Personalized Selinexor-based Therapy for Relapsed/Refractory Multiple Myeloma

  • STATUS
    Recruiting
  • End date
    Nov 25, 2025
  • participants needed
    25
  • sponsor
    University of Colorado, Denver
Updated on 25 March 2022

Summary

Selinexor (KPT-330, Xpovio) is a first in class selective inhibitor of nuclear export which has been approved for use in relapsed and refractory multiple myeloma (RRMM). This trial will seek to evaluate the outcomes achieved with selinexor based combination in RRMM selected by physician's choice and compared prospectively to ex vivo drug sensitivity testing results. Participants will be enrolled and assigned into one of the following treatment arms:

Arm 1: Selinexor + pomalidomide + dexamethasone (SPd)

Arm 2: Selinexor + daratumumab + dexamethasone (SDd)

Arm 3: Selinexor + carfilzomib + dexamethasone (SKd)

Description

This study is a single institution, open-label phase II study to evaluate the overall response rate achieved with selinexor and dexamethasone based three drug combination therapy, selected by physician's choice, in patients with relapsed/refractory multiple myeloma.

Patients with RRMM will be eligible for enrollment. During screening, in addition to standard of care disease assessments, participant's bone marrow aspirate will be evaluated using a novel ex vivo Myeloma Drug Sensitivity Testing platform (My-DST). The following agents will be eligible for physician's choice, and in parallel evaluated for sample sensitivity in MyDST: pomalidomide, carfilzomib and daratumumab. Agents will be tested individually, in combination with selinexor and in combination with selinexor and dexamethasone. Results from MyDST will be not be available to investigators at time of treatment assignment, but will be evaluated to better characterize test performance and relationship with treatment outcomes.

Investigators will assign patients to one of the following treatment combinations: Selinexor/Pomalidomide/Dexamethsone (SPd), Selinexor/Daratumumab/Dexamethasone (SDd) or Selinexor/Carfilzomib/Dexamethasone (SKd). Investigators will use patient specific considerations such as prior therapeutic exposures, response to / tolerance of prior therapies and comorbid conditions which may increase risk for toxicity with specific agents to guide expert judgement in selecting partner agent for selinexor and dexamethasone. Treatment will continue until progression of disease, unacceptable toxicity or death.

This study will evaluate if physician's choice partner drug selection for selinexor based combination therapy in RRMM will lead to an overall response rate of 75% or higher.

Details
Condition Multiple Myeloma in Relapse
Treatment Pomalidomide, Dexamethasone, Daratumumab, Carfilzomib, Selinexor
Clinical Study IdentifierNCT04925193
SponsorUniversity of Colorado, Denver
Last Modified on25 March 2022

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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