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Elotuzumab, Selinexor, and Dexamethasone for Relapsed Refractory Multiple Myeloma

NCT05170789 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2022-05-04

No results posted yet for this study

Summary

The food and drug administration (FDA) has approved the use of Selinexor, an oral, first-in class, exportin 1 (XPO1) inhibitor, in combination with low-dose dexamethasone in patients with triple-refractory (disease refractory to proteasome inhibitors (PI), immunomodulatory imid agents (IMiD), and anti-Cluster of Differentiation 38 (CD38) monoclonal antibodies (mAb)), or relapsed refractory multiple myeloma (RRMM). SLAMF7 (human Signaling Lymphocyte Activation Molecule Family 7) is a receptor that is present on immune cells, NK (Natural Killer) cells, and plasma cells. Elotuzumab, a mAb directed against the extracellular domain of SLAMF7, is used in combination with an IMiD and dexamethasone to treat RRMM. In this clinical trial, the investigators are proposing the addition of Elotuzumab to Selinexor and low-dose dexamethasone (ESd) in RRMM, previously treated with one or a combination of PI's, IMiD's, and anti-CD38 mAb.

Conditions

  • Relapsed Multiple Myeloma
  • Refractory Multiple Myeloma

Interventions

DRUG

Elotuzumab, Selinexor, and Dexamethasone (ESd)

This is a single-arm, interventional, phase II clinical trial, in which the anticipated 18 enrolled patients will receive the trial drug, a combination of Elotuzumab, Selinexor, and Dexamethasone in monthly cycles. The study tests the theory of synergy between these drugs, as detailed in the study description above.

Sponsors & Collaborators

  • Karyopharm Therapeutics Inc

    collaborator INDUSTRY

  • Tulane University School of Medicine

    lead OTHER

Principal Investigators

  • Hana Safah, MD · Tulane University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-04-27
Primary Completion
2022-04-27
Completion
2022-04-27
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05170789 on ClinicalTrials.gov