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A Study of Venetoclax and Dexamethasone Compared With Pomalidomide and Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma (CANOVA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03539744
Recruitment Status : Recruiting
First Posted : May 29, 2018
Last Update Posted : March 26, 2020
Sponsor:
Information provided by (Responsible Party):
AbbVie

Tracking Information
First Submitted Date  ICMJE May 17, 2018
First Posted Date  ICMJE May 29, 2018
Last Update Posted Date March 26, 2020
Actual Study Start Date  ICMJE October 22, 2018
Estimated Primary Completion Date January 12, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 17, 2018)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 17, 2018)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Venetoclax and Dexamethasone Compared With Pomalidomide and Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Multiple Myeloma
Intervention  ICMJE
  • Drug: Pomalidomide
    capsule, oral
    Other Name: Pomalyst
  • Drug: Dexamethasone
    oral, locally available form
  • Drug: Venetoclax
    tablet; oral
    Other Names:
    • ABT-199
    • GDC-0199
Study Arms  ICMJE
  • 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.
    Interventions:
    • Drug: Pomalidomide
    • Drug: Dexamethasone
    • Drug: Venetoclax
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 17, 2018)
244
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 7, 2022
Estimated Primary Completion Date January 12, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: ABBVIE CALL CENTER 847.283.8955 abbvieclinicaltrials@abbvie.com
Listed Location Countries  ICMJE Australia,   China,   Czechia,   France,   Germany,   Greece,   Israel,   Italy,   Japan,   Korea, Republic of,   Russian Federation,   Singapore,   Spain,   Sweden,   Turkey,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03539744
Other Study ID Numbers  ICMJE M13-494
2017-003838-88 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Clinical Study Report (CSR)
Supporting Materials: Analytic Code
Time Frame: Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
Access Criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.
URL: https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html
Responsible Party AbbVie
Study Sponsor  ICMJE AbbVie
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: AbbVie Inc. AbbVie
PRS Account AbbVie
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP