Propylene Glycol-Free Melphalan Hydrochloride (Evomela) in AL Amyloidosis Patients

Inclusion Criteria:

* Age 18 years or older
* Eastern Cooperative Oncology Group Performance Status 0-2
* Histologic diagnosis of primary systemic (AL) amyloidosis based on:

  * Deposition of amyloid material by Congo red stain showing characteristic apple green birefringence AND
  * Evidence of a clonal plasma cell dyscrasia with monoclonal protein in the serum or urine by immunofixation electrophoresis AND/OR abnormal serum free light chain assay AND/OR clonal plasma cells in the bone marrow exam demonstrated by immunohistochemistry, flow cytometry, or in situ hybridization AND
  * Evidence of organ involvement
* Eligible for treatment with high dose melphalan and stem cell transplantation per institutional guidelines
* Ability to understand and willingness to sign informed consent
* Pulmonary Function Test demonstrating a diffusion capacity of lung for carbon monoxide ≥ 50%
* Left ventricular ejection fraction ≥40%
* Systolic blood pressure \>90 mm Hg (supine position)
* Eastern Cooperative Oncology Group Performance status of 2 or better (unless patient is diagnosed with AL amyloidosis involving the gastrointestinal and peripheral/autonomic nervous systems, then performance status of 3 is acceptable)

Exclusion Criteria:

* Previous high-dose melphalan and stem cell transplant
* Previous total cumulative dose of oral melphalan \> 300 mg
* Cytotoxic chemotherapy within the previous 28 days
* New York Heart Association ≥3
* Decompensated or uncontrolled heart failure
* Oxygen dependence
* epidermal growth factor receptor \< 30 ml/min
* Active infection (i.e HIV, Hepatitis B or C)
* Pregnancy or breastfeeding
* Exposure to another investigational drug within 3-4 weeks prior to start of study treatment
* Ongoing alcohol or drug addiction
* Unable or unwilling to comply with the protocol