Trial Outcomes & Findings for Pomalidomide, Bortezomib, and Dexamethasone in Treating Patients With Relapsed or Refractory Multiple Myeloma (NCT NCT01212952)
NCT ID: NCT01212952
Last Updated: 2020-04-17
Results Overview
MTD is defined as the dose level below the lowest dose that induces dose-limiting toxicity in at least one-third of patients (at least 2 of a maximum of 6 new patients).
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
50 participants
Primary outcome timeframe
2.5 years
Results posted on
2020-04-17
Participant Flow
Participant milestones
| Measure |
Phase 1 Dose Level 1
Patients receive oral pomalidomide on days 1-21; bortezomib IV on days 1, 8, 15, 22; and oral dexamethasone on days 1, 8, 15, 22. Treatment repeats every 28 days for 8 courses. Patients then receive maintenance therapy comprising oral pomalidomide on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. 1.0 mg/m2 Bortezomib, 4 mg Pomalidomide, 40 mg Dexamethasone
|
Phase 1 Dose Level 2
Patients receive oral pomalidomide on days 1-21; bortezomib IV on days 1, 8, 15, 22; and oral dexamethasone on days 1, 8, 15, 22. Treatment repeats every 28 days for 8 courses. Patients then receive maintenance therapy comprising oral pomalidomide on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. 1.3 mg/m2 Bortezomib, 4 mg Pomalidomide, 40 mg Dexamethasone
|
Phase 2 Dose Level 2
Patients receive oral pomalidomide on days 1-21; bortezomib IV on days 1, 8, 15, 22; and oral dexamethasone on days 1, 8, 15, 22. Treatment repeats every 28 days for 8 courses. Patients then receive maintenance therapy comprising oral pomalidomide on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. 1.3 mg/m2 Bortezomib, 4 mg Pomalidomide, 40 mg Dexamethasone
|
|---|---|---|---|
|
Overall Study
STARTED
|
3
|
6
|
41
|
|
Overall Study
COMPLETED
|
3
|
6
|
41
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pomalidomide, Bortezomib, and Dexamethasone in Treating Patients With Relapsed or Refractory Multiple Myeloma
Baseline characteristics by cohort
| Measure |
Phase 1; Dose Level 1
n=3 Participants
Patients receive oral pomalidomide on days 1-21; bortezomib IV on days 1, 8, 15, 22; and oral dexamethasone on days 1, 8, 15, 22. Treatment repeats every 28 days for 8 courses. Patients then receive maintenance therapy comprising oral pomalidomide on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Phase 1; Dose Level 2
n=6 Participants
Patients receive oral pomalidomide on days 1-21; bortezomib IV on days 1, 8, 15, 22; and oral dexamethasone on days 1, 8, 15, 22. Treatment repeats every 28 days for 8 courses. Patients then receive maintenance therapy comprising oral pomalidomide on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Phase 2; Dose Level 2
n=41 Participants
Patients receive oral pomalidomide on days 1-21; bortezomib IV on days 1, 8, 15, 22; and oral dexamethasone on days 1, 8, 15, 22. Treatment repeats every 28 days for 8 courses. Patients then receive maintenance therapy comprising oral pomalidomide on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
63 years
n=5 Participants
|
61 years
n=7 Participants
|
66 years
n=5 Participants
|
65.5 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
26 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
|
0 Participants
n=5 Participants
|
0 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
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
47 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 2.5 yearsPopulation: The first 9 patients accrued(All Phase 1 patients) were evaluated for the MTD.
MTD is defined as the dose level below the lowest dose that induces dose-limiting toxicity in at least one-third of patients (at least 2 of a maximum of 6 new patients).
