Phase II Trial of Enbrel in Patients With Primary Systemic Amyloidosis

NCT00224393 | Completed Phase 2

• 1 other identifier: MC018A
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to evaluate the efficacy of Enbrel in patients with primary systemic Amyloidosis.

Conditions

Primary Systemic Amyloidosis

Keywords

Amyloidosis; Enbrel

Outcome Measures

Primary Outcomes (1)

• clinical efficacy

Secondary Outcomes (4)

• Duration of response and time to progression

• Evaluate overall survival

• Identify prognostic factors

• Evaluate qualitative and quantitative toxicities of Enbrel

Interventions

Enbrel DRUG

Eligibility Criteria

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

You may qualify if:

• \>=18 years of age.
• Laboratory values obtained \<=14 days prior to registration.
• No limitation on the cardiac ejection fraction
• Bilirubin \<3 mg/dL
• Absolute neutrophil count \>=500/microliters
• Histochemical diagnosis of amyloidosis as based on detection by polarizing microscopy of green bi-refringent material in Congo red-stained tissue specimens or characteristic electron microscopy appearance.
• Demonstrable M-protein in the serum/urine or clonal population of plasma cells in the bone marrow or immunohistochemical stain with anti-light chain anti-sera of amyloid fibrils.
• ECOG performance status 0, 1, 2, or 3.
• Symptomatic organ involvement with amyloid to justify therapy. This could include liver involvement, cardiac involvement, renal involvement, peripheral neuropathy, or soft tissue involvement. Must have more than purpura or carpal tunnel syndrome.
• Previously treated or untreated. No limit to prior therapy provided there is adequate residual organ function.
• Ability to provide informed consent.
• Ability to self-inject medication or have a caregiver who can administer the drug.

You may not qualify if:

• Amyloid-specific syndrome, such as, carpal tunnel syndrome or skin purpura as only evidence of disease. The finding of vascular amyloid only in a bone marrow biopsy specimen or in a plasmacytoma is not indicative of systemic amyloidosis.
• Presence of non-AL amyloidosis.
• Melphalan or other alkylating agents, high-dose dexamethasone or alpha interferon \<=4 weeks prior to registration.
• Concurrent use of corticosteroids, but patients may be on chronic steroids if they are being given for disorders other than amyloid, i.e., adrenal insufficiency, rheumatoid arthritis, etc.
• Any of the following:
• Pregnant women
• Nursing women
• Men or women of childbearing potential who are unwilling to employ adequate contraception (condoms, diaphragm, birth control pills, injections, intrauterine device \[IUD\], surgical sterilization, abstinence, etc.)
• Uncontrolled infection.
• Clinically overt multiple myeloma (monoclonal BMPC \>30%), and at least one of the following:
• Bone lesions
• Hypercalcemia
• Active malignancy with the exception of adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for 5 years.

Sponsors & Collaborators

• The Cleveland Clinic: lead

MeSH Terms

Conditions

Immunoglobulin Light-chain Amyloidosis; Amyloidosis

Interventions

Etanercept

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Paraproteinemias

Intervention Hierarchy (Ancestors)

Immunoglobulin Fc Fragments; Immunoglobulin Fragments; Peptide Fragments; Peptides; Amino Acids, Peptides, and Proteins; Immunoglobulin Constant Regions; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins; Receptors, Tumor Necrosis Factor; Receptors, Cytokine; Receptors, Immunologic; Receptors, Cell Surface; Membrane Proteins

Study Officials

• Mohamad A Hussein, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

• John A Lust, MD, PhD

  Mayo Clinic

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 21, 2005
• First Posted: September 23, 2005
• Study Start: February 1, 2001
• Study Completion: August 31, 2005
• Last Updated: May 30, 2023

Record last verified: 2023-05