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NCT02537808 Clinical Trial

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

Multiple Myeloma Clinical Trial

— FIRST-NIS  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02537808
Other study ID # IOM-12315
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 23, 2015
Est. completion date September 13, 2023

Study information
Verified date November 2023
Source iOMEDICO AG
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 172
Est. completion date September 13, 2023
Est. primary completion date September 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Germany Hämatologisch-Onkologische Schwerpunktpraxis Bochum

Sponsors (1)
Lead Sponsor Collaborator
iOMEDICO AG

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Progression-free survival (PFS) rate at 24 months 24 months
Secondary To assess Median Overall Survival (OS) 84 month
Secondary 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
Secondary 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
Secondary 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
Secondary Overall Response Rate 24 months
Secondary Median Progression-free survival (PFS) 84 months
Secondary Median Time to Progression (TTP) 84 months
Secondary Median Time to Response (TTR) 24 months
Secondary Duration of Response 84 months
Secondary Reason for treatment discontinuation 84 months
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