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Completed

NCT Number: NCT00166413

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

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.

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Key information

Conditions

Amyloidosis Metabolic Diseases Nutritional and Metabolic Diseases Proteostasis Deficiencies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • 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

Treatment and study plan

CC-5013

Drug

40 mg/day orally on days 1-4 and 15-18 of each 28-day cycle

Other names: amino substituted analog of thalidomide

Primary outcomes

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

    Time frame: 12 months

Secondary outcomes

  1. Toxicity of single agent CC-5013 and combination CC-5013 and dexamethasone

    Time frame: 12 months

  2. Hematologic response rate of CC-5013 and dexamethasone

    Time frame: 12 months

  3. Organ response of CC-5013 and the CC-5013 dexamethasone combination

    Time frame: 12 months

  4. Time to progression

    Time frame: 5 years

  5. Survival

    Time frame: 5 years

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

A Phase II Trial of CC-5013 in Patients With Primary Systemic Amyloidosis

Important dates

Study start
2005
Primary completion
2006
First posted
Sep 14, 2005
Registry last updated
May 6, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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