Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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 28, 2018
Last Update Posted : November 13, 2019
Sponsor:
Information provided by (Responsible Party):
AbbVie

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.

Condition or disease Intervention/treatment Phase
Multiple Myeloma Drug: Pomalidomide Drug: Dexamethasone Drug: Venetoclax Phase 3

Expanded Access : An investigational treatment associated with this study is available outside the clinical trial.   More info ...

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 244 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : October 22, 2018
Estimated Primary Completion Date : January 12, 2021
Estimated Study Completion Date : July 7, 2022


Arm Intervention/treatment
Experimental: Arm 1 VenDex
Venetoclax administered orally once daily (QD) plus dexamethasone administered orally once every week (Q1W) for each 28-day cycle.
Drug: Dexamethasone
oral, locally available form

Drug: Venetoclax
tablet; oral
Other Names:
  • ABT-199
  • GDC-0199

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.
Drug: Pomalidomide
capsule, oral
Other Name: Pomalyst

Drug: Dexamethasone
oral, locally available form

Drug: Venetoclax
tablet; oral
Other Names:
  • ABT-199
  • GDC-0199




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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).

  7. 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).

  8. Cmax of Venetoclax [ Time Frame: Up to approximately 225 days from initial dose ]
    Maximum plasma concentration (Cmax) of venetoclax

  9. Trough Concentration (Ctrough) of Venetoclax [ Time Frame: Up to approximately 225 days from initial dose ]
    Observed plasma concentration at trough (Ctrough) of venetoclax.

  10. 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.

  11. 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.

  12. 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.

  13. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03539744


Contacts
Layout table for location contacts
Contact: ABBVIE CALL CENTER 847.283.8955 abbvieclinicaltrials@abbvie.com

  Show 105 Study Locations
Sponsors and Collaborators
AbbVie
Investigators
Layout table for investigator information
Study Director: AbbVie Inc. AbbVie

Layout table for additonal information
Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT03539744     History of Changes
Other Study ID Numbers: M13-494
2017-003838-88 ( EudraCT Number )
First Posted: May 28, 2018    Key Record Dates
Last Update Posted: November 13, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
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
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
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

Layout table for additional information
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
Keywords provided by AbbVie:
Cancer
Multiple Myeloma (MM)
Relapsed or Refractory Multiple Myeloma (R/R MM)
pharmacokinetics
Additional relevant MeSH terms:
Layout table for MeSH terms
Venetoclax
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Thalidomide
Dexamethasone
Dexamethasone acetate
Pomalidomide
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal