Brief Title
Study of the Combination of Bortezomib, Dexamethasone, and Rituximab in Patients With Waldenstroms Macroglobulinemia
Official Title
A Phase II Study of the Combination Bortezomib (Velcade, PS-341), Dexamethasone, and Rituximab in Patients With Waldenstroms Macroglobulinemia
Brief Summary
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.
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.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
Number of Participants With Adverse Events
Condition
Waldenstrom's Macroglobulinemia
Intervention
Bortezomib
Study Arms / Comparison Groups
Bortezomib, Dexamethasone, Rituximab
Description: A cycle of therapy consisted of bortezomib 1.3 mg/m(2) intravenously; dexamethasone 40 mg on days 1, 4, 8, and 11; and rituximab 375 mg/m(2) on day 11. Patients received four consecutive cycles for induction therapy and then four more cycles, each given 3 months apart, for maintenance therapy.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
23
Start Date
October 2005
Completion Date
February 2009
Primary Completion Date
March 2007
Eligibility 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
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Steven P. Treon, MD, MA, PhD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT00250926
Organization ID
05-180
Responsible Party
Principal Investigator
Study Sponsor
Dana-Farber Cancer Institute
Collaborators
Beth Israel Deaconess Medical Center
Study Sponsor
Steven P. Treon, MD, MA, PhD, Principal Investigator, Dana-Farber Cancer Institute
Verification Date
March 2016