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

This study has been terminated.
(Toxicity)
Sponsor:
Collaborators:
Beth Israel Deaconess Medical Center
Brigham and Women's Hospital
Celgene Corporation
Genentech, Inc.
Information provided by (Responsible Party):
Steven P. Treon, MD, PhD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT00142168
First received: September 1, 2005
Last updated: March 23, 2016
Last verified: March 2016
  Purpose
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.

Condition Intervention Phase
Waldenstrom's Macroglobulinemia
Drug: CC-5103 (lenalidomide)
Drug: Rituximab
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of CC-5103 and Rituximab in Waldenstrom's Macroglobulinemia

Resource links provided by NLM:


Further study details as provided by Dana-Farber Cancer Institute:

Primary Outcome Measures:
  • Time to Progression [ Time Frame: 34.3 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Major Response Rate [ Time Frame: 34.3 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    A minor response is defined as having achieved >25% but less than 50% reduction in serum IgM levels.


Enrollment: 16
Study Start Date: September 2004
Study Completion Date: April 2008
Primary Completion Date: May 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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:
  • lenalidomide
  • Revlimid
Drug: Rituximab
Begins on week 2 of treatment and is given intravenously once a week for 4 weeks
Other Name: Rituxan

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.
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00142168

Locations
United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Dana-Farber Cancer Institute
Beth Israel Deaconess Medical Center
Brigham and Women's Hospital
Celgene Corporation
Genentech, Inc.
Investigators
Principal Investigator: Steven Treon, MD, MA, PhD Dana-Farber Cancer Insitute
  More Information

Publications:
Responsible Party: Steven P. Treon, MD, PhD, Principal Investigator, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT00142168     History of Changes
Other Study ID Numbers: 04-158 
Study First Received: September 1, 2005
Results First Received: December 19, 2012
Last Updated: March 23, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by Dana-Farber Cancer Institute:
CC-5103 (lenalidomide)
rituximab
Waldenstrom's macroglobulinemia

Additional relevant MeSH terms:
Waldenstrom Macroglobulinemia
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lenalidomide
Rituximab
Thalidomide
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Immunosuppressive Agents
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on September 30, 2016