Ignite Creation Date:
2024-05-05 @ 5:15 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00412919
Status:
TERMINATED
Last Update Posted:
2013-12-16
First Post:
2006-12-17
Brief Title:
Study of Azacitidine to Treat Relapsed or Refractory Multiple Myeloma
Sponsor:
Bayside Health
Organization:
Bayside Health
Study Overview
Official Title:
A Prospective Single-Arm 2-Stage Open-label Phase II Trial of Azacitidine in Relapsed and Refractory Multiple Myeloma
Status:
TERMINATED
Status Verified Date:
2006-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Lack of efficacy
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed Description:
Multiple myeloma MM is an incurable disease with an annual incidence of 14000 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 25 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None