Overview

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

Status:
Completed
Trial end date:
2019-09-13
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Mayo Clinic
Collaborator:
National Cancer Institute (NCI)
Treatments:
BB 1101
Dexamethasone
Dexamethasone 21-phosphate
Dexamethasone acetate
Ichthammol
Interleukin 1 Receptor Antagonist Protein
Lenalidomide
Thalidomide
Criteria
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