Outcome measures
| Measure |
Phase 1 Dose Level 1
n=3 Participants
Patients receive oral pomalidomide on days 1-21; bortezomib IV on days 1, 8, 15, 22; and oral dexamethasone on days 1, 8, 15, 22. Treatment repeats every 28 days for 8 courses. Patients then receive maintenance therapy comprising oral pomalidomide on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. 1.0 mg/m2 Bortezomib, 4 mg Pomalidomide, 40 mg Dexamethasone
|
Phase 1 Dose Level 2
n=6 Participants
Patients receive oral pomalidomide on days 1-21; bortezomib IV on days 1, 8, 15, 22; and oral dexamethasone on days 1, 8, 15, 22. Treatment repeats every 28 days for 8 courses. Patients then receive maintenance therapy comprising oral pomalidomide on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. 1.3 mg/m2 Bortezomib, 4 mg Pomalidomide, 40 mg Dexamethasone
|
Phase II
Patients receive oral pomalidomide on days 1-21; bortezomib IV on days 1, 8, 15, 22; and oral dexamethasone on days 1, 8, 15, 22. Treatment repeats every 28 days for 8 courses. Patients then receive maintenance therapy comprising oral pomalidomide on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. 1.3 mg/m2 Bortezomib, 4 mg Pomalidomide, 40 mg Dexamethasone
|
|---|---|---|---|
|
Find Maximum Tolerated Dose (MTD) of Bortezomib in Combination With Pomalidomide and Dexamethasone Out to 2.5 Years, by Count of Patients With Dose Limiting Toxicities.
|
0 Participants
|
1 Participants
|
—
|
PRIMARY outcome
Timeframe: 2.5 yearsThe number of participants who achieve PR, VGPR, or CR as defined by The International Myeloma Working Group uniform response criteria(2011). sCR: CR as defined below plus normal FLC ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence. CR: Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and \< 5% plasma cells in bone marrow. VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or \> 90% reduction in serum M-protein plus urine M-protein level \< 100 mg/24 h. PR: \> 50% reduction of serum M-protein and reduction in 24 hours urinary M-protein by \>90% or to \< 200 mg/24 h. MR: NA. SD: Not meeting criteria for CR, VGPR, PR, or progressive disease. PD: Increase of \> 25% from lowest response value in any one or more of the following: Serum M-component and/or (the absolute increase must be \> 0.5 g/dL), Urine M-component and/or (the absolute increase must be \> 200 mg/24 h)
Outcome measures
| Measure |
Phase 1 Dose Level 1
n=3 Participants
Patients receive oral pomalidomide on days 1-21; bortezomib IV on days 1, 8, 15, 22; and oral dexamethasone on days 1, 8, 15, 22. Treatment repeats every 28 days for 8 courses. Patients then receive maintenance therapy comprising oral pomalidomide on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. 1.0 mg/m2 Bortezomib, 4 mg Pomalidomide, 40 mg Dexamethasone
|
Phase 1 Dose Level 2
n=6 Participants
Patients receive oral pomalidomide on days 1-21; bortezomib IV on days 1, 8, 15, 22; and oral dexamethasone on days 1, 8, 15, 22. Treatment repeats every 28 days for 8 courses. Patients then receive maintenance therapy comprising oral pomalidomide on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. 1.3 mg/m2 Bortezomib, 4 mg Pomalidomide, 40 mg Dexamethasone
|
Phase II
n=41 Participants
