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Phase 1

• Conditions: multiple Myeloma; MedDRA version: 17.0 Level: LLT Classification code 10028566 Term: Myeloma System Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2013-002157-29-ES
• Lead Sponsor: Ernesto Pérez Persona

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-08-14
• Last Update Posted: 30 April 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 44

Inclusion Criteria

- The patient should , in the investigator's opinion, be able to meet all
requirements of the trial.
- The patient must voluntarily sign informed consent before
performing any test study that is not part of routine care of
patients , with the knowledge that the patient can leave the
study at the time you want, without being harmed at any time their
aftercare.
- Age > 75 years
- The patient should be diagnosed symptomatic multiple myeloma according to
established criteria and may not have received any treatment for disease (see Appendix 6) . Administration is permitted steroid pulses some urgency required prior to starting treatment or induction administration of bisphosphonates .
- The patient must have measurable disease , defined as follows:
- For Multiple Myeloma secretory measurable disease is defined by the
presence of measurable serum monoclonal component, 1g/dL or if urinary excretion of light chains is greater than or equal to 200 mg/24 hours.
- For Multiple Myeloma oligosecretory or secretory , serous level chain
Free light affected 10 mg / dL (100 mg / L , with a ratio of abnormal free light chain serum)
- The patient must have a life expectancy greater than 3 months life.
- The patient must have the following laboratory values ??prior to initiation of treatment corresponding induction :
1. Platelet count 50000/mm3 , hemoglobin 8 g / dl , absolute neutrophil count 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 75

Exclusion Criteria

-Patients who have previously received treatment for multiple myeloma, with the exception of pulse steroids for some urgency required prior to initiating induction therapy, administration of bisphosphonates or radiotherapy either analgesic or due to the presence of plasmacytomas required for some urgency.
Patients with non-measurable disease or by SFLC.
-Patients with known hypersensitivity to bortezomib, boron or mannitol acid.
-Patients who have received any investigational agent within 30 days prior to inclusion.
- Patients who are currently in another clinical trial or receiving any investigational agent.
- Poorly controlled hypertension or diabetes mellitus or other serious organic disease involving excessive risk to the patient or any psychiatric disorder that interfira with understanding of informed consent.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified