A Non-interventional,Observational Post Authorization Study of Patients With Multiple Myeloma Treated With Lenalidomide TR

Multiple Myeloma Clinical Trial

Official title:

A Non-interventional, Multi-center, Observational Post Authorization Safety Study of Patients With Relapse/Refractory Multiple Myeloma Treated With Lenalidomide in Turkey

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02387879
• Other study ID #: CC-5013-PASS-TR
• Status: Active, not recruiting
• 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
• 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.

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

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