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

NCT ID: NCT00166413

Last Updated: 2011-05-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-04-30

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.

Conditions

Amyloidosis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CC5013

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

Group Type: EXPERIMENTAL

CC-5013

Intervention Type: DRUG

40 mg/day orally on days 1-4 and 15-18 of each 28-day cycle

Interventions

CC-5013

40 mg/day orally on days 1-4 and 15-18 of each 28-day cycle

Intervention Type: DRUG

Other Intervention Names

amino substituted analog of thalidomide

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Mayo Clinic Cancer Center

Principal Investigators

Angela Dispenzieri, M.D.

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic

Rochester, Minnesota, United States

Countries

United States

Other Identifiers

MC0484

Identifier Type: OTHER

Identifier Source: secondary_id

1105-04

Identifier Type: OTHER

Identifier Source: secondary_id

1105-04

Identifier Type: -

Identifier Source: org_study_id