Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Heart and Blood Diseases

Symptoms and General Pathology

Infections

Immune System Diseases

Respiratory Tract (Lung and Bronchial) Diseases

Neoplasms

Blood and Lymph Conditions

Nervous System Diseases

Rare Diseases

Renal Insufficiency

Myocardial Infarction

Infarction

Constipation

Hemorrhage

Syndrome

Hypersensitivity

Lung Diseases

Heart Failure

Multiple Myeloma

Neoplasms, Plasma Cell

Thrombocytopenia

Communicable Diseases

Diarrhea

Arrhythmias, Cardiac

Peripheral Nervous System Diseases

Lung Diseases, Interstitial

Neutropenia

Thromboembolism

Venous Thromboembolism

Tumor Lysis Syndrome

Teratogenesis

Neoplasms by Histologic Type

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hematologic Diseases

Hemorrhagic Disorders

Lymphoproliferative Disorders

Immunoproliferative Disorders

Granulocytopenia

Antineoplastic Agents

All Drugs and Chemicals

Lenalidomide

Relapsed or refractory MM patients in the special use-results surveillance (all-case surveillance) (hereinafter referred to as the all-case surveillance) who have received Revlimid treatment for at least 7 cycles at institutions cooperating in performing the all-case surveillance and this surveillance.

Bristol-Myers Squibb

To understand the safety and efficacy of Revlimid® 5 mg Capsules (hereinafter referred to as Revlimid) in patients with "relapsed or refractory multiple myeloma" (hereinafter referred to as "relapsed or refractory MM") who have received long-term treatment with it under the actual condition of use.

1. Planned registration period This period started on the date of initial marketing of Revlimid and will end at the time when the planned number of patients to be enrolled, 300, is reached (estimated to be approximately 1 year and 3 moths).
2. Planned surveillance period This period started on the date of initial marketing of Revlimid and will end 3 years after the last enrolled patient begins receiving Revlimid (estimated to be approximately 4 years and 3 months).

A Safety and Efficacy Study of Revlimid® 5 mg Capsules in Patients With Relapsed or Refractory Multiple Myeloma Who Have Received Long-term Treatment With it Under the Actual Condition of Use

Revlimid 5 mg Capsules Special Use-results Surveillance of Long Term Use

Number of participants with adverse events

Celgene

Eye Diseases

Digestive System Diseases

Ear, Nose, and Throat Diseases

Gland and Hormone Related Diseases

Behaviors and Mental Disorders

Cataract

Coronary Artery Disease

Liver Diseases

Fatigue

Lymphoma

Leukemia

Heart Diseases

Ischemia

Hypotension

Seizures

Myocardial Ischemia

Vertigo

Dizziness

Leukemia, T-Cell

Sleepiness

Hypothyroidism

Hypotension, Orthostatic

Confusion

Leukemia-Lymphoma, Adult T-Cell

Lymphatic Diseases

Lymphosarcoma

Adult T-cell Leukemia/lymphoma

Leukemia, T-cell, Chronic

Immunologic Factors

Angiogenesis Inhibitors

Growth Inhibitors

Among patients with relapsed or refractory adult T-cell leukemia lymphoma, patients who received Revlimid will be targeted in this surveillance

Revlimid

BMS Study Connect Contact Center www.BMSStudyConnect.com, Study manager

First line of the email MUST contain the NCT# and Site #.

To understand the safety and efficacy of Revlimid® Capsules 2.5 mg and 5 mg (hereinafter referred to as Revlimid) under actual conditions of use in patients with relapsed or refractory adult T-cell leukemia lymphoma (hereinafter referred to as relapsed or refractory Adult T-cell Leukemia Lymphoma (ATLL)).

