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The study is designed as a prospective, non-interventional, observational single arm study. Hundred-fifty patients over 18 with stable disease or at least partial response while on treatment with lenalidomide will be recruited from approximately 20 haematology/oncology sites in the Netherlands. Recruitment will continue until 150 patients have started the study. When this target is reached, all patients on lenalidomide will continue to be followed until the last patient has been followed for 36 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients receiving Revlimid according to clinical practice |
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| Measure | Description | Time Frame |
|---|---|---|
| Adverse Event (AE) | Adverse events will be classified using the MedDRA classification system. The severity of the toxicities will be graded according to the NCI CTCAE VERSION 4.03 whenever possible | Up to approximatly 4 years |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life | Quality of life will be measured by using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire(EORTC QL Q-C30) and EORTC QLQ-MY20 | Up to approximatly 24 months |
| Lenalidomide usage patterns |
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Inclusion Criteria:
Exclusion Criteria:
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Patients already successfully, i.e. with currently stable disease or meeting the criteria for complete response, very good partial response or partial response, on-treatment for maximally up to 6 cycles with lenalidomide at each site will be enrolled into the study. In all cases, the decision to treat the patient with lenalidomide was already made prior to the decision to enter the subject into the study.
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| Name | Affiliation | Role |
|---|---|---|
| Jeroen Stevens, MSc | Celgene BV | Study Director |
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| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| D054219 | Neoplasms, Plasma Cell |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
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Registration in case report form (CRF) and evaluation of usage patterns in daily clinical practice
| Up to approximatly 4 years |
| Lenalodomide dose modifications | Registration in case report form (CRF) and evaluation of dose modifications in daily clinical practice | Up to approximatly 4 years |
| Reasons for discontinuation of lenalidomide | Registration in case report form (CRF) and evaluation of reasons of discontinuation in daily clinical practice | Up to approximatly 4 years |
| Clinical outcome | Clinical outcome will be measured using routine assessment criteria (i.e. IMWG) | Up to approximately 4 years |
| D002318 |
| Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |