TriangleNCT02003625 · REGISTRY CONDITION SEARCH
Meloxicam vs Placebo for Mobilization
Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.
- Phase
- PHASE2
- Status at capture
- COMPLETED
- Registry last update
- 2020-05-18
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.
Open the original ClinicalTrials.gov record → · Download preserved record
What did the study report?
Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.
Participant flow
Baseline characteristics
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 Neutrophil Engraftment After AHSCT
Time to Platelet Engraftment After AHSCT
Number of Patients With Grade 3+ Treatment Related Adverse Events
Number of Participants That Received Red Blood Cell and Platelet Transfusions Prior to Engraftment
Number of Patients That Failed to Achieve Stem Cell Mobilization.
Adverse events
Limitations, agreements, and source contact
Who could take part
- eligibility Criteria
- Inclusion Criteria: * 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. * 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. Exclusion Criteria: * 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.
- healthy Volunteers
- false
- maximum Age
- 75 Years
- minimum Age
- 18 Years
- sex
- ALL
- std Ages
- ADULT
- OLDER_ADULT
Treatment arms and interventions
- arm Groups
- description
- 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.
- intervention Names
- Drug: GCSF
- Drug: Placebo
- label
- A. GCSF + Placebo
- type
- PLACEBO_COMPARATOR
- description
- 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.
- intervention Names
- Drug: GCSF
- Drug: meloxicam
- label
- B. GCSF + meloxicam
- type
- EXPERIMENTAL
- interventions
- arm Group Labels
- A. GCSF + Placebo
- B. GCSF + meloxicam
- name
- GCSF
- type
- DRUG
- arm Group Labels
- B. GCSF + meloxicam
- name
- meloxicam
- type
- DRUG
- arm Group Labels
- A. GCSF + Placebo
- name
- Placebo
- type
- DRUG
Study design
- allocation
- RANDOMIZED
- intervention Model
- PARALLEL
- masking Info
- masking
- SINGLE
- who Masked
- PARTICIPANT
- primary Purpose
- TREATMENT
Enrollment
- count
- 31
- type
- ACTUAL
Registered outcome plans (not posted results)
- primary Outcomes
- description
- Numbers of circulating CD34+ cells on the first day of apheresis
- 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)
- measure
- 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
- description
- The median to neutrophil engraftment (absolute neutrophil counts above 0.5/mcl for 3 consecutive days) .
- measure
- Time to Neutrophil Engraftment After AHSCT
- time Frame
- Up to 6 months after transplantation ( up to 66-72 days after the start of treatment)
- description
- The median to platelet engraftment (platelet count above 20,000/mcl for 3 consecutive days)
- measure
- Time to Platelet Engraftment After AHSCT
- time Frame
- Up to 6 months after transplantation ( up to 66-72 days after the start of treatment)
- secondary Outcomes
- description
- 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.
- measure
- 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)
- measure
- 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)
- description
- 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.
- measure
- 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
Full study description
- brief 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 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.
Source references
Source notices and limitations
Discovery and provenance
- release id
- ctgov-registry-1336d216cbd1bbff780dac70
- edge id
- nct-edge-a44c9fdf04d55a2b2547
- requested nct id
- NCT02003625
- primary nct id
- NCT02003625
- source kind
- ctgov_condition_query
- source record id
- Source null
- source file sha256
- 2314ce01316b2d7044d298c6d25eda12e99cc5f44273bc75efed6cd5e03a8c14
- payload sha256
- 7a652d89fae16efecddbb0751530832434e74a5d3d7422ad6062b67aa706cedb
- payload
- clinical indication matching status
- condition_index_match_asserted_by_registry_not_reviewed
- end exclusive
- true
- id
- nct-edge-a44c9fdf04d55a2b2547
- link basis
- returned_by_explicit_condition_and_posted_results_filter_query
- nct id
- NCT02003625
- occurrences
- context exact
- NCT02003625
- end
- 11
- exact text
- NCT02003625
- start
- 0
- offset unit
- unicode_code_points
- query cond
- Plasma Cell Neoplasms
- query disease state id
- ds-plasma-cell-neoplasms
- source file
- /Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-plasma-cell-neoplasms-000.json
- source file sha256
- 2314ce01316b2d7044d298c6d25eda12e99cc5f44273bc75efed6cd5e03a8c14
- source json pointer
- /studies/887/protocolSection/identificationModule/nctId
- source kind
- ctgov_condition_query
- source record id
- Source null
- source string basis
- parsed_JSON_string_unmodified
- source string sha256
- bd2e1546eeb0f825f1beb9947122b8dc36bee621d9198a79a411260ade56be71
Preserved source evidence · Not medical advice