Trial record 1 of 1 for:    NCT01537861
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Filgrastim in Treating Patients With Bortezomib-, Carfilzomib-, or IMID-Refractory Multiple Myeloma

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT01537861
First received: February 15, 2012
Last updated: October 17, 2014
Last verified: October 2014
  Purpose

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.


Condition Intervention Phase
Multiple Myeloma
Drug: Filgrastim
Drug: Bortezomib
Drug: Carfilzomib
Drug: Dexamethasone
Drug: Cyclophosphamide
Drug: Thalidomide
Drug: Lenalidomide
Drug: Pomalidomide
Phase 0

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Pilot Study of G-CSF to Disrupt the Bone Marrow Microenvironment in Bortezomib-, Carfilzomib-, or IMID-Refractory Multiple Myeloma

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • Safety of the combination of G-CSF and bortezomib-, carfilzomib-, or IMID-based treatment regimens in patients with refractory multiple myeloma. [ Time Frame: Up to 30 days after last treatment ] [ Designated as safety issue: Yes ]
    Number and grade of adverse events based on NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.


Secondary Outcome Measures:
  • Effects of G-CSF on bone marrow and bone marrow cytokine and chemokine levels. Including: Quantification of marrow osteoblasts and CAR cells, measurement of SDF-1 (CXCL12), IL-6, BAFF, assessment of myeloma cell proliferation and survival in bone marrow [ Time Frame: 14 days after last drug treatment ] [ Designated as safety issue: No ]
  • Response rate as defined by the International Myeloma Working Group (IMWG) criteria [ Time Frame: 14 days after last drug treatment ] [ Designated as safety issue: No ]
  • Overall survival duration of patients treated on study [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Defined as the date of first dose of study drug to the date of death from any cause.

  • Progression-free survival of patients treated on study [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Defined as the interval from the date of first treatment to date of first documentation of disease progression.

  • Duration of response of patients treated on study [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Defined as the interval from the date of first documentation of response to the first documentation of disease progression.


Enrollment: 7
Study Start Date: June 2012
Estimated Study Completion Date: December 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.

Drug: Filgrastim
Other Names:
  • G-CSF
  • Neupogen®
  • Granulocyte Colony-Stimulating Factor
Drug: Bortezomib
Other Name: Velcade®
Drug: Carfilzomib
Other Name: Kyprolis®
Drug: Dexamethasone Drug: Cyclophosphamide
Other Name: Cytoxan
Drug: Thalidomide
Other Name: Thalomid
Drug: Lenalidomide
Other Name: Revlimid
Drug: Pomalidomide
Other Name: Pomalyst

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01537861

Locations
United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Principal Investigator: Ravi Vij, M.D. Washington University School of Medicine
  More Information

Additional Information:
No publications provided

Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01537861     History of Changes
Other Study ID Numbers: 201204086
Study First Received: February 15, 2012
Last Updated: October 17, 2014
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Blood Protein Disorders
Cardiovascular Diseases
Hematologic Diseases
Hemorrhagic Disorders
Hemostatic Disorders
Immune System Diseases
Immunoproliferative Disorders
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Paraproteinemias
Vascular Diseases
BB 1101
Bortezomib
Cyclophosphamide
Dexamethasone
Dexamethasone 21-phosphate
Dexamethasone acetate
Lenalidomide
Lenograstim
Pomalidomide
Thalidomide
Adjuvants, Immunologic
Alkylating Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Anti-Bacterial Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on October 22, 2014