Trial Outcomes & Findings for Pomalidomide, Dexamethasone, and Filgrastim-sndz in Treating Patients With Relapsed or Refractory Multiple Myeloma (NCT NCT01946152)
NCT ID: NCT01946152
Last Updated: 2021-07-30
Results Overview
Safety and tolerability will be assessed by clinical review of all relevant parameters, including dose limiting toxicities. Toxicity type and severity will be summarized by frequency tables. Maximum tolerated dose defined as the highest dose level in which patients have been treated with less than 2 instances of dose-limiting toxicity (Phase I)
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
21 participants
Primary outcome timeframe
28 days
Results posted on
2021-07-30
Participant Flow
21 participants enrolled, 20 evaluable and 1 screen failure.
Participant milestones
| Measure |
Cohort 0
4 mg of Pomalidomide Daily days 1 - 21. 40 mg Dexamethasone On days 1, 8. 15, 22. 4mcg/kg of Zarxio (G-CSF) Days 22- 28.
|
Cohort I
5 mg of Pomalidomide Daily days 1 - 21. 40 mg Dexamethasone On days 1, 8. 15, 22. 4mcg/kg of Zarxio (G-CSF) Days 22- 28.
|
Cohort II
6 mg of Pomalidomide Daily days 1 - 21. 40 mg Dexamethasone On days 1, 8. 15, 22. 4mcg/kg of Zarxio (G-CSF) Days 22- 28.
|
Maximum Tolerated Dose (MTD)
5 mg of Pomalidomide Daily days 1 - 21. 40 mg Dexamethasone On days 1, 8. 15, 22. 4mcg/kg of Zarxio (G-CSF) Days 22- 28.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
6
|
8
|
|
Overall Study
COMPLETED
|
2
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
1
|
3
|
6
|
8
|
Reasons for withdrawal
| Measure |
Cohort 0
4 mg of Pomalidomide Daily days 1 - 21. 40 mg Dexamethasone On days 1, 8. 15, 22. 4mcg/kg of Zarxio (G-CSF) Days 22- 28.
|
Cohort I
5 mg of Pomalidomide Daily days 1 - 21. 40 mg Dexamethasone On days 1, 8. 15, 22. 4mcg/kg of Zarxio (G-CSF) Days 22- 28.
|
Cohort II
6 mg of Pomalidomide Daily days 1 - 21. 40 mg Dexamethasone On days 1, 8. 15, 22. 4mcg/kg of Zarxio (G-CSF) Days 22- 28.
|
Maximum Tolerated Dose (MTD)
5 mg of Pomalidomide Daily days 1 - 21. 40 mg Dexamethasone On days 1, 8. 15, 22. 4mcg/kg of Zarxio (G-CSF) Days 22- 28.
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
2
|
0
|
0
|
|
Overall Study
Progression
|
0
|
1
|
4
|
7
|
|
Overall Study
Physician Decision
|
0
|
0
|
1
|
0
|
|
Overall Study
Second malignancy
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Pomalidomide, Dexamethasone, and Filgrastim-sndz in Treating Patients With Relapsed or Refractory Multiple Myeloma
Baseline characteristics by cohort
| Measure |
Cohort 0
n=3 Participants
4 mg of Pomalidomide Daily days 1 - 21. 40 mg Dexamethasone On days 1, 8. 15, 22. 4mcg/kg of Zarxio (G-CSF) Days 22- 28.
|
Cohort I
n=3 Participants
5 mg of Pomalidomide Daily days 1 - 21. 40 mg Dexamethasone On days 1, 8. 15, 22. 4mcg/kg of Zarxio (G-CSF) Days 22- 28.
|
Cohort II
n=6 Participants
6 mg of Pomalidomide Daily days 1 - 21. 40 mg Dexamethasone On days 1, 8. 15, 22. 4mcg/kg of Zarxio (G-CSF) Days 22- 28.
|
Maximum Tolerated Dose (MTD)
n=8 Participants
5 mg of Pomalidomide Daily days 1 - 21. 40 mg Dexamethasone On days 1, 8. 15, 22. 4mcg/kg of Zarxio (G-CSF) Days 22- 28.
|
Total
n=20 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
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 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
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 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
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
11 Participants
n=21 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
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
6 participants
n=5 Participants
|
8 participants
n=4 Participants
|
20 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 28 daysSafety and tolerability will be assessed by clinical review of all relevant parameters, including dose limiting toxicities. Toxicity type and severity will be summarized by frequency tables. Maximum tolerated dose defined as the highest dose level in which patients have been treated with less than 2 instances of dose-limiting toxicity (Phase I)
Outcome measures
| Measure |
Maximum Tolerated Dose (MTD)
n=8 Participants
5 mg of Pomalidomide Daily days 1 - 21. 40 mg Dexamethasone On days 1, 8. 15, 22. 4mcg/kg of Zarxio (G-CSF) Days 22- 28.
|
Cohort I
5 mg of Pomalidomide Daily days 1 - 21. 40 mg Dexamethasone On days 1, 8. 15, 22. 4mcg/kg of Zarxio (G-CSF) Days 22- 28.
|
Cohort II
6 mg of Pomalidomide Daily days 1 - 21. 40 mg Dexamethasone On days 1, 8. 15, 22. 4mcg/kg of Zarxio (G-CSF) Days 22- 28.
|
Maximum Tolerated Dose (MTD)
5 mg of Pomalidomide Daily days 1 - 21. 40 mg Dexamethasone On days 1, 8. 15, 22. 4mcg/kg of Zarxio (G-CSF) Days 22- 28.
|
|---|---|---|---|---|
|
Maximum Tolerated Dose (MTD) (Phase I)
|
5 mg
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 28 daysPopulation: Data provided for the Participants who received MTD
Outcome measures
| Measure |
Maximum Tolerated Dose (MTD)
n=8 Participants
5 mg of Pomalidomide Daily days 1 - 21. 40 mg Dexamethasone On days 1, 8. 15, 22. 4mcg/kg of Zarxio (G-CSF) Days 22- 28.
|
Cohort I
5 mg of Pomalidomide Daily days 1 - 21. 40 mg Dexamethasone On days 1, 8. 15, 22. 4mcg/kg of Zarxio (G-CSF) Days 22- 28.
|
Cohort II
6 mg of Pomalidomide Daily days 1 - 21. 40 mg Dexamethasone On days 1, 8. 15, 22. 4mcg/kg of Zarxio (G-CSF) Days 22- 28.
|
Maximum Tolerated Dose (MTD)
5 mg of Pomalidomide Daily days 1 - 21. 40 mg Dexamethasone On days 1, 8. 15, 22. 4mcg/kg of Zarxio (G-CSF) Days 22- 28.
|
|---|---|---|---|---|
|
Number of Participants Recommended Phase II Dose of Pomalidomide and Dexamethasone, When Both Agents Are Administered Together With Granulocyte-colony Stimulating Factor (Filgrastim) (Phase I)
|
8 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: After 112 days (4 courses) of therapyPer International Myeloma Working Group Uniform Response Criteria (IMWG-URC): Complete Response (CR), Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and \< 5% plasma cells in bone marrow; Very Good Partial Response (VGPR): Serum and urine M-protein detectable by immunofixation but not electrophoresis or ≥ 90% reduction in serum M-protein with urine M-protein \<100 mg/24 hours; Partial Response (PR), \> 50% reduction of serum M-protein and reduction in 24 hours urinary M-protein by \>90% or to \< 200 mg/24 h; Stable Disease (SD) = CR + PR.
Outcome measures
| Measure |
Maximum Tolerated Dose (MTD)
n=3 Participants
5 mg of Pomalidomide Daily days 1 - 21. 40 mg Dexamethasone On days 1, 8. 15, 22. 4mcg/kg of Zarxio (G-CSF) Days 22- 28.
|
Cohort I
n=3 Participants
5 mg of Pomalidomide Daily days 1 - 21. 40 mg Dexamethasone On days 1, 8. 15, 22. 4mcg/kg of Zarxio (G-CSF) Days 22- 28.
|
Cohort II
n=6 Participants
6 mg of Pomalidomide Daily days 1 - 21. 40 mg Dexamethasone On days 1, 8. 15, 22. 4mcg/kg of Zarxio (G-CSF) Days 22- 28.
|
Maximum Tolerated Dose (MTD)
n=8 Participants
5 mg of Pomalidomide Daily days 1 - 21. 40 mg Dexamethasone On days 1, 8. 15, 22. 4mcg/kg of Zarxio (G-CSF) Days 22- 28.
|
|---|---|---|---|---|
|
Number of Participants With Best Overall Response Defined Using the International Myeloma Working Group Uniform Response Criteria (IMWG-URC)
Partial Response
|
1 Participants
|
2 Participants
|
3 Participants
|
6 Participants
|
|
Number of Participants With Best Overall Response Defined Using the International Myeloma Working Group Uniform Response Criteria (IMWG-URC)
Progression Disease
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Best Overall Response Defined Using the International Myeloma Working Group Uniform Response Criteria (IMWG-URC)
Stable Disease
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Best Overall Response Defined Using the International Myeloma Working Group Uniform Response Criteria (IMWG-URC)
Complete Response
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Best Overall Response Defined Using the International Myeloma Working Group Uniform Response Criteria (IMWG-URC)
Very Good Partial Response (VGPR)
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Best Overall Response Defined Using the International Myeloma Working Group Uniform Response Criteria (IMWG-URC)
Non evaluable
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 6 yearsPopulation: Data provided for the Participants who received MTD
Outcome measures
| Measure |
Maximum Tolerated Dose (MTD)
n=8 Participants
5 mg of Pomalidomide Daily days 1 - 21. 40 mg Dexamethasone On days 1, 8. 15, 22. 4mcg/kg of Zarxio (G-CSF) Days 22- 28.
|
Cohort I
5 mg of Pomalidomide Daily days 1 - 21. 40 mg Dexamethasone On days 1, 8. 15, 22. 4mcg/kg of Zarxio (G-CSF) Days 22- 28.
|
Cohort II
6 mg of Pomalidomide Daily days 1 - 21. 40 mg Dexamethasone On days 1, 8. 15, 22. 4mcg/kg of Zarxio (G-CSF) Days 22- 28.
|
Maximum Tolerated Dose (MTD)
5 mg of Pomalidomide Daily days 1 - 21. 40 mg Dexamethasone On days 1, 8. 15, 22. 4mcg/kg of Zarxio (G-CSF) Days 22- 28.
|
|---|---|---|---|---|
|
Number of Participants With Progression-free Survival
|
3 Participants
|
—
|
—
|
—
|
Adverse Events
Cohort 0
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Cohort 1
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Cohort 2
Serious events: 2 serious events
Other events: 2 other events
Deaths: 0 deaths
Maximum Tolerated Dose (MTD)
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort 0
n=3 participants at risk
4 mg of Pomalidomide Daily days 1 - 21. 40 mg Dexamethasone On days 1, 8. 15, 22. 4mcg/kg of Zarxio (G-CSF) Days 22- 28.
|
Cohort 1
n=3 participants at risk
5 mg of Pomalidomide Daily days 1 - 21. 40 mg Dexamethasone On days 1, 8. 15, 22. 4mcg/kg of Zarxio (G-CSF) Days 22- 28.
|
Cohort 2
n=6 participants at risk
6 mg of Pomalidomide Daily days 1 - 21. 40 mg Dexamethasone On days 1, 8. 15, 22. 4mcg/kg of Zarxio (G-CSF) Days 22- 28.
