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

Amyloidosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00166413
• Other study ID #: 1105-04
• Secondary ID: MC04841105-04
• Status: Completed
• Phase: Phase 2
• First received: September 12, 2005
• Last updated: May 5, 2011
• Start date: April 2005

Study information

• Verified date: May 2011
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. primary completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

1. 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

2. 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

3. ECOG performance status (PS) 0, 1, 2, or 3

4. >=18 years of age

5. 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

6. 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

7. Previously treated or untreated. No limit to prior therapy provided there is adequate residual organ function

8. Ability to provide informed consent

9. Anticipated life expectancy of at least 3 months

10. 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Amyloidosis

Intervention

Drug:
• CC-5013
40 mg/day orally on days 1-4 and 15-18 of each 28-day cycle

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the hematologic response rate of CC-5013 in patients with primary systemic amyloidosis		12 months	No
Secondary	Toxicity of single agent CC-5013 and combination CC-5013 and dexamethasone		12 months	Yes
Secondary	Hematologic response rate of CC-5013 and dexamethasone		12 months	No
Secondary	Organ response of CC-5013 and the CC-5013 dexamethasone combination		12 months	Yes
Secondary	Time to progression		5 years	No
Secondary	Survival		5 years	No