Treatment of Selinexor in Combination With Clarithromycin, Pomalidomide and Dexamethasone for Relapsed Refractory Multiple Myeloma Patients

Part of paid clinical trials in Brooklyn, New York.

Sponsor
Weill Medical College of Cornell University
Study ID
NCT04843579
Phase
PHASE2
Status
Terminated

Conditions

  • Myeloma
  • Myeloma Multiple
  • Refractory Multiple Myeloma

Eligibility Criteria

Sex
ALL
Age
18 Years - 74 Years
Healthy Volunteers
Not accepted

Interventions

  • Selinexor — DRUG
    Given as 60 mg oral capsule
  • Clarithromycin — DRUG
    Given as 500 mg oral capsule
  • Pomalidomide — DRUG
    Given as 4 mg oral capsule
  • Dexamethasone — DRUG
    Given as 40 mg oral capsule

Study Details

The purpose of this study is to determine the efficacy and safety of investigational combination therapy of Selinexor, Clarithromycin, Pomalidomide and Dexamethasone (ClaSPd) for patients with relapsed/refractory multiple myeloma. The hypothesis is that the addition of Selinexor to Clarithromycin, Pomalidomide and Dexamethasone will increase the overall response rate of patients with relapsed/refractory multiple myeloma.

Key Dates

Start date
Dec 29, 2021
Status verified
Oct 2023
Primary completion
Nov 30, 2022
Completion
Dec 30, 2022

Study Design

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

Arms

  • Experimental: Selinexor, Clarithromycin, Pomalidomide and Dexamethasone (ClaSPd)
    Selinexor • Given orally at a dose of 60 mg on days 1, 8, and 15 of a 28-day cycle. Dexamethasone * Given orally at a dose of 40 mg on days 1, 8, 15 and 22 of a 28-day cycle. * Subjects will receive a prescription for dexamethasone 4 mg tablets (generic). Clarithromycin * Given orally at a dose of 500 mg twice a day on days 1-28 of a 28-day cycle. * Subjects will receive a prescription for clarithromycin 250 or 500 mg tablets (generic) for oral administration. Pomalidomide * Given orally at a dose of 4 mg daily on days 1-21 of a 28-day cycle. * Subjects will receive a 21-day supply of pomalidomide 1, 2, 3, or 4 mg capsules for oral administration for each treatment cycle.

Primary Outcome Measure

Percentage of Participants With Overall Response Rate of Partial Response or Better [ Time Frame: Until disease progression; the maximum time any participant was followed for ORR was 287 days ]

Locations (2)

FacilityCityStateZIPSite coordinators
NewYork-Presbyterian Brooklyn Methodist HospitalBrooklynNew York11215-
Weill Cornell Medicine - Multiple Myeloma CenterNew YorkNew York10065-

Find similar trials in Brooklyn, NY

By condition
Multiple myeloma
By specialty
OncologyBlood cancer
By research site
NewYork-Presbyterian Brooklyn Methodist Hospital· Brooklyn, NYWeill Cornell Medicine - Multiple Myeloma Center· New York, NY

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