Filgrastim in Treating Patients With Bortezomib-, Carfilzomib-, or IMID-Refractory Multiple Myeloma

NCT ID: NCT01537861

Last Updated: 2015-01-26

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-06-30
• Study Completion Date: 2014-12-31

Brief Summary

Based on the pre-clinical data the investigators hypothesize that G-CSF treatment in patients with multiple myeloma will generate a 'hostile' bone marrow microenvironment for myeloma cells, depriving them of key support signals and rendering them more sensitive to chemotherapy. The investigators therefore propose to do an initial pilot study 1) to explore the safety of the combination of G-CSF and bortezomib-, carfilzomib-, or IMID-based treatment regimens in patients with bortezomib-, carfilzomib-, or IMID-refractory myeloma and 2) to generate correlative data for a subsequent larger study looking at the combination.

Conditions

Multiple Myeloma

Study Design

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

Study Groups

Arm 1

Filgrastim 5 ug/kg from Day -3 to Day 10 of a single cycle.

Bortezomib will be given at the patient's current dose on Days 1, 4, 8, and 11 OR Carfilzomib will be given at the patient's current dose on Days 1, 2, 8, 9, 15, and 16 OR IMID will be given at the patient's current dose once daily on Days 1-21. Patients receiving an IMID (thalidomide, lenalidomide, or pomalidomide) as part of a bortezomib or carfilzomb regimen should continue the same scheduled as the current regimen.

Dexamethasone should be continued at the same dose and schedule as the patient's current regimen.

PO cyclophosphamide should be continued at the same dose and schedule as the patient's current regimen.

Group Type: EXPERIMENTAL

Filgrastim

Intervention Type: DRUG

Bortezomib

Intervention Type: DRUG

Carfilzomib

Intervention Type: DRUG

Dexamethasone

Intervention Type: DRUG

Cyclophosphamide

Intervention Type: DRUG

Thalidomide

Intervention Type: DRUG

Lenalidomide

Intervention Type: DRUG

Pomalidomide

Intervention Type: DRUG

Interventions

Filgrastim

Intervention Type: DRUG

Bortezomib

Intervention Type: DRUG

Carfilzomib

Intervention Type: DRUG

Dexamethasone

Intervention Type: DRUG

Cyclophosphamide

Intervention Type: DRUG

Thalidomide

Intervention Type: DRUG

Lenalidomide

Intervention Type: DRUG

Pomalidomide

Intervention Type: DRUG

Other Intervention Names

G-CSF; Neupogen®; Granulocyte Colony-Stimulating Factor; Velcade®; Kyprolis®; Cytoxan; Thalomid; Revlimid; Pomalyst

Eligibility Criteria

Inclusion Criteria

• Patient must have a confirmed diagnosis of multiple myeloma. The patient may be any stage of multiple myeloma. The patient may have received one or more lines of prior therapy (there is no limit to number of prior lines of therapy permissible).
• Patient must be ≥18 years of age
• Patient must be in active treatment with one of the following:

• twice-weekly bortezomib (on Days 1, 4, 8, and 11 of a 21-day cycle) with or without dexamethasone
• carfilzomib (on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle) with or without dexamethasone
• an IMID with or without dexamethasone daily on Days 1 to 21.
• Patients being treated with bortezomib or carfilzomb may also be receiving an IMID or PO cyclophosphamide with the regimen.
• Patient must have shown stable or progressive disease on the current bortezomib-, carfilzomib-, or IMID-containing regimen with a measurable monoclonal protein component in the serum (at least 0.5 g/dl on electrophoresis or 0.05 g/dl [50mg/dl] on serum-free-light-chain). Patients who had an initial response on the current bortezomib-, carfilzomib-, or IMID-containing regimen but now have stable (plateaued) disease are eligible.
• Patient must have an ECOG performance status of 0 - 2
• Patient must be receiving concurrent treatment with bisphosphonates, with one dose occurring within 30 days prior to first day (Day -3) of protocol treatment
• Patient must have acceptable hematologic parameters, defined as:

• Absolute neutrophil count > 1000 cells/mm3
• Platelets ≥ 50,000 cells/mm3
• Hemoglobin ≥ 8 g/dl
• Patient must have adequate liver function, defined as:

• Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 3 x upper limit of normal
• Total bilirubin < 2 x upper limit of normal
• Patient must be able to understand and willing to sign a written informed consent document

Exclusion Criteria

• Patient must not be receiving any agents with known or suspected anti-myeloma activity (other than bortezomib, carfilzomib, dexamethasone, an IMID or PO cyclophosphamide, and bisphosphonates with the current regimen)
• Patient must not be actively using myeloid growth factors
• Patient must not have had any prior malignancy, except for adequately treated basal cell or squamous cell skin cancer, in-situ cervical cancer, or other cancer from which the subject has been disease-free for at least 2 years
• Patient must not have any uncontrolled medical problems such as diabetes mellitus, coronary artery disease, hypertension, unstable angina, arrhythmias, pulmonary disease, and symptomatic heart failure
• Patient must not have neuropathy ≥ grade 3 or painful neuropathy ≥ grade 2 (NCI CTCAE v 4.0)
• Patient must not have any known active infections requiring IV antibiotic, antiviral, or antifungal therapy
• Patient must not be pregnant or breastfeeding

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

Sponsors

Washington University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ravi Vij, M.D.

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

Washington University School of Medicine

St Louis, Missouri, United States

Countries

United States

Related Links

http://www.siteman.wustl.edu

Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

Other Identifiers

201204086

Identifier Type: -

Identifier Source: org_study_id