A Phase 1b/2 Study of Selinexor (KPT-330) in Combination with Backbone Treatments for Relapsed/Refractory Multiple Myeloma


A Phase 1b/2 Study of Selinexor (KPT-330) in Combination with Backbone Treatments for Relapsed/Refractory Multiple Myeloma

This is a research study. We invite you to participate in this research study because you have been diagnosed with Multiple Myeloma (MM). Your previous treatment(s) has/have not been successful and your cancer is progressing. The purpose of this research study is to see if selinexor (also known as KPT-330) has any effects on your cancer. Selinexor is considered to be an investigational drug, which means it has not been approved by the U.S. Food and Drug Administration (FDA), Health Canada, the European Medicines Agency (EMA) or any other regulatory agency. Cancer is a disease involving the uncontrolled growth of human cells. Normal cell growth is controlled by multiple mechanisms. Cancer cells escape these mechanisms and grow uncontrollably. One of the ways that cancer cells continue to grow is by getting rid of certain proteins called “tumor suppressor proteins” that would normally cause cancer cells to die. The study drug (selinexor) works by keeping these tumor suppressor proteins within the cell and thus causing the cancer cells to die or stop growing. Selinexor has previously been tested in humans to identify a safe dose for providing to subject(s)/participant(s) with cancer. At this time, it is not known if selinexor will have an effect on your cancer. Selinexor is also being tested in other clinical studies in subject(s)/participant(s) with other advanced cancers. This study will look at the effects of different dose schedules of selinexor in two treatment combinations on your cancer and on your body, including any side-effects that you may experience. This is an open-label study, which means that both you and your study doctor will know how much selinexor and other medications you are taking. You, and all other subject(s)/participant(s) in this study, will take the study drug selinexor, plus dexamethasone and either pomalidomide, bortezomib, or lenalidomide. The treatment period consists of blocks of time called cycles. The number of treatment cycles you receive will depend on how well you are doing on the treatment and how well your cancer responds to it.

Are you Eligible? (Inclusion Criteria)

1) Symptomatic MM, based on IMWG guidelines. Patients must have measurable
diseases defined by at least one of the following:
a. Serum M-protein >= 0.5 g/dL by serum electrophoresis (SPEP) or, for IgA
myeloma,by quantitative IgA
b. Urinary M-protein excretion at least 200 mg/24 hours
c. Serum FLC >= 100 mg/L, provided that FLC ratio is abnormal
d. If serum protein electrophoresis is felt to be unreliable for routine M-
proteinmeasurement, then quantitative Ig levels by nephelometry or
turbidometry are acceptable

2) Adequate renal function within 21 days prior to C1 D1: Estimated
creatinine clearance of >= 20mL/min for SdB and SdL arms, and >= 45 mL/min
for SdP arm (as requested by the manufacturer),calculated using the formula
of Cockroft and Gault

3) SdP (Arm 1) Only:
Relapsed and refractory MM with:
a. Documented evidence of PD after achieving at least SD for >= 1 cycle
during a previous MM
regimen (i.e., relapsed MM)
b. <= 25% response (i.e., patients never achieved >= MR) or PD during or
within 60 days from the end of the most recent MM regimen (i.e., refractory
c. Previously undergone >= 2 cycles of lenalidomide and a proteasome
inhibitor (in separate
therapeutic regimens [not for maintenance] or in combination)

4) SdB (Arm 2) Only:
Relapsed or refractory MM with
a. Documented evidence of relapse after >= 1 previous line of therapy
b. Not refractory to bortezomib in their most recent line of therapy

5) SdL (Arm 3) Only:
Patients who received >= 1 prior therapeutic regimen (prior lenalidomide is
allowed as long as
patient was not refractory to prior lenalidomide)

Specialty Area(s)