Patients receive oral pomalidomide on days 1-21; bortezomib IV on days 1, 8, 15, 22; and oral dexamethasone on days 1, 8, 15, 22. Treatment repeats every 28 days for 8 courses. Patients then receive maintenance therapy comprising oral pomalidomide on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. 1.3 mg/m2 Bortezomib, 4 mg Pomalidomide, 40 mg Dexamethasone
|
|---|---|---|---|
|
Number of Participants With a Hematologic Response (PR, VGPR, or CR)
CR
|
0 Participants
|
1 Participants
|
4 Participants
|
|
Number of Participants With a Hematologic Response (PR, VGPR, or CR)
PR
|
0 Participants
|
1 Participants
|
17 Participants
|
|
Number of Participants With a Hematologic Response (PR, VGPR, or CR)
VGPR
|
0 Participants
|
2 Participants
|
12 Participants
|
|
Number of Participants With a Hematologic Response (PR, VGPR, or CR)
SD
|
1 Participants
|
0 Participants
|
5 Participants
|
|
Number of Participants With a Hematologic Response (PR, VGPR, or CR)
MR
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With a Hematologic Response (PR, VGPR, or CR)
sCR
|
2 Participants
|
2 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 2.5 yearsThe progression-free survival (PFS) time is defined as the time from registration to progression or death due to any cause. The distribution of progression-free survival will be estimated using the method of Kaplan-Meier. PD: Increase of \> 25% from lowest response value in any one or more of the following: Serum M-component and/or (the absolute increase must be \> 0.5 g/dL), Urine M-component and/or (the absolute increase must be \> 200 mg/24 h)
Outcome measures
| Measure |
Phase 1 Dose Level 1
n=3 Participants
Patients receive oral pomalidomide on days 1-21; bortezomib IV on days 1, 8, 15, 22; and oral dexamethasone on days 1, 8, 15, 22. Treatment repeats every 28 days for 8 courses. Patients then receive maintenance therapy comprising oral pomalidomide on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. 1.0 mg/m2 Bortezomib, 4 mg Pomalidomide, 40 mg Dexamethasone
|
Phase 1 Dose Level 2
n=6 Participants
Patients receive oral pomalidomide on days 1-21; bortezomib IV on days 1, 8, 15, 22; and oral dexamethasone on days 1, 8, 15, 22. Treatment repeats every 28 days for 8 courses. Patients then receive maintenance therapy comprising oral pomalidomide on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. 1.3 mg/m2 Bortezomib, 4 mg Pomalidomide, 40 mg Dexamethasone
|
Phase II
n=41 Participants
Patients receive oral pomalidomide on days 1-21; bortezomib IV on days 1, 8, 15, 22; and oral dexamethasone on days 1, 8, 15, 22. Treatment repeats every 28 days for 8 courses. Patients then receive maintenance therapy comprising oral pomalidomide on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. 1.3 mg/m2 Bortezomib, 4 mg Pomalidomide, 40 mg Dexamethasone
|
|---|---|---|---|
|
Progression Free Survival
|
13.9 months
Interval 2.8 to 22.9
|
18.1 months
Interval 9.5 to
The 95% confidence interval upper limit was not reached (i.e. insufficient number of events).
|
10.7 months
Interval 9.0 to 16.3
|
SECONDARY outcome
Timeframe: 2.5 yearsPopulation: All participants combined in this analysis due to small numbers in Phase I portion.
Reported in Adverse Events section of the results
Outcome measures
| Measure |
Phase 1 Dose Level 1
n=3 Participants
Patients receive oral pomalidomide on days 1-21; bortezomib IV on days 1, 8, 15, 22; and oral dexamethasone on days 1, 8, 15, 22. Treatment repeats every 28 days for 8 courses. Patients then receive maintenance therapy comprising oral pomalidomide on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. 1.0 mg/m2 Bortezomib, 4 mg Pomalidomide, 40 mg Dexamethasone
