Combination Bortezomib and Rituximab in Patients With Waldenstrom’s Macroglobulinemia

Brief Title

Combination Bortezomib and Rituximab in Patients With Waldenstrom's Macroglobulinemia (WM)

Official Title

Phase II Study of Combination Bortezomib (Velcade PS-341) and Rituximab in Patients With Previously Untreated and Relapsed/Refractory Waldenstrom's Macroglobulinemia

Brief Summary

      In this study, we are trying to find out if the combination of these two drugs is effective
      in treating Waldenstrom's macroglobulinemia (WM). The combination of these two drugs has not
      been studied for patients with relapsed or refractory macroglobulinemia. The U.S. Food and
      Drug Administration (FDA) has approved bortezomib for the treatment of multiple myeloma, a
      cancer that is closely related to Waldenstrom's macroglobulinemia.
    

Detailed Description

      -  Participants will receive 6 cycles of the study treatment with bortezomib and rituximab.
           Each cycle is 28 days long (4 weeks).

        -  Participants will receive Rituximab intravenously once a week for the first and fourth
           cycles only. Participants will receive bortezomib once a week for three weeks on and one
           week off every cycle, for a total of 6 cycles.

        -  During the rituximab infusion, the participants blood pressure and pulse will be
           monitored frequently. The rate of infusion may be decreased depending upon the side
           effects that are experienced.

        -  Blood samples will be collected before the first dose and on follow up with every cycle.
           Blood counts will also be performed every week.

        -  Routine physical exams will be performed at each evaluation. A PET/CAT scan of the
           chest, abdomen and pelvis at the end of treatment. This scan is required to assess the
           response of the participants disease.

        -  In order to learn more on how bortezomib and rituximab affect WM, a bone marrow biopsy
           will be performed.

        -  We anticipate that participants will complete the active therapy over a period of 6
           cycles provided that they are benefiting from therapy and have not had any serious side
           effects. The participant will be followed every three months for 2 years for office
           visits and laboratory tests.
    

Study Phase

Phase 2

Study Type

Interventional

Primary Outcome

Overall Response Rate of Bortezomib and Rituximab (VR) in Patients With Relapsed or Refractory Waldenstrom's Macroglobulinemia (WM)

Secondary Outcome

 Time to Progression in Patients With WM

Condition

Waldenstrom's Macroglobulinemia

Intervention

Bortezomib

Study Arms / Comparison Groups

 bortezomib and rituximab

Description:  bortezomib and rituximab

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Drug

Estimated Enrollment

63

Start Date

August 30, 2006

Completion Date

October 9, 2015

Primary Completion Date

October 9, 2015

Eligibility Criteria

        Inclusion Criteria:

          -  18 years of age or older

          -  Patients with previously untreated WM and those who have received prior therapy are
             eligible

          -  Must have received prior therapy for their WM and have relapsed or refractory WM.

          -  CD20 positive disease based on any previous bone marrow immuno-histochemistry or flow
             cytometric analysis performed up to 3 months prior to enrollment.

          -  Measurable disease

          -  ECOG Performance Status 0,1, or 2

          -  Total bilirubin < 2.0 mg/dl

          -  AST < 3 x ULN

          -  Life expectancy of greater than 12 weeks

        Exclusion Criteria:

          -  Uncontrolled infection

          -  Other active malignancies

          -  Cytotoxic chemotherapy less than 3 weeks, or biologic therapy less than 2 weeks, or
             corticosteroids less than 2 weeks, prior to registration.

          -  Other concurrent chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy
             considered investigational

          -  Known to be HIV positive or HEP B positive

          -  Radiation therapy less than 2 weeks prior to registration

          -  Grade 2 or greater peripheral neuropathy

          -  Myocardial infarction within 6 months rior to enrollment or has NYHA 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 bortezomib, boron, or mannitol

          -  Pregnant or breast feeding women

          -  Other investigational drugs within 14 days of enrollment

          -  Serious medical or psychiatric illness likely to interfere with participation
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Irene Ghobrial, MD, , 

Location Countries

United States

Location Countries

United States

NCT ID

NCT00422799

Organization ID

06-008

Responsible Party

Principal Investigator

Study Sponsor

Dana-Farber Cancer Institute

Collaborators

 Millennium Pharmaceuticals, Inc.

Study Sponsor

Irene Ghobrial, MD, Principal Investigator, Dana-Farber Cancer Institute

Verification Date

October 2020