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

Waldenstrom Macroglobulinemia Clinical Trial

— WM2  

Official title:

A Phase IIA Trial Testing the Efficacy of Bortezomib (Velcade(R)) in Patients With Advanced Waldenström Macroglobulinemia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00777738
• Other study ID #: P060207
• Status: Completed
• Phase: Phase 2
• First received: October 16, 2008
• Last updated: January 17, 2013
• Start date: October 2008
• Est. completion date: August 2012

Study information

• Verified date: October 2008
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Waldenstrom Macroglobulinemia

Intervention

Drug:
• BORTEZOMIB
Bortezomib (Velcade(R)): 1.3 mg/m2 on Days 1, 4, 8, and 11 every 21 days for 2 cycles (IV route, push). For responding patients : up to 6 cycles For non responding patient : Adjunction of dexamethasone (HD DXM) : 20 mg Days 1,D2, D 4,D 5, D8, D9 and D 11,D12 every 21 days

Locations

Country	Name	City	State
France	Hopital La Pitie Salpetriere	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete and partial remission, defined by the 2nd Workshop on Waldenstrom's macroglobulinemia		3 months and 6 months	No
Secondary	Duration of the response		during the study	No
Secondary	Overall survival		during the study	No
Secondary	Quality of life		months 0, 3, 12, 24	Yes