Efficacy of Bortezomib (Velcade(R)) in Patients With Advanced Waldenström Macroglobulinemia (WM2)

Assistance Publique - Hôpitaux de Paris

Status and phase

Completed

Phase 2

Conditions

Waldenstrom Macroglobulinemia

Treatments

Drug: BORTEZOMIB

Study type

Interventional

Funder types

Other

Identifiers

NCT00777738

P060207

Details and patient eligibility

About

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.

Full description

Open, prospective, multicenter, non controlled phase IIA trial

Primary objectives Evaluation of the efficacy and safety of Velcade in monotherapy for patients with advanced stage Waldenström Macroglobulinemia.

Secondary objectives Evaluation of the activity of the association of High Dose Dexamethasone (HD DXM) with Velcade for patients resistant to Velcade Alone For all patients

Overall survival
Safety
Quality of life
Duration of response

sample size: With type I error alpha of 5% and type II error beta of 20% and a two-sided test, the number of patients needed in this study is 34 Number of centers: 28 Centers participating to the French cooperative group CLL/WM

Enrollment

34 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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