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

NCT00777738 | Completed Phase 2 DMC

• 1 other identifier: P060207
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Waldenstrom Macroglobulinemia

Keywords

Advanced Waldenström's macroglobulinemia; Bortezomib; Dexamethasone; Safety; Efficacy

Outcome Measures

Primary Outcomes (1)

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

  3 months and 6 months

Secondary Outcomes (3)

• Duration of the response

  during the study

• Overall survival

  during the study

• Quality of life

  months 0, 3, 12, 24

Study Arms (1)

bortezomib

EXPERIMENTAL

bortezomib

Drug: BORTEZOMIB

Interventions

BORTEZOMIB DRUG

* 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

bortezomib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ● 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Hopital La Pitie Salpetriere

Paris, 75013, France

Location

MeSH Terms

Conditions

Waldenstrom Macroglobulinemia

Interventions

Bortezomib

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Boronic Acids; Acids, Noncarboxylic; Acids; Inorganic Chemicals; Boron Compounds; Organic Chemicals; Pyrazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Véronique LEBLOND, MD, PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2008
• First Posted: October 22, 2008
• Study Start: October 1, 2008
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: January 18, 2013

Record last verified: 2008-10

Locations

FR (1)