Selinexor and Backbone Treatments of Multiple Myeloma Patients
Condition(s) studied
Investigational drug(s) / intervention(s)
Selinexor: Oral tablets
Dexamethasone: Oral tablets
Lenalidomide: Oral capsule
Pomalidomide: Oral tablets
Bortezomib: Subcutaneous Injection (single use vial)
Daratumumab: Intravenous Infusion
Carfilzomib: Intravenous infusion
Ixazomib: Oral capsule
Elotuzumab: Intravenous infusion
Clarithromycin: Tablets
Belantamab Mafodotin: Intravenous infusion
Mezigdomide: Oral Capsules
Study summary
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
Primary outcome measure(s)
- Phase 1 (Dose-escalation): Maximum Tolerated Dose (MTD) — 12 months
MTD for once weekly and twice weekly selinexor dose cohorts in the 11 Arms will be evaluated. - Phase 1 (Dose-escalation): Recommended Phase-2 dose (RP2D) — 12 months
RP2D for each Arm will be determined. - Phase 1 (Dose-escalation): Maximum Plasma Concentration (Cmax) of Selinexor — Pre-dose, 1 hour, 1.5, 2, 3, 4, 5, 6, 8, and 24 hours post-dose on Day 1 (without clarithromycin) and Day 8 (with clarithromycin)
Cmax of selinexor over a dosing interval when given with and without clarithromycin. - Phase 1 (Dose-escalation): Area Under the Concentration-time Curve From Time Zero to the Last Non-zero Concentration (AUC0-t) of Selinexor — Pre-dose, 1, 1.5, 2, 3, 4, 5, 6, 8, and 24 hours post-dose on Day 1 (without clarithromycin) and Day 8 (with clarithromycin)
Total exposure of selinexor in the blood (AUC0-last) from the time of dosing to the last measurable concentration collected when given with and without clarithromycin. - Phase 1 (Dose-escalation): Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated) (AUC0-inf) — Pre-dose, 1, 1.5, 2, 3, 4, 5, 6, 8, and 24 hours post-dose on Day 1 (without clarithromycin) and Day 8 (with clarithromycin)
- Phase 2 (Expansion): Overall response rate (ORR) — 12 months
ORR for each Arm independently. ORR to include stringent complete response (sCR), complete response (CR), very good partial response (VGPR), and partial response (PR), according to the International Myeloma Working Group (IMWG) criteria. - Phase 2 (Expansion): Duration of response (DOR) — 12 months
Duration of response for each Arm. DOR is defined as the number of days from the date of the first evidence of objective response until progression. - Phase 2 (Expansion): Clinical Benefit Rate (CBR) — 12 months
CBR is defined the point estimate of the percentage of patients in that arm who have a response of sCR, CR, VGPR, PR or Minimal response (MR), as assessed by IMWG criteria.
Trial sites (25)
| Facility | City | Region | Status |
|---|---|---|---|
| Banner MD Anderson Cancer Center | Gilbert | Arizona | Active Not Recruiting |
| Jonnsson Comprehensive Cancer Center / University of Los Angeles | Los Angeles | California | Active Not Recruiting |
| Sarah Cannon-Colorado Blood Cancer Institute | Denver | Colorado | Withdrawn |
| Massachusetts General Hospital | Boston | Massachusetts | Completed |
| Dana Farber Cancer Institute | Boston | Massachusetts | Recruiting |
| University of Nebraska Medical Center | Omaha | Nebraska | Completed |
| Hackensack University Medical Center - John Theurer Cancer Center | Hackensack | New Jersey | Active Not Recruiting |
| Columbia University | New York | New York | Completed |
| Weill Cornell Medicine | New York | New York | Completed |
| Wilmot Cancer Center/ University of Rochester | Rochester | New York | Active Not Recruiting |
| University of North Carolina - Chapel Hill Comprehensive Cancer Center | Chapel Hill | North Carolina | Active Not Recruiting |
| Duke Institute of Cancer/ Duke University | Durham | North Carolina | Recruiting |
| Sarah Cannon- Tennessee Oncology Nashville | Nashville | Tennessee | Active Not Recruiting |
| Fred Hutch Cancer Center | Seattle | Washington | Recruiting |
| Swedish Cancer Institute | Seattle | Washington | Completed |
| University of Wisconsin School of Medicine and Public Health | Madison | Wisconsin | Active Not Recruiting |
| Tom Baker Cancer Center/Alberta Health Services | Calgary | Alberta | Completed |
| Cross Cancer Institute / University of Alberta | Edmonton | Alberta | Completed |
| Vancouver General Hospital | Vancouver | British Columbia | Completed |
| Cancer Care Manitoba | Winnipeg | Manitoba | Active Not Recruiting |
| Memorial Hospital of Newfoundland | St. John's | Newfoundland and Labrador | Completed |
| Queen Elizabeth II Health Sciences Center | Halifax | Nova Scotia | Active Not Recruiting |
| Princess Margaret Cancer Centre | Toronto | Ontario | Active Not Recruiting |
| Maisonneuve-Rosemont Hospital | Montreal | Quebec | Completed |
| Royal Victoria Hospital / McGill University | Montreal | Quebec | Completed |
More Karyopharm Therapeutics Inc trials in Canada
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT02343042 on ClinicalTrials.gov ↗ ← All trials in Canada