Non-Hodgkin's LymphomaPhase 2NCT02003625
Meloxicam vs Placebo for Mobilization
A Phase 2 study testing GCSF and meloxicam in people with Non-Hodgkin's Lymphoma and Hodgkin's Lymphoma, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Non-Hodgkin's Lymphoma, Hodgkin's Lymphoma, Multiple Myeloma
- What is being tested?
- GCSF and meloxicam
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2013to Apr 2019
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants must meet the following criteria on screening examination to be eligible to participate in the study:
- Patients with hematologic malignancies for whom autologous stem cell transplantation is deemed clinically appropriate. Patients participating in this study are patients who are going for their first attempt at stem cell mobilization.
- Non-Hodgkin's lymphoma, or Hodgkin's lymphoma: refractory/relapsed but chemosensitive disease. Patients with CR or PR will be eligible for this protocol.
- The designation of PR requires all of the following:
- At least a 50% decrease in sum of the product of the diameters (SPD) of up to six of the largest dominant nodes or nodal masses. These nodes or masses should be selected according to all of the following: they should be clearly measurable in at least 2 perpendicular dimensions; if possible they should be from disparate regions of the body; and they should include mediastinal and retroperitoneal areas of disease whenever these sites are involved.
- No increase should be observed in the size of other nodes, liver, or spleen.
Show all 13Show fewer
- Splenic and hepatic nodules must regress by ≥ 50% in their SPD or, for single nodules, in the greatest transverse diameter.
- With the exception of splenic and hepatic nodules, involvement of other organs is usually assessable and no measurable disease should be present.
- Bone marrow assessment is irrelevant for determination of a PR if the sample was positive before treatment. However, if positive, the cell type should be specified (eg, large-cell lymphoma or small neoplastic B cells). Patients who achieve a CR by the above criteria, but who have persistent morphologic bone marrow involvement will be considered partial responders. Multiple myeloma in first or second remission. Patients with CR or VGPR will be eligible for this protocol. [VGPR: Serum and urine M-protein detectable by immunofixation only but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine M-protein level <100mg per 24 h]
- Ages 18-75 years
- ECOG performance status of 0, 1, or 2.
- Ability to understand and the willingness to sign a written informed consent
- Patients on NSAIDs will be eligible only when they are off NSAIDs for a month.
Who cannot join
- Participants who exhibit any of the following conditions at screening will not be eligible for admission into the study.
- Cardiac disease: symptomatic congestive heart failure or RVG or echocardiogram determined left ventricular ejection fraction of < 45%, active angina pectoris, or uncontrolled hypertensionParticipants may not be receiving any other study agents.
- Pulmonary disease: severe chronic obstructive lung disease, or symptomatic restrictive lung disease, or corrected DLCO of < 50% of predicted.
- Renal disease: serum creatinine > 2.0 mg/dl.
- Hepatic disease: SGOT or SGPT > 3 x normal; serum bilirubin >2.0 mg/dl that is not due to Gilbert's syndrome or hemolysis
- Uncontrolled infection.
- Pregnancy or lactation
- Patients with NSAIDs allergies, including patients who have experienced a prior GI bleed due to NSAIDs will be excluded. Patients who have had a recent GI bleed less than 2 weeks ago will be excluded. Patients who are on therapeutic dose anticoagulants will be excluded from this protocol.
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02215
About this study
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.
Read more
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.
Read the detailed description
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.
- Being tested
- GCSF, meloxicam, Placebo
- Keywords
- Non-Hodgkin's lymphoma, Hodgkin's lymphoma, Multiple myeloma, Hematopoietic stem cells
- Medical subject headings
- Lymphoma, Non-Hodgkin, Hodgkin Disease, Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GCSFDrug
meloxicamDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| A. GCSF + Placebo | Placebo comparator | 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. Receives: Drug: GCSF; Drug: Placebo |
| B. GCSF + meloxicam | Experimental | 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. Receives: Drug: GCSF; Drug: meloxicam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numbers of Circulating CD34+ Cells on the First Day of Apheresis
Numbers of circulating CD34+ cells on the first day of apheresis
Measured: 3 days after starting treatment (or 9 days for multiple myeloma patients that received cyclophosphamide)
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
Measured: Up to 6 days after the start of treatment or up to 12 days for multiple myeloma patients that received cyclophosphamide
Time to Neutrophil Engraftment After AHSCT
The median to neutrophil engraftment (absolute neutrophil counts above 0.5/mcl for 3 consecutive days) .
Measured: Up to 6 months after transplantation ( up to 66-72 days after the start of treatment)
Time to Platelet Engraftment After AHSCT
The median to platelet engraftment (platelet count above 20,000/mcl for 3 consecutive days)
Measured: Up to 6 months after transplantation ( up to 66-72 days after the start of treatment)
Secondary outcomes (3)
Number of Patients With Grade 3+ Treatment Related Adverse Events
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.
Measured: Up to 30 days after the last apheresis session (up to 36 days after the start of treatment or 42 days for multiple myeloma patients that received cyclophosphamide)
Number of Participants That Received Red Blood Cell and Platelet Transfusions Prior to Engraftment
Measured: Up to 6 months after transplantation ( up to 66-72 days after the start of treatment)
Number of Patients That Failed to Achieve Stem Cell Mobilization.
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.
Measured: Up to 6 days after the start of treatment or up to 12 days for multiple myeloma patients that received cyclophosphamide
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2013 (estimated)
- Study startOct 2013
- Primary completionFeb 2019
- Study completionApr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Non-Hodgkin's LymphomaStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The Leukemia and Lymphoma Society
- Responsible party
- Principal investigator, Bimalangshu Dey, Massachusetts General Hospital
- Investigators
- Bimalangshu Dey, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02003625
- Sponsor's protocol ID
- 13-195
- Status last verified
- May 2020
- First submitted
- 10 Oct 2013
- Last updated
- 18 May 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-steroidal Anti-inflammatory Drugs (Meloxicam) to Mobilize Hematopoietic Stem Cells: A Phase II Randomized Trial
- ClinicalTrials.gov ID
- NCT02003625
- Acronym / sponsor ID
- 13-195
- Keywords
- Non-Hodgkin's lymphoma, Hodgkin's lymphoma, Multiple myeloma, Hematopoietic stem cells
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- The Leukemia and Lymphoma Society
- Study start
- Oct 2013
- Primary completion
- Feb 2019 (actual)
- Study completion
- Apr 2019 (actual)
- First posted
- 6 Dec 2013 (estimated)
- Results
- Posted 18 May 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A. GCSF + Placebo | Placebo comparator | Drug: GCSF, Drug: PlaceboGCSF + 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 | Experimental | Drug: GCSF, Drug: meloxicamB. 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Participants must meet the following criteria on screening examination to be eligible to participate in the study:
- Patients with hematologic malignancies for whom autologous stem cell transplantation is deemed clinically appropriate. Patients participating in this study are patients who are going for their first attempt at stem cell mobilization.
- Non-Hodgkin's lymphoma, or Hodgkin's lymphoma: refractory/relapsed but chemosensitive disease. Patients with CR or PR will be eligible for this protocol.
- At least a 50% decrease in sum of the product of the diameters (SPD) of up to six of the largest dominant nodes or nodal masses. These nodes or masses should be selected according to all of the following: they should be clearly measurable in at least 2 perpendicular dimensions; if possible they should be from disparate regions of the body; and they should include mediastinal and retroperitoneal areas of disease whenever these sites are involved.
- No increase should be observed in the size of other nodes, liver, or spleen.
Key exclusion criteria (8 listed)
- Participants who exhibit any of the following conditions at screening will not be eligible for admission into the study.
- Cardiac disease: symptomatic congestive heart failure or RVG or echocardiogram determined left ventricular ejection fraction of < 45%, active angina pectoris, or uncontrolled hypertensionParticipants may not be receiving any other study agents.
- Pulmonary disease: severe chronic obstructive lung disease, or symptomatic restrictive lung disease, or corrected DLCO of < 50% of predicted.
- Renal disease: serum creatinine > 2.0 mg/dl.
- Hepatic disease: SGOT or SGPT > 3 x normal; serum bilirubin >2.0 mg/dl that is not due to Gilbert's syndrome or hemolysis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GCSF | Drug | A. GCSF + Placebo, B. GCSF + meloxicam |
| meloxicam | Drug | B. GCSF + meloxicam |
| Placebo | Drug | A. GCSF + Placebo |
Primary outcome
Numbers of Circulating CD34+ Cells on the First Day of Apheresis
Time frame: 3 days after starting treatment (or 9 days for multiple myeloma patients that received cyclophosphamide)
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 frame: Up to 6 days after the start of treatment or up to 12 days for multiple myeloma patients that received cyclophosphamide
Time to Neutrophil Engraftment After AHSCT
Time frame: Up to 6 months after transplantation ( up to 66-72 days after the start of treatment)
The median to neutrophil engraftment (absolute neutrophil counts above 0.5/mcl for 3 consecutive days) .
Time to Platelet Engraftment After AHSCT
Time frame: Up to 6 months after transplantation ( up to 66-72 days after the start of treatment)
The median to platelet engraftment (platelet count above 20,000/mcl for 3 consecutive days)
3 secondary outcomes
Number of Patients With Grade 3+ Treatment Related Adverse Events
Time frame: Up to 30 days after the last apheresis session (up to 36 days after the start of treatment or 42 days for multiple myeloma patients that received cyclophosphamide)
Number of Participants That Received Red Blood Cell and Platelet Transfusions Prior to Engraftment
Time frame: Up to 6 months after transplantation ( up to 66-72 days after the start of treatment)
Number of Patients That Failed to Achieve Stem Cell Mobilization.
Time frame: Up to 6 days after the start of treatment or up to 12 days for multiple myeloma patients that received cyclophosphamide
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bimalangshu Dey, MD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GCSF and meloxicam in people with Non-Hodgkin's Lymphoma and Hodgkin's Lymphoma, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 May 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numbers of Circulating CD34+ Cells on the First Day of Apheresis (time frame: 3 days after starting treatment (or 9 days for multiple myeloma patients that received cyclophosphamide)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2020.