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

NCT ID: NCT02078102

Last Updated: 2021-02-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-03-11
• Study Completion Date: 2019-02-21

Brief 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 chemotherapy with stem cell support. Clinical data regarding the cellular composition and function of the graft mobilized by this combination will be obtained.

Conditions

Multiple Myeloma; Non-Hodgkin's Lymphoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment

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.

Group Type: OTHER

Meloxicam

Intervention Type: DRUG

15 mg tablets of Meloxicam will be taken orally in the morning, with or without food.

Filgrastim

Intervention Type: DRUG

Filgrastim will be subcutaneously injected in one or two sites at home.

Interventions

Meloxicam

15 mg tablets of Meloxicam will be taken orally in the morning, with or without food.

Intervention Type: DRUG

Filgrastim

Filgrastim will be subcutaneously injected in one or two sites at home.

Intervention Type: DRUG

Other Intervention Names

Mobic; Neupogen

Eligibility Criteria

Inclusion Criteria

1. Has provided written informed consent prior to completing any study procedures.

2. 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.

1. Multiple myeloma should be in first or second partial response or better, as defined by International Myeloma Working Group criteria.50

2. 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
• Transformed lymphoma
• Mantle cell lymphoma
• Follicular lymphoma (any grade)
• Peripheral T cell lymphoma

3. Age ≥18 to ≤75 years at time of consent.

4. Karnofsky performance status of at least 70%.

5. Adequate organ function defined as:

1. Left ventricular ejection fraction ≥45%

2. Corrected DLCO ≥50%

3. Serum bilirubin, AST (aspartate aminotransferase) and ALT(alanine aminotransferase) ≤ twice the upper limit of normal

4. Serum creatinine ≤ 2.0 mg/dl

5. Urine M-protein ≤1 g/24 hours (MM patients only)

6. No prior attempt at mobilizing PBSC.

7. 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.

8. 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.

9. Patients must be negative for HIV.

10. Women of childbearing potential must have a negative pregnancy test (urine or serum) and must not be lactating at the time of informed consent.

1. 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.

Exclusion Criteria

Exclude a patient if any of the following conditions are observed:

1. 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).

2. Patients must not have active central nervous system involvement.

3. Patients must not have a prior autologous, syngeneic or allogeneic hematopoietic stem cell transplant.

4. Patients must not have received prior bone seeking radionuclides.

5. Patients must not have received myeloid growth factors within 2 weeks before mobilization attempt on this study.

6. Patients must not have taken nonsteroidal antiinflammatory drugs (NSAID) in the past 14 days before treatment on this protocol.

7. Patients must not have nor had active or recent peptic ulcer disease within the past 6 months.

a) Patients with active significant symptoms of dyspepsia will be excluded.

8. Patients with a history of asthma will be excluded because of the potential for NSAID to precipitate asthma in these patients.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Sherif S. Farag

OTHER

Sponsor Role: lead

Responsible Party

Sherif S. Farag

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Sherif Farag, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Indiana University

Locations

Indiana University Melvin and Bren Simon Cancer Center

Indianapolis, Indiana, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 34510361 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

CA182947

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

1312925163

Identifier Type: OTHER

Identifier Source: secondary_id

IUCRO-0419

Identifier Type: -

Identifier Source: org_study_id