Elotuzumab, Selinexor, and Dexamethasone for Relapsed Refractory Multiple Myeloma

Sponsor
Tulane University School of Medicine
Study ID
NCT05170789
Phase
PHASE2
Status
Withdrawn

Conditions

  • Refractory Multiple Myeloma
  • Relapsed Multiple Myeloma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Elotuzumab, Selinexor, and Dexamethasone (ESd) — DRUG
    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.

Study Details

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.

Key Dates

Start date
Apr 27, 2022
Status verified
Apr 2022
Primary completion
Apr 27, 2022
Completion
Apr 27, 2022

Study Design

Enrollment
0 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Intervention arm
    This study employs a single, intervention arm or group, anticipated size of which is 18 patients, in which all enrolled subjects will receive the study drug, ESd.

Primary Outcome Measure

Response of relapsed refractory multiple myeloma (RRMM) patient to elotuzumab, selinexor, and dexamethasone (ESd). [ Time Frame: 18-24 months. ]

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