A Phase 1/2 interventional study of Selinexor and Lenalidomide in Multiple Myeloma, sponsored by Karyopharm Therapeutics Inc. Withdrawn. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-01-26.
Sponsored by Karyopharm Therapeutics Inc · Phase 1/2, Interventional, and Treatment
This is an open-label, randomized clinical study with two stages to assess the maximum tolerated dose (MTD), efficacy, and safety of selinexor, lenalidomide, and dexamethasone (SLd) in patients with relapsed/refractory (RR) multiple myeloma (MM). The stages are dose escalation (Phase 1) and expansion (Phase 2).
In Phase 1 (Dose Escalation), patients will be randomized to either once-weekly (Arm A) or twice- weekly (Arm B) dosing with selinexor. Dose escalation will be performed within each arm for both lenalidomide and selinexor to determine the selinexor MTD for that arm. Each arm will be expanded until approximately 17 patients have been treated at the MTD in each arm. The Sponsor and Investigator will review the MTD, efficacy, and safety data from Phase 1 to determine which dose schedule (Arm A or B) to be used as the RP2D dose in the Expansion Phase.
In Phase 2 (Expansion), patients who had received the MTD dose that was nominated for RP2D will continue at the same dose. Patients who did not receive the RP2D for that arm will stay on their Phase 1 dose. Additional patients will be accrued, as needed, to achieve the target population size of approximately 34 patients at the RP2D.
3,632 studies on the registry are indexed under Multiple Myeloma; 745 are open to participants now.
Browse Multiple Myeloma studies →Karyopharm Therapeutics Inc is the lead sponsor of 36 studies on the registry; 4 are open to participants now.
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Lenalidomide will be dosed initially at 15 mg daily, and if that dose is tolerated per dose-limiting toxicity (DLT criteria,) it will be increased to 25 mg for that arm. Selinexor will be started at 80 mg (\~45 mg/m2) once weekly in combination with dexamethasone 40 mg once weekly with each dose of selinexor. If the selinexor 80 mg dose is tolerated per DLT criteria, the dose will be increased to 100 mg (\~60 mg/m2) and evaluated for MTD, tolerability and efficacy.
Drug: Selinexor · Drug: Lenalidomide · Drug: Dexamethasone
Lenalidomide will be dosed initially at 15 mg daily, and if that dose is tolerated per DLT criteria, it will be increased to 25 mg for that arm. Selinexor will be started at 60 mg (\~35 mg/m2) twice weekly in combination with dexamethasone 20 mg twice weekly with each dose of selinexor; dexamethasone 20 mg will also be given, without selinexor, on Days 22 and 24. If the selinexor 60 mg dose is tolerated per DLT criteria, the dose will be increased to 80 mg (\~45 mg/m2) and evaluated for MTD, tolerability and efficacy.
Drug: Selinexor · Drug: Lenalidomide · Drug: Dexamethasone
Two different dosing schedules will be tested, once weekly and twice weekly. If the selinexor 80 mg dose is tolerated, the dose will be increased to 100 mg.
Also known as: KPT-330
In both arms, lenalidomide will be started at 15 mg/day (Dose Level 1) and, if tolerated per DLT criteria, will be escalated to 25 mg/day (Dose Level 2).
Dexamethasone will be given in combination with each dose of selinexor on the once weekly treatment arm. For the twice weekly arm dexamethasone will be given in combination with each dose of selinexor and will also be given without selinexor on Days 22 and 24.
Determine maximum tolerated dose (MTD)
Determine the maximum tolerated dose (MTD) of selinexor in the combination SLd in patients with RR MM, as determined by dose limiting toxicities (DLTs), efficacy, and safety
Time frame: 12 months
Overall response rate (ORR)
According to the International Myeloma Working Group \[IMWG\] criteria, Overall Response Rate (ORR) includes: stringent complete response \[sCR\], complete response \[CR\], very good partial response \[VGPR\], and partial response \[PR\]
Time frame: 12 months
No study locations are listed for this record.
This study is withdrawn, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.
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Karyopharm Therapeutics Inc