Clinical trial NCT02537808: Non-interventional Study of Lenalidomide / Dexamethasone as First Line Therapy in Patients With Multiple Myeloma
Official title: A Non-interventional Study of Lenalidomide (Revlimid®) in Combination With Dexamethasone as First Line Therapy in Transplant-ineligible Patients With Multiple Myeloma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Myeloma
Lead sponsor: iOMEDICO AG
Sponsor class: INDUSTRY
First posted: 2015-09-02
Enrollment: 172
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Transplant-ineligible patients with previously untreated, symptomatic multiple myeloma (as defined by IMWG criteria) and with an indication for medical treatment as assessed by the investigator.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Progression-free survival (PFS) rate at 24 months
timeFrame: 24 months
Secondary outcomes:
measure: To assess Median Overall Survival (OS)
timeFrame: 84 month
measure: To assess safety and tolerability via AE and SAE reporting
timeFrame: 24 months
measure: To assess Quality of Life (EORTC QLQ-C30 and MY20
timeFrame: 24 months
measure: To assess duration of hospitalisation periods
timeFrame: 24 months
measure: Overall Response Rate
timeFrame: 24 months
measure: Median Progression-free survival (PFS)
timeFrame: 84 months
measure: Median Time to Progression (TTP)
timeFrame: 84 months
measure: Median Time to Response (TTR)
timeFrame: 24 months
measure: Duration of Response
timeFrame: 84 months
measure: Reason for treatment discontinuation
timeFrame: 84 months
Other outcomes:
Locations:
city: Bochum
country: Germany
facility: Hämatologisch-Onkologische Schwerpunktpraxis
Study officials:
affiliation: Hämatologisch-Onkologische Schwerpunktpraxis
name: Holger Nückel, Professor
role: PRINCIPAL_INVESTIGATOR
References: