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A phase II, multicenter study of etoposide, aracytin, dexamethasone and bortezomib in patients affected by relapsed/refractory multiple myeloma previously treated with thalidomide - ND

Conditions
relapsed/refractory multiple myeloma patients
MedDRA version: 9.1Level: LLTClassification code 10028228Term: Multiple myeloma
Registration Number
EUCTR2006-002588-22-IT
Lead Sponsor
AZIENDA OSPEDALIERO UNIVERSITARIA OSPEDALI RIUNITI UMBERTO I - G.M.LANCISI - G.SALESI
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Recruiting
Sex
All
Target Recruitment
Not specified
Inclusion Criteria

1-MM relapsed/refractory after thalidomide treatment

2-age < 80 years

3-written informed consent
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1-De novo MM

2-Pregnancy or lactating women

3-contracceptive methods refusal

4-inadequate hepatic, cardiac, renal and cerebral function

Study & Design

Study Type
Interventional clinical trial of medicinal product
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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