Multiple Myeloma
Conditions
Keywords
Multiple Myeloma, Teratogenicity, Thrombocytopenia and haemorrhage, Neutropenia and infection, Venous thromboembolism, Allergic reactions, Diarrhoea or constipation, Peripheral neuropathy, Cardiac failure, Arrhythmia, Renal failure, Myocardial infarction, Interstitial lung disease, Tumour lysis syndrome
Brief summary
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).
Interventions
None listed
Sponsors
Celgene
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
N/A
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events (AEs) | 3 years | Number of participants with adverse events |
Countries
Japan
Outcome results
None listed