Selinexor, Daratumumab, Carfilzomib and Dexamethasone for the Treatment of High-Risk, Recurrent or Refractory Multiple Myeloma

Part of paid clinical trials in Hackensack, New Jersey.

Sponsor
Academic and Community Cancer Research United
Study ID
NCT04756401
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Recurrent Plasma Cell Myeloma
  • Refractory Plasma Cell Myeloma

Eligibility Criteria

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

Interventions

  • Carfilzomib — DRUG
    Given IV
  • Daratumumab — BIOLOGICAL
    Given IV
  • Dexamethasone — DRUG
    Given PO
  • Quality-of-Life Assessment — OTHER
    Ancillary studies
  • Selinexor — DRUG
    Given PO

Study Details

This phase II trial studies the effect of selinexor when combined with carfilzomib, daratumumab, and dexamethasone in treating patients with high-risk multiple myeloma that has come back (recurrent) or has not responded to treatment (refractory) and who have received 1-3 prior lines of therapy. Selinexor may stop the growth of cancer cells by blocking a protein called CRM1 that is needed for cell growth. Carfilzomib is a type of drug called a proteasome inhibitor. A proteasome is a protein found within cells that has the important role of identifying and marking damaged proteins that are needed to be destroyed by the cell for survival. The inhibition of the proteasome allows for damaged protein to accumulate within cells. This accumulation of damaged protein causes the cell to die. Daratumumab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Anti-inflammatory drugs, such as dexamethasone lower the body's immune response and are used with other drugs in the treatment of some types of cancer. Giving selinexor in combination with carfilzomib, daratumumab, and dexamethasone may work better than carfilzomib, daratumumab, and dexamethasone alone in treating patients with multiple myeloma.

Key Dates

Start date
Dec 8, 2022
Status verified
Sep 2024
Primary completion
Sep 30, 2024
Completion
Dec 30, 2027

Study Design

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

Arms

  • Experimental: Treatment (carfilzomib, daratumumab, dexamethasone, selinexor)
    Patients receive carfilzomib IV over 30 minutes on days 1, 8, and 15 and daratumumab IV on days 1 and 2 of cycle 1 then days 8, 15, and 22 of cycle 1, then, days 1, 8, 15, and 22 of cycle 2, days 1 and 15 of cycles 3-6, and day 1 of subsequent cycles. Patients also receive dexamethasone PO on days 1, 8 15, and 22, and selinexor PO on days 1, 8, and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Rate of minimal residual disease (MRD) negative status [ Time Frame: Up to 5 years post-treatment ]

Locations (4)

FacilityCityStateZIPSite coordinators
Hackensack University Medical CenterHackensackNew Jersey07601-
State University of New York Upstate Medical UniversitySyracuseNew York13210-
UNC Lineberger Comprehensive Cancer Center University of North Carolina at Chapel HillChapel HillNorth Carolina27599-
Carolinas Medical Center/Levine Cancer InstituteCharlotteNorth Carolina28203-

Find similar trials in Hackensack, NJ

By research site
Hackensack University Medical Center· Hackensack, NJState University of New York Upstate Medical University· Syracuse, NYUNC Lineberger Comprehensive Cancer Center University of North Carolina at Chapel Hill· Chapel Hill, NCCarolinas Medical Center/Levine Cancer Institute· Charlotte, NC

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