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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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.

Detailed Summary:
Sponsor: Mayo Clinic

Current Primary Outcome: To evaluate the hematologic response rate of CC-5013 in patients with primary systemic amyloidosis [ Time Frame: 12 months ]

Original Primary Outcome: To evaluate the hematologic response rate of CC-5013 in patients with primary systemic amyloidosis

Current Secondary Outcome:

  • Toxicity of single agent CC-5013 and combination CC-5013 and dexamethasone [ Time Frame: 12 months ]
  • Hematologic response rate of CC-5013 and dexamethasone [ Time Frame: 12 months ]
  • Organ response of CC-5013 and the CC-5013 dexamethasone combination [ Time Frame: 12 months ]
  • Time to progression [ Time Frame: 5 years ]
  • Survival [ Time Frame: 5 years ]


Original Secondary Outcome:

  • Toxicity of single agent CC-5013 and combination CC-5013 and dexamethasone
  • Hematologic response rate of CC-5013 and dexamethasone
  • Organ response of CC-5013 and the CC-5013 dexamethasone combination
  • Time to progression
  • Survival


Information By: Mayo Clinic

Dates:
Date Received: September 12, 2005
Date Started: April 2005
Date Completion:
Last Updated: May 5, 2011
Last Verified: May 2011