Trial Outcomes & Findings for A Phase II Trial Using Meloxicam Plus Filgrastim in Patients With Multiple Myeloma and Non-Hodgkin's Lymphoma (NCT NCT02078102)
NCT ID: NCT02078102
Last Updated: 2021-02-21
Results Overview
Percent of patients who mobilize and collect at least half of the total target CD34+ cell dose in the first apheresis with binomial exact confidence intervals according to disease: Multiple myeloma patients: percent of patients with \>= 5x106 CD34 cells/kg in the first day's apheresis. Non-Hodgkin's lymphoma patients: percent of patients with \>= 2.5x106 CD34 cells/kg in the first day's apheresis.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
38 participants
Primary outcome timeframe
within 100 days of transplant
Results posted on
2021-02-21
Participant Flow
Participant milestones
| Measure |
Multiple Myeloma
This is for the patients with Multiple Myeloma.
Meloxicam and Filgrastim will be administered in fixed doses to each patient enrolled on this study. The treatments will be administered in a staggered dose schedule for a total treatment duration of 7 days prior to apheresis.
15 mg tablets of Meloxicam will be taken orally for 5 consecutive days.
10 µg/kg of Filgrastim will be subcutaneously injected for 5 consecutive days. Filgrastim may be subcutaneously injected for an additional 3 days if patients do not meet the primary endpoint for cell collection.
Meloxicam: 15 mg tablets of Meloxicam will be taken orally in the morning, with or without food.
Filgrastim: Filgrastim will be subcutaneously injected in one or two sites at home.
|
Non Hodgkins Lymphoma
This is for the patients with Non Hodgkins Lymphoma.
Meloxicam and Filgrastim will be administered in fixed doses to each patient enrolled on this study. The treatments will be administered in a staggered dose schedule for a total treatment duration of 7 days prior to apheresis.
15 mg tablets of Meloxicam will be taken orally for 5 consecutive days.
10 µg/kg of Filgrastim will be subcutaneously injected for 5 consecutive days. Filgrastim may be subcutaneously injected for an additional 3 days if patients do not meet the primary endpoint for cell collection.
Meloxicam: 15 mg tablets of Meloxicam will be taken orally in the morning, with or without food.
Filgrastim: Filgrastim will be subcutaneously injected in one or two sites at home.
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
13
|
|
Overall Study
COMPLETED
|
23
|
12
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
| Measure |
Multiple Myeloma
This is for the patients with Multiple Myeloma.
Meloxicam and Filgrastim will be administered in fixed doses to each patient enrolled on this study. The treatments will be administered in a staggered dose schedule for a total treatment duration of 7 days prior to apheresis.
15 mg tablets of Meloxicam will be taken orally for 5 consecutive days.
10 µg/kg of Filgrastim will be subcutaneously injected for 5 consecutive days. Filgrastim may be subcutaneously injected for an additional 3 days if patients do not meet the primary endpoint for cell collection.
Meloxicam: 15 mg tablets of Meloxicam will be taken orally in the morning, with or without food.
Filgrastim: Filgrastim will be subcutaneously injected in one or two sites at home.
|
Non Hodgkins Lymphoma
This is for the patients with Non Hodgkins Lymphoma.
Meloxicam and Filgrastim will be administered in fixed doses to each patient enrolled on this study. The treatments will be administered in a staggered dose schedule for a total treatment duration of 7 days prior to apheresis.
15 mg tablets of Meloxicam will be taken orally for 5 consecutive days.
10 µg/kg of Filgrastim will be subcutaneously injected for 5 consecutive days. Filgrastim may be subcutaneously injected for an additional 3 days if patients do not meet the primary endpoint for cell collection.
Meloxicam: 15 mg tablets of Meloxicam will be taken orally in the morning, with or without food.
Filgrastim: Filgrastim will be subcutaneously injected in one or two sites at home.
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Physician Decision
|
0
|
1
|
Baseline Characteristics
A Phase II Trial Using Meloxicam Plus Filgrastim in Patients With Multiple Myeloma and Non-Hodgkin's Lymphoma
Baseline characteristics by cohort
| Measure |
Multiple Myeloma
n=25 Participants
This is for the patients with Multiple Myeloma.
