Trial Outcomes & Findings for Meloxicam vs Placebo for Mobilization (NCT NCT02003625)
NCT ID: NCT02003625
Last Updated: 2020-05-18
Results Overview
The median to neutrophil engraftment (absolute neutrophil counts above 0.5/mcl for 3 consecutive days) .
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
31 participants
Primary outcome timeframe
Up to 6 months after transplantation ( up to 66-72 days after the start of treatment)
Results posted on
2020-05-18
Participant Flow
One patient assigned to the GCSF + placebo arm withdrew consent prior to the start of treatment
Participant milestones
| Measure |
A. GCSF + Placebo
GCSF + Placebo Patients in this group will receive GCSF 10 ug/kg s.c. daily, beginning 4 days prior to the 1st apheresis \[days -4, -3, -2, -1\] and continued on daily GCSF for a total of 4 apheresis or until ≥ 5 x 10\^6 CD34+ cells/kg are collected. They will also receive oral placebo for 5 days on days -6 through -2. Patients will undergo apheresis for 300 minutes to achieve approximately 3 to 4 whole blood volumes processed. This is a standard institutional protocol for autologous HSPC collection at the MGH.
GCSF
Placebo
|
B. GCSF + Meloxicam
B. GCSF + meloxicam:
Patients in this group will be treated with meloxicam and GCSF in an approximate two-day staggered dose schedule as described in our preclinical studies. Meloxicam will be given orally at a dose of 15 mg/day for 5 days (days -6 through -2). GCSF at 10 ug/kg/day subcutaneously will be started on day -4 and continued daily for a total of 4 apheresis or until ≥ 5 x 10\^6 CD34+ cells/kg are collected.
GCSF
meloxicam
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
15
|
|
Overall Study
Received Transplant
|
14
|
12
|
|
Overall Study
COMPLETED
|
14
|
12
|
|
Overall Study
NOT COMPLETED
|
1
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Meloxicam vs Placebo for Mobilization
Baseline characteristics by cohort
| Measure |
A. GCSF + Placebo
n=15 Participants
GCSF + Placebo Patients in this group will receive GCSF 10 ug/kg s.c. daily, beginning 4 days prior to the 1st apheresis \[days -4, -3, -2, -1\] and continued on daily GCSF for a total of 4 apheresis or until ≥ 5 x 10\^6 CD34+ cells/kg are collected. They will also receive oral placebo for 5 days on days -6 through -2. Patients will undergo apheresis for 300 minutes to achieve approximately 3 to 4 whole blood volumes processed. This is a standard institutional protocol for autologous HSPC collection at the MGH.
GCSF
Placebo
|
B. GCSF + Meloxicam
n=15 Participants
B. GCSF + meloxicam:
Patients in this group will be treated with meloxicam and GCSF in an approximate two-day staggered dose schedule as described in our preclinical studies. Meloxicam will be given orally at a dose of 15 mg/day for 5 days (days -6 through -2). GCSF at 10 ug/kg/day subcutaneously will be started on day -4 and continued daily for a total of 4 apheresis or until ≥ 5 x 10\^6 CD34+ cells/kg are collected.
GCSF
meloxicam
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60 years
n=5 Participants
|
60 years
n=7 Participants
|
60 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
14 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=5 Participants
|
15 participants
n=7 Participants
|
30 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 days after starting treatment (or 9 days for multiple myeloma patients that received cyclophosphamide)Numbers of circulating CD34+ cells on the first day of apheresis
Outcome measures
| Measure |
A. GCSF + Placebo
n=15 Participants
GCSF + Placebo Patients in this group will receive GCSF 10 ug/kg s.c. daily, beginning 4 days prior to the 1st apheresis \[days -4, -3, -2, -1\] and continued on daily GCSF for a total of 4 apheresis or until ≥ 5 x 10\^6 CD34+ cells/kg are collected. They will also receive oral placebo for 5 days on days -6 through -2. Patients will undergo apheresis for 300 minutes to achieve approximately 3 to 4 whole blood volumes processed. This is a standard institutional protocol for autologous HSPC collection at the MGH.
GCSF
Placebo
|
B. GCSF + Meloxicam
n=15 Participants
B. GCSF + meloxicam:
Patients in this group will be treated with meloxicam and GCSF in an approximate two-day staggered dose schedule as described in our preclinical studies. Meloxicam will be given orally at a dose of 15 mg/day for 5 days (days -6 through -2). GCSF at 10 ug/kg/day subcutaneously will be started on day -4 and continued daily for a total of 4 apheresis or until ≥ 5 x 10\^6 CD34+ cells/kg are collected.
GCSF
meloxicam
|
|---|---|---|
|
Numbers of Circulating CD34+ Cells on the First Day of Apheresis
|
26 Cells per microliter
Interval 8.38 to 148.81
|
30.7 Cells per microliter
Interval 14.0 to 61.6
|
PRIMARY outcome
Timeframe: Up to 6 days after the start of treatment or up to 12 days for multiple myeloma patients that received cyclophosphamideOutcome measures
| Measure |
A. GCSF + Placebo
n=15 Participants
GCSF + Placebo Patients in this group will receive GCSF 10 ug/kg s.c. daily, beginning 4 days prior to the 1st apheresis \[days -4, -3, -2, -1\] and continued on daily GCSF for a total of 4 apheresis or until ≥ 5 x 10\^6 CD34+ cells/kg are collected. They will also receive oral placebo for 5 days on days -6 through -2. Patients will undergo apheresis for 300 minutes to achieve approximately 3 to 4 whole blood volumes processed. This is a standard institutional protocol for autologous HSPC collection at the MGH.
GCSF
Placebo
|
B. GCSF + Meloxicam
n=15 Participants
B. GCSF + meloxicam:
Patients in this group will be treated with meloxicam and GCSF in an approximate two-day staggered dose schedule as described in our preclinical studies. Meloxicam will be given orally at a dose of 15 mg/day for 5 days (days -6 through -2). GCSF at 10 ug/kg/day subcutaneously will be started on day -4 and continued daily for a total of 4 apheresis or until ≥ 5 x 10\^6 CD34+ cells/kg are collected.
GCSF
meloxicam
|
|---|---|---|
|
Number of Apheresis Sessions Required to Collect ≥ 4 x 10^6 CD34+ Cells/kg for Multiple Myeloma Patients and ≥ 2 x 10^6 CD34+ Cells/kg for Lymphoma Patients
1 Session
|
4 Participants
|
4 Participants
|
|
Number of Apheresis Sessions Required to Collect ≥ 4 x 10^6 CD34+ Cells/kg for Multiple Myeloma Patients and ≥ 2 x 10^6 CD34+ Cells/kg for Lymphoma Patients
2 Sessions
|
6 Participants
|
10 Participants
|
|
Number of Apheresis Sessions Required to Collect ≥ 4 x 10^6 CD34+ Cells/kg for Multiple Myeloma Patients and ≥ 2 x 10^6 CD34+ Cells/kg for Lymphoma Patients
3 Sessions
|
4 Participants
|
1 Participants
|
|
Number of Apheresis Sessions Required to Collect ≥ 4 x 10^6 CD34+ Cells/kg for Multiple Myeloma Patients and ≥ 2 x 10^6 CD34+ Cells/kg for Lymphoma Patients
4 Sessions
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to 6 months after transplantation ( up to 66-72 days after the start of treatment)Population: Time to engraftment was only assessed among patients that received transplantation
The median to neutrophil engraftment (absolute neutrophil counts above 0.5/mcl for 3 consecutive days) .
