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Carfilzomib, Rituximab, and Dexamethasone (CaRD) in Waldenstrom's Macroglobulinemia


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Waldenstrom's Macroglobulinemia

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Trial Information

Carfilzomib, Rituximab, and Dexamethasone (CaRD) in Waldenstrom's Macroglobulinemia


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. Each cycles lasts 21 days. After completing Cycle 6 and if you are
eligible, there will be a 2 month break before the maintenance phase is started. During this
break, you will have a study visit with a physical exam, blood tests, and a bone marrow
biopsy. If you continue to the maintenance phase, you will receive Carfilzomib and
Dexamethasone on Days 1 and 2 and Rituximab on Day 2 of Cycles 1-8. Each cycle will continue
to last 21 days, but will take place every 2 months. Infusions will last between 2-6 hours.

During all cycles you will have a physical exam and you will be asked questions about your
general health and specific questions about any problems that you might be having and any
medications you may be taking. Blood tests will also be done at each Cycle visit, and you
will complete a questionnaire. Bone marrow and CT scan will only be repeated at physician
discretion when appropriate and in order to ensure your response to treatment.


Inclusion Criteria:



- 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 Criteria:

- 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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response Rates

Outcome Description:

To assess the overall response rate (ORR), major response rate (MRR), and Very Good Partial Response/Complete Response (VGPR/CR) rates of CaRD in symptomatic untreated on symptomatic pretreated but proteasome inhibitor and rituximab naive, WM patients.

Outcome Time Frame:

1 year

Safety Issue:

No

Principal Investigator

Steven P Treon, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dana-Farber Cancer Institute

Authority:

United States: Food and Drug Administration

Study ID:

11-279

NCT ID:

NCT01470196

Start Date:

October 2011

Completion Date:

December 2013

Related Keywords:

  • Waldenstrom's Macroglobulinemia
  • WM
  • untreated
  • symptomatic
  • Waldenstrom Macroglobulinemia

Name

Location
Dana-Farber Cancer Institute Boston, Massachusetts  02115