Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Phase II Trial Using Meloxicam Plus Filgrastim in Patients With Multiple Myeloma and Non-Hodgkin's Lymphoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02078102
Recruitment Status : Completed
First Posted : March 5, 2014
Results First Posted : February 21, 2021
Last Update Posted : February 21, 2021
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Sherif S. Farag, Indiana University School of Medicine

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Multiple Myeloma
Non-Hodgkin's Lymphoma
Interventions Drug: Meloxicam
Drug: Filgrastim
Enrollment 38
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Multiple Myeloma Non Hodgkins Lymphoma
Hide Arm/Group Description

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.

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.

Period Title: Overall Study
Started 25 13
Completed 23 12
Not Completed 2 1
Reason Not Completed
Adverse Event             1             0
Withdrawal by Subject             1             0
Physician Decision             0             1
Arm/Group Title Multiple Myeloma Non Hodgkins Lymphoma Total
Hide Arm/Group Description

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.

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 of all reporting groups
Overall Number of Baseline Participants 25 13 38
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 13 participants 38 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
16
  64.0%
11
  84.6%
27
  71.1%
>=65 years
9
  36.0%
2
  15.4%
11
  28.9%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 25 participants 13 participants 38 participants
61.1  (8.6) 51.2  (16.1) 57.8  (12.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 13 participants 38 participants
Female
12
  48.0%
5
  38.5%
17
  44.7%
Male
13
  52.0%
8
  61.5%
21
  55.3%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 13 participants 38 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
22
  88.0%
11
  84.6%
33
  86.8%
Unknown or Not Reported
3
  12.0%
2
  15.4%
5
  13.2%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 13 participants 38 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
2
   8.0%
1
   7.7%
3
   7.9%
White
21
  84.0%
10
  76.9%
31
  81.6%
More than one race
1
   4.0%
0
   0.0%
1
   2.6%
Unknown or Not Reported
1
   4.0%
2
  15.4%
3
   7.9%
Disease Status at Registration   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 13 participants 38 participants
Partial Response
19
  76.0%
0
   0.0%
19
  50.0%
Partial Response without prior Complete Response
0
   0.0%
1
   7.7%
1
   2.6%
Very Good Partial Response
5
  20.0%
1
   7.7%
6
  15.8%
Complete Remission
1
   4.0%
9
  69.2%
10
  26.3%
Complete Remission Confirmed
0
   0.0%
1
   7.7%
1
   2.6%
Unknown
0
   0.0%
1
   7.7%
1
   2.6%
[1]
Measure Description: Multiple Myeloma response was determined by the International Myeloma Working Group criteria (based on serum, urine and blood markers) and the Non-Hodgkin's response was determine by the Lymphoma Response Criteria (based on metabolic and radiographic criteria). Entry criteria for the study required a partial response or better for entry into the study.
1.Primary Outcome
Title Percent of Patients Who Mobilize and Collect at Least Half of the Total Target CD34+ Cell Dose in the First Apheresis
Hide Description

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.

Time Frame within 100 days of transplant
Hide Outcome Measure Data
Hide Analysis Population Description
Patients with available post-transplant CD34+ results.
Arm/Group Title Multiple Myeloma Non Hodgkins Lymphoma
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 25 12
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
32.0
(15.0 to 53.5)
58.3
(27.7 to 84.8)
2.Secondary Outcome
Title Number of Patients With Treatment Related Adverse Events Grade 3 or Higher for Nonhematological Toxicity
Hide Description 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.
Time Frame within 100 days of transplant
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who received a transplant.
Arm/Group Title Multiple Myeloma Non Hodgkins Lymphoma
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 25 13
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
3.Secondary Outcome
Title Summary Statistics for Graft Composition of Peripheral Blood Stem Cell Collection at Each Time Point
Hide Description 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.
Time Frame Cycle 2, Days 1-4, within 100 days of transplant
Hide Outcome Measure Data
Hide Analysis Population Description
Patients with available post-transplant CD34 (x10^6/kg) data.
Arm/Group Title Multiple Myeloma Non Hodgkins Lymphoma
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 25 12
Mean (Standard Deviation)
Unit of Measure: x10^6cells/kg
Cycle 2 Day 1 Number Analyzed 25 participants 12 participants
3.42  (2.72) 3.22  (2.20)
Cycle 2 Day 2 Number Analyzed 23 participants 9 participants
4.92  (2.86) 3.51  (2.67)
Cycle 2 Day 3 Number Analyzed 9 participants 3 participants
2.63  (1.70) 0.89  (0.45)
Cycle 2 Day 4 Number Analyzed 2 participants 1 participants
1.55  (0.35) 0.90 [1]   (NA)
[1]
Only 1 patient had a result at this time point and the standard deviation was not calculated.
4.Secondary Outcome
Title Time to Neutrophil Engraftment
Hide Description 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.
Time Frame within 100 days of transplant
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Treatment Group
Hide Arm/Group Description:

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 Number of Participants Analyzed 34
Median (95% Confidence Interval)
Unit of Measure: days
13.0
(12.0 to 14.0)
5.Secondary Outcome
Title Time to Platelet Engraftment
Hide Description 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.
Time Frame within 100 days of transplant
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Treatment Group
Hide Arm/Group Description:

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 Number of Participants Analyzed 34
Median (95% Confidence Interval)
Unit of Measure: days
16.5
(13.0 to 19.0)
Time Frame up to 100 days post-transplant
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Multiple Myeloma Non Hodgkins Lymphoma
Hide Arm/Group Description

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.

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.

All-Cause Mortality
Multiple Myeloma Non Hodgkins Lymphoma
Affected / at Risk (%) Affected / at Risk (%)
Total   4/25 (16.00%)   1/13 (7.69%) 
Hide Serious Adverse Events
Multiple Myeloma Non Hodgkins Lymphoma
Affected / at Risk (%) Affected / at Risk (%)
Total   1/25 (4.00%)   1/13 (7.69%) 
Gastrointestinal disorders     
Diarrhea * 1  1/25 (4.00%)  0/13 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Dyspnea * 1  0/25 (0.00%)  1/13 (7.69%) 
1
Term from vocabulary, CTCAE (4.0)
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Multiple Myeloma Non Hodgkins Lymphoma
Affected / at Risk (%) Affected / at Risk (%)
Total   10/25 (40.00%)   10/13 (76.92%) 
Blood and lymphatic system disorders     
Anemia * 1  0/25 (0.00%)  2/13 (15.38%) 
Cardiac disorders     
Chest pain - cardiac * 1  1/25 (4.00%)  1/13 (7.69%) 
Gastrointestinal disorders     
Abdominal pain * 1  0/25 (0.00%)  2/13 (15.38%) 
Nausea * 1  4/25 (16.00%)  6/13 (46.15%) 
Oral dysesthesia * 1  0/25 (0.00%)  1/13 (7.69%) 
General disorders     
Fatigue * 1  1/25 (4.00%)  1/13 (7.69%) 
Pain * 1  1/25 (4.00%)  2/13 (15.38%) 
Infections and infestations     
Skin infection * 1  0/25 (0.00%)  1/13 (7.69%) 
Upper respiratory infection * 1  2/25 (8.00%)  0/13 (0.00%) 
Investigations     
Platelet count decreased * 1  1/25 (4.00%)  2/13 (15.38%) 
Metabolism and nutrition disorders     
Hypocalcemia * 1  1/25 (4.00%)  3/13 (23.08%) 
Hypokalemia * 1  0/25 (0.00%)  1/13 (7.69%) 
Musculoskeletal and connective tissue disorders     
Back pain * 1  0/25 (0.00%)  1/13 (7.69%) 
Bone pain * 1  0/25 (0.00%)  2/13 (15.38%) 
Myalgia * 1  1/25 (4.00%)  1/13 (7.69%) 
Nervous system disorders     
Headache * 1  0/25 (0.00%)  1/13 (7.69%) 
Paresthesia * 1  1/25 (4.00%)  1/13 (7.69%) 
Skin and subcutaneous tissue disorders     
Rash maculo-papular * 1  0/25 (0.00%)  1/13 (7.69%) 
1
Term from vocabulary, CTCAE (4.0)
*
Indicates events were collected by non-systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Sherif Farag
Organization: IndianaU
Phone: (317) 278-0460
EMail: ssfarag@iu.edu
Layout table for additonal information
Responsible Party: Sherif S. Farag, Indiana University School of Medicine
ClinicalTrials.gov Identifier: NCT02078102    
Other Study ID Numbers: IUCRO-0419
CA182947 ( Other Grant/Funding Number: NCI )
1312925163 ( Other Identifier: Indiana University IRB )
First Submitted: February 20, 2014
First Posted: March 5, 2014
Results First Submitted: January 13, 2021
Results First Posted: February 21, 2021
Last Update Posted: February 21, 2021