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
Study type: Interventional
Phase: Phase 2

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.
    

Detailed description: 
      OBJECTIVES:

      Primary

      * Determine the response rate in patients with smoldering or indolent multiple myeloma
      treated with anakinra.

      Secondary

        -  Determine the toxicity of anakinra alone or in combination with dexamethasone in these
           patients.

        -  Evaluate the response rate in patients treated with anakinra in combination with
           dexamethasone.

        -  Evaluate the proportion of patients who are progression-free at 6 months.

        -  Determine the tolerability of anakinra in combination with dexamethasone in these
           patients.

        -  Determine the time to progression to active multiple myeloma in patients treated with
           anakinra alone or in combination with dexamethasone.

        -  Assess the duration of response in these patients.

      OUTLINE:

        -  Induction therapy: Patients receive anakinra subcutaneously (SC) once daily for 6 months
           (months 1-6). Based on response, patients continue on treatment in one of three ways.

        -  Complete response [CR], very good partial response [VGPR], partial response [PR], or
           minimal response [MR]: Patients continue to receive anakinra SC once daily for 6
           additional months (months 7-12). Patients who develop disease progression at anytime
           proceed to treatment with high dose dexamethasone.

        -  Stable disease: Patients receive low-dose oral dexamethasone once weekly for 6 months
           (months 7-12) with anakinra SC once daily. Patients who maintain stable disease or
           responded will continue low-dose oral dexamethasone and anakinra SC once daily for 6
           additional months (months 13-18). Patients who develop disease progression at any time
           proceed to treatment with high dose dexamethasone.

        -  Progressive disease: Patients receive high-dose oral dexamethasone on days 1-4, 9-12,
           and 17-20 in months 7, 9, and 11 and on days 1-4 in months 8, 10, and 12 with anakinra
           SC once daily for 6 additional months (months 7-12).

      NOTE: Patients may continue on treatment beyond 12 months at treating physician discretion.

      After completion of study treatment, patients are followed every 6 months for up to 5 years.
    

Intervention name(s): Anakinra (IL-1Ra); Dexamethasone acetate
Intervention type(s): Biological; Drug
Intervention description(s): 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
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stage I multiple myeloma; stage II multiple myeloma; stage III multiple myeloma