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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00166413
• Date of registration: 12/09/2005
• Prospective Registration: No
• Primary sponsor: Mayo Clinic
• Public title: Efficacy of CC-5013 (Revlimid or Lenalidomide) in Patients With Primary Systemic Amyloidosis
• Scientific title: A Phase II Trial of CC-5013 in Patients With Primary Systemic Amyloidosis
• Date of first enrolment: April 2005
• Target sample size: 38
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00166413
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

United States

Contacts

• Name: Angela Dispenzieri, M.D.
• Affiliation: Mayo Clinic

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Amyloidosis

Intervention(s)

Drug: CC-5013

Primary Outcome(s)

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

Secondary Outcome(s)

Toxicity of single agent CC-5013 and combination 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]

Hematologic response rate of CC-5013 and dexamethasone [Time Frame: 12 months]

Survival [Time Frame: 5 years]

Secondary ID(s)

MC0484

1105-04

Source(s) of Monetary Support

Please refer to primary and secondary sponsors