Non-interventional Study of Lenalidomide / Dexamethasone as First Line Therapy in Patients With Multiple Myeloma (FIRST-NIS)
|ClinicalTrials.gov Identifier: NCT02537808|
Recruitment Status : Active, not recruiting
First Posted : September 2, 2015
Last Update Posted : November 26, 2019
|Condition or disease|
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.
|Study Type :||Observational|
|Actual Enrollment :||172 participants|
|Official Title:||A Non-interventional Study of Lenalidomide (Revlimid®) in Combination With Dexamethasone as First Line Therapy in Transplant-ineligible Patients With Multiple Myeloma|
|Actual Study Start Date :||June 23, 2015|
|Estimated Primary Completion Date :||September 2020|
|Estimated Study Completion Date :||September 2023|
- Progression-free survival (PFS) rate at 24 months [ Time Frame: 24 months ]
- To assess Median Overall Survival (OS) [ Time Frame: 84 month ]
- To assess safety and tolerability via AE and SAE reporting [ Time Frame: 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 [ Time Frame: 24 months ]QoL data will be collected at baseline, after 3, 6, 12, 18 and 24 months
- To assess duration of hospitalisation periods [ Time Frame: 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 [ Time Frame: 24 months ]
- Median Progression-free survival (PFS) [ Time Frame: 84 months ]
- Median Time to Progression (TTP) [ Time Frame: 84 months ]
- Median Time to Response (TTR) [ Time Frame: 24 months ]
- Duration of Response [ Time Frame: 84 months ]
- Reason for treatment discontinuation [ Time Frame: 84 months ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02537808
|Bochum, Germany, 44787|
|Principal Investigator:||Holger Nückel, Professor||Hämatologisch-Onkologische Schwerpunktpraxis|