|
Phase 1 Dose Level 2
n=6 Participants
Patients receive oral pomalidomide on days 1-21; bortezomib IV on days 1, 8, 15, 22; and oral dexamethasone on days 1, 8, 15, 22. Treatment repeats every 28 days for 8 courses. Patients then receive maintenance therapy comprising oral pomalidomide on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. 1.3 mg/m2 Bortezomib, 4 mg Pomalidomide, 40 mg Dexamethasone
|
Phase II
n=41 Participants
Patients receive oral pomalidomide on days 1-21; bortezomib IV on days 1, 8, 15, 22; and oral dexamethasone on days 1, 8, 15, 22. Treatment repeats every 28 days for 8 courses. Patients then receive maintenance therapy comprising oral pomalidomide on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. 1.3 mg/m2 Bortezomib, 4 mg Pomalidomide, 40 mg Dexamethasone
|
|---|---|---|---|
|
Number of Participants With Adverse Events
|
3 Participants
|
6 Participants
|
41 Participants
|
Adverse Events
Phase 1; Dose Level 1
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Phase 1; Dose Level 2
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Phase 2; Dose Level 2
Serious events: 21 serious events
Other events: 41 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Phase 1; Dose Level 1
n=3 participants at risk
Patients receive oral pomalidomide on days 1-21; bortezomib IV on days 1, 8, 15, 22; and oral dexamethasone on days 1, 8, 15, 22. Treatment repeats every 28 days for 8 courses. Patients then receive maintenance therapy comprising oral pomalidomide on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Phase 1; Dose Level 2
n=6 participants at risk
Patients receive oral pomalidomide on days 1-21; bortezomib IV on days 1, 8, 15, 22; and oral dexamethasone on days 1, 8, 15, 22. Treatment repeats every 28 days for 8 courses. Patients then receive maintenance therapy comprising oral pomalidomide on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Phase 2; Dose Level 2
n=41 participants at risk
Patients receive oral pomalidomide on days 1-21; bortezomib IV on days 1, 8, 15, 22; and oral dexamethasone on days 1, 8, 15, 22. Treatment repeats every 28 days for 8 courses. Patients then receive maintenance therapy comprising oral pomalidomide on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
33.3%
1/3 • Number of events 1 • 2.5 years
|
0.00%
0/6 • 2.5 years
|
0.00%
0/41 • 2.5 years
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/3 • 2.5 years
|
0.00%
0/6 • 2.5 years
|
4.9%
2/41 • Number of events 2 • 2.5 years
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/3 • 2.5 years
|
0.00%
0/6 • 2.5 years
|
2.4%
1/41 • Number of events 1 • 2.5 years
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/3 • 2.5 years
|
0.00%
0/6 • 2.5 years
|
4.9%
2/41 • Number of events 2 • 2.5 years
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/3 • 2.5 years
|
0.00%
0/6 • 2.5 years
|
2.4%
1/41 • Number of events 1 • 2.5 years
|
|
General disorders
Fatigue
|
0.00%
0/3 • 2.5 years
|
0.00%
0/6 • 2.5 years
|
2.4%
1/41 • Number of events 1 • 2.5 years
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/3 • 2.5 years
|
0.00%
0/6 • 2.5 years
|
2.4%
1/41 • Number of events 1 • 2.5 years
|
|
Infections and infestations
Bronchial infection
|
0.00%
0/3 • 2.5 years
|
0.00%
0/6 • 2.5 years
|
2.4%
1/41 • Number of events 1 • 2.5 years
