO
Ixazomib: Given PO
|
Arm C (Ixazomib, Dexamethasone, Lenalidomide)
n=21 participants at risk
MUTATED NFKB2 REARRANGEMENT: Patients receive ixazomib and dexamethasone as in arm A and lenalidomide PO daily on days 1-21.
Dexamethasone: Given PO
Ixazomib: Given PO
Lenalidomide: Given PO
|
|---|---|---|---|
|
Psychiatric disorders
Agitation
|
3.7%
1/27 • 1 year
|
0.00%
0/22 • 1 year
|
0.00%
0/21 • 1 year
|
|
General disorders
Altered Mental Status
|
7.4%
2/27 • 1 year
|
0.00%
0/22 • 1 year
|
0.00%
0/21 • 1 year
|
|
Blood and lymphatic system disorders
Anemia
|
7.4%
2/27 • 1 year
|
9.1%
2/22 • 1 year
|
4.8%
1/21 • 1 year
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/27 • 1 year
|
0.00%
0/22 • 1 year
|
9.5%
2/21 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
0.00%
0/27 • 1 year
|
18.2%
4/22 • 1 year
|
9.5%
2/21 • 1 year
|
|
Cardiac disorders
Cardiopulmonary Arrest, Presumed
|
7.4%
2/27 • 1 year
|
0.00%
0/22 • 1 year
|
0.00%
0/21 • 1 year
|
|
Skin and subcutaneous tissue disorders
Cellulitis
|
3.7%
1/27 • 1 year
|
4.5%
1/22 • 1 year
|
0.00%
0/21 • 1 year
|
|
Gastrointestinal disorders
Colitis
|
22.2%
6/27 • 1 year
|
0.00%
0/22 • 1 year
|
9.5%
2/21 • 1 year
|
|
Eye disorders
Conjunctivits
|
7.4%
2/27 • 1 year
|
36.4%
8/22 • 1 year
|
0.00%
0/21 • 1 year
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/27 • 1 year
|
0.00%
0/22 • 1 year
|
4.8%
1/21 • 1 year
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/27 • 1 year
|
0.00%
0/22 • 1 year
|
9.5%
2/21 • 1 year
|
|
Gastrointestinal disorders
Diarrhea
|
14.8%
4/27 • 1 year
|
0.00%
0/22 • 1 year
|
4.8%
1/21 • 1 year
|
|
General disorders
Dress Syndrome
|
0.00%
0/27 • 1 year
|
0.00%
0/22 • 1 year
|
9.5%
2/21 • 1 year
|
|
Nervous system disorders
Dysphagia
|
7.4%
2/27 • 1 year
|
0.00%
0/22 • 1 year
|
0.00%
0/21 • 1 year
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/27 • 1 year
|
4.5%
1/22 • 1 year
|
0.00%
0/21 • 1 year
|
|
General disorders
Edema
|
3.7%
1/27 • 1 year
|
0.00%
0/22 • 1 year
|
0.00%
0/21 • 1 year
|
|
General disorders
Fatigue
|
3.7%
1/27 • 1 year
|
4.5%
1/22 • 1 year
|
0.00%
0/21 • 1 year
|
|
Gastrointestinal disorders
Gastrointestinal Bleed
|
7.4%
2/27 • 1 year
|
0.00%
0/22 • 1 year
|
0.00%
0/21 • 1 year
|
|
General disorders
Generalized Weakness
|
3.7%
1/27 • 1 year
|
0.00%
0/22 • 1 year
|
0.00%
0/21 • 1 year
|
|
Hepatobiliary disorders
Hepatitis
|
3.7%
1/27 • 1 year
|
0.00%
0/22 • 1 year
|
0.00%
0/21 • 1 year
|
|
Blood and lymphatic system disorders
Hernia
|
0.00%
0/27 • 1 year
|
0.00%
0/22 • 1 year
|
4.8%
1/21 • 1 year
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/27 • 1 year
|
0.00%
0/22 • 1 year
|
9.5%
2/21 • 1 year
|
