Study of Azacitidine to Treat Relapsed or Refractory Multiple Myeloma

Inclusion Criteria:

* diagnosis of MM as per IMWG criteria
* age greater than 17 years
* have received at least 2 but no more than 4 prior lines of therapy
* have failed to respond to the most recently administered anti-MM therapy or have demonstrably progressive disease as defined by accepted standard criteria
* have a life expectancy of at least 3 months
* ECOG performance status \< 3
* at registration haematological values within the following limits:

  1. absolute neutrophil count (ANC) \> 1.0 x 109/L
  2. platelet count \> 50 x 109/L unsupported
* At registration biochemical values within the following limits

  1. Bilirubin \< 1.5 x upper limit of normal (ULN) and transaminases \< 2 x ULN unless considered secondary to hepatic myelomatous infiltration
  2. Serum creatinine \< 0.19mMol/L
* Written informed consent
* Must agree to use adequate contraceptive measures if indicated. Specifically, women of childbearing potential (WOCBP) may participate provided they meet the following conditions:

  1. Agree to use at least 2 effective contraceptive methods throughout the study and for 30 days following the study
  2. Have a negative serum pregnancy test within 24 hours of commencing on study medication
  3. Male participants with female partners that are WOCBP must agree to use 2 effective contraceptive methods throughout the study and for 30 days following the study

Exclusion Criteria:

* Patients with monoclonal gammopathy of undetermined significance (MGUS) or indolent/smouldering MM
* Known or suspected hypersensitivity to AZA or mannitol
* Patients whose general condition makes them unsuitable for intensive treatment e.g. significant cardiac or pulmonary disease
* Active infections or other illnesses that precludes chemotherapy administration or patient compliance
* Active viral infection with known human immunodeficiency virus (HIV) or viral hepatitis type B or C
* Pregnant or lactating women