Status:
COMPLETED
Lenalidomide in Combination With Melphalan and Dexamethasone in Newly-diagnosed Light-chain (AL)-Amyloidosis
Lead Sponsor:
Nantes University Hospital
Conditions:
Amyloidosis
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
PHASE2
Brief Summary
Amyloidosis results from tissue deposition of amyloid protein, composed mainly by the fragments of monoclonal immunoglobulin heavy chains or light chains. Accumulation of amyloid protein progressively...
Eligibility Criteria
Inclusion
- De novo systemic biopsy proven AL-amyloidosis.
- Measurable organ site involvement consistent with the diagnosis.
- Adequate organ function defined as
- Absolute neutrophil count \> 1.0 x 109/L;
- platelet count \> 100x109/L;
- AST (SGOT) and ALT (SGPT) \< 2 x UNL;
- Total bilirubin £ 1.5 mg/dL ;
- creatinin serum level \<150µmol/L (1.5mg/dl);
- Evaluable immunochemical abnormalities, including abnormal serum free light chain assay with an increase of either kappa or lambda light chain level.
- ECOG performance status of £ 2 at study entry (see Appendix BB).
- Age between18 and 70 years at the time of signing the informed consent form.
- Females of childbearing potential (FCBP)† must have a negative serum or urine pregnancy test with a sensitivity of at least 25 mIU/mL at screening visit and again within 24 hours of starting lenalidomide and must either commit to continued abstinence from heterosexual intercourse or 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. FCBP 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. All patients must be counseled at a minimum of every 28 days about pregnancy precautions and risks of fetal exposure. See Appendix: Risks of Fetal Exposure, Pregnancy Testing Guidelines and Acceptable Birth Control Methods.
- Able to understand and voluntarily sign an informed consent form.
- Able to adhere to the study visit schedule and other protocol requirements.
- Able to take antithrombotic medicines such as low molecular weight heparin or warfarin (if needed).
- 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.
- Subjects affiliated with an appropriate social security system.
Exclusion
- Symptomatic multiple myeloma: multiple myeloma with related organ of tissue impairment (ROTI) according to the International Myeloma Working Group (16)
- Any other uncontrolled medical condition or comorbidity that might interfere with subject's participation.
- Pregnant or breast feeding females. (Lactating females must agree not to breast feed while taking lenalidomide).
- Use of any other experimental drug or therapy within 28 days of baseline.
- The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs.
- Any prior treatment for amyloidosis.
- Known positive for HIV or infectious hepatitis, type A, B or C.
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT00621400
Start Date
January 1 2008
End Date
December 1 2009
Last Update
May 10 2011
Active Locations (12)
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1
CHRU d'Amiens
Amiens, France, 80054
2
CHRU de Lille
Lille, France, 59037
3
CHU de Limoges
Limoges, France, 87042
4
CHU de Nantes
Nantes, France, 44093