Study of Azacitidine to Treat Relapsed or Refractory Multiple Myeloma

• Status: Terminated
• Trial end date: 2008-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bayside Health
• Treatments: Azacitidine

Criteria

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