XM02 Filgrastim to Disrupt the Bone Marrow Microenvironment in Patients With Multiple Myeloma Undergoing Autologous Transplantation

Overview

Phase II randomized study to test the safety and efficacy of the recombinant G-CSF XM-02 filgrastim (Granix) plus high dose melphalan versus high dose melphalan alone prior to autologous stem cell transplant.

SparkCures ID 532
Trial Phase Phase 2
Enrollment 176 Patients
Treatments
Trial Sponsors
  • Alvin J. Siteman Cancer Center
NCT Identifier

NCT02112045

Am I Eligible?

The following criteria is a partial list of reasons why patients may or may not be eligible to participate in this clinical trial. Further evaluation with a medical professional will be required to determine full eligibility.

The following criteria is provided for health care professionals.

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).

US Trial Locations

Please visit the ClinicalTrials.gov page for historical site information.

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