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A phase 3, prospective, randomized clinical study with Velcade-Thalidomide- Dexamethasone versus Thalidomide-Dexamethasone for previously untreated patients with symptomatic multiple myeloma who are candidates to receive double autologous transplantation. 26866138-MMY-3006

A phase 3, prospective, randomized clinical study with Velcade-Thalidomide- Dexamethasone versus Thalidomide-Dexamethasone for previously untreated patients with symptomatic multiple myeloma who are candidates to receive double autologous transplantation. 26866138-MMY-3006

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2005-003723-39-IT
Enrollment
50
Registered
2008-12-17
Start date
2005-07-26
Completion date
Unknown
Last updated
2021-10-08

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

Conditions

terapia del mieloma nultuplo in pazienti con danno d' organo e assenza di precedente terapia per MM MedDRA version: 9.1 Level: HLT Classification code 10028229 Term: Multiple myelomas

Interventions

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

Sponsors

AZIENDA OSPEDALIERA DI BOLOGNA POLICLINICO S. ORSOLA M. MALPIGHI
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) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Main Objective: To compare the probability of answer to VELCADE-thalidomide-dexamethasone (the group of A treatment) or thalidomide-dexamethasone (group of B treatment) like primary therapy of induction of the answer.;Secondary Objective: 1) comparare la probabilita' di risposta a VELCADE-Talidomide-Desametasone (gruppo di trattamento A) o a Talidomide-Desametasone (gruppo di trattamento B) come terapia di consolidamento dopo trapianto autologo; 2) comparare il tempo alla progressione nei 2 gruppi di trattamento; 3) comparare la sopravvivenza globale e libera da eventi nei 2 gruppi di pazienti; 4) comparare la tossicita' di VELCADE-Talidomide-Desametasone e Talidomide-Desametasone; 5) comparare l efficienza della raccolta di PBSC nei 2 gruppi di pazienti. ;Primary end point(s):—

Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Mar 11, 2026