Multiple MyelomaPhase 2NCT02078102

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

A Phase 2 study testing Meloxicam and Filgrastim in people with Multiple Myeloma and Non-Hodgkin's Lymphoma, run by Sherif S. Farag at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Multiple Myeloma, Non-Hodgkin's Lymphoma
What is being tested?: Meloxicam and Filgrastim
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 38 participants
Where: 1 siteUnited States
Study dates: 11 Mar 2014to 21 Feb 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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

A patient must meet all of the following inclusion criteria to be eligible for enrollment in this study:
Has provided written informed consent prior to completing any study procedures.
Patients must have a previously documented histologic diagnosis of multiple myeloma (MM) or non-Hodgkin's lymphoma (NHL), and be eligible to undergo autologous PBSC transplantation on institutional protocols.
Multiple myeloma should be in first or second partial response or better, as defined by International Myeloma Working Group criteria.50
Non-Hodgkin's lymphoma must be in either first or second partial response or better and have any one of the following histologies:
Diffuse large B cell lymphoma

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Transformed lymphoma
Mantle cell lymphoma
Follicular lymphoma (any grade)
Peripheral T cell lymphoma
Age ≥18 to ≤75 years at time of consent.
Karnofsky performance status of at least 70%.
Adequate organ function defined as:
Left ventricular ejection fraction ≥45%
Corrected DLCO ≥50%
Serum bilirubin, AST (aspartate aminotransferase) and ALT(alanine aminotransferase) ≤ twice the upper limit of normal
Serum creatinine ≤ 2.0 mg/dl
Urine M-protein ≤1 g/24 hours (MM patients only)
No prior attempt at mobilizing PBSC.
Patients must be at least 4 weeks from last cytotoxic chemotherapy (including alkylating, anthracyclines, epipodophylatoxins, and platinum drugs), or immunomodulatory drugs (including lenalidomide or pomalidomide, or related derivatives) at time of treatment on this protocol.
Patients must be at least 2 weeks from last treatment with a proteasome inhibitor (e.g., bortezomib, carfilzomib) at time of treatment on this protocol.
Patients must be negative for HIV.
Women of childbearing potential must have a negative pregnancy test (urine or serum) and must not be lactating at the time of informed consent.
Women and men must use adequate birth control while taking part in this study (such as a condom or diaphragm with contraceptive cream/jelly, birth control pills, Norplant, abstinence (no sexual intercourse) or surgical sterilization.

Who cannot join

Exclude a patient if any of the following conditions are observed:
Patients must not have received radiation therapy within the past 4 weeks, and not to more than 20% of hematopoiesis forming bones (spine, pelvis and proximal long bones).
Patients must not have active central nervous system involvement.
Patients must not have a prior autologous, syngeneic or allogeneic hematopoietic stem cell transplant.
Patients must not have received prior bone seeking radionuclides.
Patients must not have received myeloid growth factors within 2 weeks before mobilization attempt on this study.

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Patients must not have taken nonsteroidal antiinflammatory drugs (NSAID) in the past 14 days before treatment on this protocol.
Patients must not have nor had active or recent peptic ulcer disease within the past 6 months.
Patients with active significant symptoms of dyspepsia will be excluded.
Patients with a history of asthma will be excluded because of the potential for NSAID to precipitate asthma in these patients.

Trial locations and contacts

1 site in 1 country.

United States1 site

Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, 46202

Other trials in United States

About this study

Official title: 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

Conditions: Multiple Myeloma, Non-Hodgkin's Lymphoma
Being tested: Meloxicam, Filgrastim
Medical subject headings: Multiple Myeloma, Lymphoma, Non-Hodgkin

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MeloxicamDrug
Also called Mobic
15 mg tablets of Meloxicam will be taken orally in the morning, with or without food.
FilgrastimDrug
Also called Neupogen
Filgrastim will be subcutaneously injected in one or two sites at home.

Study groups in NCT02078102
Study group	Role	What they receive
Treatment	Other	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. Receives: Drug: Meloxicam; Drug: Filgrastim

What is being measured

The primary outcome is the main question the study is designed to answer.

Percent of Patients Who Mobilize and Collect at Least Half of the Total Target CD34+ Cell Dose in the First Apheresis
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.
Measured: within 100 days of transplant

Secondary outcomes (4)

Number of Patients With Treatment Related Adverse Events Grade 3 or Higher for Nonhematological Toxicity
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.
Measured: within 100 days of transplant
Summary Statistics for Graft Composition of Peripheral Blood Stem Cell Collection at Each Time Point
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.
Measured: Cycle 2, Days 1-4, within 100 days of transplant
Time to Neutrophil Engraftment
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.
Measured: within 100 days of transplant
Time to Platelet Engraftment
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.
Measured: within 100 days of transplant

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

11 Mar 201421 Feb 2019

First posted5 Mar 2014 (estimated)
Study start11 Mar 2014
Primary completion6 Nov 2018
Study completion21 Feb 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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Multiple MyelomaStudies of the same condition, open and under way.
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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 38 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02078102
Sponsor's protocol ID: IUCRO-0419
Other IDs: CA182947, 1312925163
Status last verified: Feb 2021
First submitted: 20 Feb 2014
Last updated: 21 Feb 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

Publications

Patterson AM, Zhang S, Liu L, Li H, Singh P, Liu Y, Farag SS, Pelus LM. Meloxicam with Filgrastim may Reduce Oxidative Stress in Hematopoietic Progenitor Cells during Mobilization of Autologous Peripheral Blood Stem Cells in Patients with Multiple Myeloma. Stem Cell Rev Rep. 2021 Dec;17(6):2124-2138. doi: 10.1007/s12015-021-10259-y. Epub 2021 Sep 12.
PubMed 34510361

