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

Overview

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.

SparkCures ID 962
Trial Phase Phase 3
Enrollment 244 Patients
Treatments
Trial Sponsors
  • AbbVie
NCT Identifier

NCT03539744

Am I Eligible?

The following criteria is a partial list of reasons why patients may or may not be eligible to participate in this clinical trial. Further evaluation with a medical professional will be required to determine full eligibility.

The following criteria is provided for health care professionals.

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.

US Trial Locations

Accepting Patients

The following is a listing of trial locations that are open and accepting patients.

VA Central California Health

Fresno, CA

Norton Cancer Institute - St. Matthews Campus

Louisville, KY

Not Currently Accepting Patients

The following is a listing of trial locations that are not currently open and accepting patients.

Mayo Clinic (Jacksonville)

Jacksonville, FL

Cleveland Clinic Florida

Weston, FL

Henry Ford Hospital

Detroit, MI

Mayo Clinic (Rochester)

Rochester, MN

Utah Cancer Specialists - UCS Cancer Center

Salt Lake City, UT

California
VA Central California Health

Fresno, CA

Florida
Mayo Clinic (Jacksonville)

Jacksonville, FL

Cleveland Clinic Florida

Weston, FL

Kentucky
Norton Cancer Institute - St. Matthews Campus

Louisville, KY

Michigan
Henry Ford Hospital

Detroit, MI

Minnesota
Mayo Clinic (Rochester)

Rochester, MN

Ohio
Pennsylvania
Texas
Utah
Utah Cancer Specialists - UCS Cancer Center

Salt Lake City, UT

International Locations

This trial has active trial locations in countries outside of the United States.

Our system currently only provides clinical trial matching services for myeloma patients in the United States.

You can view this clinical trial's international locations by visiting ClinicalTrials.gov. Please note the information provided through the government website may be inaccurate and/or out-dated.

Resources