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Protocol No. UW17157

Principal Investigator Callander, Natalie

Phase I/II

Age Group Adult

Scope National

Sponsor Type Industry

Title A Phase 1b/2 Study of Selinexor (KPT-330) in Combination with Backbone Treatments for Relapsed/Refractory and Newly Diagnosed Multiple Myeloma

Objective The purpose of this research study is to see if the combination study with study drug, selinexor (also known as KPT-330), has any effects on your cancer. Selinexor is considered to be an investigational drug, which means it has not been approved by the U.S. Food and Drug Administration (FDA), Health Canada, or any other regulatory agency.

Treatment
This study includes six different treatment combinations:
  • Selinexor, dexamethasone and pomalidomide (abbreviated as SPd)
  • Selinexor, dexamethasone and bortezomib (abbreviated as SVd)
  • Selinexor, dexamethasone and lenalidomide (abbreviated as SRd)
  • Selinexor, dexamethasone, pomalidomide, and bortezomib (abbreviated as SPVd)
  • Selinexor, dexamethasone, daratumumab (abbreviated SDd)
  • Selinexor, dexamethasone, carfilzomib (abbreviated SKd)
  • Selinexor, dexamethasone, lenalidomide (abbreviated as SRd) in Newly Diagnosed Multiple Myeloma (NDMM) patients

  • Description Phase 1b/2 Selinexor in Combination with Backbone Treatments for Relapsed/Refractory Multiple Myeloma

    Key Eligibility
  • 18 years of age or older
  • Histologically confirmed diagnosis, measurable disease and evidence of disease progression of Multiple Myeloma
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0,1 or 2
  • Adequate hepatic function, renal function and hematopoietic function
  • Female patients of child-bearing potential must agree to use dual methods of contraception and have a negative serum pregnancy test at Screening
  • Male patients must use an effective barrier method of contraception if sexually active with a female of child bearing potential
    EXCLUSION:
  • Smoldering Multiple Myeloma
  • Multiple Myeloma that does not express M-protein or FLC (i.e., non-secretory MM is excluded), and quantitative immunoglobulin levels cannot be used instead
  • Documented active systemic amyloid light chain amyloidosis
  • Active plasma cell leukemia
  • Active graft versus host disease after allogeneic stem cell transplantation
  • Active, unstable cardiovascular function
  • Uncontrolled active hypertension
  • Uncontrolled active infection requiring parenteral antibiotics, antivirals, or antifungals within 1 week prior to first dose
  • Known active hepatitis A, B, or C
  • Known HIV infection or HIV seropositivity
  • Any active gastrointestinal dysfunction that prevents the patient from swallowing tablets, or interferes with absorption of study treatment
  • Currently pregnant or breastfeeding
  • Prior exposure to a SINE compound, including selinexor
  • Prior history of neuropathy Grade > 2, or Grade 2 neuropathy with pain at Screening(arms 2 and 4)

  • Applicable Disease Sites Multiple Myeloma

    Status Open

    Participating Institutions UW Hospital and Clinics