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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 #.

Bristol-Myers Squibb

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

Number of participants with adverse events

Celgene

Multiple Myeloma

Neoplasms, Plasma Cell

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hematologic Diseases

Hemorrhagic Disorders

Patients with newly-diagnosed multiple myeloma (NDMM) who are treated with Revlimid Capsules (Revlimid)

To understand the safety and efficacy of Revlimid® 2.5mg and 5 mg Capsules (hereinafter referred to as Revlimid) in all patients who are treated with it under the actual condition of use pursuant to the conditions of approval.

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 is reached.
2. Planned surveillance period This period started on the date of initial marketing of Revlimid and will end on the day when the approval condition related to all-case surveillance is terminated.

Revlimid® Capsules Special Drug Use-results Survey (in Patients With Newly-diagnosed Multiple Myeloma [NDMM])

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Revlimid® Capsules Drug Use-results Surveillance (Relapsed or Refractory ATLL)	NCT03098589	Lymphoma	Revlimid	18 Years -	Celgene
Revlimid® Capsules Special Drug Use-results Survey (in Patients With Newly-diagnosed Multiple Myeloma [NDMM])	NCT02741544	Multiple Myelom...		18 Years -	Celgene
Revlimid® Capsules Special Drug Use-results Survey (in Patients With Newly-diagnosed Multiple Myeloma [NDMM])	NCT02741544	Multiple Myelom...		18 Years -	Celgene
Revlimid® Capsules Drug Use-results Surveillance (Relapsed or Refractory ATLL)	NCT03098589	Lymphoma	Revlimid	18 Years -	Celgene

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