Status:
COMPLETED
Anakinra With or Without Dexamethasone in Treating Patients With Smoldering or Indolent Multiple Myeloma
Lead Sponsor:
Mayo Clinic
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Multiple Myeloma and Plasma Cell Neoplasm
Eligibility:
All Genders
18-120 years
Phase:
PHASE2
Brief 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. Dexamet...
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 combin...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
December 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2010
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT00635154
Start Date
December 1 2002
End Date
November 1 2010
Last Update
June 7 2018
Active Locations (1)
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1
Mayo Clinic
Rochester, Minnesota, United States, 55905