Brief Title
Efficacy of Bortezomib (Velcade(R)) in Patients With Advanced Waldenström Macroglobulinemia
Official Title
A Phase IIA Trial Testing the Efficacy of Bortezomib (Velcade(R)) in Patients With Advanced Waldenström Macroglobulinemia
Brief 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.
Detailed 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
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
Complete and partial remission, defined by the 2nd Workshop on Waldenstrom's macroglobulinemia
Secondary Outcome
Duration of the response
Condition
Waldenstrom Macroglobulinemia
Intervention
BORTEZOMIB
Study Arms / Comparison Groups
bortezomib
Description: bortezomib
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
34
Start Date
October 2008
Completion Date
August 2012
Primary Completion Date
August 2012
Eligibility 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
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Véronique LEBLOND, MD, PhD, ,
Location Countries
France
Location Countries
France
Administrative Informations
NCT ID
NCT00777738
Organization ID
P060207
Responsible Party
Sponsor
Study Sponsor
Assistance Publique - Hôpitaux de Paris
Study Sponsor
Véronique LEBLOND, MD, PhD, Principal Investigator, Assistance Publique - Hôpitaux de Paris
Verification Date
October 2008