Titre A Phase 1b/2 Study of Selinexor (KPT-330) in Combination With Backbone Treatments for Relapsed/Refractory Multiple Myeloma
Protocole ID KCP-330-017 (STOMP)
ClinicalTrials.gov ID NCT02343042
Type(s) de cancer Myélome
Phase Phase I-II
Stade Maladie avancée ou métastatique
Type étude Clinique
Médicament sélinexor
Institution CHU DE QUEBEC – UNIVERSITE LAVAL
   L'HOTEL-DIEU DE QUEBEC ET CRCEO
      11 Côte du Palais, Québec, QC, G1R 2J6
Ville Québec
Investigateur(trice) principal(e) Dr Marc Lalancette
Coordonnateur(trice) Diane Bernard
 418-525-4444 poste 15782

Patricia Chabot
 418-525-4444 poste 15769
Statut Actif en recrutement
Critètes d'éligibilité
  • Histologically confirmed diagnosis, measurable disease and evidence of disease progression of MM, as described below.
  • Symptomatic MM, based on IMWG guidelines. Patients must have measurable disease as defined by at least one of the following:
  • Serum M-protein ≥ 0.5 g/dL by serum electrophoresis (SPEP) or, for IgA myeloma, by quantitative IgA
  • Urinary M-protein excretion at least 200 mg/24 hours
  • Serum FLC ≥ 100 mg/L, provided that FLC ratio is abnormal
  • If serum protein electrophoresis is felt to be unreliable for routine M-protein measurement, then quantitative Ig levels by nephelometry or turbidometry are acceptable.
  • Any non-hematological toxicities (except for peripheral neuropathy as described in exclusion criterion #22) that patients experienced from treatments in previous clinical studies must have resolved to ≤ Grade 2 by Cycle 1 Day 1.
  • Adequate hepatic function within 21 days prior to C1 D1:
  • Adequate renal function within 21 days prior to C1 D1:
  • Adequate hematopoietic function within 21 days prior to C1 D1:
SdP (Arm 1) Only:
Relapsed and refractory MM with:
  • Documented evidence of PD after achieving at least SD for ≥ 1 cycle during a previous MM regimen (i.e., relapsed MM)
  • ≤ 25% response (i.e., patients never achieved ≥ MR) or PD during or within 60 days from the end of the most recent MM regimen (i.e., refractory MM)
  • Previously undergone ≥ 2 cycles of lenalidomide and a proteasome inhibitor (in separate therapeutic regimens [not for maintenance] or in combination)
SdB (Arm 2) Only:
Relapsed or refractory MM with:
  • Documented evidence of relapse after ≥ 1 previous line of therapy
  • Not refractory to bortezomib in their most recent line of therapy 9. SdL (Arm 3) Only:
  • Patients who received ≥ 1 prior therapeutic regimen (prior lenalidomide is allowed as long as patient was not refractory to prior lenalidomide)
Critètes d'exclusion
  • Smoldering MM.
  • MM 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 MM involving the central nervous system (CNS)
  • Active plasma cell leukemia
  • Blood (or blood product) transfusions and blood growth factors within 7 days of C1 D1 only for patients enrolling into the Expansion Phase
  • Radiation, chemotherapy, or immunotherapy or any other anticancer therapy ≤ 2 weeks prior to C1 D1, and radio-immunotherapy within 6 weeks prior to C1 D1. Patients on long-term glucocorticoids during Screening, including use for spinal cord compression, do not require a washout period. Prior radiation is permitted for treatment of fractures or to prevent fractures as well as for pain management
  • Treatment with an investigational anti-cancer therapy within 3 weeks prior to C1 D1
  • Prior autologous stem cell transplantation < 1 month, or allogeneic stem cell transplantation < 3 months prior to C1 D1
  • Active graft versus host disease after allogeneic stem cell transplantation
  • A life expectancy of < 3 months
  • Major surgery within 4 weeks prior to C1 D1
  • Active, unstable cardiovascular function: