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IMMY16088 / STOMP / Brea Lipe

Research Question:
Will adding selinexor to other treatment combinations have any effect on your cancer?

Basic Study Information

This study will independently assess the efficacy and safety of 10 combination therapies in 11 arms, in dose-escalation/-evaluation and expansion phases, for the treatment of patients with relapsed/refractory multiple myeloma (RRMM) and newly diagnosed multiple myeloma (NDMM). The combinations to be evaluated are: Arm 1: Selinexor + dexamethasone + pomalidomide (SPd) Arm 2: Selinexor + dexamethasone + bortezomib (SVd); enrollment complete Arm 3: Selinexor + dexamethasone + lenalidomide (SRd) in RRMM; enrollment complete Arm 4: Selinexor + dexamethasone + pomalidomide + bortezomib (SPVd) Arm 5: Selinexor + dexamethasone + daratumumab (SDd); enrollment complete Arm 6: Selinexor + dexamethasone + carfilzomib (SKd) Arm 7: Selinexor + dexamethasone + lenalidomide (SRd) in NDMM Arm 8: Selinexor + dexamethasone + ixazomib (SNd) Arm 9: Selinexor + dexamethasone + pomalidomide + elotuzumab (SPEd) Arm 10: Selinexor + dexamethasone + belantamab mafodotin (SBd) Arm 11: Selinexor + dexamethasone + pomalidomide + daratumumab (SDPd) Selinexor pharmacokinetics: PK Run-in (Days 1-14): Starting in protocol version 8.0, patients enrolled to any arm in the Dose Escalation Phase (i.e., Arm 4 [SPVd], Arm 6 [SKd], Arm 8 [SNd], Arm 9 [SPEd], Arm 10 [SBd], and Arm 11 [SDPd]) will also first be enrolled to a pharmacokinetics (PK) Run-in period until 9 patients have been enrolled to this period to evaluate the PK of selinexor before and after co-administration with a strong CYP3A4 inhibitor.

Location: Cancer center
Study Web URL:
Study Reference #: IMMY-16088

Lead Researcher (Principal Investigator)

Lead Researcher:  Brea Lipe

Study Contact Information

Study Coordinator: Tina Bowdish
Phone: +1 585-275-9475

Additional Study Details

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