MedDRA version: 16.1 Level: HLT Classification code 10028229 Term: Multiple myelomas System Organ Class: 100000004851
Conditions
Interventions
Trade Name: REVLIMID
Product Name: Lenalidomida
Product Code: LENA25
Pharmaceutical Form: Capsule
INN or Proposed INN: LENALIDOMIDE
CAS Number: 191732-72-6
Current Sponsor code: LENA25
Other descripti
Sponsors
Ernesto Pérez Persona
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients must voluntarily sign informed consent before performing any test of study that is not part of routine care of patients. Furthermore patients must be informed about the right of leaving the study at any moment and without detriment of subsequent care. The patient must be diagnosed of symptomatic multiple myeloma according to established criteria. Multiple myeloma with measurable disease at the time of relapse, according to the international criteria and for which doctor considers indicated the treatment with lenalidomide (25 mg / day) and dexamethasone (dexamethasone pulses or weekly dexamethasone). At the time of relapse must have filed measurable disease defined as follows: For secretory Multiple Myeloma measurable disease is defined by the presence of measurable monoclonal serum component superior or equal to 1 g / dL, or in urine when light chain excretion is superior or equal to 200 mg / 24 hours. For oligo secretory or nonsecretory Multiple Myeloma, serum levels of free light chain affected, superior or equal to 10 mg / dL (erior or equal to 100 mg / L, with a ratio of abnormal free light chain serum) At the time of randomization the patient should be receiving a dose of lenalidomide superior or equal to 10 mg / day, at least 5 mg weekly dexamethasone. Randomization was performed at the time it has reached maximum response with lenalidomide and dexamethasone, defined as follows: · CR with negative IFE. Once objectified the RC, this should be confirmed at 8 weeks, during which time the patient will continue without change the dose of lenalidomide and dexamethasone. That is, once RC is documented, patients receive two cycles of lenalidomide and dexamethasone until confirmation of the same. · PR phase "Plateau", defined as at least 3 months with a stable monoclonal component, and have completed at least one year of treatment with lenalidomide and dexamethasone. The patient should have the following laboratory values ??prior to corresponding induction treatment initiation: : Platelet count erior or equal to 50,000 / mm3, hemoglobin erior or equal to 8 g / dl and counting absolute neutrophil erior or equal to 1000 / mm3. Lower values ??are permitted if they are due to infiltration of the MO Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30
Exclusion criteria
Exclusion criteria: Patients in second or subsequent relapses. Patients may have received only treatment for newly diagnosed multiple myeloma. Is allowed at the time of relapse; - steroid treatment pulses for some urgency required prior to initiating second-line treatment, -administration of bisphosphonates or antialgic radiotherapy due to the presence of plasmacytomas Patients with non-measurable disease or by SFLC. Patients with known hypersensitivity to lenalidomide. Patients who have received any investigational agent within 30 days prior to enrollment. Patients receiving doses below 10 mg / day of lenalidomide Dexamethasone intolerant patients. Patients who are currently in another clinical trial or receiving any investigational agent. Hypertension or poorly controlled diabetes mellitus or other serious organic disease involving excessive risk to the patient or any psychiatric disorder interfering with the understanding of informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: At two years, at progression moment or at death moment due any cause. The first thing is;Main Objective: Compare disease-free survival between patients with lenalidomide at low-dose and patients with lenalidomide at standard dose and dexamethasone;Secondary Objective: Compare the effectiveness in terms of response rate , duration of response, time to progression (TTP) and overal survivall (OS) of both schemes of treatment. Determine the percentaje of pacients of both limbs who achieve complete response (CR) once observed biologic progression. Compare the safety and tolerability of both schemes.;Primary end point(s): Primary efficacy endpoint: progression-free survival (PFS) from the date of initiation of lenalidomide up to the date of disease progression or death from any cause. Safety and tolerability of the proposed schemes: key safety variables. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): No;Timepoint(s) of evaluation of this end point: Secondary efficacy endpoints: efficacy in terms of response rate, duration of response, TTP and OS in both treatment groups. Determining the cause of death of patients, and its relationship with the MM or treatment. | — |
Countries
Spain
Contacts
Public ContactServicio hematología
Ernesto Pérez Persona
Outcome results
None listed