Expanded Treatment Prot of Panobinostat in Combo w/ Bortez and Dex in Pts w/ Relapsed and/or Refractory Multiple Myeloma

Inclusion Criteria:

- This study is intended for patients with relapsed and/or refractory multiple myeloma,
who have received at least one prior line of therapy. Patients must require
retreatment as per IMWG definitions (Kyle et al 2003). Approximately 50-100 patients
are expected to be enrolled into this trial.

- Patient has a previous diagnosis of multiple myeloma, based on IMWG 2003 definitions
all three of the following criteria had been met:

- Monoclonal immunoglobulin (M component) on electrophoresis, and on immunofixation on
serum or on total 24 hour urine (or demonstration of M protein in cytoplasm of plasma
cell for non secretory myeloma).

- Bone marrow (clonal) plasma cells ≥ 10% or biopsy proven plasmacytoma

- Related organ or tissue impairment (CRAB symptoms: anemia, hypercalcemia, lytic bone
lesions, renal insufficiency, hyperviscosity, amyloidosis or recurrent infections)

- Patients who have received allogeneic stem cell transplant and do not have active
graft vs host disease requiring immunosuppressive therapy are eligible.

- Patient with multiple myeloma (per IMWG 2003 definition) that is relapsed and/or
refractory to at least one prior line of therapy and requires retreatment

- Relapsed-and-refractory to a therapy, provided that the patient meets any of the
following conditions:

- Relapsed, defined by disease that recurred in a patient that responded under a prior
therapy, by reaching a MR or better, and had not progressed under this therapy nor up
to 60 days of last dose of this therapy. Patients who previously responded to
treatment with BTZ are eligible.

- Patient has relapsed to at least one prior line and patient was refractory to at
least one prior line by either not reaching a MR, or progressed while under this
therapy, or within 60 days of its last dose. Patients previously refractory to BTZ
are also eligible.

- Patients with primary refractory disease are eligible.

- Patients who have previously received high dose therapy/autologous stem cell
transplant are eligible

- Patients who have received allogeneic stem cell transplant and do not have active
graft vs host disease requiring immunosuppressive therapy are eligible

Exclusion Criteria:

- Patient has shown intolerance to bortezomib, dexamethasone or panobinostat or has any
contraindications to any of these therapies. following available prescribing
information

- Allogeneic stem cell transplant recipient presenting with graft versus host disease
either active or requiring immunosuppression

- Patient has grade ≥ 2 peripheral neuropathy or grade 1 peripheral neuropathy with
pain on clinical examination within 14 days of treatment

- Patient taking any anti-cancer therapy concomitantly

- Patient has second primary malignancy < 3 years of first dose of study treatment
(except for treated basal or squamous cell carcinoma, or in situ cancer of the
cervix)