|
Maximum Tolerated Dose (MTD)
n=8 participants at risk
5 mg of Pomalidomide Daily days 1 - 21. 40 mg Dexamethasone On days 1, 8. 15, 22. 4mcg/kg of Zarxio (G-CSF) Days 22- 28.
|
|---|---|---|---|---|
|
Ear and labyrinth disorders
Sinusitis
|
0.00%
0/3 • From start of treatment until 30 days after last dose, up to 6 years
|
0.00%
0/3 • From start of treatment until 30 days after last dose, up to 6 years
|
33.3%
2/6 • From start of treatment until 30 days after last dose, up to 6 years
|
0.00%
0/8 • From start of treatment until 30 days after last dose, up to 6 years
|
|
Infections and infestations
Febrile Neutropenia
|
0.00%
0/3 • From start of treatment until 30 days after last dose, up to 6 years
|
0.00%
0/3 • From start of treatment until 30 days after last dose, up to 6 years
|
16.7%
1/6 • From start of treatment until 30 days after last dose, up to 6 years
|
0.00%
0/8 • From start of treatment until 30 days after last dose, up to 6 years
|
|
General disorders
Squamous Cell CA
|
0.00%
0/3 • From start of treatment until 30 days after last dose, up to 6 years
|
0.00%
0/3 • From start of treatment until 30 days after last dose, up to 6 years
|
16.7%
1/6 • From start of treatment until 30 days after last dose, up to 6 years
|
0.00%
0/8 • From start of treatment until 30 days after last dose, up to 6 years
|
|
Surgical and medical procedures
Fall/Hip Surgery
|
0.00%
0/3 • From start of treatment until 30 days after last dose, up to 6 years
|
33.3%
1/3 • From start of treatment until 30 days after last dose, up to 6 years
|
0.00%
0/6 • From start of treatment until 30 days after last dose, up to 6 years
|
0.00%
0/8 • From start of treatment until 30 days after last dose, up to 6 years
|
|
Gastrointestinal disorders
Fecal Incontinence
|
0.00%
0/3 • From start of treatment until 30 days after last dose, up to 6 years
|
0.00%
0/3 • From start of treatment until 30 days after last dose, up to 6 years
|
16.7%
1/6 • From start of treatment until 30 days after last dose, up to 6 years
|
0.00%
0/8 • From start of treatment until 30 days after last dose, up to 6 years
|
|
Cardiac disorders
Syncope
|
0.00%
0/3 • From start of treatment until 30 days after last dose, up to 6 years
|
0.00%
0/3 • From start of treatment until 30 days after last dose, up to 6 years
|
0.00%
0/6 • From start of treatment until 30 days after last dose, up to 6 years
|
12.5%
1/8 • From start of treatment until 30 days after last dose, up to 6 years
|
|
Cardiac disorders
Dyspnea
|
0.00%
0/3 • From start of treatment until 30 days after last dose, up to 6 years
|
0.00%
0/3 • From start of treatment until 30 days after last dose, up to 6 years
|
0.00%
0/6 • From start of treatment until 30 days after last dose, up to 6 years
|
12.5%
1/8 • From start of treatment until 30 days after last dose, up to 6 years
|
|
Respiratory, thoracic and mediastinal disorders
Lung Infection
|
0.00%
0/3 • From start of treatment until 30 days after last dose, up to 6 years
|
0.00%
0/3 • From start of treatment until 30 days after last dose, up to 6 years
|
0.00%
0/6 • From start of treatment until 30 days after last dose, up to 6 years
|
12.5%
1/8 • From start of treatment until 30 days after last dose, up to 6 years
|
|
Infections and infestations
Upper Respiratory Infection
|
0.00%
0/3 • From start of treatment until 30 days after last dose, up to 6 years
|
0.00%
0/3 • From start of treatment until 30 days after last dose, up to 6 years
|
16.7%
1/6 • From start of treatment until 30 days after last dose, up to 6 years
|
0.00%
0/8 • From start of treatment until 30 days after last dose, up to 6 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/3 • From start of treatment until 30 days after last dose, up to 6 years
|
0.00%
0/3 • From start of treatment until 30 days after last dose, up to 6 years
|
0.00%
0/6 • From start of treatment until 30 days after last dose, up to 6 years
|
12.5%
1/8 • From start of treatment until 30 days after last dose, up to 6 years
|
Other adverse events
| Measure |
Cohort 0
n=3 participants at risk
4 mg of Pomalidomide Daily days 1 - 21. 40 mg Dexamethasone On days 1, 8. 15, 22. 4mcg/kg of Zarxio (G-CSF) Days 22- 28.
