A Study of Granix to Disrupt the Bone Marrow Microenvironment in Patients With Multiple Myeloma Undergoing Autologous Transplantation
Information source: Washington University School of Medicine
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Multiple Myeloma
Intervention: Granix (Drug); High dose melphalan (HDR) (Drug); Autologous Stem Cell Transplant (ASCT) (Procedure)
Phase: Phase 2
Status: Recruiting
Sponsored by: Washington University School of Medicine Official(s) and/or principal investigator(s): Meagan Jacoby, M.D., Ph.D., Principal Investigator, Affiliation: Washington University School of Medicine
Overall contact: Meagan Jacoby, M.D., Ph.D., Phone: 314-454-8304, Email: mjacoby@dom.wustl.edu
Summary
This randomized phase II trial compares how well adding filgrastim to melphalan before a
stem cell transplant works in treating patients with multiple myeloma. Chemotherapy drugs,
such as melphalan, are given to prepare the bone marrow for the stem cell transplant. Giving
colony-stimulating factors, such as filgrastim, may help multiple myeloma cells move from
the patient's bone marrow to the blood where they may be more sensitive to treatment with
melphalan. It is not yet known whether adding filgrastim to melphalan before a stem cell
transplant will work better than melphalan alone in treating multiple myeloma.
Clinical Details
Official title: A Study of Granix to Disrupt the Bone Marrow Microenvironment in Patients With Multiple Myeloma Undergoing Autologous Stem Cell Transplantation
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Comparison of complete response (CR) and stringent complete response (sCR) of the two arms
Secondary outcome: Comparison of toxicity between the two armsComparison of overall response rate of the two arms Comparison of overall survival (OS) of the two arms Comparison of progression free survival (PFS) of the two arms Comparison of the rate of neutrophil engraftment between the two arms Comparison of the rate of platelet engraftment between the two arms
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Symptomatic multiple myeloma requiring treatment
- Received at least two cycles of any regimen as initial systemic therapy for multiple
myeloma and are within 2-12 months of the first dose of initial therapy
- At least 18 years of age
- Adequate autologous stem cell collection, defined as an unmanipulated, cryopreserved,
peripheral blood stem cell collection containing at least 2 × 10^6 CD34+ cells/kg
based on patient body weight.
- Adequate organ function as measured by:
- Cardiac function: Left ventricular ejection fraction at rest ≥40%
- Hepatic function: Bilirubin ≤2 × ULN and aspartate amino transferase/alanine
amino transferase (AST/ALT) ≤3 × ULN
- Renal function: Creatinine clearance ≥40 mL/minute (measured or
calculated/estimated)
- Pulmonary function: Carbon monoxide diffusing capacity (DLCO; corrected for
hemoglobin [Hgb]), forced expiratory volume in 1 second (FEV1), forced
expiratory vital capacity (FVC) ≥50% of predicted value
- Oxygen saturation ≥92% on room air
- Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2.
- Able to understand and willing to sign an IRB-approved written informed consent
document
Exclusion Criteria:
- Evidence of multiple myeloma disease progression (as defined by IMWG) any time prior
to ASCT
- Prior stem cell transplant (autologous or allogeneic)
- Smoldering MM not requiring therapy
- Plasma cell leukemia
- Systemic amyloid light chain amyloidosis
- Active bacterial, viral, or fungal infection
- Seropositive for human immunodeficiency virus (HIV)
- Known, active hepatitis A, B, or C Infection
- Pregnant or breastfeeding.
- Receiving other concurrent anticancer therapy (including chemotherapy, radiation,
hormonal treatment, or immunotherapy, but excluding corticosteroids) within 7 days
prior to the ASCT or planning to receive any of these treatments prior to the last
study visit on Day +100.
- Hypersensitive or intolerant to any component of the study drug(s) formulation
- Receiving growth factors (filgrastim, XM02-filgrastim, peg-filgrastim, plerixafor,
etc) or undergoing apheresis < 14 days prior to the start of treatment on protocol
(Day - 7).
Locations and Contacts
Meagan Jacoby, M.D., Ph.D., Phone: 314-454-8304, Email: mjacoby@dom.wustl.edu
Washington University School of Medicine, St. Louis, Missouri 63110, United States; Recruiting Meagan Jacoby, M.D., Ph.D., Phone: 314-454-8304, Email: mjacoby@dom.wustl.edu Camille Abboud, M.D., Sub-Investigator Amanda Cashen, M.D., Sub-Investigator Matthew Christopher, M.D., Ph.D., Sub-Investigator John DiPersio, M.D., Ph.D., Sub-Investigator Todd Fehniger, M.D., Ph.D., Sub-Investigator Iskra Pusic, M.D., Sub-Investigator Rizwan Romee, M.D., Sub-Investigator Mark Schroeder, M.D., Sub-Investigator Keith Stockerl-Goldstein, M.D., Sub-Investigator Micheal Tomasson, M.D., Sub-Investigator Geoffrey Uy, M.D., Sub-Investigator Matthew Walter, M.D., Sub-Investigator Lucas Wartman, M.D., Sub-Investigator John Welch, M.D., Ph.D., Sub-Investigator Peter Westervelt, M.D., Ph.D., Sub-Investigator Ravi Vij, M.D., Sub-Investigator Meagan Jacoby, M.D., Ph.D., Principal Investigator
Additional Information
Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine
Starting date: January 2015
Last updated: May 27, 2015
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