| 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:
|
Groupe d'étude en oncologie du Québec