Skip Navigation Links
A Phase 3 Randomized, Controlled, Open-Label Study of Selinexor, Bortezomib, and Dexamethasone (SVd) versus Bortezomib and Dexamethasone (Vd) in Patients with Relapsed or Refractory Multiple Myeloma (RRMM)
Overall Recruitment Status: Active, enrollment completed
 
Official Title
A Phase 3 Randomized, Controlled, Open-Label Study of Selinexor, Bortezomib, and Dexamethasone (SVd) versus Bortezomib and Dexamethasone (Vd) in Patients with Relapsed or Refractory Multiple Myeloma (RRMM)
 
Region Sponsors
Hawaii
Karyopharm Therapeutics
 
Acronym KP IRB No.
BOSTON STUDY00000660
 
Study Type Phase
Clinical Trial Phase III
 
Study Population Description
 
Purpose
This Phase 3, 2-arm, randomized, active comparator-controlled, open-label, multicenter study will compare the efficacy and health-related quality of life (HR-QoL) and assess the safety of selinexor plus bortezomib (VelcadeĀ® or generic equivalent) plus low-dose dexamethasone (SVd) versus bortezomib plus low-dose dexamethasone (Vd) in adult patients with RRMM who have received 1 to 3 prior anti-multiple myeloma (MM) regimens. After progressive disease (PD), patients in the Vd Arm may cross over to SVd treatment. Patients who cross over will be referred to as SVdX patients
 
Detailed Description
 
Gender Age Limit
Male & Female
 
Inclusion Criteria
  • Histologically confirmed MM with measurable disease per IMWG guidelines as defined by at least 1 of the following: Serum M-protein = 0.5 g/dL (> 5 g/L) by serum protein electrophoresis (SPEP) or for immunoglobulin (Ig) A myeloma, by quantitative serum IgA levels: or Urinary M-protein excretion at least 200 mg/24 hours: or Serum free light chain (FLC) = 100 mg/L, provided that the serum FLC ratio is abnormal
  • Had at least 1 prior anti-MM regimen and no more than 3 prior anti-MM regimens. Induction therapy followed by stem cell transplant and consolidation/maintenance therapy will be considered as 1 anti-MM regimen
  • Documented evidence of progressive MM (based on the Investigator's determination according to the modified IMWG response criteria) on or after their most recent regimen
  • Prior treatment with bortezomib or other Proteasome Inhibitor (PI) is allowed, provided all of the following criteria are met: Best response achieved with prior bortezomib at any time was = PR and with the last PI (PI therapy (alone or in combination) was = PR, AND Participant did not discontinue bortezomib due to = Grade 3 related toxicity, AND Must have had at least a 6-month PI-treatment-free interval prior to Cycle 1 Day 1 (C1D1) of study treatment
  • Resolution of any clinically significant non-hematological toxicities (if any) from previous treatments to = Grade 1 by C1D1
 
Exclusion Criteria
  • Has received selinexor or another XPO1 inhibitor previously
  • Prior malignancy that required treatment, or has shown evidence of recurrence (except for non-melanoma skin cancer or adequately treated cervical carcinoma in situ) during the 5 years prior to randomization
  • Any concurrent medical condition or disease (e.g., uncontrolled active hypertension, uncontrolled active diabetes, active systemic infection, etc.) that is likely to interfere with study procedures
  • Uncontrolled active infection requiring parenteral antibiotics, antivirals, or antifungals within 1 week prior to C1D1
  • Active plasma cell leukemia

 
Keywords and/or Specific Medical Conditions
  • Oncology (Adult)
 
KP Clinical Facility
  • Moanalua Medical Center and Clinic
 
Clinical Area
  • Oncology (Adult)


Principal Investigator:
Jennifer Carney, MD
Contact Information:
- Shelley Clark, RN
-Moanalua Medical Center and Clinic


smilelady1
Do you want to receive
Email Alerts?

Sign Up Here!





Regional Research Sites: