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Bortezomib and Rituximab for Patients With Waldenstrom's Macroglobulinemia
This study is currently recruiting participants.
Verified by M.D. Anderson Cancer Center, December 2008
Sponsors and Collaborators: M.D. Anderson Cancer Center
Millennium Pharmaceuticals, Inc.
Information provided by: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00492050
  Purpose

Primary Objectives:

  1. To assess response rate in newly diagnosed patients with Waldenstrom's Macroglobulinemia treated with bortezomib and rituximab.
  2. To assess ability to collect stem cells after treatment with bortezomib and rituximab in newly diagnosed patients with Waldenstrom's Macroglobulinemia.

Secondary Objectives:

  1. To assess overall response rate to treatment with bortezomib and rituximab followed by cladribine, cyclophosphamide and rituximab in newly diagnosed patients with Waldenstrom's Macroglobulinemia
  2. To assess time to progression and time to retreatment, following treatment with bortezomib and rituximab followed by cladribine, cyclophosphamide and rituximab in newly diagnosed patients with Waldenstrom's Macroglobulinemia
  3. To assess toxicity of treatment with bortezomib and rituximab in newly diagnosed patients with Waldenstrom's Macroglobulinemia.

Condition Intervention Phase
Waldenstrom's Macroglobulinemia
Drug: Bortezomib
Drug: Rituximab
Phase II

Genetics Home Reference related topics: aceruloplasminemia hemophilia
MedlinePlus related topics: Cancer
Drug Information available for: Rituximab Bortezomib
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title: Primary Treatment of Waldenstrom's Macroglobulinemia With Bortezomib (Velcade) and Rituximab (Rituxan) Followed by Autologous Stem Cell Collection

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • To learn if Velcade (bortezomib) given with rituximab can help to control WM. [ Time Frame: 3 Years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To review safety and tolerability of this drug combination followed by treatment with other drug combinations. [ Time Frame: 3 Years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 38
Study Start Date: August 2006
Estimated Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
Bortezomib + Rituximab
Drug: Bortezomib
1.6 mg/m^2 IV Weekly on Days 1, 8, 15 and 22.
Drug: Rituximab
375 mg/m^2 IV on Day 8 and 22.

  Show Detailed Description

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with symptomatic macroglobulinemic lymphoma who have had no prior treatment, or whose prior treatment has been limited to steroids and/or alpha-interferon, are eligible. Macroglobulinemic lymphoma includes patients with either biopsy proven clonal lymphocytic or lymphoplasmacytic proliferation and monoclonal IgM. Also included are symptomatic patients with clonal proliferation producing a pathologic monoclonal IgM that causes cryoglobulinemia, peripheral neuropathy or cold agglutinin hemolytic anemia.
  • Patients must have acceptable liver function (total bilirubin < 2.5mg/dL) and renal function (creatinine < 2.0mg/dL). Patients with impaired renal function will only be included if the renal failure is secondary to macroglobulinemic lymphoma (i.e. Bence Jones proteinuria, cryoglobulinemia, ureteral obstruction due to mass) that might reverse with improvement of disease.
  • Female subject is either post-menopausal or surgically sterilized or willing to use an acceptable method of birth control (i.e., a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study.
  • Male subject agrees to use an acceptable method for contraception for the duration of the study.
  • Patients must voluntarily sign an informed consent form indicating that they are aware of the investigational nature of the study, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future care.
  • Patient has a heart rate (HR) of greater than or equal to 50 bpm.

Exclusion Criteria:

  • Patient has a platelet count of <30x10^9/L within 28 days before enrollment unless due to >/= 75% marrow infiltration by macroglobulinemic lymphoma or splenomegaly.
  • Patient has an absolute neutrophil count of <1.0x10^9/L within 28 days before enrollment unless due to >/= 75% marrow infiltration by macroglobulinemic lymphoma.
  • Patient has a calculated or measured creatinine >/= to 2.0mg/dL on baseline evaluation. Patients with impaired renal function will only be included if the renal failure is secondary to macroglobulinemic lymphoma (i.e. Bence Jones proteinuria, cryoglobulinemia, ureteral obstruction due to mass).
  • Patient has >/= Grade 2 peripheral neuropathy on baseline evaluation.
  • Myocardial infarction within 6 months prior to enrollment or has New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. Prior to study entry, any ECG abnormality at Screening has to be documented by the investigator as not medically relevant.
  • Patient has hypersensitivity to boron, mannitol, or murine proteins.
  • Female subject is pregnant or breast-feeding. Confirmation that the subject is not pregnant must be established by a negative serum or urine Beta -human chorionic gonadotropin (B-hCG) pregnancy test result obtained during screening. Pregnancy testing is not required for post-menopausal or surgically sterilized women.
  • Patient has received other investigational drugs within 14 days before enrollment
  • Patient has a serious medical or psychiatric illness that is likely to interfere with participation in this clinical study.
  • Eastern Cooperative Oncology Group (ECOG) performance status of > 2.
  • Patient with a "currently active" second malignancy, other than non-melanoma skin cancer and carcinoma in situ of the cervix, should not be enrolled. Patients are not considered to have a "currently active" malignancy if they have completed therapy for a prior malignancy, are disease free from prior malignancies for > 5 years and are considered by their physician to be at less than 30 % risk of relapse.
  • Patient with a lifetime cumulative dose of > 450 mg/m^2 of anthracyclines.
  • Patients with an active hepatitis B infection.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00492050

Contacts
Contact: Sheeba Thomas, MD 713-792-2860

Locations
United States, Texas
U.T.M.D. Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Sheeba Thomas, MD            
Sponsors and Collaborators
M.D. Anderson Cancer Center
Millennium Pharmaceuticals, Inc.
Investigators
Principal Investigator: Sheeba Thomas, MD U.T.M.D. Anderson Cancer Center
  More Information

UT MD Anderson Cancer Center  This link exits the ClinicalTrials.gov site

Responsible Party: U.T.M.D. Anderson Cancer Center ( Sheeba K. Thomas, MD/Assistant Professor )
Study ID Numbers: 2005-0733
Study First Received: June 26, 2007
Last Updated: December 15, 2008
ClinicalTrials.gov Identifier: NCT00492050  
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Waldenstrom's Macroglobulinemia
Macroglobulinemic Lymphoma
Stem Cell Collection
Bortezomib
LDP-341
MLN341
PS-341
Velcade
Rituximab
Rituxan

Study placed in the following topic categories:
Immunoproliferative Disorders
Rituximab
Blood Protein Disorders
Hematologic Diseases
Blood Coagulation Disorders
Bortezomib
Vascular Diseases
Paraproteinemias
Hemostatic Disorders
Lymphatic Diseases
Waldenstrom Macroglobulinemia
Hemorrhagic Disorders
Waldenstrom macroglobulinemia
Lymphoproliferative Disorders
Lymphoma
Neoplasms, Plasma Cell

Additional relevant MeSH terms:
Neoplasms by Histologic Type
Immune System Diseases
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Enzyme Inhibitors
Pharmacologic Actions
Protease Inhibitors
Neoplasms
Therapeutic Uses
Cardiovascular Diseases
Antirheumatic Agents

ClinicalTrials.gov processed this record on January 16, 2009