Pomalidomide or Lenalidomide and Dexamethasone in Treating Patients With Relapsed or Refractory Multiple Myeloma Previously Treated With Lenalidomide
Condition: Recurrent Plasma Cell Myeloma; Refractory Plasma Cell Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Intervention: Dexamethasone; Lenalidomide; Pomalidomide
Intervention description: Given PO; Given PO; Given PO
Intervention MeSH terms: Dexamethasone; Dexamethasone acetate; Lenalidomide; Pomalidomide; Ichthammol; BB 1101
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 9.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This randomized phase II trial studies how well pomalidomide and dexamethasone work compared
      to lenalidomide and dexamethasone in treating patients with multiple myeloma that has
      returned after a period of improvement (relapsed) or did not respond to previous treatment
      with lenalidomide (refractory). Pomalidomide and lenalidomide may help the immune system kill
      cancer cells and may also prevent the growth of new blood vessels that tumors need to grow.
      Drugs used in chemotherapy, such as dexamethasone, work in different ways to stop the growth
      of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping
      them from spreading. Dexamethasone may also help pomalidomide and lenalidomide work better by
      making cancer cells more sensitive to the drugs. It is not yet known whether pomalidomide and
      dexamethasone or lenalidomide and dexamethasone are effective in treating patients with
      relapsed or refractory multiple myeloma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Calculated creatinine clearance >= 30 ml/min by Cockcroft-Gault formula

          -  Absolute neutrophil count >= 1000uL

          -  (Untransfused) platelet count >= 50000/uL

          -  Hemoglobin >= 8.0 g/dL

          -  Relapsed myeloma that previously became refractory to lenalidomide, after initial
             response of partial response or better to the drug; refractory is defined as
             progression on treatment with a dose of at least 10 mg daily for lenalidomide; greater
             than or equal to 180 days must have elapsed since previous lenalidomide therapy was
             stopped

          -  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

               -  Monoclonal bone marrow plasmacytosis >= 30% (evaluable disease)

          -  Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2

          -  Previously treated; NOTE: no limit to prior therapy provided there is adequate
             residual organ function

          -  Provide informed written consent

          -  Females of childbearing potential (FCBP)* must have a negative serum pregnancy test
             with a sensitivity of at least 50 mIU/mL within 10 - 14 days prior to and again within
             24 hours prior to prescribing lenalidomide for cycle 1 (prescriptions must be filled
             within 7 days as required by Revlimid Risk Evaluation and Mitigation Strategy [REMS]),
             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; all study participants must be registered into the Revlimid REMS
             program, and be willing and able to comply with the requirements of Revlimid REMS
             program

               -  A female of childbearing potential 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)

          -  Willing to return to Mayo Clinic enrolling institution for follow-up

        Exclusion Criteria:

          -  Residual toxicity of > grade 1 from prior therapy

          -  Other active malignancy < 1 year prior to registration; EXCEPTIONS: non-melanotic skin
             cancer or carcinoma-in-situ of the cervix; NOTE: 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 (lactating females must agree not to breast feed while taking
                  lenalidomide)

               -  Men or women of childbearing potential who are unwilling to employ adequate
                  contraception (condoms, diaphragm, birth control pills, injections, intrauterine
                  device [IUD], or abstinence, etc.)

          -  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; NOTE: bisphosphonates are considered to be supportive care rather
             than therapy, and are thus allowed while on protocol treatment

          -  New York Heart Association classification III or IV

          -  Diagnosed active deep vein thrombosis (DVT) that has not been therapeutically
             anticoagulated