Study of Azacitidine to Treat Relapsed or Refractory Multiple Myeloma - Full Text View

Sponsors and Collaborators:	Bayside Health Investigator initiated study
Information provided by:	Bayside Health
ClinicalTrials.gov Identifier:	NCT00412919

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 II

Genetics Home Reference related topics: aceruloplasminemia hemophilia

MedlinePlus related topics: Multiple Myeloma

Drug Information available for: Azacitidine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Prospective, Single-Arm, 2-Stage, Open-Label, Phase II Trial of Azacitidine in Relapsed and Refractory Multiple Myeloma.

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

Estimated Enrollment:	14
Study Start Date:	December 2006

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

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

Locations

Australia, Victoria
The Alfred Hospital	Recruiting
Melbourne, Victoria, Australia, 3004
Contact: Andrew Sepncer, Assoc. Prof +61 (3) 9276 3392 aspencer@netspace.net.au
Principal Investigator: Andrew Spencer, Assoc. Prof

Sponsors and Collaborators

Bayside Health

Investigator initiated study

Investigators

Study Chair:

Andrew Spencer, Assoc. Prof

Unaffiliated

More Information

No publications provided

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

Keywords provided by Bayside Health:

Myeloma
Relapsed
Refractory

Study placed in the following topic categories:

Antimetabolites
Immunoproliferative Disorders
Blood Protein Disorders
Hematologic Diseases
Blood Coagulation Disorders
Vascular Diseases
Paraproteinemias

Hemostatic Disorders
Multiple Myeloma
Hemorrhagic Disorders
Azacitidine
Lymphoproliferative Disorders
Neoplasms, Plasma Cell

Additional relevant MeSH terms:

Antimetabolites
Antimetabolites, Antineoplastic
Neoplasms by Histologic Type
Immunoproliferative Disorders
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Antineoplastic Agents
Blood Protein Disorders
Hematologic Diseases
Vascular Diseases
Enzyme Inhibitors

Paraproteinemias
Hemostatic Disorders
Pharmacologic Actions
Multiple Myeloma
Neoplasms
Hemorrhagic Disorders
Therapeutic Uses
Azacitidine
Cardiovascular Diseases
Lymphoproliferative Disorders
Neoplasms, Plasma Cell

ClinicalTrials.gov processed this record on May 07, 2009