|
|
Infections and infestations
Infections and infestations - Other, specify
|
0.00%
0/3 • 2.5 years
|
16.7%
1/6 • Number of events 1 • 2.5 years
|
0.00%
0/41 • 2.5 years
|
|
Infections and infestations
Lung infection
|
0.00%
0/3 • 2.5 years
|
16.7%
1/6 • Number of events 1 • 2.5 years
|
19.5%
8/41 • Number of events 11 • 2.5 years
|
|
Infections and infestations
Meningitis
|
0.00%
0/3 • 2.5 years
|
0.00%
0/6 • 2.5 years
|
2.4%
1/41 • Number of events 1 • 2.5 years
|
|
Infections and infestations
Sepsis
|
0.00%
0/3 • 2.5 years
|
0.00%
0/6 • 2.5 years
|
2.4%
1/41 • Number of events 1 • 2.5 years
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/3 • 2.5 years
|
0.00%
0/6 • 2.5 years
|
2.4%
1/41 • Number of events 1 • 2.5 years
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/3 • 2.5 years
|
0.00%
0/6 • 2.5 years
|
2.4%
1/41 • Number of events 1 • 2.5 years
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications - Other, specify
|
0.00%
0/3 • 2.5 years
|
0.00%
0/6 • 2.5 years
|
2.4%
1/41 • Number of events 1 • 2.5 years
|
|
Investigations
Creatinine increased
|
0.00%
0/3 • 2.5 years
|
0.00%
0/6 • 2.5 years
|
2.4%
1/41 • Number of events 1 • 2.5 years
|
|
Investigations
Platelet count decreased
|
0.00%
0/3 • 2.5 years
|
16.7%
1/6 • Number of events 1 • 2.5 years
|
0.00%
0/41 • 2.5 years
|
|
Investigations
White blood cell decreased
|
0.00%
0/3 • 2.5 years
|
16.7%
1/6 • Number of events 1 • 2.5 years
|
0.00%
0/41 • 2.5 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/3 • 2.5 years
|
0.00%
0/6 • 2.5 years
|
2.4%
1/41 • Number of events 1 • 2.5 years
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/3 • 2.5 years
|
0.00%
0/6 • 2.5 years
|
2.4%
1/41 • Number of events 1 • 2.5 years
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
0.00%
0/3 • 2.5 years
|
0.00%
0/6 • 2.5 years
|
2.4%
1/41 • Number of events 1 • 2.5 years
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
0.00%
0/3 • 2.5 years
|
0.00%
0/6 • 2.5 years
|
2.4%
1/41 • Number of events 1 • 2.5 years
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/3 • 2.5 years
|
0.00%
0/6 • 2.5 years
|
2.4%
1/41 • Number of events 1 • 2.5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
|
0.00%
0/3 • 2.5 years
|
0.00%
0/6 • 2.5 years
|
4.9%
2/41 • Number of events 2 • 2.5 years
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3 • 2.5 years
|
0.00%
0/6 • 2.5 years
|
2.4%
1/41 • Number of events 1 • 2.5 years
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/3 • 2.5 years
|
0.00%
0/6 • 2.5 years
|
2.4%
1/41 • Number of events 1 • 2.5 years
|
|
Nervous system disorders
Headache
|
0.00%
0/3 • 2.5 years
|
16.7%
1/6 • Number of events 1 • 2.5 years
|
0.00%
0/41 • 2.5 years
|
|
Nervous system disorders
Syncope
|
0.00%
0/3 • 2.5 years
|
0.00%
0/6 • 2.5 years
|
4.9%
2/41 • Number of events 2 • 2.5 years
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/3 • 2.5 years
|
0.00%
0/6 • 2.5 years
|
2.4%
1/41 • Number of events 1 • 2.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/3 • 2.5 years
|
0.00%
0/6 • 2.5 years
|
4.9%
2/41 • Number of events 2 • 2.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify
|
0.00%
0/3 • 2.5 years
|
0.00%
0/6 • 2.5 years
|
2.4%
1/41 • Number of events 1 • 2.5 years
|
|
Surgical and medical procedures
Surgical and medical procedures - Other, specify
|
0.00%
0/3 • 2.5 years
|
0.00%
0/6 • 2.5 years
|
2.4%
1/41 • Number of events 1 • 2.5 years
