A Phase I/II Trial of Bendamustine in Combination With Bortezomib and Pegylated Liposomal Doxorubicin in Patients With Relapsed or Refractory Multiple Myeloma

Inclusion Criteria:

- A histologically established diagnosis of multiple myeloma with evidence of relapse
or refractory disease.

- Must have a detectable serum or urine M-Protein by protein electrophoresis that is at
least 500 mg/dL (serum) or 1 gm/24 hours (urine), respectively, or serum free light
chain level >100 mg/l for the involved free light chain.

- Must have received at least one (1) prior line of systemic treatment that has
included either lenalidomide or thalidomide.

- Must be willing to provide correlative blood samples.

Exclusion Criteria:

- Must not have received an excessive cumulative dose of anthracycline

- No ≥ grade 2 peripheral neuropathy.

- No cytotoxic chemotherapy within 30 days prior to registration for protocol therapy.

- No autologous stem cell transplant within 6 months prior to registration for protocol
therapy

- No prior radiation therapy to > 25% of bone marrow forming bones (i.e., pelvis)
within 30 days prior to registration for protocol therapy. See Study Procedures
Manual to calculate percent of prior radiation.

- No current corticosteroid therapy in doses greater than 10 mg daily of prednisone (or
equivalent) if given for management of co-morbid conditions.

- No known central nervous system involvement by myeloma.

- No poorly controlled intercurrent illness including, but not limited to, ongoing or
active infection, poorly controlled diabetes, symptomatic congestive heart failure,
cardiac arrhythmia, or psychiatric illness/social climate that in the opinion of the
investigator would limit compliance with study requirements.

- No patients known to be positive for HIV, or active Hepatitis A, B, or C.

- No major surgery within 30 days prior to registration for protocol therapy.
Placement of a venous access device within 30 days prior to registration for protocol
therapy is allowed.