comparison of 25mg versus 5 mg lenalidomide as maintenance therapy in patients with multiple myeloma

Conditions: Multiple Myeloma

Summary: this trial is a randomised, parallel-group, multicenter phase iii study for maintenance therapy with lenalidomide in patients with multiple myeloma who were treated with high-dose therapy and autologous stem cell transplantation as first line therapy.

high-dose therapy will be performed as first line treatment. after high-dose therapy and autologous stem cell transplantation the patients will be included and randomised. three month after high-dose therapy all patients will receive consolidation therapy with 6 cycles of lenalidomide 25 mg daily for 21 days every 28 days. afterwards patients will receive maintenance therapy according to their assigned treatment arm. randomisation will be performed in a 1:1 ratio to continuous maintenance therapy with either 25mg or 5mg lenalidomide daily for 21 days every 28 days.randomisation will be stratified by iss-stage (1+2 vs 3, age (younger than 66 years versus 66 years or older), response after high-dose therapy (cr+vgpr vs pr vs mr/sd. patients will be treated until disease progression.

Eligibility criteria:
inclusion criteria: * signed informed consent form * age 18-75 years * able to adhere to the study visit schedule and other protocol requirements * patients with multiple myeloma who have received high-dose therapy and autologous stem cell transplantation as first-line therapy within the last 90 - 120 days and have not shown progressive disease afterwards. * patients may have received up to 6 cycles of prior induction therapy and up to 2 cycles of prior mobilisation chemotherapy. a bortezomib or thalidomide induction therapy is allowed. patients may also have received prior radiation therapy * measurable levels of myeloma paraprotein in serum (\>0.5 g/dl) or urine (\>0.2 g/24hours) or measurable free light chains (flc) in serum (\>50 mg/l) with an abnormal flc ratio must be documented at the time of first diagnosis. * ecog performance status = 2 at study entry * laboratory and functional test results within these ranges: * anc ≥ 1,000/μl * platelet count ≥ 100,000/μl * total bilirubin 2.5 mg/dl * ast (sgot) and alt (sgpt) 3 x uln * patients with impaired renal function can be included * the patient must be able to adhere to the pregnancy precautions * 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 exclusion criteria: * 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 * any condition or laboratory abnormality which places the subject at an unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study * known allergic/hypersensitivity reaction to thalidomide, lenalidomide or any components of the treatment * any cutaneous grade ≥ 3 adverse reaction (for example desquamating rash) while taking thalidomide or similar drugs * any prior use of lenalidomide * known positive for hiv or active infectious hepatitis, type a, b or c

Keywords: multiple myeloma maintenance therapy lenalidomide