Phase 2
N=23
Study of the Combination of Bortezomib, Dexamethasone, and Rituximab in Patients With Waldenstroms Macroglobulinemia
Waldenstrom's Macroglobulinemia
Bottom Line
View on ClinicalTrials.gov: NCT00250926 ↗Enrolled (actual)
23
Serious AEs
82.6%
Results posted
Apr 2016
Primary outcome: Primary: Number of Participants With Adverse Events — 23 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Bortezomib (Drug); Dexamethasone (Drug); Rituximab (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Dana-Farber Cancer Institute
- Primary completion
- Mar 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events |
23 | — |
| PRIMARY Response Rate |
3; 2; 3; 11; 3; 1 | — |
| PRIMARY Time to Best Response |
15 | — |
| PRIMARY Time to Progression |
NA | — |
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.
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) 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
Data sourced from ClinicalTrials.gov (NCT00250926). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.