CC-5013 (Lenalidomide) and Rituximab in Waldenstrom's Macroglobulinemia
|ClinicalTrials.gov Identifier: NCT00142168|
Recruitment Status : Terminated (Toxicity)
First Posted : September 2, 2005
Results First Posted : December 16, 2015
Last Update Posted : April 21, 2016
|Condition or disease||Intervention/treatment||Phase|
|Waldenstrom's Macroglobulinemia||Drug: CC-5103 (lenalidomide) Drug: Rituximab||Phase 2|
- 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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||16 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of CC-5103 and Rituximab in Waldenstrom's Macroglobulinemia|
|Study Start Date :||September 2004|
|Actual Primary Completion Date :||May 2006|
|Actual Study Completion Date :||April 2008|
Experimental: CC-5103 (Lenalidomide) and Rituximab
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.
Drug: CC-5103 (lenalidomide)
Taken orally once a day for 21 days followed by 7 days of no CC-5103 (lenalidomide)
Other Names:Drug: Rituximab
Begins on week 2 of treatment and is given intravenously once a week for 4 weeks
Other Name: Rituxan
- Time to Progression [ Time Frame: 34.3 months ]Time to progression is measured as the length in time in months from starting therapy until progression, defined as 25% increase in serum IgM from nadir.
- Overall Response [ Time Frame: 34.3 months ]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.
- Major Response Rate [ Time Frame: 34.3 months ]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.
- Minor Response Rate [ Time Frame: 34.3 months ]A minor response is defined as having achieved >25% but less than 50% reduction in serum IgM levels.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00142168
|United States, Massachusetts|
|Dana-Farber Cancer Institute|
|Boston, Massachusetts, United States, 02115|
|Beth Israel Deaconess Medical Center|
|Boston, Massachusetts, United States, 02215|
|Principal Investigator:||Steven Treon, MD, MA, PhD||Dana-Farber Cancer Insitute|