Meloxicam and Filgrastim will be administered in fixed doses to each patient enrolled on this study. The treatments will be administered in a staggered dose schedule for a total treatment duration of 7 days prior to apheresis.
15 mg tablets of Meloxicam will be taken orally for 5 consecutive days.
10 µg/kg of Filgrastim will be subcutaneously injected for 5 consecutive days. Filgrastim may be subcutaneously injected for an additional 3 days if patients do not meet the primary endpoint for cell collection.
Meloxicam: 15 mg tablets of Meloxicam will be taken orally in the morning, with or without food.
Filgrastim: Filgrastim will be subcutaneously injected in one or two sites at home.
|
Non Hodgkins Lymphoma
n=13 Participants
This is for the patients with Non Hodgkins Lymphoma.
Meloxicam and Filgrastim will be administered in fixed doses to each patient enrolled on this study. The treatments will be administered in a staggered dose schedule for a total treatment duration of 7 days prior to apheresis.
15 mg tablets of Meloxicam will be taken orally for 5 consecutive days.
10 µg/kg of Filgrastim will be subcutaneously injected for 5 consecutive days. Filgrastim may be subcutaneously injected for an additional 3 days if patients do not meet the primary endpoint for cell collection.
Meloxicam: 15 mg tablets of Meloxicam will be taken orally in the morning, with or without food.
Filgrastim: Filgrastim will be subcutaneously injected in one or two sites at home.
|
Total
n=38 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
|
|
Age, Categorical
Between 18 and 65 years
|
16 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
9 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Age, Continuous
|
61.1 years
STANDARD_DEVIATION 8.6 • n=5 Participants
|
51.2 years
STANDARD_DEVIATION 16.1 • n=7 Participants
|
57.8 years
STANDARD_DEVIATION 12.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
22 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 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
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
21 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Disease Status at Registration
Partial Response
|
19 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Disease Status at Registration
Partial Response without prior Complete Response
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Disease Status at Registration
Very Good Partial Response
|
5 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Disease Status at Registration
Complete Remission
|
1 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Disease Status at Registration
Complete Remission Confirmed
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Disease Status at Registration
Unknown
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: within 100 days of transplantPopulation: Patients with available post-transplant CD34+ results.
Percent of patients who mobilize and collect at least half of the total target CD34+ cell dose in the first apheresis with binomial exact confidence intervals according to disease: Multiple myeloma patients: percent of patients with \>= 5x106 CD34 cells/kg in the first day's apheresis. Non-Hodgkin's lymphoma patients: percent of patients with \>= 2.5x106 CD34 cells/kg in the first day's apheresis.
Outcome measures
| Measure |
Multiple Myeloma
n=25 Participants
This is for the patients with Multiple Myeloma.
Meloxicam and Filgrastim will be administered in fixed doses to each patient enrolled on this study. The treatments will be administered in a staggered dose schedule for a total treatment duration of 7 days prior to apheresis.
15 mg tablets of Meloxicam will be taken orally for 5 consecutive days.
10 µg/kg of Filgrastim will be subcutaneously injected for 5 consecutive days. Filgrastim may be subcutaneously injected for an additional 3 days if patients do not meet the primary endpoint for cell collection.
Meloxicam: 15 mg tablets of Meloxicam will be taken orally in the morning, with or without food.
Filgrastim: Filgrastim will be subcutaneously injected in one or two sites at home.
|
Non Hodgkins Lymphoma
n=12 Participants
This is for the patients with Non Hodgkins Lymphoma.
Meloxicam and Filgrastim will be administered in fixed doses to each patient enrolled on this study. The treatments will be administered in a staggered dose schedule for a total treatment duration of 7 days prior to apheresis.
15 mg tablets of Meloxicam will be taken orally for 5 consecutive days.
10 µg/kg of Filgrastim will be subcutaneously injected for 5 consecutive days. Filgrastim may be subcutaneously injected for an additional 3 days if patients do not meet the primary endpoint for cell collection.
