Clinical trial NCT00114101 (phase 3, status: active, not recruiting)
Conditions: ds stage i plasma cell myeloma, ds stage ii plasma cell myeloma, ds stage iii plasma cell myeloma, refractory plasma cell myeloma, smoldering plasma cell myeloma
ICD codes: D46.4, D46.1, D46.A, D46.0, D46.20, D46.21, D46.22
Drugs: lenalidomide, melphalan
SMILES: 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:

        Inclusion Criteria:

          -  Patients must have active multiple myeloma requiring treatment (Durie-Salmon stage >=
             1) and have stable disease or be responsive to at least 2 months of any induction
             therapy; patients with smoldering myeloma are not eligible unless the disease has
             progressed to >= stage 1

          -  No more than 12 months of any prior therapy, including CC-5013 and thalidomide

          -  Within 12 months of initiation of induction therapy

          -  No prior progression after initial therapy; in addition, no more than two regimens
             will be allowed excluding dexamethasone alone

          -  No prior peripheral blood, bone marrow, or solid organ transplant

          -  Patients must have peripheral blood stem cell collection of >= 2 x 10^6 cluster of
             differentiation (CD)34+ cells/kg (patient body weight) and preferably 5 x 10^6
             cells/kg (patient body weight); stem cells may be collected at any time prior to
             transplant; peripheral blood stem cell collection may occur before or after
             registration

          -  Patients must have Eastern Cooperative Oncology Group (ECOG) performance status of 0-1

          -  Patients must have diffusing capacity of the lung for carbon monoxide (DLCO) > 50%
             predicted with no symptomatic pulmonary disease

          -  Patients must have left ventricular ejection fraction (LVEF) >= 40% by multi gated
             acquisition scan (MUGA) or echocardiogram

          -  Patients must not have uncontrolled diabetes mellitus

          -  Patients must not have an active serious infection

          -  Patients must not be human immunodeficiency virus (HIV), hepatitis B surface antigen
             (HBSag), or hepatitis (Hep) C positive

          -  Patients must be non-pregnant and non-nursing; women of childbearing potential must
             have a negative serum or urine pregnancy test with a sensitivity of at least 25 mIU/mL
             10-14 days prior to registration and repeated within 24 hours prior to the first dose
             of lenalidomide; in addition, women of childbearing potential taking lenalidomide must
             have a pregnancy test performed by the doctor weekly during the first 4 weeks of
             treatment, and then every 4 weeks if menses are regular and every 2 weeks if menses
             are irregular, and then 30 days following the last dose of lenalidomide; women of
             childbearing potential must either commit to continued abstinence from heterosexual
             intercourse or begin two acceptable methods of birth control - one highly effective
             method (intrauterine device [IUD], hormonal, tubal ligation, or partner's vasectomy),
             and one additional effective method (latex condom, diaphragm, or cervical cap) - at
             the same time, at least 4 weeks before she begins lenalidomide therapy; "women of
             childbearing" potential is defined as a sexually mature woman who has not undergone a
             hysterectomy or who has had menses at any time in the preceding 24 consecutive months;
             men must agree not to father a child and must use a latex condom during any sexual
             contact with women of childbearing potential while taking lenalidomide and for 4 weeks
             after therapy is stopped, even if they have undergone a successful vasectomy

          -  Absolute neutrophil count (ANC) >= 1000/uL

          -  Platelets >= 100,000/uL

          -  Creatinine clearance* >= 40 cc/min

               -  To be calculated by method of Cockcroft-Gault or after 24-hour urine collection

          -  Creatinine =< 2 mg/dL

          -  Total bilirubin =< 2 mg/dL

          -  Aspartate aminotransferase (AST) =< 3 x upper limits of normal

          -  Alkaline phosphatase =< 3 x upper limits of normal

          -  Urine (U)-human chorionic gonadotropin (HCG) or serum HCG negative (if patient of
             childbearing potential)