A Study of Granix to Disrupt the Bone Marrow Microenvironment in Patients With Multiple Myeloma Undergoing Autologous Transplantation
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Intervention: Granix; High dose melphalan (HDR); Autologous Stem Cell Transplant (ASCT)
Intervention MeSH terms: Melphalan
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 90.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This randomized phase II trial compares how well adding XMO2 Filgrastim (Granix) 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 XMO2 Filgrastim (Granix), 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 XMO2 Filgrastim
      (Granix) to melphalan before a stem cell transplant will work better than melphalan alone in
      treating multiple myeloma
    

Eligibility 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).