Phase II Trial of Nab-paclitaxel (Abraxane®) in Patients With Relapsed or Refractory Multiple Myeloma

Inclusion Criteria:

- Absolute neutrophil count >= 500/mm^3

- Platelet count >= 25000/mm^3

- Hemoglobin >= 6 g/dL

- Total bilirubin =< 2.5 X institutional upper limit of normal (ULN)

- Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) =<
5 X ULN

- Serum glutamic pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) =< 5 X
ULN

- Creatinine =< 3 mg/dL

- Patients with relapsed or refractory myeloma who have had >= 3 lines of prior therapy

- Measurable disease of multiple myeloma as defined by at least ONE of the following:

- Serum monoclonal protein >= 1.0 g/dL

- > 200 mg of monoclonal protein in the urine on 24 hour electrophoresis

- Serum immunoglobulin free light chain >= 10 mg/dL AND abnormal serum
immunoglobulin kappa to lambda free light chain ratio

- Eastern Cooperative Oncology Group (ECOG) performance status (PS) >= 2 (2, 3 or 4)

- Ability to understand and the willingness to sign a written informed consent document

- Negative (serum) pregnancy test done =< 7 days prior to registration, for women of
childbearing potential only; NOTE: Should a woman become pregnant or suspect she is
pregnant while participating in this study, she should inform her treating physician
immediately

- Willing to return to enrolling institution (Mayo Clinic in Arizona) for follow-up and
all study treatments

Exclusion Criteria:

- Myelosuppressive therapy for myeloma =< 14 days prior to registration or those who
have not recovered from acute reversible adverse events due to agents administered >
21 days earlier

- Other concurrent chemotherapy, radiotherapy, or any ancillary therapy considered
investigational

*NOTE: Bisphosphonates are considered to be supportive care rather than therapy, and
are thus allowed while on protocol treatment; patients may be receiving stable doses
of corticosteroids with a maximum dose of 10 mg of prednisone per day if they are
being given for disorders other than lymphoma such as rheumatoid arthritis,
polymyalgia rheumatica or adrenal insufficiency, or asthma

- Other active malignancy =< 3 years prior to registration; EXCEPTIONS: Non-melanotic
skin cancer or carcinoma-in-situ of the cervix; NOTE: If there is a history or prior
malignancy, they must not be receiving other specific treatment (i.e. other
investigational therapy, anti-neoplastic therapy, etc.) for their cancer

- Any of the following:

- Pregnant women or women of reproductive ability who are unwilling to use
effective contraception

- Nursing women - NOTE: Because there is an unknown but potential risk for adverse
events in nursing infants secondary to treatment of the mother with
nab-paclitaxel (Abraxane®), breastfeeding should be discontinued if the mother
is treated with nab-paclitaxel (Abraxane®)

- Men who are unwilling to use a condom (even if they have undergone a prior
vasectomy) while having intercourse with any woman, while taking the drug and
for 28 days after stopping treatment

- Other co-morbidity which would interfere with patient's ability to participate in
trial, e.g. uncontrolled infection, uncompensated heart or lung disease

- Patients with a >= grade 2 peripheral neuropathy