|
|
Vascular disorders
Hypotension
|
0.00%
0/3 • 2.5 years
|
0.00%
0/6 • 2.5 years
|
4.9%
2/41 • Number of events 2 • 2.5 years
|
|
Vascular disorders
Vascular disorders - Other, specify
|
0.00%
0/3 • 2.5 years
|
0.00%
0/6 • 2.5 years
|
2.4%
1/41 • Number of events 2 • 2.5 years
|
Other adverse events
| Measure |
Phase 1; Dose Level 1
n=3 participants at risk
Patients receive oral pomalidomide on days 1-21; bortezomib IV on days 1, 8, 15, 22; and oral dexamethasone on days 1, 8, 15, 22. Treatment repeats every 28 days for 8 courses. Patients then receive maintenance therapy comprising oral pomalidomide on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Phase 1; Dose Level 2
n=6 participants at risk
Patients receive oral pomalidomide on days 1-21; bortezomib IV on days 1, 8, 15, 22; and oral dexamethasone on days 1, 8, 15, 22. Treatment repeats every 28 days for 8 courses. Patients then receive maintenance therapy comprising oral pomalidomide on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Phase 2; Dose Level 2
n=41 participants at risk
Patients receive oral pomalidomide on days 1-21; bortezomib IV on days 1, 8, 15, 22; and oral dexamethasone on days 1, 8, 15, 22. Treatment repeats every 28 days for 8 courses. Patients then receive maintenance therapy comprising oral pomalidomide on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
100.0%
3/3 • Number of events 39 • 2.5 years
|
83.3%
5/6 • Number of events 55 • 2.5 years
|
95.1%
39/41 • Number of events 363 • 2.5 years
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/3 • 2.5 years
|
0.00%
0/6 • 2.5 years
|
2.4%
1/41 • Number of events 1 • 2.5 years
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/3 • 2.5 years
|
0.00%
0/6 • 2.5 years
|
2.4%
1/41 • Number of events 2 • 2.5 years
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/3 • 2.5 years
|
0.00%
0/6 • 2.5 years
|
2.4%
1/41 • Number of events 1 • 2.5 years
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/3 • 2.5 years
|
0.00%
0/6 • 2.5 years
|
2.4%
1/41 • Number of events 1 • 2.5 years
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/3 • 2.5 years
|
16.7%
1/6 • Number of events 2 • 2.5 years
|
2.4%
1/41 • Number of events 2 • 2.5 years
|
|
Gastrointestinal disorders
Diarrhea
|
100.0%
3/3 • Number of events 10 • 2.5 years
|
66.7%
4/6 • Number of events 19 • 2.5 years
|
70.7%
29/41 • Number of events 118 • 2.5 years
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/3 • 2.5 years
|
0.00%
0/6 • 2.5 years
|
2.4%
1/41 • Number of events 1 • 2.5 years
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
0.00%
0/3 • 2.5 years
|
0.00%
0/6 • 2.5 years
|
2.4%
1/41 • Number of events 1 • 2.5 years
|
|
Gastrointestinal disorders
Nausea
|
33.3%
1/3 • Number of events 1 • 2.5 years
|
66.7%
4/6 • Number of events 10 • 2.5 years
|
48.8%
20/41 • Number of events 100 • 2.5 years
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • 2.5 years
|
0.00%
0/6 • 2.5 years
|
19.5%
8/41 • Number of events 20 • 2.5 years
|
|
General disorders
Edema limbs
|
0.00%
0/3 • 2.5 years
|
0.00%
0/6 • 2.5 years
|
7.3%
3/41 • Number of events 4 • 2.5 years
|
|
General disorders
Fatigue
|
100.0%
3/3 • Number of events 29 • 2.5 years
|
100.0%
6/6 • Number of events 115 • 2.5 years
|
95.1%
39/41 • Number of events 436 • 2.5 years
|
|
General disorders
Fever
|
0.00%
0/3 • 2.5 years
|
0.00%
0/6 • 2.5 years
|
7.3%
3/41 • Number of events 3 • 2.5 years
|
|
