Non-interventional Study of Lenalidomide / Dexamethasone as First Line Therapy in Patients With Multiple Myeloma

Study Overview
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Brief Summary
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The objective of this non-interventional study is to explore the safety, effectiveness and quality of life of lenalidomide / dexamethasone as first line treatment for transplant-ineligible patients with multiple myeloma in a real life setting.

Detailed Description
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The introduction of new drugs that can be differently combined with conventional chemotherapy or low-dose dexamethasone has changed substantially the treatment paradigm for patients with multiple myeloma. A variety of treatment options is now available for elderly patients. To compare the efficacy and safety of continuous lenalidomide in combination with low-dose dexamethasone (Rd) until progression vs. Rd for 18 cycles/72 weeks (Rd18) vs. melphalan, prednisone and thalidomide (MPT) for 12 cycles/72 weeks a multicenter, open-label phase III study (MM-020/IFM 07-01, FIRST trial) was performed in transplant ineligible patients. After market approval of lenalidomide for previously untreated transplant-ineligible patients with multiple myeloma, the purpose of the FIRST-NIS is to evaluate the safety, effectiveness and quality of life of lenalidomide in combination with dexamethasone as first line treatment of multiple myeloma in a real life setting.

Official Title
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A Non-interventional Study of Lenalidomide (Revlimid®) in Combination With Dexamethasone as First Line Therapy in Transplant-ineligible Patients With Multiple Myeloma

Conditions
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Multiple Myeloma

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of multiple myeloma (2008 WHO classification) requiring treatment (as defined by IMWG) Indication for treatment as assessed by the treating physician Decision for first line combination therapy with lenalidomide and low-dose dexamethasone No previous systemic therapy for multiple myeloma Ineligibility for transplantation Aged 18 years or older Written informed consent signed The conditions of the risk management plan/pregnancy prevention program (refer to the SmPC Revlimid®) must be followed by female and male patients Other criteria according to the SmPC. Special warnings and precautions of the SmPC have to be considered by the treating physician Exclusion Criteria: Pregnant or breast-feeding women Any objections or contraindications according to the SmPC

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival (PFS) rate at 24 months |  | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess Median Overall Survival (OS) |  | 84 month | 
| To assess safety and tolerability via AE and SAE reporting | AE, SAE and ADR are documented in the eCRF and will be used for safety assessment. | 24 months | 
| To assess Quality of Life (EORTC QLQ-C30 and MY20 | QoL data will be collected at baseline, after 3, 6, 12, 18 and 24 months | 24 months | 
| To assess duration of hospitalisation periods | To estimate hospital resource utilization by documenting how much time (days/weeks) patients spend in the hospital during their treatment period. | 24 months | 
| Overall Response Rate |  | 24 months | 
| Median Progression-free survival (PFS) |  | 84 months | 
| Median Time to Progression (TTP) |  | 84 months | 
| Median Time to Response (TTR) |  | 24 months | 
| Duration of Response |  | 84 months | 
| Reason for treatment discontinuation |  | 84 months |