Multiple myeloma
Conditions
Interventions
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Product Name: Velcade
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Sponsors
FUNDACIÓN PETHEMA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: All patients must meet the following inclusion criteria: The patient must, in the opinion of the investigator, be able to fulfill all the requirements of the assay. Signed informed consent Age between 18-65 years and a candidate for the realization of an autologous transplant. ECOG performance status greater than 2 (or 3 if the ECOG myeloma is due to, eg. Pathologic fracture) Patients newly diagnosed symptomatic multiple myeloma based on standard criteria (Appendix 6) and has not received any previous chemotherapy treatment for MM. Patients with measurable disease defined by the following criteria: For the secretory MM, measurable disease was defined as any measurable value monoclonal protein in serum (IgG greater or equal 10 g / L or higher IgA or equal to 5 g / L) and / or where applicable, a chain excretion light in urine greater than or equal to 200 mg/24 hours. For multiple myeloma oligosecretor or secretory measurable disease defined by the presence of soft tissue plasmacytomas (not bone) determined by clinical examination or radiographic methods (eg. MRI, CT-Scan). Life expectancy greater than 3 months. The patient must have the following laboratory values ??within 21 days before the start of treatment (day 1, cycle 1): Platelet count greater than or equal to 100 x 109 / L and absolute neutrophil count greater than or equal to 1.0 x 109 / L Corrected serum calcium less than 14 mg / dL. Aspartate transaminase (AST) and alanine transaminase (ALT) less than or equal to 2.5 x the upper limit of normal (ULN). Total bilirubin within normal limits. Serum creatinine less than or equal to 2 mg / dL Women of childbearing potential and men (including those undergoing vasectomy and if your partner is a woman of childbearing potential), must use two forms of contraception throughout treatment, during dose interruptions and for 4 weeks after receiving the last dose, and meet all the requirements of Annex 10. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 460 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: Patients with any of the following exclusion criteria may not be included in the clinical trial: Non-secretory myeloma without measurable plasmacytomas. Patient who has previously received treatment for multiple myeloma, with the exception of pulse steroids, bisphosphonates or radiotherapy for some emergency treatment before induction. Peripheral neuropathy greater than or equal to grade 2 within 21 days prior to inclusion. Hypersensitivity to bortezomib, boric acid, mannitol or lenalidomide. Patients who have received any investigational agent within 28 days prior to inclusion. Patient who has had a myocardial infarction within 6 months prior to inclusion in the clinical trial or has a functional class III or IV according to the New York Heart Association (NYHA) heart failure, uncontrolled angina, ventricular arrhythmias not controlled or detected electrocardiographically acute ischemia or conduction system disorders. Patients who are currently in another clinical trial or receiving any investigational agent. Positive serology for HBV, HCV or HIV.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Progression-free survival after autologous transplantation with BuMel vs. MEL-200 in patients receiving GEM VRD-induction regimen prior.;Secondary Objective: Rate of complete remission (CR) with negative immunofixation after each stage of treatment (induction and consolidation autotransplantation). Evaluation of minimal residual disease (MRD) in patients with negative immunofixation RC-after each stage of treatment (induction and consolidation autotransplantation). Overall survival (OS) after PBSCT with BuMel vs. MEL-200. To evaluate the safety and tolerability of induction and consolidation treatment.;Primary end point(s): Progression-free survival (PFS) after the two packaging schemes;Timepoint(s) of evaluation of this end point: 60 meses | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Tasa de remisiones completas tras cada etapa de tratamiento (inducción, autotrasplante y consolidación). Estudios secuenciales de enfermedad mínima residual negativa (EMR) en pacientes en remisión completa tras cada etapa de tratamiento (inducción, autotrasplante y consolidación). Supervivencia global. Seguridad de la combinación VRD-GEM en inducción y consolidación y de ambos esquemas de acondicionamiento.;Timepoint(s) of evaluation of this end point: 60 meses | — |
Countries
Spain
Contacts
Public ContactBegoña García
Trial Form Support, S.L.
Outcome results
None listed