Multiple Myeloma Clinical Trial
Official title:
Non-steroidal Anti-inflammatory Drugs (Meloxicam) to Mobilize Hematopoietic Stem Cells: A Phase II Randomized Trial
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.
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