Meloxicam: 15 mg tablets of Meloxicam will be taken orally in the morning, with or without food.
Filgrastim: Filgrastim will be subcutaneously injected in one or two sites at home.
|
|---|---|---|
|
Percent of Patients Who Mobilize and Collect at Least Half of the Total Target CD34+ Cell Dose in the First Apheresis
|
32.0 percentage of participants
Interval 15.0 to 53.5
|
58.3 percentage of participants
Interval 27.7 to 84.8
|
SECONDARY outcome
Timeframe: within 100 days of transplantPopulation: All patients who received a transplant.
Number of unique patients who had a treatment related (possible, probable or definite) non-hematological adverse event that was graded 3 or greater using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Outcome measures
| Measure |
Multiple Myeloma
n=25 Participants
This is for the patients with Multiple Myeloma.
Meloxicam and Filgrastim will be administered in fixed doses to each patient enrolled on this study. The treatments will be administered in a staggered dose schedule for a total treatment duration of 7 days prior to apheresis.
15 mg tablets of Meloxicam will be taken orally for 5 consecutive days.
10 µg/kg of Filgrastim will be subcutaneously injected for 5 consecutive days. Filgrastim may be subcutaneously injected for an additional 3 days if patients do not meet the primary endpoint for cell collection.
Meloxicam: 15 mg tablets of Meloxicam will be taken orally in the morning, with or without food.
Filgrastim: Filgrastim will be subcutaneously injected in one or two sites at home.
|
Non Hodgkins Lymphoma
n=13 Participants
This is for the patients with Non Hodgkins Lymphoma.
Meloxicam and Filgrastim will be administered in fixed doses to each patient enrolled on this study. The treatments will be administered in a staggered dose schedule for a total treatment duration of 7 days prior to apheresis.
15 mg tablets of Meloxicam will be taken orally for 5 consecutive days.
10 µg/kg of Filgrastim will be subcutaneously injected for 5 consecutive days. Filgrastim may be subcutaneously injected for an additional 3 days if patients do not meet the primary endpoint for cell collection.
Meloxicam: 15 mg tablets of Meloxicam will be taken orally in the morning, with or without food.
Filgrastim: Filgrastim will be subcutaneously injected in one or two sites at home.
|
|---|---|---|
|
Number of Patients With Treatment Related Adverse Events Grade 3 or Higher for Nonhematological Toxicity
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Cycle 2, Days 1-4, within 100 days of transplantPopulation: Patients with available post-transplant CD34 (x10\^6/kg) data.
Mean and Standard Deviation of the Graft Composition of Peripheral Blood Stem Cell Collection (CD34 (x10\^6cells/kg)) at each time point collected during Cycle 2.
Outcome measures
| Measure |
Multiple Myeloma
n=25 Participants
This is for the patients with Multiple Myeloma.
Meloxicam and Filgrastim will be administered in fixed doses to each patient enrolled on this study. The treatments will be administered in a staggered dose schedule for a total treatment duration of 7 days prior to apheresis.
15 mg tablets of Meloxicam will be taken orally for 5 consecutive days.
10 µg/kg of Filgrastim will be subcutaneously injected for 5 consecutive days. Filgrastim may be subcutaneously injected for an additional 3 days if patients do not meet the primary endpoint for cell collection.
Meloxicam: 15 mg tablets of Meloxicam will be taken orally in the morning, with or without food.
Filgrastim: Filgrastim will be subcutaneously injected in one or two sites at home.
|
Non Hodgkins Lymphoma
n=12 Participants
This is for the patients with Non Hodgkins Lymphoma.
Meloxicam and Filgrastim will be administered in fixed doses to each patient enrolled on this study. The treatments will be administered in a staggered dose schedule for a total treatment duration of 7 days prior to apheresis.
15 mg tablets of Meloxicam will be taken orally for 5 consecutive days.
10 µg/kg of Filgrastim will be subcutaneously injected for 5 consecutive days. Filgrastim may be subcutaneously injected for an additional 3 days if patients do not meet the primary endpoint for cell collection.
