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

NCT03353545 | Completed

• 1 other identifier: NIS-GEN-POM-001
• Study Type: observational
• Target: 110
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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.

  median time from start of Pom/LoDex treatment to disease progression or death, through study completion and maximum 50 months

Secondary Outcomes (8)

• Response to Pom/LoDex treatment in terms of ORR

  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

  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

  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)

  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)

  median from start of Pom/LoDex to first disease progrestion or death (DoR), through study completion and maximum 50 months

Other Outcomes (2)

• 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

  from start of Pom/LoDex until 12 month follow-up

• To evaluate the improvement of the QoR with Pom/LoDex continued treatment

  from start of Pom/LoDex until 12 month follow-up

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Genesis Pharma S.A.: lead

Study Sites (1)

Ag.Andreas General Hospital

Pátrai, Greece

Location

Related Publications (1)

• 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.

  PMID: 33916376 RESULT

MeSH Terms

Conditions

Recurrence; Multiple Myeloma

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Kiki Karvounis

  Genesis Pharma S.A.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2017
• First Posted: November 27, 2017
• Study Start: November 16, 2017
• Primary Completion: February 21, 2020
• Study Completion: February 28, 2020
• Last Updated: May 12, 2021

Record last verified: 2021-05

Locations

GR (1)