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