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