Lenalidomide or Observation in Treating Patients With Asymptomatic High-Risk Smoldering Multiple Myeloma
Condition: Light Chain Deposition Disease; Smoldering Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell; Smoldering Multiple Myeloma
Intervention: Clinical Observation; Lenalidomide; Quality-of-Life Assessment
Intervention description: Undergo observation; Given PO; Ancillary studies
Intervention MeSH terms: Lenalidomide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 226.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This randomized phase II/III trial studies how well lenalidomide works and compares it to
      observation in treating patients with asymptomatic high-risk asymptomatic (smoldering)
      multiple myeloma. Biological therapies such as lenalidomide, may stimulate the immune system
      in different ways and stop cancer cells from growing. Sometimes the cancer may not need
      treatment until it progresses. In this case, observation may be sufficient. It is not yet
      known whether lenalidomide is effective in treating patients with high-risk smoldering
      multiple myeloma than observation alone.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must be diagnosed with asymptomatic high-risk smoldering multiple myeloma
             (SMM) within the past 60 months, as confirmed by both of the following:

               -  Bone marrow plasmacytosis with >= 10% plasma cells or sheets of plasma cells at
                  any time before initiating study treatment, including a marrow which must be
                  obtained by bone marrow aspiration and/or biopsy within 4 weeks prior to
                  randomization

               -  Abnormal serum free light chain ratio (< 0.26 or > 1.65) by serum free light
                  chain (FLC) assay; FLC assay must be performed within 28 days of randomization

          -  Patients must have measurable levels of monoclonal protein (M-protein): >= 1g/dL on
             serum protein electrophoresis or >= 200 mg of monoclonal protein on a 24 hour urine
             protein electrophoresis which must be obtained within 4 weeks prior to randomization

          -  Patients must have no lytic lesions on skeletal surveys and no hypercalcemia (i.e., >=
             11 mg/dL)

          -  Hemoglobin >= 11 g/dL within four weeks prior to randomization

          -  Platelet count >= 100,000/mm^3 within four weeks prior to randomization

          -  Absolute neutrophil count (ANC) >= 1,500/mm^3 within four weeks prior to randomization

          -  Calculated creatinine clearance >= 30 mL/min within four weeks prior to randomization

          -  Bilirubin =< 1.5 mg/dL within four weeks prior to randomization

          -  Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) and
             serum glutamic oxaloacetic transaminase (SGPT) (aspartate aminotransferase [AST]) =<
             2.5 times upper limit of normal within four weeks prior to randomization

          -  No prior or concurrent systemic or radiation therapy for the treatment of myeloma

          -  Concurrent use of bisphosphonates is not permitted; however, prior bisphosphonates or
             once-a-year intravenous bisphosphonate given for the treatment of osteoporosis is
             permitted

          -  Prior or concurrent use of erythropoietin is disallowed

          -  Prior glucocorticosteroid therapy for the treatment of multiple myeloma is not
             permitted

          -  Prior systemic glucocorticosteroid use for the treatment of non-malignant disorders is
             permitted; concurrent use after registration on the study should be restricted to the
             equivalent of prednisone 10 mg per day

          -  Prior or concurrent topical or localized glucocorticosteroid therapy to treat
             non-malignant comorbid disorders is permitted

          -  Patients must not have active, uncontrolled seizure disorder; patients must have had
             no seizures in the last 6 months

          -  Patients must not have uncontrolled intercurrent illness including uncontrolled
             hypertension, symptomatic congestive heart failure, unstable angina, uncontrolled
             cardiac arrhythmia, uncontrolled psychiatric illness or social situation that would
             limit compliance with the study, or a prior history of Stevens Johnson syndrome

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2

          -  Patients must not have baseline bone lesions or plasmacytomas

          -  Patients with monoclonal gammopathy of undetermined significance are not eligible

          -  Patients must not have grade 2 or higher peripheral neuropathy

          -  Patients must not have active, uncontrolled infection

          -  Patients may have a history of current or previous deep vein thrombosis or pulmonary
             embolism but are required to take some form of anti-coagulation as prophylaxis if they
             are not currently on full-dose anticoagulation

          -  Patients should not have New York Heart Association classification III or IV heart
             failure

          -  Patients with a history of prior malignancy are eligible provided they were treated
             with curative intent and have been free of disease for the time period considered
             appropriate for cure of the specific cancer; for most diseases this time frame is 5
             years

          -  Patients should not be felt to have an immediate need for chemotherapy

          -  Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy
             test with a sensitivity of at least 25 mIU/mL within 10 - 14 days prior to and again
             within 24 hours of starting cycle 1 of lenalidomide and must either commit to
             continued abstinence from heterosexual intercourse or begin TWO acceptable methods of
             birth control, one highly effective method and one additional effective method AT THE
             SAME TIME, at least 28 days before she starts taking lenalidomide; FCBP must also
             agree to ongoing pregnancy testing; men must agree to use a latex condom during sexual
             contact with a FCBP even if they have had a successful vasectomy; a FCBP is a sexually
             mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2)
             has not been naturally postmenopausal for at least 24 consecutive months (i.e., has
             had menses at any time in the preceding 24 consecutive months); all patients must be
             counseled by a trained counselor every 28 days about pregnancy precautions and risks
             of fetal exposure

          -  Human immunodeficiency virus (HIV) infection is not excluded; HIV+ patients must meet
             the following criteria:

               -  Cluster of differentiation (CD)4 cell count >= 350/mm^3

               -  No history of acquired immune deficiency syndrome (AIDS)-related illness

               -  Not currently prescribed zidovudine or stavudine