Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Trial Description

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.

Further Study Information

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.

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

Trial Contact Information

Trial Lead Organizations/Sponsors

Mayo Clinic Cancer Center

John A. Lust

Principal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00635154
Information obtained from ClinicalTrials.gov on December 15, 2011

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