This is a randomized, Phase 2 study involving two arms evaluating the efficacy and safety of
ixazomib alone and the combination of both ixazomib and lenalidomide as maintenance therapy
for patients with multiple myeloma who have achieved at least partial response (PR) or better
after receiving a bortezomib- and lenalidomide-containing combination front-line therapy.
Patients who have achieved PR or better on a bortezomib- and lenalidomide-containing
combination therapy will be randomized to receive maintenance therapy with 28-day cycles of
either ixazomib alone or the combination of ixazomib and lenalidomide. If steroids were part
of the patient's qualifying regimen, steroids will be administered using the same drug(s),
schedule(s) and dose(s) as those of the last treatment cycle of the bortezomib-,
lenalidomide- and steroid-containing regimen. Ixazomib will be administered per orem (PO) at
3 mg on days 1, 8 and 15 of 28-day cycles. Lenalidomide will be taken PO, once daily at the
same dose as the last treatment on days 1 through 28 of the 28-day cycles. Patients will
start the randomized maintenance therapy after receiving a minimum of 6 cycles of a
bortezomib- and lenalidomide-containing combination treatment but may have received up to 8
cycles if they continued to show improvement in their response after the first 6 cycles.
During cycle 1, patients will have clinical laboratory tests weekly (days 1, 8, 15 and 22)
and MM disease assessments on day 22 to monitor for efficacy and potential toxicity.
Beginning with cycle 2, patients will have clinical laboratory tests performed twice a month
and MM disease assessments once a month. Patients will be treated until documentation of PD
or if subject meets any of the treatment discontinuation criteria.
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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