Multiple Myeloma
Conditions
Brief summary
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
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.
Interventions
None listed
Sponsors
iOMEDICO AG
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival (PFS) rate at 24 months | 24 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To assess safety and tolerability via AE and SAE reporting | 24 months | AE, SAE and ADR are documented in the eCRF and will be used for safety assessment. |
| To assess Quality of Life (EORTC QLQ-C30 and MY20 | 24 months | QoL data will be collected at baseline, after 3, 6, 12, 18 and 24 months |
| To assess duration of hospitalisation periods | 24 months | To estimate hospital resource utilization by documenting how much time (days/weeks) patients spend in the hospital during their treatment period. |
| Overall Response Rate | 24 months | — |
| To assess Median Overall Survival (OS) | 84 month | — |
| 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 | — |
| Median Progression-free survival (PFS) | 84 months | — |
Countries
Germany
Outcome results
None listed