Meloxicam vs Placebo for Mobilization
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.
Hematopoietic Stem Cells
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
|Official Title:||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 [ Time Frame: 2 Years ] [ Designated as safety issue: No ]numbers of circulating CD34+ cells on the first day of apheresis
- number of apheresis sessions required to collect ³ 5 x 10^6 CD34+ cells/kgCD34+ cells/kg [ Time Frame: 2 Years ] [ Designated as safety issue: No ]number of apheresis sessions required to collect ³ 5 x 10^6 CD34+ cells/kg
- time to neutrophil and platelet engraftment after AHSCT [ Time Frame: 2 Years ] [ Designated as safety issue: No ]time to neutrophil and platelet engraftment after AHSCT
- identify the toxicities associated with meloxicam when used with GCSF for stem cell mobilization. [ Time Frame: 2 Years ] [ Designated as safety issue: Yes ]identify the toxicities associated with meloxicam when used with GCSF for stem cell mobilization.
- number of red cell and platelet transfusions prior to engraftment [ Time Frame: 2 Years ] [ Designated as safety issue: No ]number of red cell and platelet transfusions prior to engraftment
- Proportion of patients failing stem cell mobilization. [ Time Frame: 2 years ] [ Designated as safety issue: No ]Proportion of patients failing stem cell mobilization.
|Study Start Date:||October 2013|
|Estimated Study Completion Date:||March 2021|
|Estimated Primary Completion Date:||July 2017 (Final data collection date for primary outcome measure)|
Placebo Comparator: 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.
|Drug: GCSF Drug: Placebo|
Experimental: 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.
|Drug: GCSF Drug: meloxicam|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02003625
|Contact: Bimalangshu Dey, MD||(617)-email@example.com|
|United States, Massachusetts|
|Massachusetts General Hospital||Not yet recruiting|
|Boston, Massachusetts, United States, 02215|
|Contact: Bimalangshu Dey, MD 617-724-1124 firstname.lastname@example.org|
|Principal Investigator: Bimalangshu Dey, MD|
|Principal Investigator:||Bimalangshu Dey, MD||Massachusetts General Hospital|