A Trial of Selinexor, Ruxolitinib and Methylprednisolone

Part of paid clinical trials in West Hollywood, California.

Sponsor
Oncotherapeutics
Study ID
NCT06225310
Phase
PHASE1
Status
Recruiting
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Conditions

  • Multiple Myeloma in Relapse
  • Multiple Myeloma, Refractory

Eligibility Criteria

Sex
ALL
Age
N/A - 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 t
  • Ruxolitinib — DRUG
    elective inhibitor of Janus kinase (JAK)
  • Methylprednisolone — DRUG
    Glucocorticoid, steroid

Study Details

Selinexor, a first-in-class, oral selective exportin 1 (XPO1) inhibitor, has shown promise in pre-clinical and clinical studies. It functions by inhibiting the nuclear export protein XPO1, resulting in the accumulation of tumor suppressor proteins and inhibition of oncoprotein mRNAs, which is selectively lethal to myeloma cells. Selinexor has demonstrated activity in combination with various drugs, including glucocorticoids and proteasome inhibitors, leading to its FDA approval for the treatment of relapsed or refractory multiple myeloma.

Key Dates

Start date
Aug 6, 2024
Status verified
Jan 2025
Primary completion
Apr 1, 2027
Completion
May 1, 2027

Study Design

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

Arms

  • Other: Experimental: Selinexor/Ruxolitinib/Steroids
    The regimen will follow a 3+3 dose escalation schedule starting at dose level 0. Subjects enrolled at dose level 0 will receive 1) selinexor (once weekly) starting at 40 mg, 2) ruxolitinib (twice a day (BID) on days 1-28) starting at 10 mg, and 3) oral methylprednisolone (every other day (QOD)) a set dose at 40 mg. Subjects at dose level 1 will receive 1) selinexor (once weekly) 60 mg, 2) ruxolitinib (BID) on days 1-28 10 mg, and 3) methylprednisolone (QOD) 40 mg. Subjects at dose level 2 will receive 1) selinexor (once weekly) 60 mg, 2) ruxolitinib (BID) on days 1-28 15 mg, and 3) oral methylprednisolone (QOD) 40 mg.

Primary Outcome Measure

1. Maximum Tolerated Dose (MTD): [ Time Frame: 30 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Berenson Cancer CenterWest HollywoodCalifornia90069
Marceya Soto
[email protected]
310-623-1218
Victor Tellez
[email protected]
310-623-1218
James Berenson, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Berenson Cancer Center· West Hollywood, CA

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