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Efficacy of CC-5013 (Revlimid or Lenalidomide) in Patients With Primary Systemic Amyloidosis

Sponsor
Mayo Clinic (Other)
Overall Status
Completed
CT.gov ID
NCT00166413
Collaborator
(none)
38
Enrollment
1
Location
1
Arm

Study Details

Study Description

Brief Summary

Patients with primary systemic amyloidosis will be treated with CC-5013 (lenalidomide; Revlimid) as a single agent for 3 months. If their disease worsens or does not improve during that time frame dexamethasone will be added to the treatment program.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
38 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase II Trial of CC-5013 in Patients With Primary Systemic Amyloidosis
Study Start Date :
Apr 1, 2005
Actual Primary Completion Date :
Dec 1, 2006

Arms and Interventions

Arm Intervention/Treatment
Experimental: CC5013

Assess the proportion of confirmed hematologic responses (HCR, HPR) resulting from treatment with CC5013 after 3 months in patients with primary systemic amyloidosis.

Drug: CC-5013
40 mg/day orally on days 1-4 and 15-18 of each 28-day cycle
Other Names:
  • amino substituted analog of thalidomide

    		•

    Outcome Measures

    Primary Outcome Measures

    1. To evaluate the hematologic response rate of CC-5013 in patients with primary systemic amyloidosis [12 months]

    Secondary Outcome Measures

    1. Toxicity of single agent CC-5013 and combination CC-5013 and dexamethasone [12 months]

    2. Hematologic response rate of CC-5013 and dexamethasone [12 months]

    3. Organ response of CC-5013 and the CC-5013 dexamethasone combination [12 months]

    4. Time to progression [5 years]

    5. Survival [5 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    1. Histochemical diagnosis of amyloidosis as based on detection by polarizing microscopy of green birefringent material in Congo red-stained tissue specimens and immunohistochemical proof of AL

    2. Measurable disease of AL amyloidosis as defined by one of the following:

    • Serum monoclonal protein >=1.0 g by protein electrophoresis

    • 200 mg of monoclonal protein in the urine on 24 hour electrophoresis

    • Serum immunoglobulin free light chain & >=10 mg/dL AND abnormal serum immunoglobulin kappa to lambda free light chain ratio

    1. ECOG performance status (PS) 0, 1, 2, or 3

    2. =18 years of age

    3. The following laboratory values obtained <=14 days prior to registration:

    • Creatinine < = 3 mg/dL

    • Absolute neutrophil count >=1000/microliter

    • Platelet >=75000/microliter

    • Hemoglobin > = 8.0 g/dL

    1. Symptomatic organ involvement with amyloid to justify therapy. This could include liver involvement, cardiac involvement, renal involvement, peripheral neuropathy grade 1, or soft tissue involvement. Must have more than purpura or carpal tunnel syndrome

    2. Previously treated or untreated. No limit to prior therapy provided there is adequate residual organ function

    3. Ability to provide informed consent

    4. Anticipated life expectancy of at least 3 months

    5. None of the following:

    • Pregnant women or women of reproductive ability who are unwilling to use effective contraception

    • Nursing women

    • Men who are unwilling to use a condom (even if they have undergone a prior vasectomy) while having intercourse with any woman, while taking the drug and for 4 weeks after stopping treatment

    • Myelosuppressive chemotherapy < 4 weeks prior to registration

    • Concomitant high dose corticosteroids

    • Grade 2 (or higher) peripheral neuropathy

    • Uncontrolled infection

    • Clinically overt multiple myeloma

    • Active malignancy

    • Prior hypersensitivity reaction to Thalidomide

    • Syncope within the past 30 days

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Mayo Clinic Rochester Minnesota United States 55905

    Sponsors and Collaborators

    • Mayo Clinic

    Investigators

    • Principal Investigator: Angela Dispenzieri, M.D., Mayo Clinic

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00166413
    Other Study ID Numbers:
    • 1105-04
    • MC0484
    • 1105-04
    First Posted:
    Sep 14, 2005
    Last Update Posted:
    May 6, 2011
    Last Verified:
    May 1, 2011
    Additional relevant MeSH terms:
    Immunoglobulin Light-chain Amyloidosis
    Amyloidosis
    Thalidomide
    Lenalidomide

    Study Results

    No Results Posted as of May 6, 2011