A Study of Selinexor, in Combination With Carfilzomib, Daratumumab or Pomalidomide in Patients With Multiple Myeloma

Part of paid clinical trials in Washington D.C., District of Columbia.

Sponsor
Hackensack Meridian Health
Study ID
NCT04661137
Phase
PHASE2
Status
Suspended

Conditions

Eligibility Criteria

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

Interventions

  • Selinexor 60 MG — DRUG
    Selinexor 60 mg PO on days 1, 8 and 15
  • Selinexor 80 MG — DRUG
    Selinexor 80 mg PO on days 1, 8 and 15
  • Selinexor 100 MG — DRUG
    Selinexor 100 mg PO on days 1, 8, 15 and 22
  • Carfilzomib — DRUG
    56 mg/m2 IV on days 1, 8 and 15
  • Pomalidomide — DRUG
    4 mg PO daily for 21 days
  • Daratumumab — DRUG
    16 mg/kg IV days 1, 8, 15 and 22 for cycles 1-2; days 1 and 15 for cycles 3-6; day 1 for cycle 7 and on
  • Dexamethasone — DRUG
    20 mg if ≥ 75 years old and 40 mg if \< 75 years old on days 1, 8, 15 and 22

Study Details

This is a prospective, 2-arm (with an additional exploratory arm), open-label, multicenter study looking at the response rate of patients receiving selinexor (KPT-330), in combination with carfilzomib, daratumumab or pomalidomide. Multiple Myeloma patients with documented disease progression or refractory disease while on current treatment with any carfilzomib-containing regimen (arm 1), any pomalidomide-containing regimen (arm 2) or any daratumumab-containing regimen (exploratory arm) will be included in the study. Patients will be assigned to the respective groups according to their current treatment. If a subject has received more than one of the above therapies, then assignment will be made at their physician's discretion (e.g treatment decision can be made based upon patient and physician preferred tolerance.). Patients will receive treatment until progressive disease (PD), death, toxicity that cannot be managed by standard of care, or withdrawal, whichever occurs first.

Key Dates

Start date
Mar 16, 2021
Status verified
Feb 2026
Primary completion
Feb 28, 2027
Completion
Feb 28, 2027

Study Design

Enrollment
96 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Carfilzomib-containing Regimen
    Carfilzomib 56 mg/m2 on days 1, 8 and 15. Dexamethasone 20 mg if ≥ 75 years old and 40 mg if \< 75 years old on days 1, 8, 15 and 22. Selinexor 80 mg on days 1, 8 and 15.
  • Experimental: Pomalidomide-containing Regimen
    Pomalidomide 4 mg po daily for 21 days. Dexamethasone 20 mg if ≥ 75 years old and 40 mg if \< 75 years old on days 1, 8, 15 and 22. Selinexor 60 mg on days 1, 8 and 15.
  • Experimental: Exploratory/Daratumumab-containing Regimen
    Daratumumab on current schedule (16 mg/kg IV days 1, 8, 15 and 22 for cycles 1-2; days 1 and 15 for cycles 3-6; day 1 for cycle 7 and on). Dexamethasone 20 mg if ≥ 75 years old and 40 mg if \< 75 years old on days 1, 8, 15 and 22. Selinexor 100 mg on days 1, 8, 15 and 22.

Primary Outcome Measure

Overall Response Rate (ORR) of patients receiving selinexor with carfilzomib and dexamethasone (Arm 1) [ Time Frame: 30 Months ]

Locations (2)

FacilityCityStateZIPSite coordinators
Lombardi Comprehensive Cancer CenterWashington D.C.District of Columbia20007-
John Theurer Cancer CenterHackensackNew Jersey07601-

Find similar trials in Washington D.C., DC

By condition
Multiple myeloma
By specialty
OncologyBlood cancer
By research site
Lombardi Comprehensive Cancer Center· Washington D.C., DCJohn Theurer Cancer Center· Hackensack, NJ

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