Outcome measures
| Measure |
A. GCSF + Placebo
n=14 Participants
GCSF + Placebo Patients in this group will receive GCSF 10 ug/kg s.c. daily, beginning 4 days prior to the 1st apheresis \[days -4, -3, -2, -1\] and continued on daily GCSF for a total of 4 apheresis or until ≥ 5 x 10\^6 CD34+ cells/kg are collected. They will also receive oral placebo for 5 days on days -6 through -2. Patients will undergo apheresis for 300 minutes to achieve approximately 3 to 4 whole blood volumes processed. This is a standard institutional protocol for autologous HSPC collection at the MGH.
GCSF
Placebo
|
B. GCSF + Meloxicam
n=12 Participants
B. GCSF + meloxicam:
Patients in this group will be treated with meloxicam and GCSF in an approximate two-day staggered dose schedule as described in our preclinical studies. Meloxicam will be given orally at a dose of 15 mg/day for 5 days (days -6 through -2). GCSF at 10 ug/kg/day subcutaneously will be started on day -4 and continued daily for a total of 4 apheresis or until ≥ 5 x 10\^6 CD34+ cells/kg are collected.
GCSF
meloxicam
|
|---|---|---|
|
Time to Neutrophil Engraftment After AHSCT
|
10 Days
Interval 10.0 to 12.0
|
10 Days
Interval 9.0 to 11.0
|
PRIMARY outcome
Timeframe: Up to 6 months after transplantation ( up to 66-72 days after the start of treatment)Population: Time to engraftment was only assessed among patients that received transplantation
The median to platelet engraftment (platelet count above 20,000/mcl for 3 consecutive days)
Outcome measures
| Measure |
A. GCSF + Placebo
n=14 Participants
GCSF + Placebo Patients in this group will receive GCSF 10 ug/kg s.c. daily, beginning 4 days prior to the 1st apheresis \[days -4, -3, -2, -1\] and continued on daily GCSF for a total of 4 apheresis or until ≥ 5 x 10\^6 CD34+ cells/kg are collected. They will also receive oral placebo for 5 days on days -6 through -2. Patients will undergo apheresis for 300 minutes to achieve approximately 3 to 4 whole blood volumes processed. This is a standard institutional protocol for autologous HSPC collection at the MGH.
GCSF
Placebo
|
B. GCSF + Meloxicam
n=12 Participants
B. GCSF + meloxicam:
Patients in this group will be treated with meloxicam and GCSF in an approximate two-day staggered dose schedule as described in our preclinical studies. Meloxicam will be given orally at a dose of 15 mg/day for 5 days (days -6 through -2). GCSF at 10 ug/kg/day subcutaneously will be started on day -4 and continued daily for a total of 4 apheresis or until ≥ 5 x 10\^6 CD34+ cells/kg are collected.
GCSF
meloxicam
|
|---|---|---|
|
Time to Platelet Engraftment After AHSCT
|
18 Days
Interval 11.0 to 33.0
|
19 Days
Interval 9.0 to 23.0
|
SECONDARY outcome
Timeframe: Up to 30 days after the last apheresis session (up to 36 days after the start of treatment or 42 days for multiple myeloma patients that received cyclophosphamide)Adverse events were assessed using Common Terminology Criteria for Adverse Events (CTCAE v4). Related adverse events were defined as adverse events that were deemed to be possibly, probably, or definitely related to study treatment.
Outcome measures
| Measure |
A. GCSF + Placebo
n=15 Participants
GCSF + Placebo Patients in this group will receive GCSF 10 ug/kg s.c. daily, beginning 4 days prior to the 1st apheresis \[days -4, -3, -2, -1\] and continued on daily GCSF for a total of 4 apheresis or until ≥ 5 x 10\^6 CD34+ cells/kg are collected. They will also receive oral placebo for 5 days on days -6 through -2. Patients will undergo apheresis for 300 minutes to achieve approximately 3 to 4 whole blood volumes processed. This is a standard institutional protocol for autologous HSPC collection at the MGH.
