Lenalidomide and Dexamethasone With or Without Anakinra in Treating Patients With Early Stage Multiple Myeloma


This partially randomized phase I/II trial studies the side effects and best dose of anakinra when given together with lenalidomide and dexamethasone in treating patients with early stage multiple myeloma. Biological therapies, such as lenalidomide and anakinra, may stimulate or suppress the immune system in different ways and stop cancer cells from growing. Drugs used in chemotherapy, such as dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether lenalidomide and dexamethasone are more effective with or without anakinra in treating patients with multiple myeloma.
SparkCures ID 743
Trial Phase Phase 1/2
Enrollment 120 Patients
Trial Sponsors
  • Mayo Clinic
Trial Collaborators
  • National Cancer Institute (NCI)
NCT Identifier


Am I Eligible?

The following criteria is a partial list of reasons why patients may or may not be eligible to participate in this clinical trial. Further evaluation with a medical professional will be required to determine full eligibility.

The following criteria is provided for health care professionals.

Inclusion Criteria:

  • Serum creatinine =< 1.5 x upper limit of normal (ULN)
  • Absolute neutrophil count (ANC) >= 1700/mm^3
  • Platelet count >= 100,000/mm^3
  • Hemoglobin >= 8.0 g/dL
  • Diagnosis of multiple myeloma according to International Myeloma Working Group criteria and one of the following:
    • Smoldering multiple myeloma (SMM)
    • Indolent multiple myeloma (IMM)
    • Newly diagnosed multiple myeloma (MM)
    • Note: patients with lytic disease and anemia are eligible
  • High risk disease defined by all of the following:
    • >= 10% bone marrow plasma cells AND
    • Serum monoclonal immunoglobulin (M-protein) >= 3 g/dL OR urine M-protein >= 500 mg/24 hours (hr) AND
    • Monotypic plasma cell S-phase >= 1%
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2
  • Provide signed informed consent
  • Negative (serum or urine) pregnancy test done =< 7 days prior to registration, for women of childbearing potential only; NOTE: a second pregnancy test must be performed within 24 hours prior to the start of lenalidomide; the subject may not receive lenalidomide until the study doctor has verified that the results of these pregnancy tests are negative
  • Willing to return to enrolling institution for follow-up (during the active monitoring phase of the study)

Exclusion Criteria:

  • Prior treatment with any other agent that may affect M-protein =< 30 days prior to registration
  • Acute/chronic infections, open wounds, or any active infection requiring intravenous antibiotic therapy =< 12 weeks prior to registration
  • Other active malignancy (=< 3 years) prior to registration; exceptions: non-melanotic skin cancer or carcinoma-in-situ of the cervix or low-risk prostate cancer after curative therapy
  • Any of the following:
    • Pregnant women
    • Nursing women
    • Men or women of childbearing potential who are unwilling to employ adequate contraception
  • New York Heart Association (NYHA) class 3 or 4 congestive heart failure (CHF) symptoms
  • Other concurrent chemotherapy, radiotherapy, or any ancillary therapy considered investigational; NOTE: bisphosphonates are considered to be supportive care rather than therapy, and are thus allowed while on protocol treatment

US Trial Locations

Please visit the ClinicalTrials.gov page for historical site information.

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