Status:
COMPLETED
Efficacy of CC-5013 (Revlimid or Lenalidomide) in Patients With Primary Systemic Amyloidosis
Lead Sponsor:
Mayo Clinic
Conditions:
Amyloidosis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 dex...
Eligibility Criteria
Inclusion
- 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
- 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
- ECOG performance status (PS) 0, 1, 2, or 3
- \>=18 years of age
- 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
- 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
- Previously treated or untreated. No limit to prior therapy provided there is adequate residual organ function
- Ability to provide informed consent
- Anticipated life expectancy of at least 3 months
- 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
Exclusion
Key Trial Info
Start Date :
April 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT00166413
Start Date
April 1 2005
Last Update
May 6 2011
Active Locations (1)
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1
Mayo Clinic
Rochester, Minnesota, United States, 55905