Ignite Creation Date:
2024-05-05 @ 4:49 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00323505
Status:
COMPLETED
Last Update Posted:
2006-05-09
First Post:
2006-05-08
Brief Title:
A Phase II Trial Comparing the Quality of Life Tolerability and Toxicity of PEG Intron With INTRON A in Patients With Multiple Myeloma
Sponsor:
Royal Marsden NHS Foundation Trust
Organization:
Royal Marsden NHS Foundation Trust
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2006-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Multiple myeloma is a rare form of malignancy in which neoplastic plasma cells accumulate in the bone marrow Most malignant plasma cells continue to produce immunoglobulin The activity of multiple myeloma can therefore usually be monitored easily by serial measurement of the serum paraprotein levels Except for a few patients who receive a donor bone marrow transplant multiple myeloma remains incurable despite intensive chemotherapy Its course is typically marked by periods of active disease alternating with increasingly shorter remissions
Interferons are substances produced in human cells in response to a variety of stimuli such as viral infection When given to myeloma patients as part of maintenance treatment interferon-alpha 2 b INTRONA has been shown to be of value in prolonging the periods of remission Until now INTRONA could only be given as injections under the skin three times a week Some patients experience flu-like symptoms with each injection particularly early on during maintenance therapy This as well as the chronic fatigue and even depression that INTRONA can induce may considerably reduce the quality of life of myeloma patients on interferon so much so that sometimes this useful adjunct to chemotherapy for myeloma has to be stopped
Recently a new preparation of interferon namely pegylated interferon PEG Intron has become available It has the advantage of being broken down much more slowly by the body and therefore only needs to be given once a week This minimises the swings in blood interferon levels that may be responsible for some of the interferon side effects The safety and superior tolerability of PEG Intron has already been demonstrated in patients with hepatitis C for which it now carries a licence but not in myeloma patients Here we propose to study whether the quality of life and side effect profile of myeloma patients on PEG Intron is better compared to that of IntronA
In the main study consenting eligible myeloma patients who are well and have been established on INTRONA maintenance therapy for at least six weeks will be randomly allocated to receive PEG Intron for three months followed by INTRONA for 3 months or to continue with INTRONA for 3 months followed by PEG Intron for 3 months All patients will be monitored regularly for any side effects and will be asked to fill in a quality of life questionnaire at the beginning ie before receiving the first randomised treatment and at the end of each study period ie at 3 and 6 months Initially we are aiming at enrolling 60 patients into this part of the study
In a smaller sub-study involving only 14 patients initially we are proposing to investigate whether myeloma patients who need to be taken off IntronA because of its side effects can tolerate PEG Intron more easily Should their tolerance of PEG Intron also be poor we would stop the interferon maintenance therapy altogether However should PEG Intron be found to be acceptable to them we intend to switch these patients back to the standard treatment at the end of six weeks treatment with PEG Intron to assess whether they have become more tolerant of IntronA in the intervening period Patients will again be monitored carefully for any side effects and will be asked to fill in three quality of life questionnaires at 0 6 and 12 weeks
Interferons are substances produced in human cells in response to a variety of stimuli such as viral infection When given to myeloma patients as part of maintenance treatment interferon-alpha 2 b INTRONA has been shown to be of value in prolonging the periods of remission Until now INTRONA could only be given as injections under the skin three times a week Some patients experience flu-like symptoms with each injection particularly early on during maintenance therapy This as well as the chronic fatigue and even depression that INTRONA can induce may considerably reduce the quality of life of myeloma patients on interferon so much so that sometimes this useful adjunct to chemotherapy for myeloma has to be stopped
Recently a new preparation of interferon namely pegylated interferon PEG Intron has become available It has the advantage of being broken down much more slowly by the body and therefore only needs to be given once a week This minimises the swings in blood interferon levels that may be responsible for some of the interferon side effects The safety and superior tolerability of PEG Intron has already been demonstrated in patients with hepatitis C for which it now carries a licence but not in myeloma patients Here we propose to study whether the quality of life and side effect profile of myeloma patients on PEG Intron is better compared to that of IntronA
In the main study consenting eligible myeloma patients who are well and have been established on INTRONA maintenance therapy for at least six weeks will be randomly allocated to receive PEG Intron for three months followed by INTRONA for 3 months or to continue with INTRONA for 3 months followed by PEG Intron for 3 months All patients will be monitored regularly for any side effects and will be asked to fill in a quality of life questionnaire at the beginning ie before receiving the first randomised treatment and at the end of each study period ie at 3 and 6 months Initially we are aiming at enrolling 60 patients into this part of the study
In a smaller sub-study involving only 14 patients initially we are proposing to investigate whether myeloma patients who need to be taken off IntronA because of its side effects can tolerate PEG Intron more easily Should their tolerance of PEG Intron also be poor we would stop the interferon maintenance therapy altogether However should PEG Intron be found to be acceptable to them we intend to switch these patients back to the standard treatment at the end of six weeks treatment with PEG Intron to assess whether they have become more tolerant of IntronA in the intervening period Patients will again be monitored carefully for any side effects and will be asked to fill in three quality of life questionnaires at 0 6 and 12 weeks
Detailed Description:
None
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