CompletedPhase 1/2

Lenalidomide, Dexamethasone and Cyclophosphamide in Amyloidosis (AL)

Greece37 participantsStarted 2008-02

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Understand and voluntarily sign an informed consent form.
✓. Age \>=18 years at the time of signing the informed consent form.
✓. Able to adhere to the study visit schedule and other protocol requirements.
✓. Confirmed diagnosis of AL amyloidosis (see appendix 3)
✓. Need for treatment in the judgment of their treating physician
✓. Evaluable or measurable disease defined by any of the following:
✓. ECOG Performance Status (PS) 0, 1, 2 or 3
✓. Laboratory test results within these ranges:

Exclusion criteria

✕. Patients with symptomatic multiple myeloma with asymptomatic biopsy confirmed AL amyloidosis (Appendix 3)
✕. Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
✕. Pregnant or breast feeding females. (Lactating females must agree not to breast feed while taking lenalidomide).
✕. 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.
✕. Use of any other experimental drug or therapy within 28 days of baseline.
✕. Known hypersensitivity to thalidomide.
✕. The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs.
✕. Any prior use of lenalidomide.

What they're measuring

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.

Timeframe: At month 2 for assesment of maximum tolerated dose and monthly for hematologic response

Trial details

NCT IDNCT00981708

SponsorUniversity of Athens

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2011-01-11

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