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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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2006-002588-22-IT
Enrollment
Unknown
Registered
2007-07-12
Start date
2006-07-20
Completion date
Unknown
Last updated
2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

relapsed/refractory multiple myeloma patients MedDRA version: 9.1 Level: LLT Classification code 10028228 Term: Multiple myeloma

Interventions

Trade Name: VELCADE*INIET 1FL 3,5MG 1MG/ML Pharmaceutical Form: Powder for solution for injection INN or Proposed INN: Bortezomib Concentration unit: mg milligram(s) Concentration type: equal Concentr

Sponsors

AZIENDA OSPEDALIERO UNIVERSITARIA OSPEDALI RIUNITI UMBERTO I - G.M.LANCISI - G.SALESI
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1-MM relapsed/refractory after thalidomide treatment 2-age =65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1-De novo MM 2-Pregnancy or lactating women 3-contracceptive methods refusal 4-inadequate hepatic, cardiac, renal and cerebral function

Design outcomes

Primary

MeasureTime frame
Main Objective: overall response rate complete remission rate toxicity;Secondary Objective: progression free survival event free survival overall survival;Primary end point(s): Evaluation of activity and toxicity of the association—

Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026