Pomalidomide naive disease
Prior pomalidomide treatment (for patients on the pomalidomide arm)
Females of child bearing potential (FCBP) must have a negative serum or urine pregnancy test prior to start of treatment. Participants must agree to ongoing pregnancy testing. All patients must be willing to comply with all requirements of the USA pomalidomide Risk Evaluation and Mitigation Strategy (REMS) program or the pomalidomide Pregnancy Prevention Plan (PPP).
Prior exposure to pomalidomide
Previous treatment with ixazomib or pomalidomide
Pts who have received prior treatment with pomalidomide (Phase II only)
Medically supervised (ie, performed in a clinic) pregnancy testing, including those who commit to true abstinence. Two pregnancy tests must be conducted prior to starting pomalidomide. The first pregnancy test must be performed 10 to 14 days prior to the start of pomalidomide and the second pregnancy test must be performed within 24 hours prior to starting pomalidomide. Females of childbearing potential with regular or no menstrual cycles must also agree to have pregnancy tests weekly for the first 28 days study participation, every 28 days while on study, at study treatment discontinuation, and at Day 28 following pomalidomide discontinuation. If menstrual cycles are irregular, the pregnancy testing must occur weekly for the first 28 days of study participation and then every 14 days while on study, at study treatment discontinuation visit, and at Days 14 and 28 following pomalidomide discontinuation.
All male and female subjects must follow all requirements defined in the pomalidomide Pregnancy Prevention Program.
Must be willing and able to adhere to pomalidomide-related risk mitigation activities if randomized to the pomalidomide+dexamethasone (pom+dex) arm (e.g., Risk Evaluation and Mitigation Strategies [REMS], pregnancy prevention programs).
Prior exposure to elotuzumab or pomalidomide
Any prior use of pomalidomide
Prior therapy with pomalidomide
History of treatment with venetoclax or another B-Cell Lymphoma (BCL)-2 inhibitor or pomalidomide.
Prior treatment with pomalidomide
Prior exposure to pomalidomide or HDAC inhibitors is allowed
Patients unable to receive adequate thromboprophylaxis in combination with pomalidomide
Patients that have previously progressed on pomalidomide treatment
Has received previous therapy with pomalidomide
Prior treatment with pomalidomide
Has received previous therapy with pomalidomide and did not achieve at least a stable disease
May have undergone prior treatment with pomalidomide if patient is not refractory to pomalidomide and has previously achieved a response of MR or better to pomalidomide.
Prior therapy with pomalidomide with best response of PD or SD.
Must be Pomalidomide naïve.
Prior therapy with pomalidomide.
Previous treatment with pomalidomide
Prior therapy with a combination regimen containing pomalidomide except the 2 drug combination of pomalidomide and dexamethasone
Patients who are pomalidomide refractory, defined as patients who progress on or within 60 days of pomalidomide when given as a single agent or with dexamethasone
Patients who are receiving any other investigational agents or who have received pomalidomide in the past
Prior treatment of any duration with pomalidomide
Any prior use of thalidomide or pomalidomide
Previous therapy with pomalidomide.
Prior exposure to pomalidomide for subjects enrolling in the pomalidomide/dexamethasone combination arm.
No prior therapy with pomalidomide or everolimus
Prior pomalidomide exposure
Males must also agree to refrain from donating semen or sperm while on pomalidomide and for 28 days after discontinuation from this study
Previous therapy with Pomalidomide
A minimum of 2 prior lines of therapy including an IMiD and a PI and is refractory to pomalidomide and/or daratumumab