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Multiple Myeloma
Active, not recruitingPhase 3
A Phase III Study of Eque-cel in Subjects With Len-refractory RRMM (FUMANBA-03)
Multiple Myeloma
Active, not recruitingPhase 1/2
A Window of Opportunity Trial to Learn if Linvoseltamab is Safe and Well Tolerated, and How Well it Works in Adult Participants With Recently Diagnosed Multiple Myeloma Who Have Not Already Received Treatment
Multiple Myeloma
Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm

All Multiple Myeloma trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT02078102
Acronym / sponsor ID: IUCRO-0419
Conditions: Multiple Myeloma, Non-Hodgkin's Lymphoma
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 38 participants (actual)
Lead sponsor: Sherif S. FaragUniversity, hospital or other
Collaborators: National Cancer Institute (NCI)
Study start: 11 Mar 2014 (actual)
Primary completion: 6 Nov 2018 (actual)
Study completion: 21 Feb 2019 (actual)
First posted: 5 Mar 2014 (estimated)
Results: Posted 21 Feb 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Treatment	Other	Drug: Meloxicam, Drug: FilgrastimMeloxicam 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (24 listed)

A patient must meet all of the following inclusion criteria to be eligible for enrollment in this study:
Has provided written informed consent prior to completing any study procedures.
Patients must have a previously documented histologic diagnosis of multiple myeloma (MM) or non-Hodgkin's lymphoma (NHL), and be eligible to undergo autologous PBSC transplantation on institutional protocols.
Age ≥18 to ≤75 years at time of consent.
Karnofsky performance status of at least 70%.

Key exclusion criteria (10 listed)

Patients must not have received radiation therapy within the past 4 weeks, and not to more than 20% of hematopoiesis forming bones (spine, pelvis and proximal long bones).
Patients must not have active central nervous system involvement.
Patients must not have a prior autologous, syngeneic or allogeneic hematopoietic stem cell transplant.
Patients must not have received prior bone seeking radionuclides.
Patients must not have received myeloid growth factors within 2 weeks before mobilization attempt on this study.

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
MeloxicamAlso: Mobic15 mg tablets of Meloxicam will be taken orally in the morning, with or without food.	Drug	Treatment
FilgrastimAlso: NeupogenFilgrastim will be subcutaneously injected in one or two sites at home.	Drug	Treatment

Primary outcome

Percent of Patients Who Mobilize and Collect at Least Half of the Total Target CD34+ Cell Dose in the First Apheresis
Time frame: within 100 days of transplant
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.

4 secondary outcomes

Number of Patients With Treatment Related Adverse Events Grade 3 or Higher for Nonhematological Toxicity
Time frame: within 100 days of transplant
Summary Statistics for Graft Composition of Peripheral Blood Stem Cell Collection at Each Time Point
Time frame: Cycle 2, Days 1-4, within 100 days of transplant
Time to Neutrophil Engraftment
Time frame: within 100 days of transplant
Time to Platelet Engraftment
Time frame: within 100 days of transplant

Results and safety

Results posted to the registry on 21 Feb 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Multiple Myeloma	25	23
Non Hodgkins Lymphoma	13	12

Primary outcome: Percent of Patients Who Mobilize and Collect at Least Half of the Total Target CD34+ Cell Dose in the First Apheresis

Time frame: within 100 days of transplant. Number (95% Confidence Interval). Unit: percentage of participants

Measure	Multiple Myeloma n = 25	Non Hodgkins Lymphoma n = 12
Value	32.0 (15.0 to 53.5)	58.3 (27.7 to 84.8)

Population analysed: Patients with available post-transplant CD34+ results.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: up to 100 days post-transplant. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Multiple Myeloma	1 of 25 (4%)	10 of 25 (40%)	4 of 25
Non Hodgkins Lymphoma	1 of 13 (7.7%)	10 of 13 (76.9%)	1 of 13

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 34510361Patterson AM, Zhang S, Liu L, Li H, Singh P, Liu Y, Farag SS, Pelus LM. Meloxicam with Filgrastim may Reduce Oxidative Stress in Hematopoietic Progenitor Cells during Mobilization of Autologous Peripheral Blood Stem Cells in Patients with Multiple Myeloma. Stem Cell Rev Rep. 2021 Dec;17(6):2124-2138. doi: 10.1007/s12015-021-10259-y. Epub 2021 Sep 12.

Related trials for Multiple Myeloma

Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Multiple Myeloma
Active, not recruitingPhase 3
A Phase III Study of Eque-cel in Subjects With Len-refractory RRMM (FUMANBA-03)
Multiple Myeloma
Active, not recruitingPhase 1/2
A Window of Opportunity Trial to Learn if Linvoseltamab is Safe and Well Tolerated, and How Well it Works in Adult Participants With Recently Diagnosed Multiple Myeloma Who Have Not Already Received Treatment
Multiple Myeloma
Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm

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.

Sherif Farag, M.D., Ph.D. principal investigator

Indiana University

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 Meloxicam and Filgrastim in people with Multiple Myeloma and Non-Hodgkin's Lymphoma, run by Sherif S. Farag 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 24 inclusion and 10 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 21 Feb 2021. 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. 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 21 Feb 2021). 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?

Percent of Patients Who Mobilize and Collect at Least Half of the Total Target CD34+ Cell Dose in the First Apheresis (time frame: within 100 days of transplant). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02078102, which also lists 1 linked publication.

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 21 Feb 2021.