Panobinostat (LBH589): Multiple Myeloma - Autologous Hematopoietic Cell Transplantation (HCT)

Inclusion Criteria:

- Adult patients, age ≥ 18 years old

- Ability to provide written informed consent obtained prior to participation in the
study and any related procedures being performed

- Histologically confirmed diagnosis of multiple myeloma

- Meeting the Criteria for Symptomatic Multiple Myeloma (CRAB criteria) before the
initiation of systemic chemotherapy

- Received high-dose melphalan (≥ 140 mg/m^2) followed by autologous HCT based on the
institutional guidelines and within +45 and +180 after autologous HCT at the time of
panobinostat maintenance initiation

- Must have achieved at least partial response (PR) prior to autologous HCT and must not
have progressive disease (PD) prior to the initiation of maintenance therapy

- Must meet the following laboratory criteria (prior to the initiation of panobinostat
maintenance): Absolute neutrophil count (ANC) ≥ 1 x 10^9/L; Hemoglobin ≥ 8 g/dl;
Platelets ≥ 50 x 10^9/L (without transfusion support); Creatinine clearance ≥ 40
ml/min or serum creatinine ≤ 2.5 x upper limit of normal (ULN); aspartate
aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN; Serum bilirubin
≤ 1.5 x ULN; Albumin > 3.0 g/dl; Clinically euthyroid. Note: Participants are
permitted to receive thyroid hormone supplements to treat underlying hypothyroidism.

- Baseline (pre-HCT) multigated acquisition (MUGA) or echocardiogram (ECHO) must
demonstrate left ventricular ejection fraction (LVEF) ≥ the limit of normal (LLN) of
the institutional normal

- Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 2 or Karnofsky
performance status ≥ 70%

- Prior histone deacetylase (HDAC), deacetylase (DAC), HSP90 inhibitors or valproic acid
for the treatment of cancer is allowed

Exclusion Criteria:

- Potential participants who have purely non-secretory multiple myeloma (i.e., the
absence of a measurable protein in serum by electrophoresis and immunofixation and the
absence of Bence-Jones protein in the urine defined by use of electrophoresis and
immunofixation)

- Prior allogeneic HCT

- Prior solid organ transplant requiring immunosuppressive therapy

- Potential participants who will need valproic acid for any medical condition during
the study or within 5 days prior to first panobinostat treatment

- Impaired cardiac function or clinically significant cardiac diseases

- Diarrhea > Common Terminology Criteria for Adverse Events (CTCAE) grade 2

- Other concurrent severe and/or uncontrolled medical conditions (e.g., uncontrolled
diabetes or active or uncontrolled infection) including abnormal laboratory values,
that could cause unacceptable safety risks or compromise compliance with the protocol

- Using medications that have a relative risk of prolonging the QT interval or inducing
torsade de pointes if treatment cannot be discontinued or switched to a different
medication prior to starting study drug

- Have received targeted agents within 2 weeks or within 5 half-lives of the agent and
active metabolites (whichever is longer) and who have not recovered from side effects
of those therapies.

- Have received either immunotherapy within < 8 weeks; chemotherapy within < 4 weeks; or
radiation therapy to > 30% of marrow-bearing bone within < 2 weeks prior to starting
study treatment; or who have not yet recovered from side effects of such therapies

- Have undergone major surgery ≤ 4 weeks prior to starting study drug or have not
recovered from side effects of such therapy

- Women who are pregnant or breast feeding or women of childbearing potential (WOCBP)
not using an effective method of birth control. WOCBP must have a negative serum
pregnancy test within 24 hours of receiving the first dose of study medication.

- Male patients whose sexual partners are WOCBP not using effective birth control

- A prior malignancy with in the last 5 years (except for basal or squamous cell
carcinoma, or in situ cancer of the cervix)

- Known positivity for human immunodeficiency virus (HIV) or hepatitis C; baseline
testing for HIV and hepatitis C is not required

- Any significant history of non-compliance to medical regimens or unwilling or unable
to comply with the instructions given to him/her by the study staff