ISRCTN64455289CompletedNot Applicable
A randomised 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
Dutch Haemato-oncology Association (Stichting Haemato-Oncologie voor Volwassenen Nederland [HOVON])0 sites800 target enrollmentStarted: November 3, 2005Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 800
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •1. Patients with a confirmed diagnosis of multiple myeloma stage II or III according to the Salmon and Durie criteria
- •2. Age 18 to 65 years inclusive
- •3. World Health Organisation (WHO) performance status zero to three (WHO = three is allowed only when caused by multiple myeloma and not by co-morbid conditions)
- •4. Negative pregnancy test at inclusion if applicable
- •5. Written informed consent
Exclusion Criteria
- •1. Known intolerance of thalidomide or boron
- •2. Systemic AL amyloidosis
- •3. Non-secretory multiple myeloma
- •4. Previous chemotherapy or radiotherapy except two cycles of melphalan/prednisone or local radiotherapy in case of local myeloma progression
- •5. Severe cardiac dysfunction (New York Heart Association [NYHA] classification II - IV)
- •6. Significant hepatic dysfunction (serum bilirubin more than or equal to 30 µmol/l or transaminases more than or equal to 2.5 times normal level), unless related to myeloma
- •7. Patients known to be Human Immunodeficiency Virus (HIV) positive
- •8. Patients with active, uncontrolled infections
- •9. Patients with neuropathy, CTC grade two or higher
- •10. Patients with a history of active malignancy during the past five years with the exception of basal carcinoma of the skin or stage zero cervical carcinoma
- •11. Patients who will not give permission for collection of Bone Marrow (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 or less with a Human Leukocyte Antigen (HLA) identical sibling who will undergo non-myeloablative AlloSCT
- •14. Lactating women
Investigators
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