Anakinra With or Without Dexamethasone in Treating Patients With Smoldering or Indolent Multiple Myeloma
Condition: Multiple Myeloma and Plasma Cell Neoplasm
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell; Plasmacytoma
Intervention: Anakinra (IL-1Ra); Dexamethasone acetate
Intervention description: 100mg daily subcutaneously administered; Low dose - 20 mg/week
High dose - 40mg days 1-4, 9-12, 17-20 every 28 days ODD cycles OR 40 mg days 1-4 every 28 days EVEN cycles. (Starting dose was determined by treating physician)
Intervention MeSH terms: Dexamethasone; Dexamethasone acetate; Interleukin 1 Receptor Antagonist Protein; BB 1101
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 55.0
Sex: All
Minimum age: 18 Years
Maximum age: 120 Years
Healthy volunteers: No
Keywords: stage I multiple myeloma; stage II multiple myeloma; stage III multiple myeloma

Summary:

      RATIONALE: Some cancers need growth factors which are made by the body's white blood cells to
      keep growing.Anakinra may interfere with the growth factor and stop multiple myeloma from
      growing. Dexamethasone may stop cancer cells from growing. Giving anakinra together with
      dexamethasone may be an effective treatment for multiple myeloma.

      PURPOSE: This phase II trial is studying how well anakinra works when given with or without
      dexamethasone in treating patients with smoldering myeloma or indolent multiple myeloma.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  New or preexisting diagnosis of multiple myeloma

             - Smoldering or indolent multiple myeloma meeting one of the following criteria:

               -  Bone marrow plasma cells ≥ 10%

               -  Serum monoclonal IgG or IgA protein ≥ 3.0 g/dL OR urine monoclonal light chain ≥
                  1g by 24-hour urine protein electrophoresis

          -  Measurable disease

          -  Does not require immediate chemotherapy, in the opinion of the treating physician

          -  No active myeloma or primary amyloidosis requiring chemotherapy or any agents that may
             interact with anakinra (e.g., etanercept, infliximab, or thalidomide)

        PATIENT CHARACTERISTICS:

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0

          -  Total WBC ≥ 3,500/mm^3

          -  ANC ≥ 1,700/mm^3

          -  Creatinine ≤ 1.5 times upper limit of normal

          -  Able to self-inject medication or have a caregiver who can administer the drug

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  No acute or chronic infections, open wounds, or any active infection requiring
             intravenous antibiotic therapy within the past 12 weeks

          -  No active malignancy within the past 5 years except basal cell carcinoma of the skin
             or carcinoma in situ of cervix

             - Patients with a previously resected malignancy that does not require further
             treatment are eligible

          -  No New York Heart Association (NYHA) class III or IV congestive heart failure

          -  No rheumatoid arthritis or other diseases requiring immunosuppressive therapy

          -  No asthma, inflammatory bowel disease, or any debilitating physical or psychiatric
             illness that, in the judgment of the investigator, would interfere with the conduct of
             the study

        PRIOR CONCURRENT THERAPY:

        * More than 30 days since prior treatment with dehydroepiandrosterone (DHEA),
        clarithromycin, pamidronate, steroids, or any other agent that may affect M-protein