Study of the Combination of Bortezomib, Dexamethasone, and Rituximab in Patients With Waldenstroms Macroglobulinemia - Full Text View

Sponsors and Collaborators:	Dana-Farber Cancer Institute Beth Israel Deaconess Medical Center Millennium Pharmaceuticals, Inc.
Information provided by:	Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:	NCT00250926

Purpose

The purpose of this study is to find out if the combination of bortezomib (Velcade), dexamethasone (Decadron) and rituximab (Rituxan) is effective in treating Waldenstrom's macroglobulinemia.

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

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Phase II Study of the Combination Bortezomib (Velcade, PS-341), Dexamethasone, and Rituximab in Patients With Waldenstroms Macroglobulinemia

Resource links provided by NLM:

Genetics Home Reference related topics: aceruloplasminemia hemophilia

MedlinePlus related topics: Cancer

Drug Information available for: Dexamethasone Dexamethasone acetate Doxiproct plus Rituximab Bortezomib Dexamethasone Sodium Phosphate

U.S. FDA Resources

Further study details as provided by Dana-Farber Cancer Institute:

Primary Outcome Measures:

To assess the safety and tolerability of bortezomib, dexamethasone and rituximab in patients with untreated Waldenstroms macroglobulinemia. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

To determine the response rate along with attainment of stable disease and time to disease progression following treatment with this patient population. [ Time Frame: TBD ] [ Designated as safety issue: No ]

Estimated Enrollment:	30
Study Start Date:	October 2005
Estimated Study Completion Date:	March 2010
Primary Completion Date:	March 2007 (Final data collection date for primary outcome measure)

Intervention Details:

Given intravenously on days 1, 4, 8, and 11 of a 21-day cycle for 8 cycles

Given intravenously after bortezomib and dexamethasone on day 11 of a 21-day cycle for 8 cycles

Detailed Description:

This is an open-label study which means both the patient and the doctor will know what drugs and doses the patient is receiving throughout the study.
Patients will receive 8 cycles of study treatment with bortezomib, dexamethasone and rituximab. Each cycle is 21 days long. Therapy is given on the first, fourth, eighth and eleventh day of each cycle, followed by a 10 day rest period. The first 4 cycles will be given one after the other. Three months after completing the fourth cycle of therapy, patients will receive one cycle of therapy every three months for a total of four more cycles.
On the first, fourth, eighth and eleventh day of each cycle, the patient will receive bortezomib and dexamethasone as an intravenous injection through a needle in your vein. On the eleventh day only, the patient will also receive rituximab as an intravenous infusion after getting bortezomib and dexamethasone.
Prior to each infusion of rituximab therapy, the patient will be asked to take some medications to prevent or reduce side effects of rituximab. These medications are benadryl, tylenol, and possibly more steroids. The doctor will determine which of these drugs are appropriate for the individual patient.
During the rituximab infusion, the patients blood pressure and pulse will be monitored frequently and the infusion rate may be decreased depending upon the side effects experienced.
After therapy is completed, the patient will be followed every three months for 2 more years for office visits and laboratory tests to determine how well they are doing and if the therapy continues to benefit them.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Clinicopathological diagnosis of Waldenstrom's macroglobulinemia (WM)
No previous therapy for WM
Measurable disease, defined as presence of immunoglobulin M (IgM) paraprotein with a minimum IgM level of greater than or equal to 2 times the upper limit of each institution's normal value
CD20 positive disease based on any previous bone marrow immuno-histochemistry or flow cytometric analysis performed up to 3 months prior to enrollment
Karnofsky performance status > 60
Life expectancy > 3 months
AST (SGOT) < 3 x ULN
ALT (SGPT) < 3 x ULN
Total bilirubin < 2 x ULN
Calculated or measured creatinine clearance > 30mL/minute
Serum sodium > 130 mmol/L
Female subject is either post-menopausal or surgically sterilized or willing to use an acceptable method of birth control
Male subject agrees to use an acceptable method for contraception for the duration of the study

Exclusion Criteria:

Previous therapy for Waldenstrom's macroglobulinemia
Myocardial infarction within 6 months prior to enrollment or has New York Hospital Association Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities.
Hypersensitivity to dexamethasone, boron or mannitol
Pregnant or breast-feeding women
Serious medical or psychiatric illness likely to interfere with participation in this clinical study

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00250926

Locations

United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215

Sponsors and Collaborators

Dana-Farber Cancer Institute

Beth Israel Deaconess Medical Center

Millennium Pharmaceuticals, Inc.

Investigators

Principal Investigator:

Steven P. Treon, MD, MA, PhD

Dana-Farber Cancer Institute

More Information

No publications provided

Responsible Party:	Dana-Farber Cancer Institute ( Steven P. Treon, MD, PhD )
Study ID Numbers:	05-180
Study First Received:	November 8, 2005
Last Updated:	December 19, 2007
ClinicalTrials.gov Identifier:	NCT00250926 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Dana-Farber Cancer Institute:

bortezomib
dexamethasone
rituximab

Study placed in the following topic categories:

Dexamethasone
Anti-Inflammatory Agents
Immunologic Factors
Blood Protein Disorders
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Antiemetics
Paraproteinemias
Hemostatic Disorders
Hormones
Hemorrhagic Disorders
Dexamethasone acetate
Immunoproliferative Disorders
Antineoplastic Agents, Hormonal

Hematologic Diseases
Rituximab
Blood Coagulation Disorders
Bortezomib
Vascular Diseases
Glucocorticoids
Protease Inhibitors
Lymphatic Diseases
Waldenstrom Macroglobulinemia
Peripheral Nervous System Agents
Antirheumatic Agents
Lymphoproliferative Disorders
Neoplasms, Plasma Cell

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Dexamethasone
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Blood Protein Disorders
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Antiemetics
Paraproteinemias
Hemostatic Disorders
Hormones
Hemorrhagic Disorders
Therapeutic Uses
Cardiovascular Diseases

Dexamethasone acetate
Neoplasms by Histologic Type
Immunoproliferative Disorders
Antineoplastic Agents, Hormonal
Immune System Diseases
Hematologic Diseases
Rituximab
Bortezomib
Gastrointestinal Agents
Vascular Diseases
Enzyme Inhibitors
Glucocorticoids
Pharmacologic Actions
Protease Inhibitors
Lymphatic Diseases

ClinicalTrials.gov processed this record on September 10, 2009