|
Cohort 1
n=3 participants at risk
5 mg of Pomalidomide Daily days 1 - 21. 40 mg Dexamethasone On days 1, 8. 15, 22. 4mcg/kg of Zarxio (G-CSF) Days 22- 28.
|
Cohort 2
n=6 participants at risk
6 mg of Pomalidomide Daily days 1 - 21. 40 mg Dexamethasone On days 1, 8. 15, 22. 4mcg/kg of Zarxio (G-CSF) Days 22- 28.
|
Maximum Tolerated Dose (MTD)
n=8 participants at risk
5 mg of Pomalidomide Daily days 1 - 21. 40 mg Dexamethasone On days 1, 8. 15, 22. 4mcg/kg of Zarxio (G-CSF) Days 22- 28.
|
|---|---|---|---|---|
|
Infections and infestations
Febrile Neutropenia
|
0.00%
0/3 • From start of treatment until 30 days after last dose, up to 6 years
|
0.00%
0/3 • From start of treatment until 30 days after last dose, up to 6 years
|
16.7%
1/6 • From start of treatment until 30 days after last dose, up to 6 years
|
0.00%
0/8 • From start of treatment until 30 days after last dose, up to 6 years
|
|
Infections and infestations
Infection
|
0.00%
0/3 • From start of treatment until 30 days after last dose, up to 6 years
|
0.00%
0/3 • From start of treatment until 30 days after last dose, up to 6 years
|
16.7%
1/6 • From start of treatment until 30 days after last dose, up to 6 years
|
50.0%
4/8 • From start of treatment until 30 days after last dose, up to 6 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/3 • From start of treatment until 30 days after last dose, up to 6 years
|
0.00%
0/3 • From start of treatment until 30 days after last dose, up to 6 years
|
33.3%
2/6 • From start of treatment until 30 days after last dose, up to 6 years
|
0.00%
0/8 • From start of treatment until 30 days after last dose, up to 6 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/3 • From start of treatment until 30 days after last dose, up to 6 years
|
33.3%
1/3 • From start of treatment until 30 days after last dose, up to 6 years
|
16.7%
1/6 • From start of treatment until 30 days after last dose, up to 6 years
|
0.00%
0/8 • From start of treatment until 30 days after last dose, up to 6 years
|
|
General disorders
Fatigue
|
33.3%
1/3 • From start of treatment until 30 days after last dose, up to 6 years
|
0.00%
0/3 • From start of treatment until 30 days after last dose, up to 6 years
|
16.7%
1/6 • From start of treatment until 30 days after last dose, up to 6 years
|
0.00%
0/8 • From start of treatment until 30 days after last dose, up to 6 years
|
|
General disorders
Secondary Cancers
|
0.00%
0/3 • From start of treatment until 30 days after last dose, up to 6 years
|
0.00%
0/3 • From start of treatment until 30 days after last dose, up to 6 years
|
0.00%
0/6 • From start of treatment until 30 days after last dose, up to 6 years
|
25.0%
2/8 • From start of treatment until 30 days after last dose, up to 6 years
|
|
Musculoskeletal and connective tissue disorders
Pain Extremity
|
33.3%
1/3 • From start of treatment until 30 days after last dose, up to 6 years
|
0.00%
0/3 • From start of treatment until 30 days after last dose, up to 6 years
|
16.7%
1/6 • From start of treatment until 30 days after last dose, up to 6 years
|
0.00%
0/8 • From start of treatment until 30 days after last dose, up to 6 years
|
|
Nervous system disorders
Peripheral Sensory Neuropathy
|
33.3%
1/3 • From start of treatment until 30 days after last dose, up to 6 years
|
33.3%
1/3 • From start of treatment until 30 days after last dose, up to 6 years
|
0.00%
