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

• 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: Sherif S. Farag
• 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

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	Multiple Myeloma	Non Hodgkins Lymphoma
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

Baseline Characteristics

Arm/Group Title		Multiple Myeloma	Non Hodgkins Lymphoma	Total
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
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.

Outcome Measures

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
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

Outcome Measure Data

Analysis Population Description

Patients with available post-transplant CD34+ results.

Arm/Group Title	Multiple Myeloma	Non Hodgkins Lymphoma
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
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

Outcome Measure Data

Analysis Population Description

All patients who received a transplant.

Arm/Group Title	Multiple Myeloma	Non Hodgkins Lymphoma
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
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

Outcome Measure Data

Analysis Population Description

Patients with available post-transplant CD34 (x10^6/kg) data.

Arm/Group Title		Multiple Myeloma	Non Hodgkins Lymphoma
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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)

Adverse Events

Time Frame	up to 100 days post-transplant
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Multiple Myeloma	Non Hodgkins Lymphoma
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%)
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
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

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact

• Name/Title: Dr. Sherif Farag
• Organization: IndianaU
• Phone: (317) 278-0460
• EMail: ssfarag@iu.edu

• 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