|
Vascular disorders
Hypertension
|
7.4%
2/27 • 1 year
|
0.00%
0/22 • 1 year
|
4.8%
1/21 • 1 year
|
|
Metabolism and nutrition disorders
Hyponatremia
|
7.4%
2/27 • 1 year
|
0.00%
0/22 • 1 year
|
0.00%
0/21 • 1 year
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
0.00%
0/27 • 1 year
|
0.00%
0/22 • 1 year
|
4.8%
1/21 • 1 year
|
|
Psychiatric disorders
Insomnia
|
7.4%
2/27 • 1 year
|
0.00%
0/22 • 1 year
|
0.00%
0/21 • 1 year
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/27 • 1 year
|
0.00%
0/22 • 1 year
|
9.5%
2/21 • 1 year
|
|
General disorders
Lymphopenia
|
3.7%
1/27 • 1 year
|
0.00%
0/22 • 1 year
|
0.00%
0/21 • 1 year
|
|
Gastrointestinal disorders
Nausea And Vomiting
|
7.4%
2/27 • 1 year
|
0.00%
0/22 • 1 year
|
0.00%
0/21 • 1 year
|
|
Nervous system disorders
Neuropathy
|
7.4%
2/27 • 1 year
|
0.00%
0/22 • 1 year
|
14.3%
3/21 • 1 year
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/27 • 1 year
|
0.00%
0/22 • 1 year
|
19.0%
4/21 • 1 year
|
|
General disorders
Neutropenic Fever
|
0.00%
0/27 • 1 year
|
0.00%
0/22 • 1 year
|
4.8%
1/21 • 1 year
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/27 • 1 year
|
0.00%
0/22 • 1 year
|
4.8%
1/21 • 1 year
|
|
General disorders
Pedestrian In Motor Vehicle Accident
|
7.4%
2/27 • 1 year
|
0.00%
0/22 • 1 year
|
0.00%
0/21 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
33.3%
9/27 • 1 year
|
18.2%
4/22 • 1 year
|
19.0%
4/21 • 1 year
|
|
Skin and subcutaneous tissue disorders
Rash
|
7.4%
2/27 • 1 year
|
0.00%
0/22 • 1 year
|
9.5%
2/21 • 1 year
|
|
Infections and infestations
Sepsis; Negative Blood Cultures
|
7.4%
2/27 • 1 year
|
0.00%
0/22 • 1 year
|
0.00%
0/21 • 1 year
|
|
Cardiac disorders
Sinus Tachycardia
|
3.7%
1/27 • 1 year
|
0.00%
0/22 • 1 year
|
0.00%
0/21 • 1 year
|
|
Cardiac disorders
Supraventricular Tachycardia
|
0.00%
0/27 • 1 year
|
0.00%
0/22 • 1 year
|
4.8%
1/21 • 1 year
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
11.1%
3/27 • 1 year
|
0.00%
0/22 • 1 year
|
42.9%
9/21 • 1 year
|
|
Nervous system disorders
Tremors
|
0.00%
0/27 • 1 year
|
0.00%
0/22 • 1 year
|
4.8%
1/21 • 1 year
|
|
Metabolism and nutrition disorders
Tumor Lysis Syndrome
|
7.4%
2/27 • 1 year
|
0.00%
0/22 • 1 year
|
0.00%
0/21 • 1 year
|
|
Infections and infestations
Upper Respiratory Infection
|
22.2%
6/27 • 1 year
|
0.00%
0/22 • 1 year
|
0.00%
0/21 • 1 year
|
|
Renal and urinary disorders
Urinary Tract Infection
|
7.4%
2/27 • 1 year
|
9.1%
2/22 • 1 year
|
0.00%
0/21 • 1 year
|
Additional Information
Leon Bernal-Mizrachi, MD
Atrium Health Wake Forest Baptist Comprehensive Cancer Center
Phone: 336-716-9253
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place