Efficacy of Bortezomib (Velcade(R)) in Patients With Advanced Waldenström Macroglobulinemia (WM2)
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ClinicalTrials.gov Identifier: NCT00777738 |
Recruitment Status :
Completed
First Posted : October 22, 2008
Last Update Posted : January 18, 2013
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Waldenstrom Macroglobulinemia | Drug: BORTEZOMIB | Phase 2 |
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 Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 34 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase IIA Trial Testing the Efficacy of Bortezomib (Velcade(R)) in Patients With Advanced Waldenström Macroglobulinemia |
Study Start Date : | October 2008 |
Actual Primary Completion Date : | August 2012 |
Actual Study Completion Date : | August 2012 |

Arm | Intervention/treatment |
---|---|
Experimental: bortezomib
bortezomib
|
Drug: BORTEZOMIB
|
- Complete and partial remission, defined by the 2nd Workshop on Waldenstrom's macroglobulinemia [ Time Frame: 3 months and 6 months ]
- Duration of the response [ Time Frame: during the study ]
- Overall survival [ Time Frame: during the study ]
- Quality of life [ Time Frame: months 0, 3, 12, 24 ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00777738
France | |
Hopital La Pitie Salpetriere | |
Paris, France, 75013 |
Principal Investigator: | Véronique LEBLOND, MD, PhD | Assistance Publique - Hôpitaux de Paris |
Responsible Party: | Assistance Publique - Hôpitaux de Paris |
ClinicalTrials.gov Identifier: | NCT00777738 |
Other Study ID Numbers: |
P060207 |
First Posted: | October 22, 2008 Key Record Dates |
Last Update Posted: | January 18, 2013 |
Last Verified: | October 2008 |
Advanced Waldenström's macroglobulinemia Bortezomib Dexamethasone Safety Efficacy |
Waldenstrom Macroglobulinemia Neoplasms, Plasma Cell Neoplasms by Histologic Type Neoplasms Hemostatic Disorders Vascular Diseases Cardiovascular Diseases Paraproteinemias Blood Protein Disorders |
Hematologic Diseases Hemorrhagic Disorders Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Bortezomib Antineoplastic Agents |