0/6 • From start of treatment until 30 days after last dose, up to 6 years
|
0.00%
0/8 • From start of treatment until 30 days after last dose, up to 6 years
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
0.00%
0/3 • From start of treatment until 30 days after last dose, up to 6 years
|
33.3%
1/3 • From start of treatment until 30 days after last dose, up to 6 years
|
33.3%
2/6 • From start of treatment until 30 days after last dose, up to 6 years
|
0.00%
0/8 • From start of treatment until 30 days after last dose, up to 6 years
|
|
Cardiac disorders
Chest Pain
|
0.00%
0/3 • From start of treatment until 30 days after last dose, up to 6 years
|
0.00%
0/3 • From start of treatment until 30 days after last dose, up to 6 years
|
16.7%
1/6 • From start of treatment until 30 days after last dose, up to 6 years
|
12.5%
1/8 • From start of treatment until 30 days after last dose, up to 6 years
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3 • From start of treatment until 30 days after last dose, up to 6 years
|
33.3%
1/3 • From start of treatment until 30 days after last dose, up to 6 years
|
0.00%
0/6 • From start of treatment until 30 days after last dose, up to 6 years
|
0.00%
0/8 • From start of treatment until 30 days after last dose, up to 6 years
|
|
Respiratory, thoracic and mediastinal disorders
Lung Infection
|
0.00%
0/3 • From start of treatment until 30 days after last dose, up to 6 years
|
0.00%
0/3 • From start of treatment until 30 days after last dose, up to 6 years
|
0.00%
0/6 • From start of treatment until 30 days after last dose, up to 6 years
|
12.5%
1/8 • From start of treatment until 30 days after last dose, up to 6 years
|
|
General disorders
Myalgia
|
0.00%
0/3 • From start of treatment until 30 days after last dose, up to 6 years
|
33.3%
1/3 • From start of treatment until 30 days after last dose, up to 6 years
|
0.00%
0/6 • From start of treatment until 30 days after last dose, up to 6 years
|
0.00%
0/8 • From start of treatment until 30 days after last dose, up to 6 years
|
|
Respiratory, thoracic and mediastinal disorders
Sinusitis
|
0.00%
0/3 • From start of treatment until 30 days after last dose, up to 6 years
|
0.00%
0/3 • From start of treatment until 30 days after last dose, up to 6 years
|
0.00%
0/6 • From start of treatment until 30 days after last dose, up to 6 years
|
12.5%
1/8 • From start of treatment until 30 days after last dose, up to 6 years
|
|
Immune system disorders
Anemia
|
0.00%
0/3 • From start of treatment until 30 days after last dose, up to 6 years
|
33.3%
1/3 • From start of treatment until 30 days after last dose, up to 6 years
|
0.00%
0/6 • From start of treatment until 30 days after last dose, up to 6 years
|
0.00%
0/8 • From start of treatment until 30 days after last dose, up to 6 years
|
|
Skin and subcutaneous tissue disorders
Skin Disorders
|
33.3%
1/3 • From start of treatment until 30 days after last dose, up to 6 years
|
0.00%
0/3 • From start of treatment until 30 days after last dose, up to 6 years
|
0.00%
0/6 • From start of treatment until 30 days after last dose, up to 6 years
|
0.00%
0/8 • From start of treatment until 30 days after last dose, up to 6 years
|
Additional Information
Michael Wang,MD/ Professor, Lymphoma-Myeloma
UT MD Anderson Cancer Center
Phone: (713) 792-2860
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place