Paclitaxel Albumin-Stabilized Nanoparticle Formulation in Treating Patients With Relapsed or Refractory Multiple Myeloma
Condition: Refractory Plasma Cell Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Intervention: Paclitaxel Albumin-Stabilized Nanoparticle Formulation; Laboratory Biomarker Analysis
Intervention description: Given IV; Correlative studies
Intervention MeSH terms: Paclitaxel; Albumin-Bound Paclitaxel
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 13.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This phase II trial studies how well paclitaxel albumin-stabilized nanoparticle formulation
      works in treating patients with multiple myeloma that has returned or did not respond to
      treatment. Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle
      formulation, work in different ways to stop the growth of cancer cells, either by killing the
      cells, by stopping them from dividing, or by stopping them from spreading.
    

Eligibility criteria:

        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 glutamate 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

          -  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 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: 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