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A Phase II Trial of Lenalidomide (Revlimid®), Cyclophosphamide and Dexamethasone in Patients With Primary Systemic Amyloidosis

Phase 2
18 Years
Not Enrolling
Multiple Myeloma and Plasma Cell Neoplasm

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Trial Information

A Phase II Trial of Lenalidomide (Revlimid®), Cyclophosphamide and Dexamethasone in Patients With Primary Systemic Amyloidosis



* Assess the hematologic response rate in patients with primary systemic amyloidosis treated
with lenalidomide, cyclophosphamide, and dexamethasone.


- Determine the organ response rate in patients treated with this regimen.

- Determine the toxicity of this regimen in these patients.

- Determine the time to progression in patients treated with this regimen.

- Determine the survival of patients treated with this regimen.

OUTLINE: Patients receive oral lenalidomide on days 1-21, oral cyclophosphamide* on days 1,
8, and 15, and oral dexamethasone on days 1, 8, 15, and 22. Courses repeat every 28 days in
the absence of disease progression or unacceptable toxicity.

NOTE: *Patients may receive cyclophosphamide for up to 1 year. After completion of study
treatment, patients are followed every 6 months for up to 3 years.

Inclusion Criteria


- Histochemical diagnosis of AL amyloidosis based on detection of green birefringent
material in Congo red-stained tissue specimens by polarizing microscopy

- Measurable disease, as defined by one of the following:

- Serum monoclonal protein ≥ 1.0 g by serum electrophoresis

- Urine monoclonal protein > 200 mg by 24-hour urine electrophoresis

- Serum immunoglobulin free light chain ≥ 10 mg/dL AND abnormal serum
immunoglobulin kappa to lambda free light chain ratio

- Symptomatic organ involvement with amyloid to justify therapy

- May include liver involvement, cardiac involvement, renal involvement, grade 1
peripheral neuropathy, or soft tissue involvement

- Must have more than skin purpura or carpal tunnel syndrome

- No amyloid-specific syndrome, such as carpal tunnel syndrome or skin purpura, as only
evidence of disease

- Vascular amyloid only in a bone marrow biopsy specimen or in a plasmacytoma is not
indicative of systemic amyloidosis

- No clinically overt multiple myeloma (i.e., monoclonal BMPC > 30%, bone lesions, or


- ECOG performance status 0-2

- ANC ≥ 1,000/μL

- Platelet count ≥ 75,000/μL

- Creatinine < 3.0 mg/dL

- Not pregnant

- Negative pregnancy test

- Fertile patients must use two acceptable methods of contraception for ≥ 28 days prior
to, during, and for ≥ 28 days after completion of study treatment

- No nursing during and for ≥ 28 days after completion of study treatment

- No blood, semen, or sperm donation during and for ≥ 28 days after completion of study

- No malignancies within the past 5 years except treated basal cell or squamous cell
carcinoma of the skin, or carcinoma "in situ" of the cervix or breast

- No neuropathy ≥ grade 2, defined as motor neuropathy (symptomatic weakness
interfering with function, but not interfering with activities of daily living [ADL])
or sensory neuropathy (sensory alteration or paresthesia [including tingling],
interfering with function, but not interfering with ADL)

- No uncontrolled infection

- No syncope within the past 30 days

- No known hypersensitivity to thalidomide, including desquamating rash with
thalidomide in the past

- No known seropositivity for HIV

- No active hepatitis A, B, or C

- No New York Heart Association class III or IV heart disease

- No venous thromboembolic event within the past 42 days

- Able to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation - Patients
intolerant to aspirin may use low molecular weight heparin


- No prior lenalidomide

- More than 2 weeks since prior and no other concurrent anticancer agents or treatments

- More than 4 weeks since prior experimental agents

- No other concurrent corticosteroids except chronic steroids (maximum dose 20 mg/day
of prednisone equivalent) for disorders other than amyloidosis (e.g., adrenal
insufficiency or rheumatoid arthritis)

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of Participants Who Achieved a Confirmed Response Defined as a Complete Response (CR), Very Good Partial Response (VGPR) or Partial Response (PR)

Outcome Description:

Response that was confirmed on 2 consecutive evaluations during treatment. Complete Response(CR): Complete disappearance of M-protein from serum and urine on immunofixation, normalization of Free Light Chain (FLC) ratio and <5% plasma cells in bone marrow. Very Good Partial Response(VGPR): >=90% reduction in serum M-component; Urine M-Component <=100 mg per 24 hours. Partial Response(PR): >=50% reduction in serum M-component and/or Urine M-Component >=90% reduction or <200 mg per 24 hours; or >=50% decrease in difference between involved and uninvolved FLC levels.

Outcome Time Frame:

Duration on study (up to 3 years)

Safety Issue:


Principal Investigator

Shaji K. Kumar, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic


United States: Food and Drug Administration

Study ID:




Start Date:

December 2007

Completion Date:

June 2012

Related Keywords:

  • Multiple Myeloma and Plasma Cell Neoplasm
  • primary systemic amyloidosis
  • Amyloidosis
  • Neoplasms
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Plasmacytoma



Mayo Clinic Rochester, Minnesota  55905
Mayo Clinic in Arizona Scottsdale, Arizona  85259-5404
Mayo Clinic in Florida Jacksonville, Florida  32224