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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 arms

Comparison 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

Page last updated: August 23, 2015

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