Phase II Study of IRD (Ixazomib, Lenalidomide, Dexamethasone) Post Autologous Stem Cell Transplantation Followed by Maintenance Ixazomib or Lenalidomide for Multiple Myeloma

Overview

About this study

The purpose of this research study is to evaluate a treatment regimen called IRD which will be given to participants after their stem cell transplant in an effort to help prolong the amount of time the participants are disease-free after transplant. IRD is a three-drug regimen consisting of ixazomib, lenalidomide (also called Revlimid), and dexamethasone. After 4 cycles of IRD, the participants will be randomized to receive maintenance therapy either with ixazomib or lenalidomide. 09/23/2019: Upon review of the interim analysis that suggested inferior progression-free survival in the ixazomib maintenance arm, there will be no further randomizations into the maintenance portion of the trial. All patients will be enrolled into the lenalidomide arm with the exception of those who discontinue lenalidomide during the consolidation phase due to toxicity. Patients who discontinue lenalidomide may be enrolled into the ixazomib arm following approval from the principal investigator.

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: 

Each patient must meet all of the following inclusion criteria to begin IRD Consolidation:

  • Between the ages of 18 and 70 years of age (inclusive) at time of enrollment.
  • 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of any study-related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care.
  • Histologically confirmed diagnosis of symptomatic multiple myeloma. (Patients with multiple myeloma with secondary amyloidosis are eligible).
  • Received at least two cycles of any regimen as initial systemic therapy for multiple myeloma and are within 2-16 months of the first dose of initial therapy.
  • Eastern Cooperative Oncology Group (ECOG) performance status and/or other performance status 0, 1, or 2.
  • Adequate organ function as defined below:
    • Absolute neutrophil count (ANC) ≥ 1,000 mm^3;
    • Platelet count ≥ 75,000/mm^3;
    • Platelet transfusions to help patient meet eligibility criteria are not allowed within 7 days before study enrollment;
    • Total bilirubin ≤ 1.5 x upper limit of normal range (ULN);
    • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 x ULN;
    • Calculated creatinine clearance ≥ 30 mL/min.
  • Women of childbearing potential must follow pregnancy testing requirements as outlined in the Revlimid REMS program material. This is defined as either committing to continued abstinence from heterosexual intercourse or beginning TWO acceptable methods of contraception (one highly effective method and one additional effective method AT THE SAME TIME) at least 28 days prior to the start of lenalidomide, for the duration of study participation, and for 28 days following the last dose of lenalidomide. Women of childbearing potential must also agree to ongoing pregnancy testing.
  • Men must agree to use a latex condom during sexual contact with a woman of childbearing potential even if they have had a successful vasectomy.
  • Additional Inclusion Criteria may apply.

Exclusion Criteria: 

Patients meeting any of the following exclusion criteria are not to be enrolled in the study:

  • Female patients who are lactating or have a positive serum pregnancy test during the screening period.
  • Evidence of MM disease progression any time prior to enrollment. Progression from smoldering/asymptomatic MM to symptomatic MM is not exclusionary.
  • Tandem autologous transplantation -History of plasma cell leukemia or MM CNS involvement.
  • Administration or planned administration of any other concomitant chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy which would be considered a treatment of multiple myeloma until Day +28 post-transplant through discontinuation from study. Patients may be on corticosteroids if they are being given for disorders other than multiple myeloma (e.g., adrenal insufficiency, rheumatoid arthritis, etc.).
  • Any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to this protocol.
  • Prior organ transplant requiring immunosuppressive therapy.
  • Active hepatitis A, B or C virus infection, or known human immunodeficiency virus (HIV) positive.
  • Known allergy to any of the study medications, their analogues, or excipients in the various formulations of any agent.
  • Additional Exclusion Criteria may apply.

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

Francis Buadi, M.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20366154

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