Ignite Creation Date:
2024-05-06 @ 11:15 AM
Last Modification Date:
2024-10-26 @ 12:42 PM
Study NCT ID:
NCT03477643
Status:
COMPLETED
Last Update Posted:
2021-02-05
First Post:
2018-03-13
Brief Title:
Retrospective Viability Study of the PETHEMA-POMCIDEX Clinical Practice Guidelines for the Treatment of Patients With Relapsed and Refractory Multiple Myeloma RRMM
Sponsor:
PETHEMA Foundation
Organization:
PETHEMA Foundation
Study Overview
Official Title:
Retrospective Viability Study of the PETHEMA-POMCIDEX Clinical Practice Guidelines for the Treatment of Patients With Relapsed and Refractory Multiple Myeloma RRMM
Status:
COMPLETED
Status Verified Date:
2021-02
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 MM is a plasma cell neoplasm representing the second most common type of hematologic tumor after lymphomas The incorporation of novel agents such as bortezomib lenalidomide or thalidomide into first-line treatment as well as in relapse settings has led to a significant improvement in survival rates for MM patients which have doubled in the last 5-7 years 12 However except for a small percentage of patients 10-303 that may achieve a cure after first-line treatment in the majority of cases MM behaves as an incurable disease whose clinical course is characterized by repeated relapses shorter and shorter periods of remission and by becoming refractory to succesive treatments bortezomib or lenalidomide In this situation survival is generally less than 9 months which underscores the need to develop new drugs for MM patients Pomalidomide a third-generation immunomodulatory drug IMiD has demonstrated efficacy in patients with relapsed and refractory MM with an overall response rate that fluctuates between 30-60 depending on whether it is administered in combination with low-dose dexamethasone or in association with treatment with a cytostatic agent such as cyclophosphamide
In clinical trial CC-4047-MM-003 treatment with pomalidomide and low-dose dexamethasone in patients with relapsed and refractory MM or those intolerant to bortezomib or lenalidomide was a successful rescue treatment in 30 of patients with a median progression-free survival of 4 months The association of cyclophosphamide at dose of 400mgday on days 1 8 and 15 of each cycle is able to increase the overall response rate from 39 for combination pomalidomide-dexamethasone to up to 65 for the triple regimen pomalidomide cyclophosphamide dexamethasone - POMCIDEX as well as the median PFS from 44 mo to 92 mo respectively As well the tolerance and safety profiles of the triple combination pomalidomide cyclophosphamide and dexamethasone were acceptable
The association of bortezomib with pomalidomide-dexamethasone also increases the overall response rate 85 and prolongs PFS 107 months
The BiRD study lenalidomide dexamethasone and clarithromycin suggests that clarithromycin intensifies the effect of corticosteroids increasing their anti-myeloma effect A study evaluating the combination of clarithromycin with pomalidomide and low-dose dexamethasone in RRMM patients showed an overall response rate of 57 and clinical benefit rate considered equal or superior to minor response of 66
Since July 2014 pomalidomide Imnovid in combination with dexamethasone has been approved for the treatment of adult patients with relapsed and refractory MM who have received at least two prior lines of therapy including bortezomib and lenalidomide and who have shown progressive disease to the last line of treatment
In Spain in January of 2015 and in the Spanish Myeloma Group GEM context we implemented clinical practice guidelines for the treatment of RRMM patients who are candidates for pomalidomide treatment with a triple therapy combination pomalidomide cyclophosphamide low-dose dexamethasone POMCIDEX Appendix 1 The goal of the clinical practice guidelines was to increase the overall response rate quality of response and progression-free survival in patients treated with POMCIDEX In patients with suboptimal response defined as stable disease in the first 3 cycles or inferior to partial response after six cycles according to International Myeloma Working Group Uniform Response Criteria 7 clarithromycin can be added to their treatment at a dose of 500mg12hrs on days 1-28 of each cycle Treatment can be administered until disease progression unacceptable toxicity or based on patient decision
Keeping in mind the time that has passed since the approval of pomalidomide for use in Spain and the publication of the clinical practice guidelines we believe it is now time for a retrospective evaluation of the results of the therapeutic guidelines for Spanish MM patients and to review the viability of the recommendations contained in the guidelines with respect to compliance with the same and effectiveness of the planned course of treatment Once the viability of the proposed therapy regimen has been evaluated other analyses for the purpose of studying the clinical results of treatment can be carried out as a separate analysis
The therapeutic paradigm for MM is rapidly changing due to the availability of new drugs for the treatment of patients with refractory or relapsed disease making clinical decisions more challenging For this reason the availability of data obtained from real-life settings outside of clinical trials is essential in order to choose the appropriate treatment for each patient
