An observational study in Relapse/Refractory Multiple Myeloma, sponsored by Genesis Pharma S.A.. Completed at 1 site in Greece. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-05-12.
Sponsored by Genesis Pharma S.A. · Observational
The importance of real-world evidence studies stems from the following considerations. The study population of a specific clinical trial needs to meet strict inclusion and exclusion criteria, which result in a population of participants that is not necessarily representative of the study population of interest treated in routine care. Furthermore, the outcomes of a clinical trial occur under controlled conditions that do not necessarily reflect the routine healthcare practice. This is especially true among patient populations with challenging to treat disease such as in MM, where personalized therapeutic approaches are commonly considered taking into consideration the patients' age and associated comorbidities, among other factors. In addition, observational studies, due to their non-interventional nature, often show increased degree of heterogeneity across the enrolled patient populations compared to clinical studies, thus aiding generalizability of the results.
In light of the above and due to the scarcity of evidence regarding the outcomes for patients with RRMM receiving Pom/LoDex in routine clinical practice, this retrospective chart review and prospective observational study aims to assess the PFS and response to treatment as well as to obtain real-world evidence on the utilization patterns and management strategy of Pom/LoDex in routine clinical care settings in Greece.
This is a non-interventional, multicenter, single-country, retrospective chart review and prospective cohort study which will include a representative sample of patients with RRMM who have been initiated on Pom/LoDex between 01 January 2016 and 28 February 2019 in the third line and beyond treatment setting under routine care conditions in Greece.
The study will be carried out by hospital-based hematology specialists practicing in geographically diverse locations throughout Greece and will be conducted under real-world conditions of daily clinical practice.
3,760 studies on the registry are indexed under Multiple Myeloma; 769 are open to participants now.
This study's enrollment of 110 is below the median of 150 across 486 observational studies indexed under Multiple Myeloma.
Browse Multiple Myeloma studies →Genesis Pharma S.A. is the lead sponsor of 6 studies on the registry; none are open to participants now.
Compared within Multiple Myeloma, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Recurrence. The counts are of registry records indexed under each term, refreshed daily. How we classify →
A total of 100 adult patients with RRMM who have been initiated on Pom/LoDex treatment as indicated in the product's Summary of Product Characteristics (SmPC) (i.e., after having received at least two prior therapies including both lenalidomide and bortezomib and whose disease progressed after the last treatment) between 01 January 2016 and 28 February 2019 and who are eligible for participation in the study according to the inclusion and exclusion criteria -as outlined in Section 10- are planned to be recruited in the present clinical study. For the justification of the sample size please refer to Section 13.1.
Patients eligible for inclusion in this study have to meet all of the following criteria:
Provision of signed form (ICF) for collecting and analyzing medical data pertinent to the objectives of this study.**
Exclusion Criteria:
A patient who meets any of the following criteria will be excluded from participation in this study:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Effectiveness of Pom/LoDex in terms of median PFS
To evaluate the effectiveness of Pom/LoDex in terms of median PFS, in eligible patients with RRMM in a real world setting in Greece.
Time frame: median time from start of Pom/LoDex treatment to disease progression or death, through study completion and maximum 50 months
Response to Pom/LoDex treatment in terms of ORR
To estimate the response to Pom/LoDex treatment in terms of ORR in the study RRMM population
Time frame: from start of Pom/LoDex until achievement of PR or better, through study completion and maximum 50 months
Response to Pom/LoDex treatment in terms of CBR
To estimate the response to Pom/LoDex treatment in terms of clinical benefit rate (CBR) in the study RRMM population
Time frame: from start of Pom/LoDex until achievement of MR or better, through study completion and maximum 50 months
Response to Pom/LoDex treatment in terms of DCR
To estimate the response to Pom/LoDex treatment in terms of disease control rate (DCR) in the study RRMM population
Time frame: from start of Pom/LoDex until achievement of SD or better, through study completion and maximum 50 months
TTR among the RRMM study population who achieved at least partial response (PR)
To estimate time to response (TTR) to Pom/LoDex among the RRMM study population who achieved at least partial response (PR);
Time frame: median from start of Pom/LoDex to first documented response (TTR), through study completion and maximum 50 months
DoR among the RRMM study population who achieved at least partial response (PR)
To estimate duration of response (DoR) to Pom/LoDex among the RRMM study population who achieved at least partial response (PR);
Time frame: median from start of Pom/LoDex to first disease progrestion or death (DoR), through study completion and maximum 50 months
12-month PFS rate
To evaluate the 12-month PFS rate under treatment with Pom/LoDex in the RRMM study population
Time frame: time from start of Pom/LoDex until 12 months
Time to progression
To estimate time to progression (TTP) under treatment with Pom/LoDex in the RRMM study population
Time frame: median time from start of Pom/LoDex until disease progression or death, through study completion and maximum 50 months
Real-world utilization patterns of Pom/LoDex in the RRMM study population
To capture the real-world utilization patterns of Pom/LoDex in the RRMM study population, in terms of the rate of its incorporation in the third versus a later-line therapeutic strategy, and the prior treatment modalities employed in real-life clinical practice
Time frame: no time frame - only proportion of patients in 12 month follow-up
Evaluate the effectiveness and response to Pom/LoDex treatment in the subpopulations of RRMM patients who have been initiated on Pom/LoDex in the third line versus later line setting
Separation of Pom/Dex treatment outcomes in two subgroups of patients (treated in the third line versus later lines)
Time frame: from start of Pom/LoDex until 12 month follow-up
To evaluate the improvement of the QoR with Pom/LoDex continued treatment
To measure the improvement of the quality of response with Pom/LoDex continued treatment over time (i.e. improvement from PR to VGPR)
Time frame: from start of Pom/LoDex until 12 month follow-up
Ran from Nov 2017 to primary completion in Feb 2020, 27 months.
Of 66 industry-sponsored observational studies under Multiple Myeloma, half reached primary completion within 49 months of starting (the median), counting those still running; a quarter within 28 and three quarters within 70. This study's 27 months is below that.
Counting every sponsor, half of 239 studies reached it within 61 months; a quarter within 30 and three quarters within 126.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2021. You cannot join it, but the record below documents what was studied.
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Genesis Pharma S.A.