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

iOMEDICO

Status: Completed

Conditions: Multiple Myeloma

Study type: Observational

Funder types: Industry

Identifiers

NCT02537808

IOM-12315

Details and patient eligibility

About

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.

Full 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.

Enrollment: 172 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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