CC-5013 (Lenalidomide) and Rituximab in Waldenstrom’s Macroglobulinemia

Brief Title

CC-5013 (Lenalidomide) and Rituximab in Waldenstrom's Macroglobulinemia

Official Title

Phase II Study of CC-5103 and Rituximab in Waldenstrom's Macroglobulinemia

Brief Summary

      The purpose of this study is to determine the number of patients with Waldenstrom's
      macroglobulinemia that will benefit from treatment with CC-5103 (lenalidomide) and rituximab,
      what the side effects are and how long the benefit will last.
    

Detailed Description

      -  The study drug CC-5103 (lenalidomide) will be administered orally once daily for 21 days
           followed by 7 days of no CC-5103 (lenalidomide) (this will be one 28 day treatment
           cycle). This cycle will repeat itself every 28 days as long as the patient is tolerating
           the medication and there is no disease progression.

        -  Starting on the second week, patients will begin treatment with rituximab intravenously
           once a week for 4 weeks (week 2-5). Prior to each treatment, patients will receive
           medications to prevent or reduce the side effects of rituximab (benadryl, tylenol and
           possible decadron). During the infusion, the patients' blood pressure and pulse will be
           monitored frequently and the rate of infusion may decrease depending upon the side
           effects. Blood work will also be performed each week.

        -  On week 12 the disease status will be evaluated. A physical exam, blood test, CT scan
           and bone marrow biopsy may be repeated if necessary to fully evaluate the disease. If
           the disease has gone away completely, some tests may be repeated again to confirm this.

        -  If the disease has gotten worse after 12 weeks, then the patient will be removed from
           the study.

        -  If the disease is stable or getting better, the patient will continue with therapy.
           During weeks 13-16 rituximab infusions will be repeated and CC-5103 will continue to be
           taken daily for 21 days followed by 7 days of rest. This 28 day cycle may be repeated
           until the patient has completed 48 weeks (12 months) of treatment as long as the side
           effects are acceptable and the disease does not progress.

        -  All patients will undergo an off-study evaluation that includes a physical exam, blood
           work, CT scans and bone marrow biopsy. If the patient completes 78 weeks of therapy and
           the disease does not get worse, they will be evaluated every 12 weeks to determine the
           status of their disease for up to 2 years.
    

Study Phase

Phase 2

Study Type

Interventional

Primary Outcome

Time to Progression

Secondary Outcome

 Major Response Rate

Condition

Waldenstrom's Macroglobulinemia

Intervention

CC-5103 (lenalidomide)

Study Arms / Comparison Groups

 CC-5103 (Lenalidomide) and Rituximab

Description:  Intended therapy consisted of 48 weeks of CC-5103 (lenalidomide)(25 mg/d for 3 weeks and then 1 week off) along with rituximab (375 mg/m(2)/wk) dosed on weeks 2 to 5 and 13 to 16.

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

16

Start Date

September 2004

Completion Date

April 2008

Primary Completion Date

May 2006

Eligibility Criteria

        Inclusion Criteria:

          -  Clinicopathological diagnosis of Waldenstrom's macroglobulinemia using consensus panel
             criteria

          -  Age 18 years or older

          -  CD20 positive based on any previous bone marrow immunohistochemistry or flow
             cytometric analysis

          -  All previous cancer therapy, including radiation, hormonal therapy and surgery, must
             have been discontinued at least 4 weeks prior to treatment in this study

          -  Measurable disease, defined as presence of immunoglobulin M paraprotein with a minimum
             IgM level of equal to or greater than 2 times the upper limit of normal.

          -  ECOG performance status of 0-2

          -  Absolute neutrophil count ≥ 100,000,000/L

          -  Platelet count ≥ 50,000,000,000/L

          -  Hemoglobin > 8 g/dL

          -  Serum creatinine < 2.5 mg/dL

          -  Total bilirubin < 1.5 mg/dL

          -  AST and ALT < 2.5 x ULN

          -  Disease free of prior malignancies fir 5 years with exception of currently treated
             basal cell, squamous cell carcinoma of the skin, or carcinoma in situ of the cervix or
             breast

        Exclusion Criteria:

          -  Any serious medical condition, laboratory abnormality, or psychiatric illness

          -  Pregnant or lactating women

          -  Prior therapy with rituximab or CC-5103

          -  Known hypersensitivity to thalidomide

          -  Development of erythema nodosum if characterized by a desquamating rash while taking
             thalidomide or similar drugs.

          -  Concurrent use of other anti-cancer agents or treatments
      

Gender

All

Ages

18 Years - 80 Years

Accepts Healthy Volunteers

No

Contacts

Steven Treon, MD, MA, PhD, , 

Location Countries

United States

Location Countries

United States

NCT ID

NCT00142168

Organization ID

04-158

Responsible Party

Principal Investigator

Study Sponsor

Dana-Farber Cancer Institute

Collaborators

 Beth Israel Deaconess Medical Center

Study Sponsor

Steven Treon, MD, MA, PhD, Principal Investigator, Dana-Farber Cancer Insitute

Verification Date

March 2016