Ensayos clínicos

Inclusion Criteria:

• Calculated creatinine clearance (using Cockcroft-Gault equation) ≥ 60 mL/min.
• Absolute neutrophil count (ANC) ≥ 1000/mm^3.
• Platelet count ≥ 75000/mm^3.
• Hemoglobin ≥ 8.0 g/dL.
• Must have relapsed and symptomatic multiple myeloma.
• Measurable disease of multiple myeloma as defined by at least one of the following:
  • Serum monoclonal protein ≥ 1.0 g/dL;
  • > 200 mg of monoclonal protein in the urine on 24 hour electrophoresis;
  • Serum immunoglobulin free light chain ≥ 10 mg/dL AND abnormal serum immunoglobulin kappa to lambda free light chain ratio.
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2.
• Patients must have received at least 1 prior regimen.
• Provide informed written consent.
• Negative pregnancy test done ≤ 7 days prior to registration, for women of childbearing potential only.
• Willing to return to enrolling institution for follow-up (during the active monitoring phase of the study).
• Willing to provide bone marrow and blood samples for correlative research purposes.

Exclusion Criteria:

• Monoclonal gammopathy of undetermined significance (MGUS) or smoldering myeloma.
• Has received > 3 prior treatment regimens for multiple myeloma.
• Other malignancy requiring active therapy with exceptions of non-melanotic skin cancer or carcinoma-in-situ of the cervix: 
  • If there is a history of prior malignancy, they must not be receiving other specific treatment for their cancer.
• Any of the following:
  • Pregnant women;
  • Nursing women;
  • Men or women of childbearing potential who are unwilling to employ adequate contraception.
• Other co-morbidity which would interfere with patient's ability to participate in trial, e.g. uncontrolled infection, uncompensated heart or lung disease.
• Other concurrent chemotherapy, radiotherapy, or any ancillary therapy considered investigational:
  • Bisphosphonates are considered to be supportive care rather than therapy, and are thus allowed while on protocol treatment.
• Prior severe skin reaction (toxic epidermal necrosis) with immunomodulating agents.
• Major surgery ≤ 14 days before study registration.
• Concurrent medical problems that preclude use of deep vein thrombosis (DVT) prophylaxis with lenalidomide treatment.
• Evidence of current uncontrolled cardiovascular conditions, including cardiac arrhythmias, congestive heart failure, angina, or myocardial infarction ≤ 6 months prior to registration.
• Known human immunodeficiency virus (HIV) positive.
• Any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to this protocol.
• Known allergy to any of the study medications, their analogues or excipients in the various formulations.