A Phase 3, Randomized, Open Label Trial of Lenalidomide/dexamethasone With or Without Elotuzumab in Relapsed or Refractory Multiple Myeloma
Subjects will be randomized (assigned to a treatment group by chance, like flipping a coin) to 1 of 2 treatment groups. They will have an equal chance (1:1) of being in either treatment group. They will be told which group they have been assigned to, and there are no placebos used in this trial. The treatments to be evaluated in this study are:
? Lenalidomide by mouth (swallowed) once daily on Days 1 to 21 of each 28-day cycle, and dexamethasone by mouth (swallowed) weekly on Days 1, 8, 15, and 22 of each 28-day cycle.
? On weeks of elotuzumab dosing (on Days 1, 8, 15, and 22 of Cycles 1 and 2 and on Days 1 and 15 of subsequent cycles), lenalidomide by mouth (swallowed) once daily, on Days 1 to 21 and dexamethasone administered weekly by mouth (swallowed) + dexamethasone (intravenously).
? On weeks when elotuzumab is not administered, lenalidomide by mouth (swallowed) once daily on Days 1 to 21 of each cycle, and dexamethasone by mouth (swallowed) on Days 1, 8, 15, and 22 of each cycle.
The dose of dexamethasone or lenalidomide may be decreased below the standard dose if the Sponsor and/or subjects study doctor feel that it is safer for them.
1) Signed Written Informed Consent
a) Subject is, in the investigator’s opinion, willing and able to comply with the
b) Subject has given voluntary written informed consent before performance of any
study-related procedure not part of normal medical care, with the understanding
that consent may be withdrawn by the subject at any time without prejudice to
their future medical care.
2) Target Population
a) Age ≥ 18 years or legal age of consent per local regulations
b) ECOG performance status ≤ 2
c) Life-expectancy > 3 months
d) Documented evidence of multiple myeloma and
i) Received between 1 to 3 prior lines of therapy with documented progression
by EBMT criteria after the most recent therapy (see Appendix 1 for definition
of patient population and lines of prior therapy) AND
ii) Measureable disease: serum IgG, IgA, IgM M-protein ≥ 0.5 g/dL or serum
IgD M-protein ≥ 0.05 g/dL or ≥ 200 mg urinary M-protein excretion /24-hour.e) Prior lenalidomide exposure is permitted only if they fulfill all of the following:
i) Best response achieved was ≥ PR
ii) Were not refractory to prior lenalidomide defined as no progression while
receiving lenalidomide or within 9 months of last dose of lenalidomide
iii) Subject did not discontinue lenalidomide due to a Grade ≥ 3 related AE
iv) Subject did not receive more than 9 cycles of lenalidomide and had at least
9 months between the last dose of lenalidomide and progression
3) Age and Reproductive Status
a) Men and women of childbearing potential (WOCBP) must be using 2 acceptable
methods of contraception to avoid pregnancy throughout the study for a period of
at least 1 month (4 weeks) before and women for up to 8 weeks, men for up to 90
days after the last dose of investigational product in such a manner that the risk of
pregnancy is minimized. See Section 3.3.3 for the definition of WOCBP and
Revlimid risk management plan guidelines.
b) Women must have a negative serum or urine pregnancy test (minimum sensitivity
25 IU/L or equivalent units of HCG). The first should be performed within
10 - 14 days and the second within 24 hours prior to the start of the investigational
product. A prescription for lenalidomide for a female of childbearing potential
must not be issued by the prescriber until negative pregnancy tests have been
verified by the prescriber.
c) Women must not be breastfeeding.
d) Men must agree to use a latex condom and a second form of birth control during
sexual contact with WOCBP, even if they have had a successful vasectomy, and
must agree to not donate semen during study drug therapy and for 90 days after
e) Subjects must be willing to refrain from blood donations during study drug
therapy and for 8 weeks after therapy.