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A Pilot Study of G-CSF to Disrupt the Bone Marrow Microenvironment in Bortezomib- or Carfilzomib-Refractory Multiple Myeloma

18 Years
Open (Enrolling)
Multiple Myeloma

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Trial Information

A Pilot Study of G-CSF to Disrupt the Bone Marrow Microenvironment in Bortezomib- or Carfilzomib-Refractory Multiple Myeloma

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 twice-weekly bortezomib (on Days 1, 4, 8,
and 11 of a 21-day cycle) with or without dexamethasone or carfilzomib (on Days 1, 2,
8, 9, 15, and 16 of a 28-day cycle) with or without dexamethasone. Patient may also
be receiving an immunomodulatory drug (IMID) or PO cyclophosphamide with the regimen.

- Patient must have shown stable or progressive disease on the twice-weekly bortezomib-
or carfilzomib-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 twice-weekly
bortezomib or carfilzomib-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

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

Type of Study:


Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety of the combination of G-CSF and bortezomib- or carfilzomib-based treatment regimens in patients with bortezomib- or carfilzomib-refractory multiple myeloma.

Outcome Description:

Number and grade of adverse events based on NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.

Outcome Time Frame:

21 days

Safety Issue:


Principal Investigator

Ravi Vij, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Washington University School of Medicine


United States: Institutional Review Board

Study ID:




Start Date:

June 2012

Completion Date:

June 2014

Related Keywords:

  • Multiple Myeloma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell



Washington University School of Medicine Saint Louis, Missouri  63110