About this trial
This study will independently assess the efficacy and safety of 11 combination therapies in 12 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); enrollment complete * 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); enrollment complete * Arm 5: Selinexor + dexamethasone + daratumumab (SDd); enrollment complete * Arm 6: Selinexor + dexamethasone + carfilzomib (SKd); enrollment complete * Arm 7: Selinexor + dexamethasone + lenalidomide (SRd) in NDMM; enrollment complete * Arm 8: Selinexor + dexamethasone + ixazomib (SNd); enrollment complete * Arm 9: Selinexor + dexamethasone + pomalidomide + elotuzumab (SPEd); enrollment complete * Arm 10: Selinexor + dexamethasone + belantamab mafodotin (SBd); enrollment complete * Arm 11: Selinexor + dexamethasone + pomalidomide + daratumumab (SDPd); enrollment complete * Arm 12: Selinexor + dexamethasone + mezigdomide (SMd); actively recruiting
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. This run-in period does not apply to Arm 12 (SMd).
Eligibility criteria
Qualifiers
Written informed consent signed in accordance with federal, local, and institutional guidelines.
Age greater than or equal to (≥) 18 years at the time of informed consent.
Histologically confirmed diagnosis with measurable disease for relapsed/refractory myeloma.
Symptomatic MM, based on IMWG guidelines.
Disqualifiers
Smoldering MM.
MM that does not express M-protein or FLC (i.e., non-secretory MM is excluded), and quantitative immunoglobulin levels cannot be used instead.
Documented active systemic amyloid light chain amyloidosis.
Active plasma cell leukemia.
Trial design
Treatments tested in this trial
- Selinexor
- Dexamethasone
- Lenalidomide
- Pomalidomide
- Bortezomib
- Daratumumab
- Carfilzomib
- Ixazomib
- Elotuzumab
- Clarithromycin
- Belantamab Mafodotin
- Mezigdomide
Treatment groups
12
Treatment groupsSee each treatment group below.
Sponsors and collaborators
Karyopharm Therapeutics Inc
Lead sponsor
Bristol-Myers Squibb
Collaborator