Anakinra With or Without Dexamethasone in Treating Patients With Smoldering or Indolent Multiple Myeloma
Multiple Myeloma and Plasma Cell Neoplasm
About this trial
This is an interventional treatment trial for Multiple Myeloma and Plasma Cell Neoplasm focused on measuring stage I multiple myeloma, stage II multiple myeloma, stage III 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
Sites / Locations
- Mayo Clinic
Arms of the Study
Arm 1
Experimental
Anakinra with/without Dexamethasone
Anakinra was given alone for 6 months at which time response was assessed. If participants achieved a minor response or better they continued on Anakinra alone until disease progression. If participants achieved stable disease, they added low dose Dexamethasone to Anakinra until progression. If at any time a participant progresses, they were administered high dose Dexamethasone with Anakinra.