Lenalidomide, Dexamethasone and Cyclophosphamide in Amyloidosis (AL)

• Status: Completed
• Trial end date: 2016-01-11
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the safety and activity of the combination of lenalidomide with intermediate dose dexamethasone and cyclophosphamide in patients with primary systemic (AL ) amyloidosis.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Athens
• Collaborator: Hellenic Cooperative Oncology Group
• Treatments: BB 1101; Cyclophosphamide; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Lenalidomide; Thalidomide

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 present.

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