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Karyopharm Therapeutics KCP-330-023
Overall Recruitment Status: Active, currently enrolling
 
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) (BOSTON)
 
Region Sponsors
Northwest
Karyopharm Therapeutics Inc
 
Acronym KP IRB No.
BOSTON STUDY00000669
 
Study Type Phase
Clinical Trial Phase III
 
Study Population Description
Multiple Myeloma;
 
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:1. 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 2. Urinary M-protein excretion at least 200 mg/24 hours, or 3. 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
  • Adequate hepatic function within 28 days prior to C1D1
  • Adequate renal function within 28 days prior to C1D1
  • Adequate hematopoietic function within 7 days prior to 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.
  • Documented systemic light chain amyloidosis.
  • MM involving the central nervous system.
  • Polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes (POEMS) syndrome.
  • Spinal cord compression.
  • Greater than Grade 2 neuropathy or >/= Grade 2 neuropathy with pain at baseline, regardless of whether or not the patient is currently receiving medication
  • Intolerance, hypersensitivity, or contraindication to glucocorticoids.
  • Radiation, chemotherapy, or immunotherapy or any other anticancer therapy
  • Prior autologous stem cell transplantation < 1 month or allogeneic stem cell transplantation < 4 months prior to C1D1.
  • Active graft versus host disease (after allogeneic stem cell transplantation) at C1D1.
  • Please contact study team for more eligibility criteria

 
Keywords and/or Specific Medical Conditions
  • Multiple Myeloma
  • Oncology (Adult)
 
KP Clinical Facility
  • Central Interstate Medical Office
 
Clinical Area
  • Oncology (Adult)


Principal Investigator:
Abdul Mansoor, MD
Contact Information:
- Rhonda Stephenson, RN
-Interstate Medical Office East


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