Clinical trial NCT00305812 (phase 2, status: completed)
Conditions: multiple myeloma and plasma cell neoplasm
ICD codes: C96.20, C96.29, D47.09
Drugs: dexamethasone, lenalidomide, melphalan
SMILES: C[C@@H](O[C@H]1OCCN(CC2=NNC(=O)N2)[C@H]1C1=CC=C(F)C=C1)C1=CC(=CC(=C1)C(F)(F)F)C(F)(F)F, NC1=CC=CC2=C1CN(C1CCC(=O)NC1=O)C2=O, N[C@@H](CC1=CC=C(C=C1)N(CCCl)CCCl)C(O)=O
Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed multiple myeloma by one of the following:

               -  Biopsy of an osteolytic lesion or soft tissue tumor composed of plasma cells

               -  Bone marrow aspirate and/or biopsy demonstrating ≥ 10% plasmacytosis

               -  Bone marrow < 10% plasma cells but with ≥ 1 bony lesion AND meets the M-protein
                  criteria

          -  Ineligible for stem cell transplantation due to any of the following:

               -  Advanced age

               -  Comorbid illness

               -  Patient preference

          -  Previously untreated disease

          -  Measurable (i.e., quantifiable) serum M-component of IgG, IgA, IgD, or IgE at initial
             diagnosis OR, if only light-chain disease is present (urine M-protein only), urinary
             excretion of light-chain protein (Bence Jones) ≥ 1.0 g/24 hours at initial diagnosis

               -  No nonsecretory myeloma

        PATIENT CHARACTERISTICS:

          -  ECOG performance status 0-2

          -  Life expectancy ≥ 12 months

          -  Absolute neutrophil count ≥ 1,500/mm^3

          -  Platelet count ≥ 150,000/mm^3

          -  Creatinine ≤ 3 times upper limit of normal (ULN)

          -  Bilirubin ≤ 1.5 times ULN

          -  AST and/or ALT ≤ 1.5 times ULN

          -  Alkaline phosphatase ≤ 1.5 times ULN

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use 2 methods of effective contraception during and for 4 weeks
             after completion of study treatment

          -  No other malignancies within the past 5 years, except adequately treated nonmelanoma
             skin cancer or curatively treated in situ cancer of the cervix

          -  No hypersensitivity to thalidomide or its components, including the development of a
             desquamating rash

          -  No other serious illness or medical condition that would preclude study participation

          -  No history of significant neurologic or psychiatric disorder that would preclude
             informed consent

          -  No known HIV positivity

          -  No pre-existing cardiovascular conditions and/or symptomatic cardiac dysfunction,
             including any of the following:

               -  Significant cardiac event (including symptomatic heart failure or angina) within
                  3 months prior to randomization

               -  Any cardiac disease that increases risk for ventricular arrhythmia

               -  History of ventricular arrhythmia that was symptomatic or required treatment,
                  including any of the following:

                    -  Multifocal premature ventricular contractions

                    -  Bigeminy

                    -  Trigeminy

                    -  Ventricular tachycardia/fibrillation/flutter/arrhythmia NOS

        PRIOR CONCURRENT THERAPY:

          -  No prior chemotherapy or corticosteroids for the treatment of multiple myeloma

               -  Prior corticosteroids for the treatment of hypercalcemia or spinal cord
                  compression allowed provided maximum levels have not been reached (i.e.,< 120 mg
                  for dexamethasone or < 792 mg for prednisone)

          -  Prior radiotherapy to single sites for pain control or local plasmacytoma allowed

          -  Prior or concurrent bisphosphonates allowed

          -  At least 28 days since prior investigational anticancer agents or therapy

          -  No concurrent corticosteroids above physiologic replacement doses

          -  Concurrent radiotherapy to sites of active myeloma with pain or neurologic compromise
             allowed

          -  No concurrent filgrastim (G-CSF) on day 1 of course 1

          -  No other concurrent anticancer therapy

          -  No other concurrent investigational therapy