Alternating Ixazomib Citrate and Lenalidomide as Maintenance Therapy After Stem Cell Transplant in Treating Patients With Multiple Myeloma
Condition: Plasma Cell Myeloma; Transplant-Related Carcinoma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Intervention: Ixazomib Citrate; Laboratory Biomarker Analysis; Lenalidomide
Intervention description: Given PO; Correlative studies; Given PO
Intervention MeSH terms: Lenalidomide; Ixazomib; Glycine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This phase II trial studies the safety of alternating ixazomib citrate and lenalidomide as
      treatment to help keep cancer from coming back after stem cell transplant (maintenance
      therapy) in treating patients with multiple myeloma. Ixazomib citrate may stop the growth of
      cancer cells by blocking some of the enzymes needed for cell growth. Lenalidomide may
      stimulate the immune system to attack cancer cells. Giving ixazomib citrate and lenalidomide
      as maintenance therapy after transplant may prolong the length of time until the cancer
      returns.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Eastern Cooperative Oncology Group (ECOG) performance status and/or other performance
             status 0, 1, or 2

          -  Any autologous patient who underwent high dose melphalan (>= 140 mg/m^2)
             therapy/peripheral blood stem cell (PBSC) rescue for any stage of multiple myeloma and
             did not participate in another clinical transplant trial whose primary endpoint is
             also evaluating long-term, disease-free survival or survival; consenting for study
             between 30 days to 120 days after transplant; earliest can start therapy is 30 days
             post transplant after recovered from acute toxicity of autologous stem cell transplant
             (ASCT)

          -  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             be withdrawn by the patient at any time without prejudice to future medical care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)

          -  Absolute neutrophil count (ANC) >= 1,000/mm^3

          -  Platelet count (transfusion independent) >= 75,000/mm^3

          -  Total bilirubin =< 1.5 x the upper limit of the normal range (ULN)

          -  Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =< 3 x ULN

          -  Calculated creatinine clearance >= 30 mL/min

        Exclusion Criteria:

          -  Female patients who are lactating or have a positive serum pregnancy test during the
             screening period

          -  Failure to have fully recovered (i.e., =< grade 1 toxicity) from the reversible
             effects of prior ASCT chemotherapy

          -  Major surgery within 14 days before enrollment

          -  Radiotherapy within 14 days before enrollment; if the involved field is small, 7 days
             will be considered a sufficient interval between treatment and administration of the
             ixazomib

          -  History of central nervous system multiple myeloma involvement

          -  Infection requiring systemic antibiotic therapy or other serious infection within 14
             days before study enrollment

          -  Evidence of current uncontrolled cardiovascular conditions, including uncontrolled
             hypertension, uncontrolled cardiac arrhythmias, symptomatic congestive heart failure,
             unstable angina, or myocardial infarction within the past 6 months

          -  Systemic treatment, within 14 days before the first dose of ixazomib, with strong
             inhibitors of cytochrome P450, family 1, subfamily A, polypeptide 2 gene (CYP1A2)
             (fluvoxamine, enoxacin, ciprofloxacin), strong inhibitors of cytochrome P450, family
             3, subfamily A gene locus (CYP3A) (clarithromycin, telithromycin, itraconazole,
             voriconazole, ketoconazole, nefazodone, posaconazole) or 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; patient cannot be allergic to boron

          -  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 2 peripheral neuropathy, or grade 1 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

          -  Patients with history prior to transplant of progression on lenalidomide therapy