A Study of Granix to Disrupt the Bone Marrow Microenvironment in Patients With Multiple Myeloma Undergoing Autologous Transplantation

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).