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A PHASE II MULTICENTER STUDY OF BORTEZOMIB, THALIDOMIDE, PEGHILATED LIPOSOMAL DOXORUBICIN, DEXAMETHASONE (ThaDD-V)IN PATIENTS AFFECTED BY RELAPSED-REFRACTORY MULTIPLE MYELOMA - ND

A PHASE II MULTICENTER STUDY OF BORTEZOMIB, THALIDOMIDE, PEGHILATED LIPOSOMAL DOXORUBICIN, DEXAMETHASONE (ThaDD-V)IN PATIENTS AFFECTED BY RELAPSED-REFRACTORY MULTIPLE MYELOMA - ND

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2006-002564-25-IT
Enrollment
Unknown
Registered
2007-07-13
Start date
2006-08-08
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 MM MedDRA version: 6.1 Level: PT Classification code 10028228

Interventions

Trade Name: CAELYX*INFUS 1FL 2MG/ML 25ML Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: Doxorubicin CAS Number: 25316-40-9 Concentration unit: mg milligram(s) 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-Realapsed-refractory multiple myeloma (MM) 2-Less or equal 2 previuos chemotherapy regimens 3-Age =65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1-De novo or treated with > 2 chemotherapy regimens MM 2-Pregnant or lactated women 3-Refuse of contracceptive methods 4-Neuropathy > grade 2 5-Inadequate cardiac, hepatic, bone marrow and cerebral functions 6-Other active or in remission from <5 years neoplasia

Design outcomes

Primary

MeasureTime frame
Main Objective: COMPLETE REMISSION RATE TOXICITY;Secondary Objective: PROGRESSION FREE SURVIVAL EVENT FREE SURVIVAL OVERALL SURVIVAL;Primary end point(s): Evaluation of activity and toxicity of thalidomide,dexamethasone, pegilated liposomal doxorubicin e bortezomib association—

Countries

Italy

Outcome results

None listed

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