Selinexor and Backbone Treatments of Multiple Myeloma Patients
Status:
Recruiting
Trial end date:
2022-05-01
Target enrollment:
Participant gender:
Summary
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.