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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02387879
Other study ID # CC-5013-PASS-TR
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date December 25, 2013
Est. completion date December 31, 2022

Study information

Verified date September 2019
Source Celgene
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

CC-5013-PASS-TR/A non-interventional, multi-center, observational post authorization safety study of patients with relapsed/refractory multiple myeloma treated with Lenalidomide in Turkey.

The study is anticipated to last for approximately 8 years. Recruitment period will continue until 500 subjects have commenced the third cycle of treatment with lenalidomide.


Description:

Objectives:

- Primary: To characterize and determine the incidence of adverse events of special interest; in subjects treated with Lenalidomide in real life setting in given indication.

- Secondary:

1. To observe the basic adverse event management approaches of physicians

2. To evaluate the effectiveness of Lenalidomide in given indication and to evaluate the prescription line.

3. To monitor the reasons of patients' noncompliance with lenalidomide usage recommended in Patient Information Leaflet.

Subjects will be recruited from approximately 36 hematology/oncology sites in Turkey. In all cases, the decision to treat the patient will be made prior to the decision to enter the subject into the study. All subjects enrolled will be prospectively followed up for up to 36 months, where feasible, following the end of observed treatment period. This 36 month observation period will start from end of treatment. The observation follow up period will end 36 months after the end of lenalidomide or background observed treatment period, or at time of death, withdrawal of consent, or loss to follow up. Following completion of treatment, subjects will be followed up after 30 days and then every 6 months to assess status.

Patients who are eligible and signed a consent form will be recruited consecutively. Subjects who temporarily discontinue treatment for any reason for more than 30 days will be withdrawn from treatment observation but will be observed for safety for up to 36 months (from the end of treatment). If the reason for discontinuation for subjects is due to an adverse event, the follow up of the adverse event will not be time limited and will continue until resolution or stabilization or when, in the opinion of the investigator, no additional useful information can be obtained from the event or the subject withdraws their consent to any more data being collected. Subjects will discontinue from the study if they switch to another treatment. No intervention will be performed to physician. Treatment will be according to physician's regular clinical practice.

All treatments will be prescribed by the treating investigator in accordance with regular clinical practice.

All assessments will be made according to the regular clinical practice of the treating investigator. Therefore if a parameter is requested on the case report form (CRF) but the investigator's normal practice is not to carry out such an assessment, then the field will not be completed.

Statistical Analysis:

Data from all subjects who receive at least one dose of treatment will be included in the safety analysis.

Adverse events will be classified using the MedDRA classification system. The severity of the toxicities will be graded according to the NCI CTCAE V. 4.03 whenever possible.

Adverse event frequency will be tabulated by body system and MedDRA term. In the by subject analysis, a subject having the same event more than once will be counted only once. Adverse events will be summarized by worst NCI CTCAE V. 4.03 grade.

Adverse events leading to death or to discontinuation from treatment, study-drug-related events, and serious adverse events will be listed separately.

The Kaplan-Meier procedures will be used to characterize time to onset and time to resolution for adverse events of special interest. Multivariate logistic regression will be used to determine the demographic and baseline characteristics most predictive of developing adverse events of interest. A forward selection stepwise procedure will be used to identify the subset of relevant factors.

Summary tables will also be provided for clinically relevant subgroups. Analyses will be undertaken to explore the course of neuropathy for subjects who have pre-existing neuropathy at baseline. Specifically, cross-tabulations will be used to summarize changes in severity observed during lenalidomide treatment and summary statistics will be provided for other relevant variables.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 500
Est. completion date December 31, 2022
Est. primary completion date December 31, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Male or female multiple myeloma patients with =18 years of age.

- Subjects who understand and voluntarily sign an informed consent

- Subjects who are receiving lenalidomide treatment in combination with dexamethasone not longer than four weeks.

Exclusion Criteria:

- - Refusal to participate in the study.

- Patients who are currently on an interventional clinical trial

- Subjects who previously received lenalidomide treatment and whose treatment is ceased or who had a treatment interruption for four weeks or longer.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Turkey Baskent University Adana Application and Research Hospital Adana
Turkey Cukurova University Medical Faculty Adana
Turkey Ankara Bayindir Hospital Ankara
Turkey Ankara Numune Training and Research Hospital Ankara
Turkey Ankara University Medical Faculty Ankara
Turkey Baskent University Ankara Hospital Ankara
Turkey Diskapi Yildirim Beyazit Training and Research Hospital Ankara
Turkey Dr. Abdurrahman Yurtaslan Ankara Onkology Training and Research Hospital Ankara
Turkey Gazi University Medical Faculty Ankara
Turkey Gulhane Military Medical Academy Ankara
Turkey Hacettepe University Medical Faculty Ankara
Turkey Akdeniz University Medical Faculty Antalya
Turkey Antalya Medstar Hospital Antalya
Turkey Ali Osman Sonmez Oncology Hospital Bursa
Turkey Uludag University Medical Faculty Bursa
Turkey Pamukkale University Medical Faculty Denizli
Turkey Dicle University Medical Faculty Diyarbakir
Turkey Trakya University Medical Faculty Edirne
Turkey Osmangazi University Medical Faculty Eskisehir
Turkey Gaziantep University Medical Faculty Gaziantep
Turkey Bakirkoy Dr.Sadi Konuk Training and Research Hospital Istanbul
Turkey Istanbul University Cerrahpasa Medical Faculty Istanbul
Turkey Istanbul University Istanbul Medical Faculty Istanbul
Turkey Kartal Training and Research Hospital Istanbul
Turkey Marmara University Pendik Training and Research Istanbul
Turkey Medipol University Medical Faculty Istanbul
Turkey Dokuz Eylul University Medical Faculty Izmir
Turkey Ege University Medical Faculty Izmir
Turkey Izmir Medical Park Hospital Izmir
Turkey Erciyes University Medical Faculty Kayseri
Turkey Kocaeli University Medical Faculty Kocaeli
Turkey Necmettin Erbakan University Meram Medical Faculty Konya
Turkey Inonu University Medical Faculty Malatya
Turkey Celal Bayar University Medical Faculty Manisa
Turkey Mersin University Medical Faculty Mersin
Turkey Ondokuz Mayis University Medical Faculty Samsun
Turkey Namik Kemal University Medical Faculty Tekirdag
Turkey Karadeniz Technical University Medical Faculty Trabzon

Sponsors (1)

Lead Sponsor Collaborator
Celgene

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Adverse Events (AEs) Number of participants with Adverse Events Up to 5 years
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