General disorders
Irritability
|
0.00%
0/3 • 2.5 years
|
16.7%
1/6 • Number of events 1 • 2.5 years
|
0.00%
0/41 • 2.5 years
|
|
General disorders
Malaise
|
0.00%
0/3 • 2.5 years
|
16.7%
1/6 • Number of events 1 • 2.5 years
|
0.00%
0/41 • 2.5 years
|
|
General disorders
Pain
|
0.00%
0/3 • 2.5 years
|
0.00%
0/6 • 2.5 years
|
2.4%
1/41 • Number of events 1 • 2.5 years
|
|
Infections and infestations
Infections and infestations - Other, specify
|
0.00%
0/3 • 2.5 years
|
16.7%
1/6 • Number of events 1 • 2.5 years
|
12.2%
5/41 • Number of events 11 • 2.5 years
|
|
Infections and infestations
Lung infection
|
33.3%
1/3 • Number of events 1 • 2.5 years
|
33.3%
2/6 • Number of events 3 • 2.5 years
|
29.3%
12/41 • Number of events 20 • 2.5 years
|
|
Infections and infestations
Sinusitis
|
0.00%
0/3 • 2.5 years
|
0.00%
0/6 • 2.5 years
|
4.9%
2/41 • Number of events 2 • 2.5 years
|
|
Infections and infestations
Upper respiratory infection
|
0.00%
0/3 • 2.5 years
|
0.00%
0/6 • 2.5 years
|
7.3%
3/41 • Number of events 4 • 2.5 years
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/3 • 2.5 years
|
0.00%
0/6 • 2.5 years
|
2.4%
1/41 • Number of events 1 • 2.5 years
|
|
Infections and infestations
Vaginal infection
|
0.00%
0/3 • 2.5 years
|
0.00%
0/6 • 2.5 years
|
2.4%
1/41 • Number of events 1 • 2.5 years
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/3 • 2.5 years
|
0.00%
0/6 • 2.5 years
|
2.4%
1/41 • Number of events 3 • 2.5 years
|
|
Investigations
CD4 lymphocytes decreased
|
0.00%
0/3 • 2.5 years
|
0.00%
0/6 • 2.5 years
|
4.9%
2/41 • Number of events 3 • 2.5 years
|
|
Investigations
Creatinine increased
|
33.3%
1/3 • Number of events 6 • 2.5 years
|
0.00%
0/6 • 2.5 years
|
0.00%
0/41 • 2.5 years
|
|
Investigations
Lymphocyte count decreased
|
33.3%
1/3 • Number of events 4 • 2.5 years
|
50.0%
3/6 • Number of events 9 • 2.5 years
|
39.0%
16/41 • Number of events 83 • 2.5 years
|
|
Investigations
Neutrophil count decreased
|
100.0%
3/3 • Number of events 33 • 2.5 years
|
100.0%
6/6 • Number of events 81 • 2.5 years
|
100.0%
41/41 • Number of events 310 • 2.5 years
|
|
Investigations
Platelet count decreased
|
66.7%
2/3 • Number of events 37 • 2.5 years
|
83.3%
5/6 • Number of events 41 • 2.5 years
|
87.8%
36/41 • Number of events 236 • 2.5 years
|
|
Investigations
Weight gain
|
0.00%
0/3 • 2.5 years
|
0.00%
0/6 • 2.5 years
|
2.4%
1/41 • Number of events 2 • 2.5 years
|
|
Investigations
White blood cell decreased
|
100.0%
3/3 • Number of events 33 • 2.5 years
|
100.0%
6/6 • Number of events 61 • 2.5 years
|
95.1%
39/41 • Number of events 291 • 2.5 years
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/3 • 2.5 years
|
0.00%
0/6 • 2.5 years
|
2.4%
1/41 • Number of events 1 • 2.5 years
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
0.00%
0/3 • 2.5 years
|
0.00%
0/6 • 2.5 years
|
2.4%
1/41 • Number of events 1 • 2.5 years
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
33.3%
1/3 • Number of events 1 • 2.5 years
|
0.00%
0/6 • 2.5 years
|
0.00%
0/41 • 2.5 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/3 • 2.5 years
|
0.00%
0/6 • 2.5 years
|
2.4%
1/41 • Number of events 1 • 2.5 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
33.3%
1/3 • Number of events 1 • 2.5 years
|
16.7%
1/6 • Number of events 1 • 2.5 years
|
2.4%
1/41 • Number of events 1 • 2.5 years
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
33.3%
1/3 • Number of events 1 • 2.5 years
