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

NCT00142168 | Terminated Phase 2 Results DMC

• 1 other identifier: 04-158
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 2

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.

Conditions

Waldenstrom's Macroglobulinemia

Keywords

CC-5103 (lenalidomide); rituximab; Waldenstrom's macroglobulinemia

Outcome Measures

Primary Outcomes (2)

• Time to Progression

  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.

  34.3 months

• 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

Secondary Outcomes (2)

• Major Response Rate

  34.3 months

• Minor Response Rate

  34.3 months

Study Arms (1)

CC-5103 (Lenalidomide) and Rituximab

EXPERIMENTAL

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); Drug: Rituximab

Interventions

CC-5103 (lenalidomide) DRUG

Taken orally once a day for 21 days followed by 7 days of no CC-5103 (lenalidomide)

Also known as: lenalidomide, Revlimid

CC-5103 (Lenalidomide) and Rituximab

Rituximab DRUG

Begins on week 2 of treatment and is given intravenously once a week for 4 weeks

Also known as: Rituxan

CC-5103 (Lenalidomide) and Rituximab

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dana-Farber Cancer Institute: lead
• Beth Israel Deaconess Medical Center: collaborator
• Brigham and Women's Hospital: collaborator
• Celgene Corporation: collaborator
• Genentech, Inc.: collaborator

Study Sites (2)

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Related 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. Clin Cancer Res. 2009 Jan 1;15(1):355-60. doi: 10.1158/1078-0432.CCR-08-0862.

  PMID: 19118065 RESULT

MeSH Terms

Conditions

Waldenstrom Macroglobulinemia

Interventions

Lenalidomide; Rituximab

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Limitations and Caveats

Due to toxicity, study was terminated.

Results Point of Contact

• Title: Steven P. Treon MD PhD
• Organization: DFCI

steven_treon@dfci.harvard.edu

617 632 2681

Study Officials

• Steven Treon, MD, MA, PhD

  Dana-Farber Cancer Insitute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 1, 2005
• First Posted: September 2, 2005
• Study Start: September 1, 2004
• Primary Completion: May 1, 2006
• Study Completion: April 1, 2008
• Last Updated: April 21, 2016
• Results First Posted: December 16, 2015

Record last verified: 2016-03

Locations

US (2)