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
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

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