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

iOMEDICO AG172 enrolled

Overview

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.

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

Enrollment

172

Conditions

Multiple Myeloma

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Hämatologisch-Onkologische Schwerpunktpraxis

Bochum, Germany

Outcomes

Primary Outcomes

Progression-free survival (PFS) rate at 24 months

Time frame: 24 months

Secondary Outcomes

To assess Median Overall Survival (OS)

Time frame: 84 month

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.

Time frame: 24 months

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

Time frame: 24 months

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.

Time frame: 24 months

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

Data from ClinicalTrials.gov

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