Study of Azacitidine to Treat Relapsed or Refractory Multiple Myeloma
Recruitment status was Recruiting
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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. |
- Overall response rate
- 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 |
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 |
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:
- 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 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| 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 | |
| Study Chair: | Andrew Spencer, Assoc. Prof |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00412919 History of Changes |
| Other Study ID Numbers: | AH213/06 |
| Study First Received: | December 17, 2006 |
| Last Updated: | December 17, 2006 |
| 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 Neoplasms by Histologic Type Neoplasms Hemostatic Disorders Vascular Diseases Cardiovascular Diseases Paraproteinemias Blood Protein Disorders Hematologic Diseases Hemorrhagic Disorders |
Lymphoproliferative Disorders Immunoproliferative Disorders Immune System Diseases Azacitidine Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Enzyme Inhibitors |
ClinicalTrials.gov processed this record on June 18, 2013