Meloxicam: 15 mg tablets of Meloxicam will be taken orally in the morning, with or without food.
Filgrastim: Filgrastim will be subcutaneously injected in one or two sites at home.
|
|---|---|---|
|
Summary Statistics for Graft Composition of Peripheral Blood Stem Cell Collection at Each Time Point
Cycle 2 Day 1
|
3.42 x10^6cells/kg
Standard Deviation 2.72
|
3.22 x10^6cells/kg
Standard Deviation 2.20
|
|
Summary Statistics for Graft Composition of Peripheral Blood Stem Cell Collection at Each Time Point
Cycle 2 Day 2
|
4.92 x10^6cells/kg
Standard Deviation 2.86
|
3.51 x10^6cells/kg
Standard Deviation 2.67
|
|
Summary Statistics for Graft Composition of Peripheral Blood Stem Cell Collection at Each Time Point
Cycle 2 Day 3
|
2.63 x10^6cells/kg
Standard Deviation 1.70
|
0.89 x10^6cells/kg
Standard Deviation 0.45
|
|
Summary Statistics for Graft Composition of Peripheral Blood Stem Cell Collection at Each Time Point
Cycle 2 Day 4
|
1.55 x10^6cells/kg
Standard Deviation 0.35
|
0.90 x10^6cells/kg
Standard Deviation NA
Only 1 patient had a result at this time point and the standard deviation was not calculated.
|
SECONDARY outcome
Timeframe: within 100 days of transplantPopulation: All patients who had a transplant and engrafted. All patients were analyzed together since the definition for neutrophil engraftment is the same regardless of disease and only the time until overall neutrophil engraftment was the outcome of interest.
Time to neutrophil engraftment will be analyzed by the Kaplan-Meier method. The time to engraftment of neutrophils is defined as the time from day 0 to the date of the first of three consecutive days after transplantation during which the absolute neutrophils count (ANC) is at least 0.5 x109/l. The median and 95% confidence intervals will be provided. Only patients with neutrophil engraftment will be included.
Outcome measures
| Measure |
Multiple Myeloma
n=34 Participants
This is for the patients with Multiple Myeloma.
Meloxicam and Filgrastim will be administered in fixed doses to each patient enrolled on this study. The treatments will be administered in a staggered dose schedule for a total treatment duration of 7 days prior to apheresis.
15 mg tablets of Meloxicam will be taken orally for 5 consecutive days.
10 µg/kg of Filgrastim will be subcutaneously injected for 5 consecutive days. Filgrastim may be subcutaneously injected for an additional 3 days if patients do not meet the primary endpoint for cell collection.
Meloxicam: 15 mg tablets of Meloxicam will be taken orally in the morning, with or without food.
Filgrastim: Filgrastim will be subcutaneously injected in one or two sites at home.
|
Non Hodgkins Lymphoma
This is for the patients with Non Hodgkins Lymphoma.
Meloxicam and Filgrastim will be administered in fixed doses to each patient enrolled on this study. The treatments will be administered in a staggered dose schedule for a total treatment duration of 7 days prior to apheresis.
15 mg tablets of Meloxicam will be taken orally for 5 consecutive days.
10 µg/kg of Filgrastim will be subcutaneously injected for 5 consecutive days. Filgrastim may be subcutaneously injected for an additional 3 days if patients do not meet the primary endpoint for cell collection.
Meloxicam: 15 mg tablets of Meloxicam will be taken orally in the morning, with or without food.
Filgrastim: Filgrastim will be subcutaneously injected in one or two sites at home.
|
|---|---|---|
|
Time to Neutrophil Engraftment
|
13.0 days
Interval 12.0 to 14.0
|
—
|
SECONDARY outcome
Timeframe: within 100 days of transplantPopulation: All patients who received a transplant and engrafted. All patients were analyzed together since the definition for platelet engraftment is the same regardless of disease and only the time until overall platelet engraftment was the outcome of interest.