1. Planned registration period 3 years
2. Planned surveillance period 4 years and 6 months after a month after the approval for partial changes in the approved items is granted for relapsed or refractory ATLL

Revlimid® Capsules Drug Use-results Surveillance (Relapsed or Refractory ATLL)

Revlimid® Capsules Drug Use-results Surveillance Relapsed or Refractory Adult T-cell Leukemia Lymphoma

Skin and Connective Tissue Diseases

Diseases and Abnormalities at or Before Birth

Nutritional and Metabolic Diseases

Musculoskeletal Diseases

Mouth and Tooth Diseases

Skin Diseases

Carcinoma

Psoriasis

Keratosis, Actinic

Keratosis

Carcinoma, Basal Cell

Skin Neoplasms

Ichthyosis

Hypertriglyceridemia

Basal Cell Nevus Syndrome

Keratoderma, Palmoplantar

Darier Disease

Keratoderma, Palmoplantar, Diffuse

Nevus, Pigmented

Nevus

Neoplasms, Glandular and Epithelial

Skin Diseases, Papulosquamous

Neoplasms, Basal Cell

Cysts

Odontogenic Cysts

Jaw Cysts

Bone Cysts

Neoplastic Syndromes, Hereditary

Bone Diseases

Bone Diseases, Developmental

Jaw Diseases

Stomatognathic Diseases

Congenital Abnormalities

Abnormalities, Multiple

Genetic Diseases, Inborn

Skin Diseases, Genetic

Nevoid Basal Cell Carcinoma Syndrome

Palmoplantar Keratoderma

Basal Cell Carcinoma, Multiple

Dermatologic Agents

Acitretin

This is a continuing study which evaluates the long-term safety and efficacy of oral acitretin in an open manner in the treatment of psoriasis, cutaneous disorders of keratinization, multiple basal cell carcinomas and other retinoid responsive diseases.

The Evaluation of Oral Acitretin in the Treatment of Psoriasis, Cutaneous Disorders of Keratinization, Multiple Basal Cell Carcinomas and Other Retinoid Responsive Diseases

National Cancer Institute (NCI)

Acute Kidney Injury

Depression

Pneumonia

Jaundice

Acute Graft Versus Host Disease

Pomalidomide

Among relapsed or refractory multiple myeloma patients, all patients who received Pomalyst will be targeted in this surveillance.

Jinshu Cho

1. Planned enrollment period One year (The planned number of patients to be enrolled is set to 400 patients.) Since all patients who are prescribed with Pomalyst are registered in RevMate®, enrollment using the Registration Form of the surveillance will be completed at the time when the planned number of patients to be enrolled is reached. During a period until conditions for approval are removed, a system enabling to retrospectively collect appropriate information based on patient data from RevMate® will be, as necessary, maintained.
2. Planned duration of the surveillance Anticipated to be 2 years and 6 months from the start date of release of Pomalyst

A Safety and Efficacy of Pomalyst® Capsules Under the Actual Use in All Patients Who Are Treated With Pomalyst at a Dose of 1 mg, 2 mg, 3 mg, or 4 mg

Pomalyst®Capsules Special Use-results Surveillance (All-case Surveillance)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Safety and Efficacy Study of Revlimid® 5 mg Capsules in Patients With Relapsed or Refractory Multiple Myeloma Who Have Received Long-term Treatment With it Under the Actual Condition of Use	NCT02922543	Multiple Myelom...		18 Years -	Celgene
Revlimid® Capsules Drug Use-results Surveillance (Relapsed or Refractory ATLL)	NCT03098589	Lymphoma	Revlimid	18 Years -	Celgene
The Evaluation of Oral Acitretin in the Treatment of Psoriasis, Cutaneous Disorders of Keratinization, Multiple Basal Cell Carcinomas and Other Retinoid Responsive Diseases	NCT00005660	Basal Cell Carc... Keratosis Palma... Psoriasis		-	National Institutes of Health Clinical Center (CC)
A Safety and Efficacy Study of Revlimid® 5 mg Capsules in Patients With Relapsed or Refractory Multiple Myeloma Who Have Received Long-term Treatment With it Under the Actual Condition of Use	NCT02922543	Multiple Myelom...		18 Years -	Celgene
Revlimid® Capsules Drug Use-results Surveillance (Relapsed or Refractory ATLL)	NCT03098589	Lymphoma	Revlimid	18 Years -	Celgene
A Safety and Efficacy of Pomalyst® Capsules Under the Actual Use in All Patients Who Are Treated With Pomalyst at a Dose of 1 mg, 2 mg, 3 mg, or 4 mg	NCT02921828	Multiple Myelom...		18 Years -	Celgene

Spots Global Cancer Trial Database for teratogenicity