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 intensive
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 (WHO=3 is allowed only when caused by MM and not by co-morbid conditions); 4. Negative pregnancy test at inclusion if applicable; 5. Written informed consent.
Exclusion criteria
Exclusion criteria: 1. Known intolerance of Thalidomide or Boron; 2. Systemic AL amyloidosis; 3. Non-secretory MM; 4. Previous chemotherapy or radiotherapy except 2 cycles of Melphalan/Prednisone or local radiotherapy in case of local myeloma progression; 5. Severe cardiac dysfunction (NYHA classification II-IV); 6. Significant hepatic dysfunction (serum bilirubin >= 30 mmol/l or transaminases >= 2.5 times normal level), unless related to myeloma; 7. Patients known to be HIV-positive; 8. Patients with active, uncontrolled infections; 9. Patients with neuropathy, CTC grade 2 or higher; 10. 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; 11. Patients who will not give permission for collection of BM aspirate at entry; 12. Patients who are not willing or capable to use adequate contraception during the therapy (all men, all pre-menopausal women); 13. Patients <= 65 years with an HLA-identical sibling who will undergo non-myeloablative AlloSCT; 14. Lactating women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival (i.e. time from registration to progression or death from any cause whichever occurs first). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Response (PR, VGPR and CR); 2. Overall survival measured from the time of registration. Patients still alive or lost to follow up are censored at the date they were last known to be alive; 3. Toxicity; 4. Progression free survival from HDM (i.e. time from last HDM treatment to progression or death from any cause whichever occurs first for patients who received at least PR on HDM); 5. Progression free survival analysed as primary endpoint, but patients with an allogeneic transplant not censored. This primarily to check whether censoring has a major impact. | — |
Contacts
Public ContactP. Sonneveld
P.O. Box 2040
Outcome results
None listed