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

Phase 2
18 Years
Not Enrolling
Waldenstrom Macroglobulinemia

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Trial Information

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

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

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

- Total bilirubin < 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

Type of Study:


Study Design:

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

Outcome Measure:

Complete and partial remission, defined by the 2nd Workshop on Waldenstrom's macroglobulinemia

Outcome Time Frame:

3 months and 6 months

Safety Issue:


Principal Investigator

Véronique LEBLOND, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Assistance Publique - Hôpitaux de Paris


France: Ministry of Health

Study ID:




Start Date:

October 2008

Completion Date:

August 2012

Related Keywords:

  • Waldenström Macroglobulinemia
  • Advanced Waldenström's macroglobulinemia
  • Bortezomib
  • Dexamethasone
  • Safety
  • Efficacy
  • Waldenstrom Macroglobulinemia