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| ID | Type | Description | Link |
|---|---|---|---|
| CA182947 | Other Grant/Funding Number | NCI | |
| 1312925163 | Other Identifier | Indiana University IRB |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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The trial is an open label Simon optimal two-stage Phase II trial of fixed doses of oral meloxicam and subcutaneous filgrastim to assess the safety and efficacy in mobilizing autologous peripheral blood stem cells (PBSC) from multiple myeloma (MM) and non-Hodgkin's lymphoma (NHL) patients planning to undergo high-dose chemotherapy with stem cell support. Clinical data regarding the cellular composition and function of the graft mobilized by this combination will be obtained.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Other | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Meloxicam | Drug | 15 mg tablets of Meloxicam will be taken orally in the morning, with or without food. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent of Patients Who Mobilize and Collect at Least Half of the Total Target CD34+ Cell Dose in the First Apheresis | 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. | within 100 days of transplant |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With Treatment Related Adverse Events Grade 3 or Higher for Nonhematological Toxicity | 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. | within 100 days of transplant |
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Inclusion Criteria:
A patient must meet all of the following inclusion criteria to be eligible for enrollment in this study:
Has provided written informed consent prior to completing any study procedures.
Patients must have a previously documented histologic diagnosis of multiple myeloma (MM) or non-Hodgkin's lymphoma (NHL), and be eligible to undergo autologous PBSC transplantation on institutional protocols.
Multiple myeloma should be in first or second partial response or better, as defined by International Myeloma Working Group criteria.50
Non-Hodgkin's lymphoma must be in either first or second partial response or better and have any one of the following histologies:
Age ≥18 to ≤75 years at time of consent.
Karnofsky performance status of at least 70%.
Adequate organ function defined as:
No prior attempt at mobilizing PBSC.
Patients must be at least 4 weeks from last cytotoxic chemotherapy (including alkylating, anthracyclines, epipodophylatoxins, and platinum drugs), or immunomodulatory drugs (including lenalidomide or pomalidomide, or related derivatives) at time of treatment on this protocol.
Patients must be at least 2 weeks from last treatment with a proteasome inhibitor (e.g., bortezomib, carfilzomib) at time of treatment on this protocol.
Patients must be negative for HIV.
Women of childbearing potential must have a negative pregnancy test (urine or serum) and must not be lactating at the time of informed consent.
Exclusion Criteria:
Exclude a patient if any of the following conditions are observed:
Patients must not have received radiation therapy within the past 4 weeks, and not to more than 20% of hematopoiesis forming bones (spine, pelvis and proximal long bones).
Patients must not have active central nervous system involvement.
Patients must not have a prior autologous, syngeneic or allogeneic hematopoietic stem cell transplant.
Patients must not have received prior bone seeking radionuclides.
Patients must not have received myeloid growth factors within 2 weeks before mobilization attempt on this study.
Patients must not have taken nonsteroidal antiinflammatory drugs (NSAID) in the past 14 days before treatment on this protocol.
Patients must not have nor had active or recent peptic ulcer disease within the past 6 months.
a) Patients with active significant symptoms of dyspepsia will be excluded.
Patients with a history of asthma will be excluded because of the potential for NSAID to precipitate asthma in these patients.
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| Name | Affiliation | Role |
|---|---|---|
| Sherif Farag, M.D., Ph.D. | Indiana University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana University Melvin and Bren Simon Cancer Center | Indianapolis | Indiana | 46202 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34510361 | Derived | Patterson AM, Zhang S, Liu L, Li H, Singh P, Liu Y, Farag SS, Pelus LM. Meloxicam with Filgrastim may Reduce Oxidative Stress in Hematopoietic Progenitor Cells during Mobilization of Autologous Peripheral Blood Stem Cells in Patients with Multiple Myeloma. Stem Cell Rev Rep. 2021 Dec;17(6):2124-2138. doi: 10.1007/s12015-021-10259-y. Epub 2021 Sep 12. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percent of Patients Who Mobilize and Collect at Least Half of the Total Target CD34+ Cell Dose in the First Apheresis | 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. | Patients with available post-transplant CD34+ results. | Posted | Number | 95% Confidence Interval | percentage of participants | within 100 days of transplant |
|
up to 100 days post-transplant
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhea | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Sherif Farag | IndianaU | (317) 278-0460 | ssfarag@iu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 21, 2016 | Jan 12, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| D008228 | Lymphoma, Non-Hodgkin |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
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| ID | Term |
|---|---|
| D000077239 | Meloxicam |
| D000069585 | Filgrastim |
| ID | Term |
|---|---|
| D013843 | Thiazines |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D013844 | Thiazoles |
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| Filgrastim | Drug | 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 | 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. | Cycle 2, Days 1-4, within 100 days of transplant |
| Time to Neutrophil Engraftment | 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. | within 100 days of transplant |
| Time to Platelet Engraftment | 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. | within 100 days of transplant |
| Physician Decision |
|
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Disease Status at Registration | 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. | Count of Participants | Participants |
|
| OG001 | 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. |
|
|
| Secondary | Number of Patients With Treatment Related Adverse Events Grade 3 or Higher for Nonhematological Toxicity | 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. | All patients who received a transplant. | Posted | Count of Participants | Participants | within 100 days of transplant |
|
|
|
| Secondary | Summary Statistics for Graft Composition of Peripheral Blood Stem Cell Collection at Each Time Point | 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. | Patients with available post-transplant CD34 (x10^6/kg) data. | Posted | Mean | Standard Deviation | x10^6cells/kg | Cycle 2, Days 1-4, within 100 days of transplant |
|
|
|
| Secondary | Time to Neutrophil Engraftment | 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. | 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. | Posted | Median | 95% Confidence Interval | days | within 100 days of transplant |
|
|
|
| Secondary | Time to Platelet Engraftment | 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. | 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. | Posted | Median | 95% Confidence Interval | days | within 100 days of transplant |
|
|
|
| 4 |
| 25 |
| 1 |
| 25 |
| 10 |
| 25 |
| EG001 | 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. | 1 | 13 | 1 | 13 | 10 | 13 |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Chest pain - cardiac | Cardiac disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Oral dysesthesia | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Fatigue | General disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Pain | General disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Skin infection | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
|
| Upper respiratory infection | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
|
| Platelet count decreased | Investigations | CTCAE (4.0) | Non-systematic Assessment |
|
| Hypocalcemia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Hypokalemia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Bone pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Headache | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Paresthesia | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Rash maculo-papular | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
|
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| D014652 |
| Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D008223 | Lymphoma |
| D008206 | Lymphatic Diseases |
| D001393 |
| Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D016179 | Granulocyte Colony-Stimulating Factor |
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D016298 | Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
| Cycle 2 Day 2 |
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| Cycle 2 Day 3 |
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| Cycle 2 Day 4 |
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