A Study of Pomalidomide, Ixazomib Citrate, and Dexamethasone in Treating Patients with Previously Treated Multiple Myeloma or Plasma Cell Leukemia

Overview

  • Study type

    Interventional
  • Study phase

    II
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

  • Site IRB
    • Rochester, Minnesota: 14-008347
    NCT ID: NCT02547662
    Sponsor Protocol Number: MC1487

About this study

This phase II trial studies how well pomalidomide, ixazomib citrate, and dexamethasone work in treating patients with previously treated multiple myeloma or plasma cell leukemia. Biological therapies, such as pomalidomide, and dexamethasone, use substances made from living organisms that may stimulate or suppress the immune system in different ways and stop cancer cells from growing. Ixazomib citrate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving pomalidomide, ixazomib citrate, and dexamethasone together may be more effective in treating 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. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Inclusion Criteria

  • Previously treated myeloma currently with measurable disease
    • Extramedullary disease defined as Plasmacytoma outside bone marrow that is not contiguous with a bone lesion with at least one lesion that has a single diameter of ≥ 2 cm
    • Or Plasma cell leukemia defined as circulating plasma cells exceeding 5% of peripheral blood leukocytes or 0.5 X 10^9/L or 200 cells/150000 events by flow cytometry
  • Calculated creatinine clearance (using Cockcroft-Gault equation) ≥ 30 mL/min
  • Absolute neutrophil count (ANC) ≥ 1000/mm^3
  • Platelet count ≥ 50,000/mm^3
  • Hemoglobin ≥ 8.0 g/dL
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2
  • Provide informed written consent
  • Women of childbearing potential, negative pregnancy test done ≤ 7 days prior to registration
  • All study participants must be registered into the mandatory POMALYST (pomalidomide) Risk Evaluation and Mitigation Strategy (REMS™) program, and be willing and able to comply with the requirements of the POMALYST REMS™ program
  • Willing to return to enrolling institution for follow-up (during the Active Monitoring Phase of the study)
  • Willing to provide bone marrow and blood samples for correlative research purposes

 

Exclusion Criteria

  • Other malignancy requiring active therapy
    • Exceptions: Non-melanoma skin cancer, ductal breast carcinoma in situ (DCIS) or carcinoma-in-situ of the cervix
    • Note: If there is a history of prior malignancy, they must not be receiving other specific treatment for their cancer
  • Females of childbearing potential
    • must have a negative serum pregnancy test with a sensitivity of at least 50 mIU/mL within 10-14 days prior to and again within 24 hours prior to prescribing pomalidomide for cycle 1
      • prescriptions must be filled within 7 days as required by RevAssist [lenalidomide REMS program]
    • and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME at least 28 days before she starts taking pomalidomide
    • must also agree to ongoing pregnancy testing
    • men must agree to use a latex condom during sexual contact even if they have had a successful vasectomy
    • patient must follow pregnancy testing requirements as outlined in the POMALYST REMS program
  • Nursing women
  • Men or women of childbearing potential who are unwilling to employ adequate contraception
  • Other co-morbidity which would interfere with patient's ability to participate in trial, e.g. uncontrolled infection, uncompensated heart or lung disease
  • 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
  • Patient has ≥ grade 3 peripheral neuropathy, or grade 2 with pain on clinical examination during the screening period
  • Major surgery ≤ 14 days before study registration
  • Within 7 days before registration systemic treatment with
    • strong inhibitors of cytochrome P450, family 1, subfamily A, polypeptide 2 (CYP1A2)
      • fluvoxamine
      • enoxacin
      • ciprofloxacin
    • strong inhibitors of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4)
      • clarithromycin
      • telithromycin
      • itraconazole
      • voriconazole
      • ketoconazole
      • nefazodone
      • posaconazole
    • strong CYP3A4 inducers
      • rifampin
      • rifapentine
      • rifabutin
      • carbamazepine
      • phenytoin
      • phenobarbital
      • Gingko biloba
      • St. John's wort
  • Evidence of current uncontrolled cardiovascular conditions within the past 6 months, including
    • cardiac arrhythmias
    • congestive heart failure
    • angina
    • myocardial infarction 
  • Prior to study entry, any electrocardiogram (ECG) abnormality at screening must be documented by the investigator as not medically relevant
  • Corrected QT Interval (QTc) > 470 milliseconds (msec) on a 12-lead ECG obtained during the screening period
    • Note: If a machine reading is above this value, the ECG should be reviewed by a qualified reader and confirmed on a subsequent ECG
  • Known human immunodeficiency virus (HIV) positive
  • Known hepatitis B surface antigen-positive status, or known or suspected active hepatitis C infection
  • 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
  • Known gastrointestinal (GI) disease or GI procedure that could interfere with the oral absorption or tolerance of ixazomib including difficulty swallowing
  • Diarrhea > grade 1, based on the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) grading, in the absence of antidiarrheals

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Shaji Kumar, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

.
CLS-20151856

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