Multiple Myeloma.
Conditions
Interventions
Patients with multiple myeloma, meeting all eligibility criteria will be randomized on entry between:
Arm A:
standard Vincristine, Adriamycin and Dexamethasone (VAD) induction, followed by intensiv
Sponsors
Stichting Hemato-Oncologie voor Volwassenen Nederland (HOVON)
P/a HOVON Data Center
Erasmus MC - Daniel den Hoed
Postbus 5201
3008 AE Rotterdam
Tel: 010 4391568
Fax: 010 4391028
e-mail: hdc@erasmusmc.nl
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients with a confirmed diagnosis of multiple myeloma stage II or III according to the Salmon & Durie criteria; 2. Age 18-65 years inclusive; 3. WHO performance status 0-3; 4. Negative pregnancy test at inclusion if applicable; 5. Written informed consent.
Exclusion criteria
Exclusion criteria: 1. Known intolerance of Thalidomide; 2. Systemic AL amyloidosis; 3. Previous chemotherapy or radiotherapy except 2 cycles of Melphalan/Prednisone or local radiotherapy in case of local myeloma progression; 4. Severe cardiac dysfunction (NYHA classification II-IV); 5. Significant hepatic dysfunction (serum bilirubin >= 30 micromol/l or transaminases >= 2.5 times normal level), unless related to myeloma; 6. Patients known to be HIV-positive; 7. Patients with active, uncontrolled infections; 8. 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; 9. Patients who are not willing or capable to use adequate contraception during the therapy (all men, all pre-menopausal women); 10. Patients <= 55 years with an HLA-identical sibling who will undergo myeloablative AlloSCT.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Event free survival (i.e., time from registration to induction failure, progression or death, whichever occurs first); the time to failure of patients with induction failure is set at one day. Patients are considered induction failure when they have not achieved at least a PR and are not eligible for further treatment according to protocol. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Response (PR and CR); 2. Overall survival measured form the time of registration. Patient still alive or lost to follow up are censored at the date they were last known to be alive; 3. Progression free survival (duration of the first response (PR or CR)) measured from the time of achievement of PR (or CR) to date of progression or death from any cause (whichever occurs first); 4. Toxicities of Thalidomide and chemotherapy. | — |
Contacts
Public ContactH.M. Lokhorst
University Medical Center Utrecht (UMCU), Department of Hematology (B02.226), P.O. Box 85500
Outcome results
None listed