Status:
TERMINATED
Study of Azacitidine to Treat Relapsed or Refractory Multiple Myeloma
Lead Sponsor:
Bayside Health
Conditions:
Multiple Myeloma
Eligibility:
All Genders
17+ years
Phase:
PHASE2
Brief Summary
This is a Phase II trial evaluating the overall response rate, safety and tolerability to azacitidine in patients with relapsed or refractory multiple myeloma.
Detailed Description
Multiple myeloma (MM) is an incurable disease with an annual incidence of 14,000 new cases in the US alone. Despite initial sensitivity to corticosteroids, chemotherapy and radiotherapy, relapse is in...
Eligibility Criteria
Inclusion
- 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:
- absolute neutrophil count (ANC) \> 1.0 x 109/L
- platelet count \> 50 x 109/L unsupported
- At registration biochemical values within the following limits
- Bilirubin \< 1.5 x upper limit of normal (ULN) and transaminases \< 2 x ULN unless considered secondary to hepatic myelomatous infiltration
- 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:
- Agree to use at least 2 effective contraceptive methods throughout the study and for 30 days following the study
- Have a negative serum pregnancy test within 24 hours of commencing on study medication
- 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
- 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
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2008
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT00412919
Start Date
December 1 2006
End Date
November 1 2008
Last Update
December 16 2013
Active Locations (1)
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1
The Alfred Hospital
Melbourne, Victoria, Australia, 3004