Selinexor and Backbone Treatments of Multiple Myeloma Patients (STOMP)
-
- STATUS
- Recruiting
-
- End date
- Jan 7, 2025
-
- participants needed
- 518
-
- sponsor
- Karyopharm Therapeutics Inc
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.
Description
This is a multi-center, open-label, clinical study with Dose Escalation (Phase 1) and Expansion (Phase 2) to independently assess the MTD, efficacy , and safety of 10 combination therapies in 11 arms in patients with RRMM and NDMM. Patients will be assigned to treatment arms based on their diagnoses and treatment histories. For 9 patients, a PK Run-in period will precede Cycle 1 (DLT evaluation) to assess selinexor PK when co-administered with a strong CYP3A4 inhibitor. In the Dose Escalation Phase (Phase 1): (a) in Arm 1 (SPd), Arm 2 (SVd), and Arm 3 (SRd in RRMM), patients will be randomized to either QW or BIW selinexor dosing cohorts; (b) in Arm 5 (SDd), patients will be sequentially assigned in blocks of 3 to either QW or BIW selinexor dosing; (c) in Arm 4 (SPVd), Arm 6 (SKd), Arm 7 (Srd in NDMM), Arm 8 (SNd), Arm 9 (SPEd), Arm 10 (SBd), and Arm 11 (SDPd) patients will be assigned to QW selinexor dosing.
Cohort 1.4 is included from Version 10 to study safety and tolerability of SPd with selinexor 40 mg QW, is lower than RP2D (ie, selinexor 60 mg QW) in combination with pomalidomide 4 mg. Cohort 1.4 is a different expansion cohort from the one with RP2D (ie, Cohort 1.3). In Cohort 1.4, 20 patients will be enrolled in total.
Starting in protocol Version 8.0, patients enrolled to the Dose Escalation Phase of Arm 4 (SPVd), Arm 6 (SKd), Arm 8 (SNd), Arm 9 (SPEd), Arm 10 (SBd), and Arm 11 (SDPd) will first be enrolled to a 14-day PK Run-in period (selinexor +/- clarithromycin) until 9 patients have been enrolled. During this 14-day PK Run-in period, selinexor 40 milligrams (mg) will be administered alone on Day 1, clarithromycin 500 mg twice daily (BID) will be administered on Days 2-8, and selinexor 40 mg will again be administered on Day 8 with the morning clarithromycin dose. Blood samples for PK analysis will be collected pre-dose and 1 (± 10 min), 1.5 (± 10 min), 2 (± 10 min), 3 (± 10 min), 4 (± 10 min), 5 (± 10 min), 6 (± 10 min), 8 (± 10 min), and 24 h (± 30 min) hours after selinexor is dosed on Day 1 (without clarithromycin) and Day 8 (with clarithromycin). Patients will then proceed to the DLT evaluation period that will begin after the completion of the 14-day PK Run-in period; this day will be designated as Cycle 1 Day 1 (C1D1) in the Dose Escalation Phase.
Details
| Condition | Multiple Myeloma |
|---|---|
| Treatment | Pomalidomide, Dexamethasone, Lenalidomide, Bortezomib, clarithromycin, Daratumumab, Carfilzomib, Selinexor, Ixazomib, Elotuzumab, Belantamab mafodotin |
| Clinical Study Identifier | NCT02343042 |
| Sponsor | Karyopharm Therapeutics Inc |
| Last Modified on | 4 October 2022 |
Eligibility
How to participate?
,
You have contacted , on
Your message has been sent to the study team at ,
What happens next?
- You can expect the study team to contact you via email or phone in the next few days.
- Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.
You are contacting
Primary Contact
Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.
Learn moreIf you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
Learn moreComplete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.
Learn moreSimilar trials to consider
Browse trials for
Not finding what you're looking for?
Sign up as a volunteer to stay informed
Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.
Sign up as volunteer