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Lenalidomide with or without Ixazomib Citrate and Dexamethasone in Treating Patients with Residual Multiple Myeloma after Donor Stem Cell Transplant

This randomized phase II trial studies how well lenalidomide alone compared to lenalidomide, ixazomib citrate, and dexamethasone work in treating patients with multiple myeloma that remains (residual) after donor stem cell transplant. Lenalidomide may help the immune system kill abnormal blood cells or cancer cells and may also prevent the growth of new blood vessels that are needed for cancer growth. Ixazomib citrate may stop the growth of cancer cells by interfering with proteins necessary for cell growth. 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 is more effective with or without ixazomib citrate and dexamethasone in treating residual multiple myeloma.
Not Available
Phase II
Not Available
Not Available
Cornell, Robert
Vanderbilt University


18 Years
Inclusion Criteria:

Patients who completed induction treatment followed by autologous stem cell transplant as initial therapy for symptomatic myeloma as per IMWG criteria and are considered for single agent lenalidomide (Revlimid) maintenance or initiated single agent Revlimid maintenance * Patients will be eligible for enrollment in the first 0-4 months of lenalidomide maintenance provided that lenalidomide maintenance has been initiated on days 60 - 120 after transplant ** Patients do not have to be on revlimid at the time of study consent * Patients must be receiving lenalidomide 10 mg or 15 mg and be able to tolerate dose escalation to 25 mg daily * Patients receiving off protocol lenalidomide maintenance cannot exceed 4 months post-transplant * A one week break from off protocol lenalidomide is suggested, prior to initiating treatment on the study ** Any delays > 7 days to align treatment with the start of cycle 1 day 1, of either arm, must be discussed with the principal investigator (PI) * Patients who completed tandem transplantation will be eligible for enrollment

No evidence of progressive disease on lenalidomide

Evidence of minimal residual disease at the time of screening defined as at least MRD-positive disease: * The primary method of evaluation of MRD is multi-parameter flow cytometry (MFC) performed at the University of Chicago * Patients who have negative MRD by multi-parameter flow cytometry (MFC) but have residual original monoclonal protein by serum or urine immunofixation may be eligible if they are found to have MRD-positive disease by next generation sequencing (NGS) * If patient is receiving lenalidomide, any delays required to align treatment with the start of cycle 1 of either arm, must be discussed with the PI

Bone marrow specimen from diagnosis (or pre-induction) will be required at study entry; available deoxyribonucleic acid (DNA) sample will be used for calibration step for MRD evaluation by gene sequencing

Life expectancy of more than 3 months

Eastern Cooperative Oncology Group (ECOG) performance status of 0-2

Bilirubin =
Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =
Absolute neutrophil count (ANC) >= 1.0 x 10^9/L

Hemoglobin >= 8 g/dL

Platelet count >= 75 x 10^9/L

Calculated creatinine clearance (by Cockcroft-Gault) >= 50 ml/min or serum creatinine below 2 g/dL

Voluntary written consent must be given before performance of any study related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care

Female patients who: * Are postmenopausal for at least 1 year before the screening visit, OR * Are surgically sterile, OR * If they are of childbearing potential, agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent form through 90 days after the last dose of study drug, OR * Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)

Male patients, even if surgically sterilized (i.e., status post-vasectomy), must agree to one of the following: * Agree to practice effective barrier contraception during the entire study treatment period and through 90 days after the last dose of study drug, OR * Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)

Exclusion Criteria:

Evidence of progressive disease on lenalidomide maintenance as per IMWG criteria

Patients who have already started or received multi-drug consolidation regimen post-transplant expect for patients receiving up to 4 months of single agent lenalidomide maintenance

Longer than 12 months since the initiation of induction therapy at the time of randomization

Prior progression after initial therapy * Subjects whose therapy changed due to suboptimal response, intolerance, etc., remain eligible, provided they do not meet criteria for progression. * No more than two regimens will be allowed excluding dexamethasone alone

Diarrhea > grade 1 in the absence of anti-diarrheals

Central nervous system involvement of the disease under study

Female patients who are lactating or have a positive serum pregnancy test during the screening period

History of allergy to mannitol

Major surgery within 14 days before enrollment

Radiotherapy within 14 days before randomization; if the involved field is small, 7 days will be considered a sufficient interval between treatment and administration of the ixazomib

Evidence of current uncontrolled cardiovascular conditions, including uncontrolled cardiac conditions such as hypertension, or cardiac arrhythmias, or New York Heart Association stage III and IV congestive heart failure, or unstable angina or myocardial infarction within the past 6 months

Rate-corrected QT interval of electrocardiograph (QTc) > 470 msec on a 12-lead electrocardiogram (ECG) during screening

Uncontrolled diabetes

Acute infection requiring systemic anti-infectives, antivirals, or antifungals within two weeks prior to first dose

Systemic treatment, within 14 days before the first dose of ixazomib, with strong CYP3A inducers (rifampin, rifapentine, rifabutin, carbamazepine, phenytoin, phenobarbital), or use of Ginkgo biloba or St. John’s wort

Ongoing or active systemic infection, active hepatitis B or C virus infection, or known human immunodeficiency virus (HIV) positive

Any serious medical or psychiatric illness that could, in the investigator’s opinion, potentially interfere with the completion of treatment according to this protocol

Known allergy to any of the study medications, their analogues, or excipients in the various formulations of any agent

Known gastrointestinal (GI) disease or GI procedure that could interfere with the oral absorption or tolerance of ixazomib including difficulty swallowing

Diagnosed or treated for another malignancy within 2 years before study enrollment or previously diagnosed with another malignancy and have any evidence of residual disease; patients with nonmelanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection

Patient has >= grade 3 peripheral neuropathy or grade 2 with pain on clinical examination during the screening period

Participation in other clinical trials, including those with other investigational agents not included in this trial, within 30 days of the start of this trial and throughout the duration of this trial

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