Selinexor for Treatment of Light Chain Amyloidosis With Relapsed/Refractory Disease

Part of paid clinical trials in New York, New York.

Sponsor
Weill Medical College of Cornell University
Study ID
NCT04984330
Phase
EARLY_PHASE1
Status
Withdrawn

Conditions

  • AL Amyloidosis
  • Amyloid
  • Amyloidosis

Eligibility Criteria

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

Interventions

  • Selinexor — DRUG
    Selinexor will be given orally at a dose of 60mg once weekly on the first day of the week (day 1, 8, 15, and 22) for Cycle 1 and up to Cycle 12.
  • Dexamethasone — DRUG
    Dexamethasone will be given orally at a dose of 20mg, if tolerated, or at a reduced dose if required, 30 to 60 minutes prior to selinexor for first 2 days of each week only (days 1, 2, 8, 9, 15, 16, 22, and 23 of each cycle).

Study Details

The purpose of this study is to test the safety and efficacy of Selinexor and Dexamethasone and see what effects it has on AL amyloidosis.

Key Dates

Start date
Dec 31, 2021
Status verified
Nov 2022
Primary completion
Jun 30, 2023
Completion
Jun 30, 2024

Study Design

Enrollment
0 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: selinexor/ dexamethasone (Sd)
    Selinexor • 60mg PO once weekly on days 1, 8, 15, 22 until disease progression or toxicity Dexamethasone • 20 mg PO administered 30-60 minutes prior to selinexor on days 1, 2, 8, 9, 15, 16, 22, 23

Primary Outcome Measure

Compare number of dose limiting toxicity (DLT) occurence to measure safety and toxicity [ Time Frame: approximately 12 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Weill Cornell Medicine - Multiple Myeloma CenterNew YorkNew York10065-

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Weill Cornell Medicine - Multiple Myeloma Center· New York, NY

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