Clinical trial NCT02387879: A Non-interventional,Observational Post Authorization Study of Patients With Multiple Myeloma Treated With Lenalidomide TR
Official title: A Non-interventional, Multi-center, Observational Post Authorization Safety Study of Patients With Relapse/Refractory Multiple Myeloma Treated With Lenalidomide in Turkey
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Multiple Myeloma
Keywords: Multiple Myeloma
PASS
Observational
Non-interventional
Relapse
Refractory
CC-5013
Lenalidomide
Turkey
Lead sponsor: Celgene
Sponsor class: INDUSTRY
First posted: 2015-03-13
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: It will continue until 500 subjects have commenced the third cycle of treatment with lenalidomide. As a condition of market authorization, subjects should be chosen among relapsed/refractory multiple myeloma patients who have received at least one prior antimyeloma chemotherapy regimen (excluding treatment regimens with steroid only) with adequate dose and duration (≥2 cycles) or who have relapsed/refractory multiple myeloma after stem cell transplantation. Patients who are eligible for the study will be consecutively enrolled in the study until the targeted patient number is reached. The responsible investigator will be requested to keep a log of subjects who are invited to enter the study. In the case of any of these subjects will not be enrolled in the study, this information will be documented together with its reason.

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Adverse Events (AEs)
timeFrame: Up to 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Adana
country: Turkey
facility: Baskent University Adana Application and Research Hospital
city: Adana
country: Turkey
facility: Cukurova University Medical Faculty
city: Ankara
country: Turkey
facility: Gulhane Military Medical Academy
city: Ankara
country: Turkey
facility: Ankara University Medical Faculty
city: Ankara
country: Turkey
facility: Ankara Numune Training and Research Hospital
city: Ankara
country: Turkey
facility: Diskapi Yildirim Beyazit Training and Research Hospital
city: Ankara
country: Turkey
facility: Dr. Abdurrahman Yurtaslan Ankara Onkology Training and Research Hospital
city: Ankara
country: Turkey
facility: Hacettepe University Medical Faculty
city: Ankara
country: Turkey
facility: Ankara Bayindir Hospital
city: Ankara
country: Turkey
facility: Baskent University Ankara Hospital
city: Ankara
country: Turkey
facility: Gazi University Medical Faculty
city: Antalya
country: Turkey
facility: Antalya Medstar Hospital
city: Antalya
country: Turkey
facility: Akdeniz University Medical Faculty
city: Bursa
country: Turkey
facility: Ali Osman Sonmez Oncology Hospital
city: Bursa
country: Turkey
facility: Uludag University Medical Faculty
city: Denizli
country: Turkey
facility: Pamukkale University Medical Faculty
city: Diyarbakir
country: Turkey
facility: Dicle University Medical Faculty
city: Edirne
country: Turkey
facility: Trakya University Medical Faculty
city: Eskisehir
country: Turkey
facility: Osmangazi University Medical Faculty
city: Gaziantep
country: Turkey
facility: Gaziantep University Medical Faculty
city: Istanbul
country: Turkey
facility: Istanbul University Istanbul Medical Faculty
city: Istanbul
country: Turkey
facility: Istanbul University Cerrahpasa Medical Faculty
city: Istanbul
country: Turkey
facility: Bakırkoy Dr.Sadi Konuk Training and Research Hospital
city: Istanbul
country: Turkey
facility: Medipol University Medical Faculty
city: Istanbul
country: Turkey
facility: Kartal Training and Research Hospital
city: Istanbul
country: Turkey
facility: Marmara University Pendik Training and Research
city: Izmir
country: Turkey
facility: Ege University Medical Faculty
city: Izmir
country: Turkey
facility: Dokuz Eylul University Medical Faculty
city: Izmir
country: Turkey
facility: Izmir Medical Park Hospital
city: Kayseri
country: Turkey
facility: Erciyes University Medical Faculty
city: Kocaeli
country: Turkey
facility: Kocaeli University Medical Faculty
city: Konya
country: Turkey
facility: Necmettin Erbakan University Meram Medical Faculty
city: Malatya
country: Turkey
facility: Inonu University Medical Faculty
city: Manisa
country: Turkey
facility: Celal Bayar University Medical Faculty
city: Mersin
country: Turkey
facility: Mersin University Medical Faculty
city: Samsun
country: Turkey
facility: Ondokuz Mayis University Medical Faculty
city: Tekirdag
country: Turkey
facility: Namik Kemal University Medical Faculty
city: Trabzon
country: Turkey
facility: Karadeniz Technical University Medical Faculty
Study officials:
affiliation: Celgene
name: Margaret Atiba-Davies, PhD
role: STUDY_DIRECTOR
References: