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

Completed

• Conditions: Multiple Myeloma

• Registration Number: NCT02537808
• Lead Sponsor: iOMEDICO AG

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.

Study Timeline

• Study Start: 2015-06-23
• Study First Submitted: 2015-08-24
• Study First Submitted QC: 2015-08-28
• Study First Posted: 2015-09-02
• Primary Completion: 2020-09
• Study Completion: 2023-09-13
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-16
• Last Update Posted: 2023-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 172

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

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Exclusion Criteria

• Pregnant or breast-feeding women
• Any objections or contraindications according to the SmPC

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Progression-free survival (PFS) rate at 24 months	24 months

Secondary Outcome Measures

Name	Time	Method
To assess Median Overall Survival (OS)	84 month
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
Median Progression-free survival (PFS)	84 months
Median Time to Response (TTR)	24 months
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.
Median Time to Progression (TTP)	84 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
Reason for treatment discontinuation	84 months
Duration of Response	84 months

Trial Locations

Locations (1)

Hämatologisch-Onkologische Schwerpunktpraxis; 🇩🇪 Bochum, Germany