Lenalidomide and Dexamethasone With or Without Anakinra in Treating Patients With Early Stage Multiple Myeloma
Condition: Indolent Plasma Cell Myeloma; Plasma Cell Myeloma; Smoldering Plasma Cell Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell; Smoldering Multiple Myeloma
Intervention: Anakinra; Dexamethasone; Laboratory Biomarker Analysis; Lenalidomide; Placebo
Intervention description: Given SC; Given PO; Correlative studies; Given PO; Given SC
Intervention MeSH terms: Dexamethasone; Dexamethasone acetate; Lenalidomide; Interleukin 1 Receptor Antagonist Protein; Ichthammol; BB 1101
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 14.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This partially randomized phase I/II trial studies the side effects and best dose of anakinra
      when given together with lenalidomide and dexamethasone in treating patients with early stage
      multiple myeloma. Biological therapies, such as lenalidomide and anakinra, may stimulate or
      suppress 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, by stopping them from dividing, or by stopping them from
      spreading. It is not yet known whether lenalidomide and dexamethasone are more effective with
      or without anakinra in treating patients with multiple myeloma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Absolute neutrophil count (ANC) >= 1700/mm^3

          -  Platelet count >= 100,000/mm^3

          -  Hemoglobin >= 8.0 g/dL

          -  Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) =< 3
             x upper limit of normal (ULN)

          -  Creatinine clearance >= 30 mL/min (as determined by Cockroft-Gault equation)

          -  Diagnosis of multiple myeloma according to International Myeloma Working Group
             criteria and one of the following:

               -  Smoldering multiple myeloma (SMM)

               -  Indolent multiple myeloma (IMM)

               -  Newly diagnosed multiple myeloma (MM)

               -  Note: patients with lytic disease and anemia are eligible

          -  High risk disease defined by all of the following:

               -  >= 10% bone marrow plasma cells AND

               -  Abnormal serum free light chain (FLC) ratio (< 0.26 or > 1.65) by serum FLC assay
                  AND

               -  Monotypic plasma cell S-phase >= 0.3%

          -  Measurable level of M-protein > 1 g/dL on serum protein electrophoresis or > 200 mg of
             M-protein on a 24 hour urine protein electrophoresis

          -  Negative tuberculosis (TB) testing (Quantiferon - TB blood test or skin test) =< 7
             days prior to registration

          -  Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2

          -  Provide signed informed consent

          -  Negative (serum or urine) pregnancy test done =< 7 days prior to registration, for
             women of childbearing potential only; NOTE: a second pregnancy test must be performed
             within 24 hours prior to the start of lenalidomide; the subject may not receive
             lenalidomide until the study doctor has verified that the results of these pregnancy
             tests are negative

          -  Willing to return to enrolling institution for follow-up (during the active monitoring
             phase of the study)

          -  Willing and able to comply with the requirements of the Revlimid Risk Evaluation and
             Mitigation Strategy (REMS) program

          -  Females of childbearing potential must be willing to adhere to the scheduled pregnancy
             testing as required by the Revlimid REMS program

        Exclusion Criteria:

          -  Prior treatment with any other agent that may affect M-protein =< 30 days prior to
             registration

          -  Acute/chronic infections, open wounds, or any active infection requiring intravenous
             antibiotic therapy =< 12 weeks prior to registration

          -  Other active malignancy (=< 3 years) prior to registration; exceptions: basal cell
             skin cancer or carcinoma-in-situ of the cervix or low-risk prostate cancer after
             curative therapy

          -  Any of the following:

               -  Pregnant women

               -  Nursing women

               -  Men or women of childbearing potential who are unwilling to employ adequate
                  contraception

          -  New York Heart Association (NYHA) class 3 or 4 congestive heart failure (CHF) symptoms

          -  Other concurrent chemotherapy, radiotherapy, or any ancillary therapy considered
             investigational; NOTE: bisphosphonates are allowed while on protocol treatment