Lenalidomide in Treating Patients With Multiple Myeloma Undergoing Autologous Stem Cell Transplant
Condition: DS Stage I Multiple Myeloma; DS Stage II Multiple Myeloma; DS Stage III Multiple Myeloma; Refractory Multiple Myeloma; Smoldering Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell; Smoldering Multiple Myeloma
Intervention: Autologous Hematopoietic Stem Cell Transplantation; Laboratory Biomarker Analysis; Lenalidomide; Melphalan; Peripheral Blood Stem Cell Transplantation; Placebo Administration
Intervention description: Undergo autologous PBSCT; Correlative studies; Given PO; Given IV; Undergo autologous PBSCT; Given PO
Intervention MeSH terms: Lenalidomide; Melphalan; Mechlorethamine; Nitrogen Mustard Compounds
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 460.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      This randomized phase III trial studies lenalidomide to see how well it works compared to a
      placebo in treating patients with multiple myeloma who are undergoing autologous stem cell
      transplant. Giving chemotherapy before a peripheral blood stem cell transplant helps kill any
      cancer cells that are in the body and helps make room in the patient's bone marrow for new
      blood-forming cells (stem cells) to grow. After treatment, stem cells are collected from the
      patient's blood and stored. More chemotherapy is then given to prepare the bone marrow for
      the stem cell transplant. The stem cells are then returned to the patient to replace the
      blood-forming cells that were destroyed by the chemotherapy. Biological therapies, such as
      lenalidomide, may stimulate or suppress the immune system in different ways and stop cancer
      cells from growing. Giving lenalidomide after autologous stem cell transplant may be an
      effective treatment for multiple myeloma.
    

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)