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

Waldenstrom's Macroglobulinemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00142168
• Other study ID #: 04-158
• Status: Terminated
• Phase: Phase 2
• First received: September 1, 2005
• Last updated: November 11, 2015
• Start date: September 2004
• Est. completion date: April 2008

Study information

• Verified date: November 2015
• Source: Dana-Farber Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 16
• Est. completion date: April 2008
• Est. primary completion date: May 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Waldenstrom Macroglobulinemia
• Waldenstrom's Macroglobulinemia

Intervention

Drug:
• CC-5103 (lenalidomide)
Taken orally once a day for 21 days followed by 7 days of no CC-5103 (lenalidomide)
• Rituximab
Begins on week 2 of treatment and is given intravenously once a week for 4 weeks

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Dana-Farber Cancer Institute	Boston	Massachusetts

Sponsors (5)

Lead Sponsor	Collaborator
Dana-Farber Cancer Institute	Beth Israel Deaconess Medical Center, Brigham and Women's Hospital, Celgene Corporation, Genentech, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (1)

Treon SP, Soumerai JD, Branagan AR, Hunter ZR, Patterson CJ, Ioakimidis L, Chu L, Musto P, Baron AD, Nunnink JC, Kash JJ, Terjanian TO, Hyman PM, Nawfel EL, Sharon DJ, Munshi NC, Anderson KC. Lenalidomide and rituximab in Waldenstrom's macroglobulinemia. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to Progression	The overall response and major response (<50% decrease in serum IgM) rates were determined along with the time to progression and the safety for combined CC-5103 and rituximab therapy in Waldenstrom's macroglobulinemia patients.	34.3 months	No
Primary	Overall Response	Overall response is the total number of participants who respond to therapy. Patients achieving a complete response (CR) will be defined as having achieved resolution of all symptoms, normalization of their serum IgM levels with complete disappearance of their IgM paraprotein by immunofixation, and resolution of any adenopathy or splenomegaly during any point while in this study and normal bone marrow biopsy. Patients achieving a partial response (PR) and a minor response (MR) will be defined as achieving a > 50% and > 25% reduction in serum IgM levels, respectively, during any point while in this study. Patients with stable disease (SD) will be defined as having < 25% change in serum IgM levels, in the absence of new or increasing adenopathy or splenomegaly and/or other progressive signs or symptoms of WMduring any point while in this study.	34.3 months	No
Secondary	Major Response Rate	Major response rate is the number of participants who achieve at a PR or better. A PR or better will be defined as achieving a >50% reduction in serum IgM levels.	34.3 months	No
Secondary	Minor Response Rate	A minor response is defined as having achieved >25% but less than 50% reduction in serum IgM levels.	34.3 months	No