Clinical Trials

The James Cancer Center Columbus, OH

open for enrollment

Study of the Safety, Tolerability and Efficacy of KPT-8602 in Patients With Relapsed/Refractory Multiple Myeloma

Protocol: OSU-15260

Full Title

A Phase I/II Open-Label Study Of The Safety, Tolerability And Efficacy Of The Selective Inhibitor Of Nuclear Export (Sine) Compound Kpt-8602 In Patients With Relapsed/Refractory Multiple Myeloma

Purpose

This is a first-in-human, multi-center, open-label clinical study with separate dose

escalation (Phase 1) and expansion (Phase 2) stages to assess preliminary safety,

tolerability, and efficacy of the second generation oral XPO1 inhibitor KPT-8602 in patients

with relapsed/refractory MM.

Are you eligible?

Inclusion Criteria:

Evidence of disease progression:

Symptomatic relapsed or refractory requiring current treatment.

Previously treated with ≥ 3 prior regimens (lines of therapy) that included at

least one of each of the following: alkylating agent, immunomodulatory drug,

proteasome inhibitor, and a steroid.

Must be refractory to most recent anti-cancer regimen.

Must have measurable disease defined by one of the following:

Serum M-protein ≥ 0.5 g/dL by serum protein electrophoresis (SPEP) or for IgA

myeloma, by quantitative IgA. If SPEP is felt to be unreliable for routine

Mprotein measurement (e.g., for patients with IgA MM), then quantitative Ig

levels by nephelometry or turbidometry are acceptable; or

Urinary M-protein excretion at least 200 mg/24 hours; or

Serum Free Light Chain (Serum FLC) whereby the involved light chain measures ≥

10 mg/dL and with an abnormal ratio.

Eastern Cooperative Oncology Group performance status of ≤ 1.

Exclusion Criteria:

Time since the last prior therapy:

Radiation, chemotherapy, immunotherapy or any other anticancer therapy,

including investigational anticancer therapy ≤ 2 weeks prior to Cycle 1 Day 1.

Palliative steroids for disease related symptoms are allowed up to 3 days prior

to Cycle 1 Day 1.

Active graft versus host disease after allogeneic stem cell transplantation. At least

3 months must have elapsed since completion of allogeneic stem cell transplantation.

Active central nervous system malignancy. Patients who have only had prophylactic

intrathecal or intravenous chemotherapy against central nervous system disease are

eligible.

Patients with significantly diseased or obstructed gastrointestinal tract or

uncontrolled vomiting or diarrhea that could interfere with the absorption of

KPT-8602.

Prior exposure to XPO1 inhibitors.

Life expectancy of ≥ 4 months.

Multiple Myeloma