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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
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Study Description
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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.

Condition or disease Intervention/treatment Phase
Waldenstrom Macroglobulinemia Drug: BORTEZOMIB Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
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

Resource links provided by the National Library of Medicine

Drug Information available for: Bortezomib

Arms and Interventions
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Arm Intervention/treatment
Experimental: bortezomib
bortezomib
 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


Outcome Measures
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Primary Outcome Measures :
  1. Complete and partial remission, defined by the 2nd Workshop on Waldenstrom's macroglobulinemia [ Time Frame: 3 months and 6 months ]

Secondary Outcome Measures :
  1. Duration of the response [ Time Frame: during the study ]
  2. Overall survival [ Time Frame: during the study ]
  3. Quality of life [ Time Frame: months 0, 3, 12, 24 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
France
Hopital La Pitie Salpetriere
Paris, France, 75013
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Véronique LEBLOND, MD, PhD Assistance Publique - Hôpitaux de Paris
More Information
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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT00777738     History of Changes
Other Study ID Numbers: P060207
First Posted: October 22, 2008    Key Record Dates
Last Update Posted: January 18, 2013
Last Verified: October 2008

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Advanced Waldenström's macroglobulinemia
Bortezomib
Dexamethasone
Safety
Efficacy

Additional relevant MeSH terms:
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