Status:
COMPLETED
Carfilzomib, Rituximab and Dexamethasone in Waldenstrom's Macroglobulinemia
Lead Sponsor:
Dana-Farber Cancer Institute
Collaborating Sponsors:
Amgen
Conditions:
Waldenstrom's Macroglobulinemia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Carfilzomib is a drug that has shown anti-tumor activity by inhibiting the proteasome within the cell, which is responsible for degrading or breaking down a wide variety of proteins. Carfilzomib has n...
Detailed Description
If you take part in this research study, you will receive Carfilzomib and dexamethasone as an infusion on Days 1, 2, 8, and 9 for Cycles 1-6. You will then have a Rituximab infusion on Days 2 and 9. E...
Eligibility Criteria
Inclusion
- Diagnosis of Waldenstrom's Macroglobulinemia
- Symptomatic disease
- Measurable disease
- Life expectancy of greater than 12 weeks
- Adequate organ and marrow function
- CD20 positive based on any previous performed bone marrow immunohistochemistry or flow cytometric analysis
- Disease free of prior malignancies for \>/= 5 years with the exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma "in situ" of the cervix or breast
Exclusion
- More than one prior therapy
- Previous therapy with a proteasome inhibitor or rituximab
- Chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or not recovered from adverse events due to agents administered more than 4 weeks earlier
- Currently receiving treatment for any malignancy
- Major surgery within 21 days prior to study entry
- Acute active infection requiring treatment (systemic antibiotics, antivirals, or antifungals) within 14 days prior to study entry
- Uncontrolled hypertension or uncontrolled diabetes
- Significant neuropathy (Grades 3-4, or Grade 2 with pain) within 14 days prior to study entry
- Known history of allergy to Captisol
- Receiving any other study agents
- Known brain metastases
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to carfilzomib, rituximab, and/or dexamethasone
- Contraindication to any of the required concomitant drugs or supportive treatments, including hypersensitivity to all anticoagulation and antiplatelet options, antiviral drugs, or intolerance to hydration due to preexisting pulmonary or cardiac impairment
- Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Pregnant or lactating
- HIV-positive on combination antiretroviral therapy
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2016
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT01470196
Start Date
October 1 2011
End Date
September 1 2016
Last Update
November 20 2018
Active Locations (1)
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1
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215