Selinexor Treatment for Multiple Myeloma Patients Who Are Refractory to Lenalidomide-containing Therapy.

Part of paid clinical trials in West Hollywood, California.

Sponsor
Oncotherapeutics
Study ID
NCT04519476
Phase
PHASE1
Status
Unknown

Conditions

  • Refractory Multiple Myeloma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Selinexor — DRUG
    Selinexor (KPT-330) is a first-in-class, oral selective exportin 1 (XPO1) inhibitor (1,2). Selinexor functions by binding with and inhibiting the nuclear export protein XPO1 (also called CRM1), leading to the accumulation of tumor suppressor proteins in the cell nucleus along with inhibition of translation of oncoprotein mRNAs.
  • Lenalidomide — DRUG
    Immunomodulatory drug
  • Methylprednisolone — DRUG
    Glucocorticoid, steroid

Study Details

This is a pilot study evaluating the safety and efficacy of selinexor among multiple myeloma (MM) patients that are refractory to lenalidomide-containing regimens with or without steroids.

Key Dates

Start date
Nov 1, 2020
Status verified
Oct 2023
Primary completion
Dec 29, 2023
Completion
Dec 29, 2023

Study Design

Enrollment
22 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Selinexor/Lenalidomide/Steroids
    All subjects enrolled will receive: 1) selinexor, PO, at 60 mg once weekly on days 1-28 of a 28-day cycle, 2) lenalidomide, PO, 10 mg daily on days 1-21 of 28-days cycle and 3) methylprednisolone at the same dose and schedule as the last lenalidomide-containing regimen if it contained steroids. If patient's qualifying lenalidomide-containing regimen contained different type of steroid (e.g. prednisone, dexamethasone, etc.) then patient on this study will receive methylprednisolone at the equivalent dose and schedule.

Primary Outcome Measure

Overall Response [ Time Frame: 30 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
James R Berenson, MD, Inc.West HollywoodCalifornia90069
James Berenson, MD
Regina Swift, RN, BSN
[email protected]
310-623-1222

Find similar trials in West Hollywood, CA

By research site
James R Berenson, MD, Inc.· West Hollywood, CA

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