Title
Phase Ib/II Study of Selinexor in Combination with Carfilzomib, subcutaneous Isatuximab administered via investigational device, and Dexamethasone (SCID) for Patients with Relapsed and/or Relapsed Refractory Multiple Myeloma Big Ten Cancer Research Consortium BTCRC-MM21-528

Description
Phase Ib/II Study of Selinexor in Combination With Carfilzomib, Subcutaneous Isatuximab Administered Via Investigational Device and Dexamethasone (SCID) for Patients With Relapsed and/or Relapsed Refractory Multiple Myeloma

Objective
Primary Objective:
-To study the safety and tolerability of the combination of selinexor, carfilzomib, isatuximab and dexamethasone (SCID) in patients with relapsed and relapsed/refractory multiple myeloma (MM).

Secondary Objectives:
-To estimate progression-free survival (PFS) rate in patients with MM receiving SCID.
-To estimate the overall response rate (ORR) of patients with MM receiving SCID in the total group as well as patients with 1q gain or amplification.
-To examine the minimal residual disease (MRD) rate in patients with MM receiving SCID who achieve VGPR or better.
-To examine the PFS, ORR and MRD rate in patients with MM previously exposed, but not having received anti-CD38 therapy in the past 6 months prior to treatment
-To assess the impact of SCID therapy on quality-of-life metrics.

Treatment The primary objective of this Phase Ib/II trial is to study the safety and tolerability of the combination of selinexor, carfilzomib, isatuximab-OBDS (on body delivery system) and dexamethasone in patients with relapsed or relapsed/refractory multiple myeloma, who have received at least one line of therapy. The phase Ib portion comprises the safety run-in with 6-12 patients, with the option to reduce the selinexor dose from 40 mg to 20 mg if the higher dose reaches the prescribed toxicity threshold. The Phase II portion of the trial will test the Recommended Phase 2 Dose (RP2D) in an expansion cohort of up to 50 patients.

Key Eligibility For full study eligibility, see this study's ClinicalTrials.gov record.

Applicable Disease Sites
Multiple Myeloma

Participating Institutions
UW Health Eastpark Medical Center; UW Health University Hospital