Lenalidomide With or Without Ixazomib Citrate and Dexamethasone in Treating Patients With Residual Multiple Myeloma After Donor Stem Cell Transplant
Brief description of study
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.
Clinical Study Identifier: NCT02389517
Detailed Study Description
I. To determine the rate of minimal residual disease (MRD)-negative disease by
multiparameter-flow cytometry at 12 months after randomization.
I. Evidence of response as demonstrated by the improvement of the depth of response by at
least one category according to International Myeloma Working Group (IMWG) response
II. Progression free survival (PFS). III. Overall survival (OS). IV. Duration of
MRD-negative disease. V. Safety and tolerability of experimental arm (ixazomib citrate,
lenalidomide, and low dose dexamethasone [IRd]) vs. control arm (lenalidomide [Rd]).
I. Determination of markers of response based on pre-treatment characteristics using methods
described in correlative research.
II. Evaluation of MRD by gene sequencing method using the Sequenta platform (LymphoSIGHT®)
in parallel with multi-parameter flow cytometry (MFC).
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive ixazomib citrate orally (PO) on days 1, 8, and 15, lenalidomide PO
once daily (QD) on days 1-21, and dexamethasone PO on days 1, 8, 15, and 22 (of courses 1-4
ARM II: Patients receive lenalidomide PO as in Arm I.
In both arms, treatment repeats every 28 days for 12 courses in the absence of disease
progression or unacceptable toxicity.
After the completion of treatment, patients are followed up at 30 days and then every 3
months for 2 years.