Retrospective and Prospective Study of POmalidomide Plus LoW Dose Dexa Efficacy in RRMM Patients Under Real-Life Conditions

NCT ID: NCT03353545

Last Updated: 2021-05-12

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 110 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-11-16
• Study Completion Date: 2020-02-28

Brief Summary

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.

Conditions

Relapse/Refractory Multiple Myeloma

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: OTHER

Eligibility Criteria

Inclusion Criteria

• Adult subjects (aged ≥18 years) of either gender.
• Subjects with a documented RRMM diagnosis according to IMWG or EBMT criteria prior to Pom/LoDex treatment.
• Subjects who have been initiated on Pom/LoDex treatment as per the product's Summary of Product Characteristics (SmPC) between 01 January 2016 and 28 February 2019, after having received at least two prior therapies including both lenalidomide and bortezomib and whose disease progressed after the last treatment.*
• Note: Retrospective patients who at the time of their enrollment in the study have already completed 3 or more cycles with Pom/LoDex must have available at least one post-baseline response assessment
• Subjects with available medical files/records and detailed historical data on their disease course and clinical management.
• Provision of signed informed consent form (ICF) for collecting and analyzing medical data pertinent to the objectives of this study.**

• Note: For retrospective subjects who are deceased at the date of enrollment into the study a waiver of consent will be requested by the Hospital Scientific Committee and/or Administrative Board of each participating site to either implement a hospital ICF already in place or provide written approval of this study- specific waiver. In the occasion that waiver of consent is not granted by the Scientific Committee and/or Administrative Board of the study site, deceased subjects will not be enrolled in the study.

Exclusion Criteria

A patient who meets any of the following criteria will be excluded from participation in this study:

• Prior malignancy (within the 3 years preceding initial diagnosis of MM).
• Concurrent administration of anti-cancer regimens for malignancies other than MM.
• Subjects currently participating or who have participated, during the treatment phase, in any investigational program with interventions outside of routine clinical practice.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Genesis Pharma S.A.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kiki Karvounis

Role: STUDY_DIRECTOR

Genesis Pharma S.A.

Locations

Ag.Andreas General Hospital

Pátrai, , Greece

Countries

Greece

References

Terpos E, Repousis P, Lalayanni C, Hatjiharissi E, Assimakopoulou T, Vassilopoulos G, Pouli A, Spanoudakis E, Michalis E, Pangalis G, Ntanasis-Stathopoulos I, Poziopoulos C, Kyrtsonis MC, Pappa V, Symeonidis A, Georgopoulos C, Zikos PM, Gavriatopoulou M, Papadaki HA, Dadakaridou M, Karvounis-Marolachakis K, Katodritou E. Pomalidomide Plus Low-Dose Dexamethasone in Relapsed/Refractory Multiple Myeloma Patients: Results of the Real-World "POWERFUL" Study. J Clin Med. 2021 Apr 5;10(7):1509. doi: 10.3390/jcm10071509.

Reference Type: RESULT

PMID: 33916376 (View on PubMed)

Other Identifiers

NIS-GEN-POM-001

Identifier Type: -

Identifier Source: org_study_id