Neoplasms

Heart and Blood Diseases

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Multiple Myeloma

Neoplasms, Plasma Cell

Neoplasms by Histologic Type

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hematologic Diseases

Hemorrhagic Disorders

Lymphoproliferative Disorders

Immunoproliferative Disorders

Antineoplastic Agents

All Drugs and Chemicals

Lenalidomide

Subjects should be chosen among relapse/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 relapse/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

Margaret Atiba-Davies, PhD

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.

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.

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

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

Number of participants with Adverse Events

Celgene

Skin and Connective Tissue Diseases

Symptoms and General Pathology

Breast Neoplasms

Disease Progression

Breast Diseases

Skin Diseases

Disease Attributes

Hormones

Fulvestrant

Mitogens

Antineoplastic Agents, Hormonal

Estrogens

Estrogen Antagonists

Estrogen Receptor Antagonists

Hormone Antagonists

Patients treated with alpelisib in combination with fulvestrant

Prospective observational PASS study. There is no treatment allocation. Patients recruited on or before their first prescribed dose of alpelisib in combination with fulvestrant will be enrolled.

Alpelisib

Novartis Pharmaceuticals

This is a prospective, multi-national, non-interventional study (NIS) collecting data from postmenopausal women, and adult men, with HR+, HER2- locally advanced or metastatic breast cancer whose tumor harbors a PIK3CA mutation, and who are treated with alpelisib in combination with fulvestrant after disease progression following endocrine therapy as monotherapy, in the real-world setting.

Once the patient provides informed consent, he or she is enrolled in the study. Patients will be followed from enrollment until 1) 30 days after alpelisib treatment discontinuation, or 2) death, or 3) lost to follow-up, or 4) patient withdrawal, or 5) physician decision to end treatment/study, or 6) end of the study, whichever occurs first. The end of the study is defined as a maximum of 12 months after the date the last patient was enrolled (LPFV); if the last patient is still on treatment on that date, they will not be followed up any further

A NIS of Alpelisib in Combination With Fulvestrant in Postmenopausal Women, and Men, With HR+,HER2- , Locally Advanced or Metastatic Breast Cancer With a PIK3CA Mutation, After Disease Progression Following Endocrine Therapy as Monotherapy, in the Real-world Setting

Alpelisib (Piqray®) Post-Authorization Safety Study (PASS): a Non-interventional Study of Alpelisib in Combination With Fulvestrant in Postmenopausal Women, and Men, With Hormone Receptor Positive (HR+), Human Epidermal Growth Factor Receptor 2 Negative (HER2-), Locally Advanced or Metastatic Breast Cancer With a Phosphatidylinositol-3-kinase Catalytic Subunit Alpha (PIK3CA) Mutation, After Disease Progression Following Endocrine Therapy as Monotherapy, in the Real-world Setting

To assess the incidence of hyperglycemia (Adverse Event of Special Iinterest) observed during follow-up of patients treated with alpelisib in combination with fulvestrant.

Number of patients with diabetes mellitus (including gestational diabetes), tobacco use, baseline diabetic status per laboratory values for HbA1c and FPG

Number of patients with concomitant medications known to affect blood glucose levels will be measured

Number of participants with incidence proportion of ketoacidosis and HHNKS based on AE data

Incidence of AESI of Osteonecrosis of the Jaw (ONJ) will be provided

Number of participants with risk factors for ONJ will be collected. Risk factors for ONJ include:

* Patient characteristics: age, calculated BMI, sex
* Prior and/or concomitant use of bisphosphonates (e.g. zoledronic acid).
* Prior and/or concomitant use of RANKligand inhibitors (e.g. denosumab).

The incidence proportion of AESIs:

* GI toxicity (nausea, vomiting and diarrhea)
* Rash
* Hypersensitivity (e.g. anaphylactic reaction)
* Pancreatitis
* Pneumonitis
* SCARs

The incidence proportion of:

* AEs
* AEs leading to dose interruptions
* AEs leading to dose reductions
* AEs leading to permanent discontinuation of alpelisib in combination with fulvestrant
* SAEs

Number of patients with hematological and biochemical laboratory abnormalities will be provided

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Non-interventional,Observational Post Authorization Study of Patients With Multiple Myeloma Treated With Lenalidomide TR	NCT02387879	Multiple Myelom...		18 Years -	Celgene
A NIS of Alpelisib in Combination With Fulvestrant in Postmenopausal Women, and Men, With HR+,HER2- , Locally Advanced or Metastatic Breast Cancer With a PIK3CA Mutation, After Disease Progression Following Endocrine Therapy as Monotherapy, in the Real-world Setting	NCT04967248	Hormone Recepto...	Alpelisib Fulvestrant	18 Years -	Novartis

Spots Global Cancer Trial Database for pass

Every month we try and update this database with for pass cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for pass

Every month we try and update this database with for pass cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for pass cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.