| Titre |
A Phase 3, Multicenter, Randomized, Open Label Study of Venetoclax and Dexamethasone Compared With Pomalidomide and Dexamethasone in Subjects With t(11;14)-Positive Relapsed or Refractory Multiple Myeloma |
| Protocole ID |
M13-494 |
| ClinicalTrials.gov ID |
NCT03539744 |
| Type(s) de cancer |
Myélome |
| Phase |
Phase III |
| Stade |
Récidivant/réfractaire (2ième ligne de traitement et plus) |
| Type étude |
Clinique |
| Médicament |
Venetoclax et dexaméthasone comparé à pomalidomide et dexaméthasone |
| Institution |
CISSS DE CHAUDIERE-APPALACHES
 HOTEL-DIEU DE LEVIS
143 rue Wolfe, Lévis, QC, G6V 3Z1
|
| Ville |
Beauceville |
| Investigateur(trice) principal(e) |
Dre Danièle Marceau
|
| Coordonnateur(trice) |
Pierre Bédard
418-835-7121
|
| Statut |
![]() Fermé |
| Critètes d'éligibilité |
- Documented diagnosis of multiple myeloma (MM) based on standard IMWG criteria.
- Measurable disease at screening as defined per protocol.
- Has received at least 2 prior lines of therapy as described in the protocol.
- Has had documented disease progression on or within 60 days after completion of the last therapy.
- Has received at least 2 consecutive cycles of lenalidomide and be relapsed/refractory to lenalidomide, as defined per protocol.
- Has received at least 2 consecutive cycles of a proteasome inhibitor (PI).
- Has MM positive for t(11;14).
- An Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2.
- Laboratory values (liver, kidney and hematology laboratory values) that meet criteria as described per protocol.
|
| Critètes d'exclusion |
- History of treatment with venetoclax or another B-Cell Lymphoma (BCL)-2 inhibitor or pomalidomide.
- History of other active malignancies, including myelodysplastic syndromes (MDS), within the past 3 years (exceptions described in the protocol).
- Evidence of ongoing graft-versus-host disease (GvHD) if prior stem cell transplant (SCT).
- Prior treatment with any of the following: allogeneic or syngeneic SCT within 16 weeks prior to randomization; or autologous SCT within 12 weeks prior to randomization.
- Known central nervous system involvement of MM.
- Concurrent conditions as listed in the protocol.
|
Groupe d'étude en oncologie du Québec