Neoplasms

Heart and Blood Diseases

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Multiple Myeloma

Neoplasms, Plasma Cell

Lymphoma

Lymphoma, Non-Hodgkin

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hematologic Diseases

Hemorrhagic Disorders

Lymphosarcoma

All Drugs and Chemicals

Anti-Inflammatory Agents

Antirheumatic Agents

Analgesics

Reproductive Control Agents

Lenograstim

Meloxicam

Dinoprostone

Anti-Inflammatory Agents, Non-Steroidal

Analgesics, Non-Narcotic

Cyclooxygenase 2 Inhibitors

Cyclooxygenase Inhibitors

Enzyme Inhibitors

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.

15 mg tablets of Meloxicam will be taken orally in the morning, with or without food.

Filgrastim will be subcutaneously injected in one or two sites at home.

Filgrastim

Sherif Farag, M.D., Ph.D.

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.

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

A Phase II Trial of Prostaglandin E2 Inhibition, Using Meloxicam, Plus Filgrastim for Mobilization of Autologous Peripheral Blood Stem Cells in Patients With Multiple Myeloma and Non-Hodgkin's Lymphoma

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.

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.

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 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 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.

National Cancer Institute (NCI)

Sherif S. Farag

Principal Investigator

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.

Non Hodgkins Lymphoma

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

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.

Disease Status at Registration

Dr. Sherif Farag

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

Number of Patients With Treatment Related Adverse Events Grade 3 or Higher for Nonhematological Toxicity

Cycle 2 Day 1

Cycle 2 Day 2

Cycle 2 Day 3

Cycle 2 Day 4

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

Summary Statistics for Graft Composition of Peripheral Blood Stem Cell Collection at Each Time Point

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.

Treatment Group

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

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

Overall Study

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Juanita Crook, MD

Swelling of the prostate can occur during and after a brachytherapy. This swelling can cause urinary problems ranging from difficulty voiding to urinary retention. The purpose of this study is to investigate whether Mobicox started one week before brachytherapy and then continued afterwards is more effective in reducing the risk of needing a catheter than Mobicox given only afterwards.

Mobicox: Study of Meloxicam to Reduce Prostate Swelling in Permanent Seed Prostate Brachytherapy

A Comparison of 2 Schedules of Meloxicam to Reduce Prostate Swelling in Permanent Seed Prostate Brachytherapy - A Randomized Phase III Trial

Princess Margaret Hospital, Canada

University Health Network, Toronto

Hodgkin Disease

Hodgkin Lymphoma

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.

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

Placebo

Bimalangshu Dey, MD

This research study is evaluating a drug called meloxicam to see if it provides a benefit to people receiving Autologous Hematopoietic Stem Cell Transplantation (AHSCT).

The participant is currently scheduled to receive an AHSCT, which is a procedure that removes blood-forming stem cells (cells from which all blood cells develop) from the body. These stem cells are stored and later given back to the participant by a process called apheresis. This is a standard procedure to treat certain blood diseases such as lymphoma and multiple myeloma. However the use of meloxicam with this procedure is considered investigational.

Meloxicam is a non-steroidal anti-inflammatory drug (NSAID) which is given to decrease fever, swelling and pain that may come with inflammation. It has been approved by the FDA for the treatment of arthritis however it has not been approved for use in people receiving AHSCT.

This study will compare the combination of meloxicam with a drug called G-CSF (also called neupogen), to the combination of G-CSF with an agent that has no medicine (placebo). G-CSF is a substance that causes blood stem cells to change or increase in number when given to people undergoing AHSCT. The researchers would like to learn if giving meloxicam in combination with G-CSF to people before they undergo AHSCT will increase the number of stem cells available in the blood to collect and make the collection process easier.

After the screening procedures confirm that the participant is eligible to participate in the research study:

Because no one knows which of the study options is best, the participant will be "randomized" into one of the study groups:

* G-CSF with meloxicam
* G-CSF with placebo (pills with no medicine)

Randomization means that the participants are put into a group by chance. It is like flipping a coin. Neither the participant nor the research doctor will choose what group the participant will be in. The participant will have an equal chance of being placed in any group.

- Study Drug (meloxicam or placebo): If the participant takes part in this research study, the participant will be given a study drug-dosing diary. The study drug will come as a pill that the participant will take by mouth daily for 5 days, starting 6 days (Day -6) before the participant is scheduled to undergo the first apheresis procedure (Day 0) and continuing until 2 days before apheresis (Day -2). The participant will take meloxicam or placebo for a total of 5 days. The diary will also include special instructions for taking the study drug(s).

-G-CSF: All participants receive G-CSF as an injection under the skin (subcutaneous) in the clinic, daily starting 4 days (Day -4) before the first apheresis procedure (Day 0). The participant will continue to receive G-CSF for 3 days after apheresis.

- Apheresis: The participant may receive up to 4 apheresis procedures, depending on how their body reacts to the stem cell mobilization. The participant will receive either meloxicam or placebo in combination with G-CSF on Days -6 to -2 as described above.

Clinical Exams: While the participant is receiving this procedure, the participant will have regular physical exams and they will be asked specific questions about any problems that they might be having. The participant will also have blood tests every day to look at how their bone marrow is recovering, to give possible transfusional support, and how to see how their liver and kidneys are functioning.

Planned Follow-up: The investigators would like to keep track of the participant's medical condition for the rest of their life. The investigators would like keep track of the participant's medical condition for 6 months after the study to see how they are doing.

Meloxicam vs Placebo for Mobilization

Non-steroidal Anti-inflammatory Drugs (Meloxicam) to Mobilize Hematopoietic Stem Cells: A Phase II Randomized Trial

Numbers of circulating CD34+ cells on the first day of apheresis

The median to neutrophil engraftment (absolute neutrophil counts above 0.5/mcl for 3 consecutive days) .

The median to platelet engraftment (platelet count above 20,000/mcl for 3 consecutive days)

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.

The 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.

The Leukemia and Lymphoma Society

Massachusetts General Hospital

Only grade 3+ toxicities were recorded for the study

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

A. GCSF + Placebo

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

B. GCSF + Meloxicam

United States

Region of Enrollment

Bimalangshu Dey, MD, PhD

Numbers of Circulating CD34+ Cells on the First Day of Apheresis

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

Time to engraftment was only assessed among patients that received transplantation

Time to Neutrophil Engraftment After AHSCT

Time to Platelet Engraftment After AHSCT

Number of Patients With Grade 3+ Treatment Related Adverse Events

Platelet transfusions

Red blood cell transfusions

Number of transfusions needed were only counted among patients that underwent transplantation

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Phase II Trial Using Meloxicam Plus Filgrastim in Patients With Multiple Myeloma and Non-Hodgkin's Lymphoma	NCT02078102	Multiple Myelom... Non-Hodgkin's L...	Meloxicam Filgrastim	18 Years -	Indiana University
Mobicox: Study of Meloxicam to Reduce Prostate Swelling in Permanent Seed Prostate Brachytherapy	NCT00152919	Prostatic Neopl...	Meloxicam	18 Years -	University Health Network, Toronto
Mobicox: Study of Meloxicam to Reduce Prostate Swelling in Permanent Seed Prostate Brachytherapy	NCT00152919	Prostatic Neopl...	Meloxicam	18 Years -	University Health Network, Toronto
Meloxicam vs Placebo for Mobilization	NCT02003625	Non-Hodgkin's L... Hodgkin's Lymph... Multiple Myelom... Hematopoietic S...	GCSF meloxicam Placebo	18 Years - 75 Years	Massachusetts General Hospital

Spots Global Cancer Trial Database for meloxicam

Every month we try and update this database with for meloxicam cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for meloxicam

Every month we try and update this database with for meloxicam cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for meloxicam cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.