Time to platelet engraftment will be analyzed by the Kaplan-Meier method. The time to engraftment of platelets is defined as the time from day 0 to the first of seven consecutive Complete Blood Counts (CBCs) obtained on different days after transplantation during which the platelet count is at least 20 x109/l. The CBCs obtained should be at least seven days after the most recent platelet transfusion. The median and 95% confidence intervals will be provided. Only patients achieving platelet engraftment will be included.
Outcome measures
| Measure |
Multiple Myeloma
n=34 Participants
This is for the patients with Multiple Myeloma.
Meloxicam and Filgrastim will be administered in fixed doses to each patient enrolled on this study. The treatments will be administered in a staggered dose schedule for a total treatment duration of 7 days prior to apheresis.
15 mg tablets of Meloxicam will be taken orally for 5 consecutive days.
10 µg/kg of Filgrastim will be subcutaneously injected for 5 consecutive days. Filgrastim may be subcutaneously injected for an additional 3 days if patients do not meet the primary endpoint for cell collection.
Meloxicam: 15 mg tablets of Meloxicam will be taken orally in the morning, with or without food.
Filgrastim: Filgrastim will be subcutaneously injected in one or two sites at home.
|
Non Hodgkins Lymphoma
This is for the patients with Non Hodgkins Lymphoma.
Meloxicam and Filgrastim will be administered in fixed doses to each patient enrolled on this study. The treatments will be administered in a staggered dose schedule for a total treatment duration of 7 days prior to apheresis.
15 mg tablets of Meloxicam will be taken orally for 5 consecutive days.
10 µg/kg of Filgrastim will be subcutaneously injected for 5 consecutive days. Filgrastim may be subcutaneously injected for an additional 3 days if patients do not meet the primary endpoint for cell collection.
Meloxicam: 15 mg tablets of Meloxicam will be taken orally in the morning, with or without food.
Filgrastim: Filgrastim will be subcutaneously injected in one or two sites at home.
|
|---|---|---|
|
Time to Platelet Engraftment
|
16.5 days
Interval 13.0 to 19.0
|
—
|
Adverse Events
Multiple Myeloma
Serious events: 1 serious events
Other events: 10 other events
Deaths: 4 deaths
Non Hodgkins Lymphoma
Serious events: 1 serious events
Other events: 10 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Multiple Myeloma
n=25 participants at risk
This is for the patients with Multiple Myeloma.
Meloxicam and Filgrastim will be administered in fixed doses to each patient enrolled on this study. The treatments will be administered in a staggered dose schedule for a total treatment duration of 7 days prior to apheresis.
15 mg tablets of Meloxicam will be taken orally for 5 consecutive days.
10 µg/kg of Filgrastim will be subcutaneously injected for 5 consecutive days. Filgrastim may be subcutaneously injected for an additional 3 days if patients do not meet the primary endpoint for cell collection.
Meloxicam: 15 mg tablets of Meloxicam will be taken orally in the morning, with or without food.
Filgrastim: Filgrastim will be subcutaneously injected in one or two sites at home.
|
Non Hodgkins Lymphoma
n=13 participants at risk
This is for the patients with Non Hodgkins Lymphoma.
Meloxicam and Filgrastim will be administered in fixed doses to each patient enrolled on this study. The treatments will be administered in a staggered dose schedule for a total treatment duration of 7 days prior to apheresis.
15 mg tablets of Meloxicam will be taken orally for 5 consecutive days.
10 µg/kg of Filgrastim will be subcutaneously injected for 5 consecutive days. Filgrastim may be subcutaneously injected for an additional 3 days if patients do not meet the primary endpoint for cell collection.
Meloxicam: 15 mg tablets of Meloxicam will be taken orally in the morning, with or without food.
Filgrastim: Filgrastim will be subcutaneously injected in one or two sites at home.
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
4.0%
1/25 • up to 100 days post-transplant
|
0.00%
0/13 • up to 100 days post-transplant
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/25 • up to 100 days post-transplant
|
7.7%
1/13 • up to 100 days post-transplant
|
Other adverse events
| Measure |
Multiple Myeloma
n=25 participants at risk
This is for the patients with Multiple Myeloma.
