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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00777738
First received: October 16, 2008
Last updated: January 17, 2013
Last verified: October 2008
History of Changes
  Purpose

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 Intervention Phase
Waldenstrom Macroglobulinemia
 Drug: BORTEZOMIB
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase IIA Trial Testing the Efficacy of Bortezomib (Velcade(R)) in Patients With Advanced Waldenström Macroglobulinemia

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Complete and partial remission, defined by the 2nd Workshop on Waldenstrom's macroglobulinemia [ Time Frame: 3 months and 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Duration of the response [ Time Frame: during the study ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: during the study ] [ Designated as safety issue: No ]
  • Quality of life [ Time Frame: months 0, 3, 12, 24 ] [ Designated as safety issue: Yes ]

Enrollment: 34
Study Start Date: October 2008
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Other Name: BORTEZOMIB

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT00777738     History of Changes
Other Study ID Numbers: P060207
Study First Received: October 16, 2008
Last Updated: January 17, 2013
Health Authority: France: Ministry of Health

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
 Dexamethasone
Bortezomib
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal

ClinicalTrials.gov processed this record on May 21, 2013