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

Conditions:Blood Cancer, Hematology, Hematology
Therapuetic Areas:Hematology, Oncology
Age Range:18 - 70
Start Date:January 20, 2015
End Date:August 31, 2024
Contact:Ravi Vij, M.D.

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

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.

Based on the further need to improve progression-free survival and overall survival
post-autologous stem cell transplantation (ASCT) for multiple myeloma and the benefits seen
of consolidation/maintenance treatment with immunomodulatory drugs thalidomide and
lenalidomide and the proteasome inhibitor bortezomib, the natural next step is to evaluate
combination regimens of immunomodulatory drugs and proteasome inhibitors as
consolidation/maintenance post-ASCT. The regimen consisting of ixazomib, lenalidomide, and
dexamethasone (IRD) has been shown to have low toxicity, and the availability of an oral
formulation of ixazomib allows for easier administration when compared to bortezomib.

In this study, following consolidation with IRD, patients will be randomized to maintenance
therapy with lenalidomide or ixazomib in order to collect pilot data comparing the toxicity
and efficacy of maintenance therapy with immunomodulatory drugs and proteasome inhibitors.

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be withdrawn by the patient at any time without prejudice to future medical care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. All patients must
be counseled at a minimum of every 28 days about pregnancy precautions and risks of
fetal exposure. Should a woman become pregnant or suspect she is pregnant while
participating in this study, she must inform her treating physician immediately.

- All study participants must be registered into the mandatory Revlimind REMS program
and be willing to comply with its requirements. Per standard Revlimid REMS program
requirements, all physicians who prescribe lenalidomide for research subjects enrolled
into this trial, must be registered in, and must comply with, all requirements of the
Revlimid REMS program.

Exclusion Criteria

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

- 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

- Known GI disease or GI procedure that could interfere with the oral absorption or
tolerance of ixazomib

- Concurrent hematologic or non-hematologic malignancy requiring treatment (other than
multiple myeloma and secondary amyloidosis)

- Cardiac syncope, uncompensated NYHA Class 3 or 4 congestive heart failure, myocardial
infarction within the previous six months, unstable angina pectoris, clinically
significant repetitive ventricular arrhythmias despite antiarrhythmic treatment,
severe orthostatic hypotension, or clinically important autonomic disease

- Grade >= 3 peripheral neuropathy, or Grade 2 with pain on clinical examination during
the screening period

- Major surgery within 14 days prior to start of study treatment

- Infection requiring systemic antibiotic therapy or other serious infection within 14
days prior to start of study treatment

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