A Study of Low Dose Lenalidomide and Dexamethasone in Relapsed/Refractory Myeloma in Patients at … (NCT00482261) | Clinical Trial Compass
CompletedPhase 2
A Study of Low Dose Lenalidomide and Dexamethasone in Relapsed/Refractory Myeloma in Patients at High Risk for Myelosuppression
Australia150 participantsStarted 2007-06
Plain-language summary
The purpose of this study is to see whether combination of low dose lenalidomide(10mg)+ dexamethasone is equally effective in treating relapsed/refractory myeloma in the group of elderly patients and other patients at risk of myelosuppression, whilst producing less side effects, especially myelosuppression compared to the higher dose of lenalidomide of 25mg used in the MM-009 and MM-010 trials.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Understand and voluntarily sign consent form.
✓. Must meet one of following age group requirements at the time of signing consent form.
✓. age 18-59 years
✓. \>59 years
✓. Patients 18-59 years are eligible only if:
✓. Able to adhere to the study visit schedule and other protocol requirements.
✓. Subject was previously diagnosed with multiple myeloma based on standard diagnostic criteria.
✓. Must have relapsed or refractory disease.
Exclusion criteria
✕. Dexamethasone resistant myeloma based on last therapy. Patients are defined as being refractory to high-dose dexamethasone if they achieved less than a partial response, or developed progressive disease within 6 months of discontinuing dexamethasone, or dexamethasone was discontinued because of ≥Grade 3 dexamethasone-related toxicity. High-dose dexamethasone therapy is defined as \>500mg dexamethasone or equivalent over a 10-week period, whether administered alone or as part of the VAD regimen.
✕. 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.