A Study of Granix to Disrupt the Bone Marrow Microenvironment in Patients With Multiple Myeloma Undergoing Autologous Transplantation
Conditions
Multiple Myeloma
Conditions: official terms
Multiple Myeloma - Neoplasms, Plasma Cell
Study Type
Interventional
Study Phase
Phase 2
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Granix Type: Drug
Name: High dose melphalan (HDR) Type: Drug
Name: Autologous Stem Cell Transplant (ASCT) Type: Procedure
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: 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).
Location
Washington University School of Medicine
St. Louis, Missouri, United States
Status: Recruiting
Contact: Meagan Jacoby, M.D., Ph.D. - 314-454-8304 - mjacoby@dom.wustl.edu
Start Date
January 2015
Completion Date
November 2018
Sponsors
Washington University School of Medicine
Source
Washington University School of Medicine
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page