Bortezomib, Lenalidomide, and Dexamethasone in Treating Patients With Multiple Myeloma Undergoing Stem Cell Transplant
Condition: Refractory Plasma Cell Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Intervention: Bortezomib; Lenalidomide; Dexamethasone
Intervention description: Given IV; Given PO; Given PO or IV
Intervention MeSH terms: Dexamethasone; Lenalidomide; Bortezomib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 3.0
Sex: All
Minimum age: 19 Years
Healthy volunteers: No

Summary:

      This phase II trial studies how well giving bortezomib, lenalidomide, and dexamethasone
      together works in treating patients with multiple myeloma undergoing stem cell transplant.
      Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for
      cell growth. Biological therapies, such as lenalidomide, may stimulate the immune system in
      different ways and stop cancer cells from growing. Drugs used in chemotherapy, such as
      dexamethasone, work in different ways to stop the growth of cancer cells, either by killing
      the cells or by stopping them from dividing. Giving bortezomib, lenalidomide, and
      dexamethasone together may kill more cancer cells.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with symptomatic active multiple myeloma who have completed autotransplant
             are eligible for the study; patients should be assessed for eligibility within 35 days
             of the transplant and treatment should commence within 10 weeks of the transplant

          -  Performance status of 0-2 based on Southwest Oncology Group (SWOG) criteria; patients
             with a poor performance status (3-4) are also eligible, if complications of the bone
             such as compression fracture, hyperviscosity or infection such as pneumonia have been
             adequately treated

          -  No significant co-morbid medical conditions; no uncontrolled life threatening
             infection

          -  Unsupported platelet count > 80,000/uL

          -  Absolute neutrophil count (ANC) > 1000/uL

          -  Signed informed consent should be obtained from all patients in accordance with
             institutional and federal guidelines

        Exclusion Criteria:

          -  Patients with a history of recent (< 6 months) myocardial infarction, unstable angina,
             difficult to control congestive heart failure, uncontrolled hypertension, difficult to
             control significant cardiac arrhythmias, or arrhythmia associated with prolonged QT
             interval

          -  Pregnant or nursing women; women of child-bearing potential must have a negative
             pregnancy documented within one week of registration; women/men of reproductive
             potential may not participate unless they have agreed to use two forms of effective
             contraceptive method

          -  Patients with a grade 3-4 neuropathy related to prior exposure to bortezomib,
             thalidomide, or other agents

          -  Human immunodeficiency virus (HIV) positive patients

          -  Transaminases > 2 x normal values

          -  Bilirubin > 2 x normal values

          -  Active uncontrolled infection

          -  History of significant psychiatric illness; steroid induced psychosis