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
Natalie Callander
Summary
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Written informed consent and HIPAA authorization for release of personal health information. NOTE: HIPAA authorization may be included in the informed consent or obtained separately. 2. Age ≥ 18 years at the time of consent. 3. ECOG Performance Status of ≤2 within 28 days prior to registration. A performance status of \>2 will be allowed only if it is related to bone pain that is expected to improve with treatment. 4. Patients with a diagnosis of relapsed or relapsed/refractory MM who have received at least 1 line of prior therapy. In the phase 2 component, we will spec…
Interventions
- DrugSelinexor
Phase I: Selinexor at assigned dose by mouth begin Day 1, 8, 15, and 22 until study treatment stop. - Dose Levels: -1: 20mg weekly 0 (Starting Dose): 40mg weekly 1: 60mg weekly Phase II: Selinexor at assigned dose by mouth based on the phase 1 findings. Selinexor will be taken weekly (Days 1, 8, 15, and 22).
- DrugCarfilzomib
Phase I and Phase II: Carfilzomib IV will be administered on Day 1, 8, and 15. The first dose of carfilzomib will be carfilzomib 20mg/m2 IV. Every dose after will be carfilzomib 56mg/m2.
- DrugIsatuximab
Phase I and Phase II: Isatuximab 1400mg will be administered by injection from the wearable device. For the first 28 days isatuximab will be administered on days 1, 8, 15, and 22. For every cycle after isatuximab will be administered on days 1 and 15.
- DeviceIsatuximab SC Wearable Injection System
Phase I and Phase II: Isatuximab 1400mg will be administered by injection from the wearable device. For the first 28 days isatuximab will be administered on days 1, 8, 15, and 22. For every cycle after isatuximab will be administered on days 1 and 15.
- DrugDexamethasone
Phase I and Phase II: Dexamethasone 40mg will be administered either by IV or orally on Days 1, 8, 15, and 22.
Location
- University of WisconsinMadison, Wisconsin