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A PHASE II, MULTI-CENTER STUDY OF BORTEZOMIB, ADRIAMYCIN, DEXAMETHASONE (PAD) as induction and MELPHALAN 100 mg/m2 (MEL 100) as transplant, IN ELDERLY NEWLY DIAGNOSED MULTIPLE MYELOMA PATIENTS.

A PHASE II, MULTI-CENTER STUDY OF BORTEZOMIB, ADRIAMYCIN, DEXAMETHASONE (PAD) as induction and MELPHALAN 100 mg/m2 (MEL 100) as transplant, IN ELDERLY NEWLY DIAGNOSED MULTIPLE MYELOMA PATIENTS.

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2005-004714-32-IT
Enrollment
Unknown
Registered
2007-12-19
Start date
2006-05-02
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

Treatment in elderly newly diagnosed multiple myeloma patients MedDRA version: 9.1 Level: LLT Classification code 10028228 Term: Multiple myeloma

Interventions

Trade Name: BORTEZOMIB Pharmaceutical Form: Powder for solution for injection INN or Proposed INN: Bortezomib Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 1.3-

Sponsors

FONDAZIONE NEOPLASIE SANGUE ONLUS
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) 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

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Main Objective: L’obiettivo primario di questo studio e': Determinare se la sequenza VELCADE, Adriamicina, Desametasone (PAD)- MEL100 e' sicura e comporta benefici in pazienti con nuova diagnosi di mieloma. ;Secondary Objective: Gli obiettivi secondari di questo studio sono: -Determinare se il trattamento proposto prolunga la sopravvivenza globale (OS). -Determinare se la sopravvivenza libera da progressione (PFS) @ 3 anni e' <del 35% -Verificare se le remissioni molecolari ottenute con la sequenza PAD-MEL100 sono transitorie o durature. -Verificare se le remissioni molecolari ottenute con il trattamento proposto sono associate ad un prolungamento della remissione libera da malattia (PFS). -Determinare se la risposta al tumore e la sopravvivenza potrebbe cambiare in modo significativo in particolare nei sottogruppi di pazienti con fattori prognostici definiti (B2-microglobulina, proteina C-reattiva, citogenetica, gene expression profile). ;Primary end point(s):—

Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Mar 2, 2026