Estudio fase III nacional, multicéntrico, abierto, aleatorizado, de tratamiento de inducción con bortezomib/lenalidomida/dexametasona (VRD-GEM), seguido de altas dosis de quimioterapia con melfalán-200 (MEL-200) vs. busulfan-melfalán (BUMEL) y consolidación con VRD-GEM para pacientes con mieloma múltiple sintomático de nuevo diagnóstico menores de 65 años

Phase 1

Conditions: Multiple myeloma
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2012-005683-10-ES

Lead Sponsor: FUNDACIÓN PETHEMA

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

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

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.