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A PHASE II, MULTI-CENTRE, OPEN LABEL STUDY OF MELPHALAN, PREDNISONE, THALIDOMIDE AND BORTEZOMIB IN ADVANCED AND REFRACTORY MULTIPLE MYELOMA PATIENTS.

A PHASE II, MULTI-CENTRE, OPEN LABEL STUDY OF MELPHALAN, PREDNISONE, THALIDOMIDE AND BORTEZOMIB IN ADVANCED AND REFRACTORY MULTIPLE MYELOMA PATIENTS.

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2004-000565-34-IT
Enrollment
Unknown
Registered
2007-10-09
Start date
2004-10-01
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

ADVANCED AND REFRACTORY MULTIPLE MYELOMA PATIENTS. MedDRA version: 9.1 Level: LLT Classification code 10028228 Term: Multiple myeloma

Interventions

Trade Name: ALKERAN*25CPR RIV 2MG Pharmaceutical Form: Tablet INN or Proposed INN: Melphalan Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 2- Trade Name: DELTACO

Sponsors

AZIENDA SANITARIA OSPEDALIERA "S. GIOVANNI BATTISTA DI TORINO"
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Main Objective: DETERMINARE SE L'ASSOCIAZIONE MPTV COME TERAPIA DI SALVATAGGIO E' SICURA E DA BENEFICI NEI PAZIENTI CON MIELOMA AVANZATO-REFRATTARIO. ;Secondary Objective: DETERMINARE SE LE RISPOSTE OTTENUTE CON IL TRATTAMENTO MPTV SONO ASSOCIATE AD UN PROLUNGAMENTO DELLA SOPRAVVIVENZA LIBERA DA MALATTIA, COMPARATO AI PAZIENTI NON RESPONSIVI. ;Primary end point(s): DETERMINAZIONE DEL TASSO DI RISPOSTA IN ACCORDO CON I CRITERI EGBMT.—

Countries

Italy

Outcome results

None listed

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