Anakinra With or Without Dexamethasone in Treating Patients With Smoldering or Indolent Multiple Myeloma

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.

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