Etude : CANOVA / M13-494



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Acronyme
Nom
Traitement
Type d'étude
MÀJ
Présentation de l'étude
Acronyme : CANOVA

Nom : M13-494

Traitement :

Type d'étude : Hors ciblage moléculaire

Dernière MÀJ : 03/09/2019
Titre
Spécialité(s)
CIM10 - Localisation(s)
Informations principales
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

Spécialité : Tissus lymphoïde, hématopoïétique et apparentés
Localisation : C90 - Myélome multiple et tumeurs malignes à plasmocytes
Schéma
Phase
Stade
Ligne(s)
Informations complémentaires
Schéma : A study designed to evaluate the safety and efficacy of venetoclax plus dexamethasone (VenDex) compared with pomalidomide plus dexamethasone (PomDex) in participants with t(11;14)-positive Relapsed or Refractory Multiple Myeloma.

Subjects randomized to Arm 2 (PomDex) may elect, if eligible, to receive VenDex therapy after documented disease progression per International Myeloma Working Group (IMWG) criteria.

Study arms:
- Experimental: Arm 1 VenDex
Venetoclax administered orally once daily (QD) plus dexamethasone administered orally once every week (Q1W) for each 28-day cycle.
Interventions:
Drug: Dexamethasone
Drug: Venetoclax

- Active Comparator: Arm 2 PomDex
Pomalidomide administered orally once daily (QD) on Days 1 - 21 for each 28-day cycle plus dexamethasone administered orally once every week (Q1W) for each 28-day cycle.
Subjects randomized to this arm may elect, if eligible, to receive VenDex therapy (venetoclax administered orally QD plus dexamethasone administered orally Q1W for each 28-day cycle) after documented disease progression per IMWG criteria.
Interventions:
Drug: Pomalidomide
Drug: Dexamethasone
Drug: Venetoclax

Current primary outcome:
Progression-Free Survival (PFS) [ Time Frame: Up to approximately 28 months from first randomization ]
PFS is defined as the time in days from subject randomization to the date of the first documented progressive disease (PD) or death due to any cause, whichever occurs first.

Current secondary outcomes:
- Very Good Partial Response or Better Response Rate (VGPR) [ Time Frame: Up to approximately 28 months from first randomization ]
VGPR or better response rate is defined as the proportion of participants with documented stringent complete response (sCR), complete response (CR), or VGPR.
- Overall Response Rate (ORR) [ Time Frame: Up to approximately 28 months from first randomization ]
ORR is defined as the proportion of participants with documented best response (sCR, CR, VGPR or partial response [PR]) prior to first documented PD.
- Overall survival (OS) [ Time Frame: Up to approximately 37 months from first randomization ]
OS is defined as the number of days from the date that the participant was randomized to the date of the participant's death.
- Duration of response (DOR) [ Time Frame: Up to approximately 28 months from first randomization ]
DOR for a participant is defined as the number of days from the date of first documented response (PR or better) to the date of first documented PD or death due to multiple myeloma, whichever occurs first.
- Time to Disease Progression (TTP) [ Time Frame: Up to approximately 28 months from first randomization ]
TTP for a participant is defined as the number of days from the date of randomization to the date of first documented PD or death due to multiple myeloma, whichever occurs first.
- Time to Response (TTR) [ Time Frame: Up to approximately 28 months from first randomization ]
TTR for a participant is defined as the number of days from the date of randomization to the date of first documented response (PR or better).
- Minimal Residual Disease (MRD) Negativity Rate [ Time Frame: Up to approximately 28 months from first randomization ]
MRD defined as the proportion of participants with MRD negativity status. MRD negativity will be defined at 10^-5 threshold as measured by centralized testing of bone marrow aspirate samples by next generation sequencing (NGS).
- Cmax of Venetoclax [ Time Frame: Up to approximately 225 days from initial dose ]
Maximum plasma concentration (Cmax) of venetoclax
- Trough Concentration (Ctrough) of Venetoclax [ Time Frame: Up to approximately 225 days from initial dose ]
Observed plasma concentration at trough (Ctrough) of venetoclax.
- Change from Baseline in PROMIS Fatigue Score. [ Time Frame: Up to approximately 28 months from first randomization ]
Change from baseline in the Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue Short Form 7a score.
- Change from Baseline in BPI-SF Worst Pain Score [ Time Frame: Up to approximately 28 months from first randomization ]
Change from baseline in the Brief Pain Inventory - Short Form (BPI-SF) worst pain score.
- Change from Baseline in EORTC QLQ-30 Physical Functioning Score [ Time Frame: Up to approximately 28 months from first randomization ]
Change from baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Core 30 Question Questionnaire (EORTC-QLQ-C30) Physical Functioning Score.
- Change from Baseline in EORTC QLQ-30 Global Health Status/Quality of Life Score [ Time Frame: Up to approximately 28 months from first randomization ]
Change from baseline in EORTC QLQ-30 Global Health Status/Quality of Life Score

Phase : III

Stade : NA

3, 4, X
Informations libres de droit
Critères d'inclusion
Critères de non-inclusion
Informations libres de droit
Critères d'inclusion et de non-inclusion
Critères d'inclusion : - 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 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.

Critères de non-inclusion : - 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 meningeal involvement of MM.
- Concurrent conditions as listed in the protocol.
NCT
Promoteur
Coordonnateur
Informations relatives au promoteur
NCT :
NCT03539744
Promoteur :
ABBVIE
Type de sponsor : Industriel
ABBVIE
00000 HORS FRANCE

Coordonnateur :
Centre investigateur
Investigateur
TEC / ARC / IDE
État
MÀJ
Informations relatives aux investigateurs
Centre investigateur :
Centre Hospitalier Universitaire de Lille - 2 Avenue Oscar Lambret - 59000 LILLE

Investigateur :
Docteur Salomon Manier

TEC / ARC / IDE :
Secrétariat de recherche
fanny.miquel@
chru-lille.fr
03.20.44.57.13

Ouverture de l'essai : OUVERT

MAJ : 22/07/2019