In clinical trial CC-4047-MM-003 treatment with pomalidomide and low-dose dexamethasone in patients with relapsed and refractory MM or those intolerant to bortezomib or lenalidomide was a successful rescue treatment in 30 of patients with a median progression-free survival of 4 months The association of cyclophosphamide at dose of 400mgday on days 1 8 and 15 of each cycle is able to increase the overall response rate from 39 for combination pomalidomide-dexamethasone to up to 65 for the triple regimen pomalidomide cyclophosphamide dexamethasone - POMCIDEX as well as the median PFS from 44 mo to 92 mo respectively As well the tolerance and safety profiles of the triple combination pomalidomide cyclophosphamide and dexamethasone were acceptable
The association of bortezomib with pomalidomide-dexamethasone also increases the overall response rate 85 and prolongs PFS 107 months
The BiRD study lenalidomide dexamethasone and clarithromycin suggests that clarithromycin intensifies the effect of corticosteroids increasing their anti-myeloma effect A study evaluating the combination of clarithromycin with pomalidomide and low-dose dexamethasone in RRMM patients showed an overall response rate of 57 and clinical benefit rate considered equal or superior to minor response of 66
Since July 2014 pomalidomide Imnovid in combination with dexamethasone has been approved for the treatment of adult patients with relapsed and refractory MM who have received at least two prior lines of therapy including bortezomib and lenalidomide and who have shown progressive disease to the last line of treatment
In Spain in January of 2015 and in the Spanish Myeloma Group GEM context we implemented clinical practice guidelines for the treatment of RRMM patients who are candidates for pomalidomide treatment with a triple therapy combination pomalidomide cyclophosphamide low-dose dexamethasone POMCIDEX Appendix 1 The goal of the clinical practice guidelines was to increase the overall response rate quality of response and progression-free survival in patients treated with POMCIDEX In patients with suboptimal response defined as stable disease in the first 3 cycles or inferior to partial response after six cycles according to International Myeloma Working Group Uniform Response Criteria 7 clarithromycin can be added to their treatment at a dose of 500mg12hrs on days 1-28 of each cycle Treatment can be administered until disease progression unacceptable toxicity or based on patient decision
Keeping in mind the time that has passed since the approval of pomalidomide for use in Spain and the publication of the clinical practice guidelines we believe it is now time for a retrospective evaluation of the results of the therapeutic guidelines for Spanish MM patients and to review the viability of the recommendations contained in the guidelines with respect to compliance with the same and effectiveness of the planned course of treatment Once the viability of the proposed therapy regimen has been evaluated other analyses for the purpose of studying the clinical results of treatment can be carried out as a separate analysis
The therapeutic paradigm for MM is rapidly changing due to the availability of new drugs for the treatment of patients with refractory or relapsed disease making clinical decisions more challenging For this reason the availability of data obtained from real-life settings outside of clinical trials is essential in order to choose the appropriate treatment for each patient
Detailed Description:
This is a national multicentre observational retrospective open-label non-randomized non-interventional study to evaluate the degree of compliance at PETHEMA centres in Spain with the clinical practice guidelines proposed by the Spanish Myeloma Group for the treatment of relapsed and refractory MM with POMCIDEX
In this study all patients will be included retrospectively who met the inclusion criteria for the GEM clinical practice guidelines and who were treated with POMCIDEX The period of retrospective data collection will be from 01012015 to 01042018
The period of data collection for the study includes a maximum period of three months to allow each centre to collect the necessary clinical and demographic data for each patient in order to fulfill the different study objectives Patient data will be anonymized and recorded in the electronic Case Report Form eCRF using the RedCap platform Afterward data cleansing and verification will be carried out on all data recorded by the study investigators This procedure will be carried out in the six months after database lock
Once the process of recording and verification of patient data is complete extraction and statistical analysis of the data will be carried out
In this study all patients will be included retrospectively who met the inclusion criteria for the GEM clinical practice guidelines and who were treated with POMCIDEX The period of retrospective data collection will be from 01012015 to 01042018
The period of data collection for the study includes a maximum period of three months to allow each centre to collect the necessary clinical and demographic data for each patient in order to fulfill the different study objectives Patient data will be anonymized and recorded in the electronic Case Report Form eCRF using the RedCap platform Afterward data cleansing and verification will be carried out on all data recorded by the study investigators This procedure will be carried out in the six months after database lock
Once the process of recording and verification of patient data is complete extraction and statistical analysis of the data will be carried out
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None