GCSF
Placebo
|
B. GCSF + Meloxicam
n=15 Participants
B. GCSF + meloxicam:
Patients in this group will be treated with meloxicam and GCSF in an approximate two-day staggered dose schedule as described in our preclinical studies. Meloxicam will be given orally at a dose of 15 mg/day for 5 days (days -6 through -2). GCSF at 10 ug/kg/day subcutaneously will be started on day -4 and continued daily for a total of 4 apheresis or until ≥ 5 x 10\^6 CD34+ cells/kg are collected.
GCSF
meloxicam
|
|---|---|---|
|
Number of Patients With Grade 3+ Treatment Related Adverse Events
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 6 months after transplantation ( up to 66-72 days after the start of treatment)Population: Number of transfusions needed were only counted among patients that underwent transplantation
Outcome measures
| Measure |
A. GCSF + Placebo
n=14 Participants
GCSF + Placebo Patients in this group will receive GCSF 10 ug/kg s.c. daily, beginning 4 days prior to the 1st apheresis \[days -4, -3, -2, -1\] and continued on daily GCSF for a total of 4 apheresis or until ≥ 5 x 10\^6 CD34+ cells/kg are collected. They will also receive oral placebo for 5 days on days -6 through -2. Patients will undergo apheresis for 300 minutes to achieve approximately 3 to 4 whole blood volumes processed. This is a standard institutional protocol for autologous HSPC collection at the MGH.
GCSF
Placebo
|
B. GCSF + Meloxicam
n=12 Participants
B. GCSF + meloxicam:
Patients in this group will be treated with meloxicam and GCSF in an approximate two-day staggered dose schedule as described in our preclinical studies. Meloxicam will be given orally at a dose of 15 mg/day for 5 days (days -6 through -2). GCSF at 10 ug/kg/day subcutaneously will be started on day -4 and continued daily for a total of 4 apheresis or until ≥ 5 x 10\^6 CD34+ cells/kg are collected.
GCSF
meloxicam
|
|---|---|---|
|
Number of Participants That Received Red Blood Cell and Platelet Transfusions Prior to Engraftment
Platelet transfusions
|
14 Participants
|
9 Participants
|
|
Number of Participants That Received Red Blood Cell and Platelet Transfusions Prior to Engraftment
Red blood cell transfusions
|
6 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Up to 6 days after the start of treatment or up to 12 days for multiple myeloma patients that received cyclophosphamideThe number of patients that did not achieve CD34+ count of ≥ 4 x 10\^6 CD34+ cells/kg for multiple myeloma patients or ≥ 2 x 10\^6 CD34+ cells/kg for lymphoma patients.
Outcome measures
| Measure |
A. GCSF + Placebo
n=15 Participants
GCSF + Placebo Patients in this group will receive GCSF 10 ug/kg s.c. daily, beginning 4 days prior to the 1st apheresis \[days -4, -3, -2, -1\] and continued on daily GCSF for a total of 4 apheresis or until ≥ 5 x 10\^6 CD34+ cells/kg are collected. They will also receive oral placebo for 5 days on days -6 through -2. Patients will undergo apheresis for 300 minutes to achieve approximately 3 to 4 whole blood volumes processed. This is a standard institutional protocol for autologous HSPC collection at the MGH.
GCSF
Placebo
|
B. GCSF + Meloxicam
n=15 Participants
B. GCSF + meloxicam:
Patients in this group will be treated with meloxicam and GCSF in an approximate two-day staggered dose schedule as described in our preclinical studies. Meloxicam will be given orally at a dose of 15 mg/day for 5 days (days -6 through -2). GCSF at 10 ug/kg/day subcutaneously will be started on day -4 and continued daily for a total of 4 apheresis or until ≥ 5 x 10\^6 CD34+ cells/kg are collected.
GCSF
meloxicam
|
|---|---|---|
|
Number of Patients That Failed to Achieve Stem Cell Mobilization.
|
0 Participants
|
0 Participants
|
Adverse Events
A. GCSF + Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
B. GCSF + Meloxicam
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Bimalangshu Dey, MD, PhD
Massachusetts General Hospital
Phone: 617-724-1124
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place