A randomized phase III study on the effect of Bortezomib combined with Adriamycin, Dexamethasone (AD) for induction treatment, followed by High Dose Melphalan and Bortezomib alone during maintenance in patients with multiple myeloma - HOVON 65 MM / GMMG-HD4

• Conditions: multiple myeloma; MedDRA version: 8.1Level: LLTClassification code 10028228Term: Multiple myeloma

• Registration Number: EUCTR2004-000944-26-BE
• Lead Sponsor: HOVON foundation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-05-02
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

-Patients with a confirmed diagnosis of multiple myeloma stage II or III according to the Salmon & Durie criteria (see appendix A);
- Age 18-65 years inclusive;
-WHO performance status 0-3 (WHO=3 is allowed only when caused by MM and not by co-morbid conditions) (see appendix D);
-Negative pregnancy test at inclusion if applicable;
-Written informed consent.

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

-Known intolerance of Thalidomide or Boron;
-Systemic AL amyloidosis;
-Non-secretory MM
-Previous chemotherapy or radiotherapy except 2 cycles of Melphalan/Prednisone or local radiotherapy in case of local myeloma progression;
-Severe cardiac dysfunction (NYHA classification II-IV, see appendix E);
-Significant hepatic dysfunction (serum bilirubin = 30 mmol/l or transaminases = 2.5 times normal level), unless related to myeloma;
-Patients known to be HIV-positive;
-Patients with active, uncontrolled infections;
-Patients with neuropathy, CTC grade 2 or higher
-Patients with a history of active malignancy during the past 5 years with the exception of basal carcinoma of the skin or stage 0 cervical carcinoma;
-Patients who are not willing or capable to use adequate contraception during the therapy (all men, all pre-menopausal women);
-Patients = 65 years with an HLA-identical sibling who will undergo non-myeloablative AlloSCT;
-Lactating women

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified