Efficacy of Bortezomib (Velcade(R)) in Patients With Advanced Waldenström Macroglobulinemia

• Status: Completed
• Trial end date: 2012-08-01
• Target enrollment: 0
• Participant gender: All

Summary

This trial is designed to evaluate the efficacy and toxicity of Bortezomib , an inhibitor of proteasome used in multiple myeloma, in patients with advanced Waldenström's Macroglobulinemia disease.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Treatments: Bortezomib

Criteria

Inclusion Criteria:

● Established diagnosis of Waldenström macroglobulinemia (the 2nd Workshop on Waldenstrom's macroglobulinemia)

Patient must have had 1 (or 2) lines of chemotherapy containing alkylating agent and/or Fludarabine :and /or monoclonal antibody and must have :

• Life expectancy > 3 months

• Age > 18 years

• ECOG performance status 0-1-2

• ANC > 1 x 109/L

• Creatinine clearance, calculated according to the formula of cockcroft and Gault > 40 ml/min

• Total bilirubin < 2x ULN

• ASAT, ALAT < 2x ULN

• A negative serum pregnancy test one week prior to treatment must be available both for pre-menopausal women and for women who are < 2 years after the onset of menopause

• Adequate contraceptive methods for males and pre-menopausal females for 6 months after treatment discontinuation.

• Written informed consent

• Platelets> 100X 109

Exclusion Criteria:

• Active secondary malignancy or chemotherapy/radiotherapy for any neoplastic disease other than Waldenström macroglobulinemia prior to the study

• Medical condition requiring the long-term (estimated to be more than one month) use of oral corticosteroids

• Patients with active bacterial, viral or fungal infection

• Known infection with HIV, Hepatitis B (except post vaccinal profile) or C

• Treatment with any, other investigational agent or participating in another trial within 30 days prior to entering this study

• Lactation/pregnancy

• Concurrent severe diseases which exclude the administration of therapy heart insufficiency NYHA grade III/IV, LEVF < 50% and or RF < 30%, myocardial infarction within the past 6 months prior to study

• Severe pulmonary or heart problems (acute diffuse pulmonary and pericardial disease)

• Severe chronic obstructive lung disease with hypoxemia

• Severe diabetes mellitus

• Hypertension difficult to control

• Impaired renal function with creatinine clearance < 40 ml/min according to the formula of Cockcroft and Gault

• Cerebral dysfunction

• Richter's syndrome

• Neuropathy> grade 1

• Positive Beta HCG

• Severe Hepato cellular alteration