Busulfan & Melphalan Conditioning for Autologous Stem Cell Transplant (ASCT) and Lenalidomide Maintenance

Exclusion criteria

• . Myeloma progression at any time since starting initial induction therapy for multiple myeloma. Changes to or additions to the existing induction therapy are allowed as long as disease progression has not been confirmed.
• . Prior treatment history of ASCT for any medical reason.
• . Prior treatment history of high-dose chemotherapy with stem cell rescue for any medical reason, not limited to myeloma treatment.
• . Prior treatment with busulfan or gemtuzumab ozogamicin for any reason.
• . Systemic amyloidosis.
• . Left ventricular ejection fraction (LVEF) \< 45% as measured by either multi-gated acquisition scan (MUGA) or echocardiogram (ECHO) performed within 75 days prior to day of busulfan dose. If cyclophosphamide was used for stem cell harvest, an ECHO or MUGA must be done after the stem cell collection and prior to enrollment to confirm adequate cardiac function.
• . Uncontrolled arrhythmia or symptomatic cardiac disease at the time of screening.
• . Symptomatic pulmonary disease, based on Forced Expiratory Volume in 1 Second (FEV1), Forced Vital Capacity (FVC) or Diffusing Capacity of the Lung for Carbon Monoxide (DLCO) \< 50% of predicted (corrected for hemoglobin) measured within 75 days prior to day of busulfan dose.