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


About this study

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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Absolute neutrophil count (ANC) ≥ 1700/mm^³
  • Platelet count ≥ 100,000/mm^³
  • Hemoglobin ≥ 8.0 g/dL
  • Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) ≤ 3 x upper limit of normal (ULN)
  • Creatinine clearance ≥ 30 mL/min (as determined by Cockroft-Gault equation)
  • 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
    • Abnormal serum free light chain (FLC) ratio (< 0.26 or > 1.65) by serum FLC assay AND
    • Monotypic Plasma Cell S-phase ≥0.3%   
  • Measurable level of M-protein > 1 g/dL on serum protein electrophoresis or > 200 mg of M-protein on a 24 hour urine protein electrophoresis
  • Negative tuberculosis (TB) testing (Quantiferon - TB blood test or skin test) ≤ 7 days prior to registration
  • 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)
  • Willing and able to comply with the requirements of the Revlimid Risk Evaluation and Mitigation Strategy (REMS) program
  • Females of childbearing potential must be willing to adhere to the scheduled pregnancy testing as required by the Revlimid REMS program

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: basal cell 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 allowed while on protocol treatment

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

John Lust, M.D., Ph.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office


More information


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