HCMT/MM2401: Ph2 Study of Selinexor + Bispecific Antibody for RRMM
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorDuke University
About this trial
The primary objectives of this study are to determine the safety of single agent Selinexor given with commercial bispecific antibody therapy in patients with Relapsed/Refractory Multiple Myeloma (RRMM) and to determine the MRD negativity rate at 10-5 at 12 months post bispecific antibody therapy.
The investigators will enroll 27 patients with RRMM who are receiving commercial bispecific antibody therapy. Patients will be on treatment for 12 months or until disease progression, and will be followed for 24 months. Study assessments include completing a drug diary, having a safety check in call, and have history, clinical assessments, and labs taken.
Twenty-seven patients will provide 80% power in a one-sample chi square test for a proportion assuming that the rate of negative MRD at 10-5 at 12 months post bispecific antibody therapy is 25% in historical control and 50% in the SEL+bispecific antibody experimental treatment group, under a one-sided 5% significance level.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 18 years old at the time of informed consent.
Willing and able to provide written informed consent in accordance with federal, local, and institutional guidelines. The patient must provide informed consent prior to the first screening procedure.
Eastern Cooperative Oncology Group (ECOG) performance status of ≤2
A diagnosis of symptomatic multiple myeloma, with relapsed or refractory disease. Patients must have received at least 4 prior lines of therapy. Prior lines of therapy must include a proteasome inhibitor, an immunomodulatory agent, and an CD38 monoclonal antibody, and may include treatment with BCMA antibody conjugates or BCMA directed chimeric antigen receptor (CAR) T cell therapy.
Disqualifiers
Patients who have received and were refractory to selinexor or another specific inhibitor of nuclear exporter (SINE) compound previously. Note: Patients who were exposed to selinexor or another SINE compound but were not refractory are eligible.
Patients with any concurrent medical condition or disease (e.g., uncontrolled active hypertension, uncontrolled active diabetes, active systemic infection) that is likely to interfere with study procedures.
Patients with any uncontrolled active infection requiring medical or surgical management within 1 week prior to Cycle 1 Day 1 (C1D1). Note: Patients on prophylactic antibiotics or with a controlled infection within 1 week prior to C1D1 are eligible.
Females who are pregnant or breastfeeding females.
Trial design
Design model
Single group
Treatments tested in this trial
Selinexor 40 mg
DrugPatients will receive 40mg of oral SEL, weekly, beginning after they have completed step-up dosing and are 5 (± 2) days out from administration of the first full treatment dose of bispecific antibody therapy for 12 months or until disease progression.
Treatment groups
27 Participants
are divided into 1 treatment groupGroup A: Selinexor + bispecific antibodyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Safety of selinexor given with commercial bispecific antibody as measured by severity of adverse events
Adverse events are defined using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Time frame
up to 13 months2
Minimal residual disease (MRD) negativity rate post bispecific antibody therapy
MRD at 10\^-5 will be performed by Clonoseq (Adaptive Biotechnologies) or, if Clonoseq could not be performed due to inability to obtain/identify original plasma cell clone, by Duke institutional flow cytometry-based MRD assay.
Time frame
up to 12 monthsSecondary outcomes
1
Overall response rate (ORR)
Disease response will be assessed according to the International Myeloma Working Group (IMWG) response criteria
Time frame
up to 13 months2
Complete remission (CR) rate
Disease response will be assessed according to the International Myeloma Working Group (IMWG) response criteria
Time frame
up to 13 months3
Very good partial response (VGPR) rate
Disease response will be assessed according to the International Myeloma Working Group (IMWG) response criteria
Time frame
up to 13 months4
Partial response (PR) rate
Disease response will be assessed according to the International Myeloma Working Group (IMWG) response criteria
Time frame
up to 13 monthsSponsors and contacts
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Source ClinicalTrials.gov