Overview

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

Status:
Completed
Trial end date:
2010-11-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Mayo Clinic
Collaborator:
National Cancer Institute (NCI)
Treatments:
BB 1101
Dexamethasone
Dexamethasone 21-phosphate
Dexamethasone acetate
Interleukin 1 Receptor Antagonist Protein
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