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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Last refreshed on: 19 February 2015
Main ID:  NCT00981708
Date of registration: 19/09/2009
Prospective Registration: No
Primary sponsor: University of Athens
Public title: Lenalidomide, Dexamethasone and Cyclophosphamide in Amyloidosis (AL)
Scientific title: A Phase I/II Trial of Lenalidomide Combined With Cyclophosphamide and Intermediate Dose Dexamethasone in Patients With Primary (AL) Systemic Amyloidosis
Date of first enrolment: February 2008
Target sample size: 37
Recruitment status: Active, not recruiting
Study type:  Interventional
Study design:  Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment  
Phase:  Phase 1/Phase 2
Countries of recruitment
Name:     Meletios A Dimopoulos, MD
Affiliation:  University of Athens, School of Medicine
Key inclusion & exclusion criteria

Inclusion Criteria:

1. Understand and voluntarily sign an informed consent form.

2. Age >=18 years at the time of signing the informed consent form.

3. Able to adhere to the study visit schedule and other protocol requirements.

4. Confirmed diagnosis of AL amyloidosis (see appendix 3)

5. Need for treatment in the judgment of their treating physician

6. Evaluable or measurable disease defined by any of the following:

- Measurable serum free light chains >= 10 mg/dL, kappa or lambda, provided
kappa/lambda ratio is abnormal (measurable disease)

- Monoclonal protein in the serum >= 1 g/dL

7. ECOG Performance Status (PS) 0, 1, 2 or 3

8. Laboratory test results within these ranges:

- Absolute neutrophil count >= 1.5 x 109/L

- Platelet count >= 100 x 109/L

- Serum creatinine >= 2.5 mg/dL

- Total bilirubin >= 1.5 mg/dL

- AST (SGOT) and ALT (SGPT) > 2 x ULN or > 5 x ULN if hepatic metastases are

9. Women of childbearing potential (WCBP)† must have a negative serum or urine pregnancy
test with a sensitivity of at least 50 mIU/mL 10 - 14 days prior to therapy and
repeated within 24 hours of starting study drug and must begin TWO acceptable methods
of birth control, one highly effective method and one additional effective method AT
THE SAME TIME, at least 4 weeks before she starts taking lenalidomide. Women must
also agree to ongoing pregnancy testing. Men must agree not to father a child and
agree to use a condom if his partner is of child bearing potential. (See Appendix 1
Pregnancy Testing Guidelines and Acceptable Birth Control Methods.)

10. Disease free of prior malignancies for >= 5 years with exception of currently treated
basal cell, squamous cell carcinoma of the skin, or carcinoma "in situ" of the cervix
or breast

11. Able to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation. (patients
intolerant to ASA may use low molecular weight heparin).

Exclusion Criteria:

1. Patients with symptomatic multiple myeloma with asymptomatic biopsy confirmed AL
amyloidosis (Appendix 3)

2. Any serious medical condition, laboratory abnormality, or psychiatric illness that
would prevent the subject from signing the informed consent form.

3. Pregnant or breast feeding females. (Lactating females must agree not to breast feed
while taking lenalidomide).

4. Any condition, including the presence of laboratory abnormalities, which places the
subject at unacceptable risk if he/she were to participate in the study or confounds
the ability to interpret data from the study.

5. Use of any other experimental drug or therapy within 28 days of baseline.

6. Known hypersensitivity to thalidomide.

7. The development of erythema nodosum if characterized by a desquamating rash while
taking thalidomide or similar drugs.

8. Any prior use of lenalidomide.

9. Concurrent use of other anti-cancer agents or treatments.

10. Known positive for HIV or infectious hepatitis, type A, B or C.

11. > grade 2 peripheral neuropathy

12. Life expectancy < 3 months

13. Concurrent use of steroids (Patients may receive prednisone up to 20 mg/d, or
equivalent corticosteroids for concurrent illness or adrenal replacement therapy

Age minimum: 18 Years
Age maximum: N/A
Gender: Both
Health Condition(s) or Problem(s) studied
Drug: Lenalidomide, Dexamethasone and Cyclophosphamide
Primary Outcome(s)
To assess the maximum tolerated dose of lenalidomide and cyclophosphamide and assess the hematologic response rate of the combination of Cyclophosphamide/Dexamethasone plus lenalidomide in patients with AL amyloidosis. [Time Frame: At month 2 for assesment of maximum tolerated dose and monthly for hematologic response]
Secondary Outcome(s)
To assess the toxicity of Cyclophosphamide/Dexamethasone plus lenalidomide combination in patients with AL amyloidosis and organ response rate [Time Frame: Monthly for toxicity and every 3-6 months for organ response]
Secondary ID(s)
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Hellenic Cooperative Oncology Group
Ethics review
Results available:
Date Posted:
Date Completed:
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