Meloxicam and Filgrastim will be administered in fixed doses to each patient enrolled on this study. The treatments will be administered in a staggered dose schedule for a total treatment duration of 7 days prior to apheresis.
15 mg tablets of Meloxicam will be taken orally for 5 consecutive days.
10 µg/kg of Filgrastim will be subcutaneously injected for 5 consecutive days. Filgrastim may be subcutaneously injected for an additional 3 days if patients do not meet the primary endpoint for cell collection.
Meloxicam: 15 mg tablets of Meloxicam will be taken orally in the morning, with or without food.
Filgrastim: Filgrastim will be subcutaneously injected in one or two sites at home.
|
Non Hodgkins Lymphoma
n=13 participants at risk
This is for the patients with Non Hodgkins Lymphoma.
Meloxicam and Filgrastim will be administered in fixed doses to each patient enrolled on this study. The treatments will be administered in a staggered dose schedule for a total treatment duration of 7 days prior to apheresis.
15 mg tablets of Meloxicam will be taken orally for 5 consecutive days.
10 µg/kg of Filgrastim will be subcutaneously injected for 5 consecutive days. Filgrastim may be subcutaneously injected for an additional 3 days if patients do not meet the primary endpoint for cell collection.
Meloxicam: 15 mg tablets of Meloxicam will be taken orally in the morning, with or without food.
Filgrastim: Filgrastim will be subcutaneously injected in one or two sites at home.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/25 • up to 100 days post-transplant
|
15.4%
2/13 • up to 100 days post-transplant
|
|
Cardiac disorders
Chest pain - cardiac
|
4.0%
1/25 • up to 100 days post-transplant
|
7.7%
1/13 • up to 100 days post-transplant
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/25 • up to 100 days post-transplant
|
15.4%
2/13 • up to 100 days post-transplant
|
|
Gastrointestinal disorders
Nausea
|
16.0%
4/25 • up to 100 days post-transplant
|
46.2%
6/13 • up to 100 days post-transplant
|
|
Gastrointestinal disorders
Oral dysesthesia
|
0.00%
0/25 • up to 100 days post-transplant
|
7.7%
1/13 • up to 100 days post-transplant
|
|
General disorders
Fatigue
|
4.0%
1/25 • up to 100 days post-transplant
|
7.7%
1/13 • up to 100 days post-transplant
|
|
General disorders
Pain
|
4.0%
1/25 • up to 100 days post-transplant
|
15.4%
2/13 • up to 100 days post-transplant
|
|
Infections and infestations
Skin infection
|
0.00%
0/25 • up to 100 days post-transplant
|
7.7%
1/13 • up to 100 days post-transplant
|
|
Infections and infestations
Upper respiratory infection
|
8.0%
2/25 • up to 100 days post-transplant
|
0.00%
0/13 • up to 100 days post-transplant
|
|
Investigations
Platelet count decreased
|
4.0%
1/25 • up to 100 days post-transplant
|
15.4%
2/13 • up to 100 days post-transplant
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
4.0%
1/25 • up to 100 days post-transplant
|
23.1%
3/13 • up to 100 days post-transplant
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/25 • up to 100 days post-transplant
|
7.7%
1/13 • up to 100 days post-transplant
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/25 • up to 100 days post-transplant
|
7.7%
1/13 • up to 100 days post-transplant
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/25 • up to 100 days post-transplant
|
15.4%
2/13 • up to 100 days post-transplant
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
4.0%
1/25 • up to 100 days post-transplant
|
7.7%
1/13 • up to 100 days post-transplant
|
|
Nervous system disorders
Headache
|
0.00%
0/25 • up to 100 days post-transplant
|
7.7%
1/13 • up to 100 days post-transplant
|
|
Nervous system disorders
Paresthesia
|
4.0%
1/25 • up to 100 days post-transplant
|
7.7%
1/13 • up to 100 days post-transplant
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/25 • up to 100 days post-transplant
|
7.7%
1/13 • up to 100 days post-transplant
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place