Study of Azacitidine to Treat Relapsed or Refractory Multiple Myeloma

NCT00412919 | Terminated Phase 2

• 1 other identifier: AH213/06
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Myeloma

Keywords

Myeloma; Relapsed; Refractory

Outcome Measures

Primary Outcomes (1)

• Overall response rate

Secondary Outcomes (6)

• time to progression

• duration of response

• number of cycles of azacitidine required to first achieve a response

• progression free survival

• safety

Interventions

Azacitidine DRUG

Eligibility Criteria

• Age: 17 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bayside Health: lead

Study Sites (1)

The Alfred Hospital

Melbourne, Victoria, 3004, Australia

Location

MeSH Terms

Conditions

Multiple Myeloma; Neoplasms, Plasma Cell; Recurrence

Interventions

Azacitidine

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Aza Compounds; Organic Chemicals; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Study Officials

• Andrew Spencer, Assoc. Prof

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2006
• First Posted: December 19, 2006
• Study Start: December 1, 2006
• Primary Completion: November 1, 2008
• Study Completion: November 1, 2008
• Last Updated: December 16, 2013

Record last verified: 2006-12

Locations

AU (1)