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Efficacy of Bortezomib (Velcade(R)) in Patients With Advanced Waldenström Macroglobulinemia (WM2)

Primary Purpose

Waldenstrom Macroglobulinemia

Status

Completed

Phase

Phase 2

Locations

France

Study Type

Interventional

Intervention

BORTEZOMIB

About this trial

This is an interventional treatment trial for Waldenstrom Macroglobulinemia focused on measuring Advanced Waldenström's macroglobulinemia, Bortezomib, Dexamethasone, Safety, Efficacy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Hopital La Pitie Salpetriere

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

bortezomib

Arm Description

bortezomib

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Duration of the response

Overall survival

Quality of life

Full Information

NCT ID

NCT00777738

First Posted

October 16, 2008

Last Updated

January 17, 2013

Sponsor

Assistance Publique - Hôpitaux de Paris

1. Study Identification

Unique Protocol Identification Number

NCT00777738

Brief Title

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

Acronym

WM2

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2008

Overall Recruitment Status

Completed

Study Start Date

October 2008 (undefined)

Primary Completion Date

August 2012 (Actual)

Study Completion Date

August 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Assistance Publique - Hôpitaux de Paris

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Waldenstrom Macroglobulinemia

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

34 (Actual)

8. Arms, Groups, and Interventions

Arm Title

bortezomib

Arm Type

Experimental

Arm Description

bortezomib

Intervention Type

Drug

Intervention Name(s)

BORTEZOMIB

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Time Frame

3 months and 6 months

Secondary Outcome Measure Information:

Title

Duration of the response

Time Frame

during the study

Title

Overall survival

Time Frame

during the study

Title

Quality of life

Time Frame

months 0, 3, 12, 24

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Véronique LEBLOND, MD, PhD

Organizational Affiliation

Assistance Publique - Hôpitaux de Paris

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hopital La Pitie Salpetriere

City

Paris

ZIP/Postal Code

75013

Country

France

12. IPD Sharing Statement

Learn more about this trial

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

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