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

Phase 2

Completed

• Conditions: Amyloidosis
• Interventions: Drug: CC-5013

• Registration Number: NCT00166413
• Lead Sponsor: Mayo Clinic

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 Description

Not available

Study Timeline

• Study Start: 2005-04
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-14
• Primary Completion: 2006-12
• Status Verified: 2011-05
• Last Update Submitted: 2011-05-05
• Last Update Posted: 2011-05-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CC5013	CC-5013	Assess the proportion of confirmed hematologic responses (HCR, HPR) resulting from treatment with CC5013 after 3 months in patients with primary systemic amyloidosis.

Primary Outcome Measures

Name	Time	Method
To evaluate the hematologic response rate of CC-5013 in patients with primary systemic amyloidosis	12 months

Secondary Outcome Measures

Name	Time	Method
Survival	5 years
Toxicity of single agent CC-5013 and combination CC-5013 and dexamethasone	12 months
Hematologic response rate of CC-5013 and dexamethasone	12 months
Organ response of CC-5013 and the CC-5013 dexamethasone combination	12 months
Time to progression	5 years

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States