|
0.00%
0/6 • 2.5 years
|
0.00%
0/41 • 2.5 years
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
33.3%
1/3 • Number of events 2 • 2.5 years
|
0.00%
0/6 • 2.5 years
|
2.4%
1/41 • Number of events 3 • 2.5 years
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/3 • 2.5 years
|
0.00%
0/6 • 2.5 years
|
2.4%
1/41 • Number of events 1 • 2.5 years
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/3 • 2.5 years
|
0.00%
0/6 • 2.5 years
|
2.4%
1/41 • Number of events 1 • 2.5 years
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/3 • 2.5 years
|
0.00%
0/6 • 2.5 years
|
2.4%
1/41 • Number of events 1 • 2.5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
|
0.00%
0/3 • 2.5 years
|
0.00%
0/6 • 2.5 years
|
2.4%
1/41 • Number of events 7 • 2.5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Treatment related secondary malignancy
|
0.00%
0/3 • 2.5 years
|
0.00%
0/6 • 2.5 years
|
2.4%
1/41 • Number of events 2 • 2.5 years
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3 • 2.5 years
|
33.3%
2/6 • Number of events 2 • 2.5 years
|
2.4%
1/41 • Number of events 1 • 2.5 years
|
|
Nervous system disorders
Headache
|
0.00%
0/3 • 2.5 years
|
0.00%
0/6 • 2.5 years
|
2.4%
1/41 • Number of events 1 • 2.5 years
|
|
Nervous system disorders
Paresthesia
|
0.00%
0/3 • 2.5 years
|
0.00%
0/6 • 2.5 years
|
2.4%
1/41 • Number of events 2 • 2.5 years
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
100.0%
3/3 • Number of events 37 • 2.5 years
|
100.0%
6/6 • Number of events 46 • 2.5 years
|
85.4%
35/41 • Number of events 346 • 2.5 years
|
|
Nervous system disorders
Syncope
|
0.00%
0/3 • 2.5 years
|
0.00%
0/6 • 2.5 years
|
2.4%
1/41 • Number of events 2 • 2.5 years
|
|
Psychiatric disorders
Agitation
|
33.3%
1/3 • Number of events 1 • 2.5 years
|
0.00%
0/6 • 2.5 years
|
0.00%
0/41 • 2.5 years
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/3 • 2.5 years
|
0.00%
0/6 • 2.5 years
|
4.9%
2/41 • Number of events 2 • 2.5 years
|
|
Psychiatric disorders
Insomnia
|
33.3%
1/3 • Number of events 3 • 2.5 years
|
16.7%
1/6 • Number of events 2 • 2.5 years
|
4.9%
2/41 • Number of events 2 • 2.5 years
|
|
Psychiatric disorders
Psychiatric disorders - Other, specify
|
0.00%
0/3 • 2.5 years
|
16.7%
1/6 • Number of events 1 • 2.5 years
|
0.00%
0/41 • 2.5 years
|
|
Psychiatric disorders
Restlessness
|
0.00%
0/3 • 2.5 years
|
0.00%
0/6 • 2.5 years
|
2.4%
1/41 • Number of events 1 • 2.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/3 • 2.5 years
|
0.00%
0/6 • 2.5 years
|
4.9%
2/41 • Number of events 2 • 2.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/3 • 2.5 years
|
0.00%
0/6 • 2.5 years
|
14.6%
6/41 • Number of events 11 • 2.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/3 • 2.5 years
|
0.00%
0/6 • 2.5 years
|
2.4%
1/41 • Number of events 1 • 2.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
0.00%
0/3 • 2.5 years
|
0.00%
0/6 • 2.5 years
|
2.4%
1/41 • Number of events 1 • 2.5 years
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/3 • 2.5 years
|
0.00%
0/6 • 2.5 years
|
2.4%
1/41 • Number of events 1 • 2.5 years
|
|
Vascular disorders
Hypertension
|
0.00%
0/3 • 2.5 years
|
0.00%
0/6 • 2.5 years
|
2.4%
1/41 • Number of events 1 • 2.5 years
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/3 • 2.5 years
|
0.00%
0/6 • 2.5 years
|
17.1%
7/41 • Number of events 9 • 2.5 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place