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Relapse/Refractory Multiple MyelomaPOWERFULNCT03353545

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

An observational study of Relapse/Refractory Multiple Myeloma, run by Genesis Pharma S.A. at 1 site in Greece.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Relapse/Refractory Multiple Myeloma
How many people
110 participants
Where
1 siteGreece
Study dates
16 Nov 2017to 28 Feb 2020
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

None listed.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Greece1 site

  • Ag.Andreas General Hospital

    Pátrai

Other trials in Greece

About this study

Official title: A Retrospective Chart Review and a Prospective Study of the POmalidomide Plus LoW Dose Dexamethasone Efficacy in Relapsed/ ReFractory Multiple Myeloma Patients Under Real-Life Conditions,

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.

Read more

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.

Medical subject headings
Recurrence, Multiple Myeloma

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (8)

  1. 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

    Measured: from start of Pom/LoDex until achievement of PR or better, through study completion and maximum 50 months

  2. 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

    Measured: from start of Pom/LoDex until achievement of MR or better, through study completion and maximum 50 months

  3. 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

    Measured: from start of Pom/LoDex until achievement of SD or better, through study completion and maximum 50 months

  4. 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);

    Measured: median from start of Pom/LoDex to first documented response (TTR), through study completion and maximum 50 months

  5. 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);

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

  6. 12-month PFS rate

    To evaluate the 12-month PFS rate under treatment with Pom/LoDex in the RRMM study population

    Measured: time from start of Pom/LoDex until 12 months

  7. Time to progression

    To estimate time to progression (TTP) under treatment with Pom/LoDex in the RRMM study population

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

  8. 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

    Measured: no time frame - only proportion of patients in 12 month follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Nov 2017
  2. Study start16 Nov 2017
  3. Primary completion21 Feb 2020
  4. Study completion28 Feb 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Other
Enrolment
110 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03353545
Sponsor's protocol ID
NIS-GEN-POM-001
Acronym
POWERFUL
Status last verified
May 2021
First submitted
31 Oct 2017
Last updated
12 May 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 33916376

Questions about this trial

What is this clinical trial studying?

An observational study of Relapse/Refractory Multiple Myeloma, run by Genesis Pharma S.A. at 1 site in Greece.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 0 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 May 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Effectiveness of Pom/LoDex in terms of median PFS (time frame: median time from start of Pom/LoDex treatment to disease progression or death, through study completion and maximum 50 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03353545, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2021; AzTrials last refreshed its copy on 6 Nov 2026.

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