Main info

Identifier:

HOVON 50 MM

Sponsor:

HOVON

Included patients:

556

Active sites:

0

(of 42)

42 sites are pending

Title:

A randomized phase III study on the effect of Thalidomide combined with Adriamycin, Dexamethasone (AD) and High Dose Melphalan in patients with multiple myeloma.

Timeline

Flow

Details

Phase:

Prospective randomized Phase III study

Monitoring Type:

Objectives:

Eligibility

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 (see appendix D);
• Negative pregnancy test at inclusion if applicable;
• Written informed consent.

Exclusion Criteria:

• Known intolerance of Thalidomide;
• Systemic AL amyloidosis;
• 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 mumol/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 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 <= 55 years with an HLA-identical sibling who will undergo myeloablative AlloSCT.

Participating Sites

= Active hospitals

= Inactive hospitals