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Study of Azacitidine to Treat Relapsed or Refractory Multiple Myeloma

This study has been terminated.
(Lack of efficacy)
Sponsor:
Information provided by (Responsible Party):
Bayside Health
ClinicalTrials.gov Identifier:
NCT00412919
First received: December 17, 2006
Last updated: December 12, 2013
Last verified: December 2006
  Purpose

This is a Phase II trial evaluating the overall response rate, safety and tolerability to azacitidine in patients with relapsed or refractory multiple myeloma.


Condition Intervention Phase
Multiple Myeloma
Drug: Azacitidine
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective, Single-Arm, 2-Stage, Open-label, Phase II Trial of Azacitidine in Relapsed and Refractory Multiple Myeloma.

Resource links provided by NLM:


Further study details as provided by Bayside Health:

Primary Outcome Measures:
  • Overall response rate

Secondary Outcome Measures:
  • time to progression
  • duration of response
  • number of cycles of azacitidine required to first achieve a response
  • progression free survival
  • safety
  • tolerability

Enrollment: 7
Study Start Date: December 2006
Study Completion Date: November 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
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 inevitable and there is a median survival of only 2.5 to 3 years. The use of autologous stem cell transplantation (SCT) has improved the duration of disease remission for younger patients but still only results in a median survival of 5 - 6 years.

Since the early 1970s, azacitidine has been investigated for the treatment of acute leukemia. More recently it has been investigated in the treatment of patients with myelodysplastic syndrome (a pre-leukaemic condition). It has been shown to prolong the time to development of acute myeloid leukaemia (AML) or death and has now been approved for use in these patients.

Azacitidine is a cytotoxic drug and is directly toxic to cells, preventing their reproduction or growth. It is also able to cause cells to undergo the process whereby they mature into normal cells. The Myeloma Research Group at The Alfred Hospital has looked at the effect of azacitidine on human myeloma cell lines in the laboratory. Azacitidine was found to prevent both cell growth and causes cell death. In mouse models with multiple myeloma azacitidine prolonged their survival.

The primary aim of this study is to determine the effectiveness of azacitidine in treating patients with multiple myeloma. The other aims of this study are to see whether treating patients with azacitidine extends the time that their myeloma is under control, to determine the number of cycles of azacitidine required to first achieve a response and to determine how safe and tolerable azacitidine is in treating multiple myeloma.

In the first stage a total of 14 people will participate in this project. If in this group of patients azacitidine is shown to be effective as a treatment against multiple myeloma then a further 10 patients will be invited to participate.

  Eligibility

Ages Eligible for Study:   17 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00412919

Locations
Australia, Victoria
The Alfred Hospital
Melbourne, Victoria, Australia, 3004
Sponsors and Collaborators
Bayside Health
Investigators
Study Chair: Andrew Spencer, Assoc. Prof
  More Information

No publications provided

Responsible Party: Bayside Health
ClinicalTrials.gov Identifier: NCT00412919     History of Changes
Other Study ID Numbers: AH213/06
Study First Received: December 17, 2006
Last Updated: December 12, 2013
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by Bayside Health:
Myeloma
Relapsed
Refractory

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Blood Protein Disorders
Cardiovascular Diseases
Hematologic Diseases
Hemorrhagic Disorders
Hemostatic Disorders
Immune System Diseases
Immunoproliferative Disorders
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Paraproteinemias
Vascular Diseases
Azacitidine
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014