A Study of Combination Therapy With Venetoclax, Daratumumab and Dexamethasone (With and Without Bortezomib) in Subjects With Relapsed or Refractory Multiple Myeloma

Overview

This is a study of venetoclax, daratumumab, and dexamethasone with and without bortezomib combination therapy to evaluate safety, tolerability, and efficacy of these combinations in participants with relapsed or refractory multiple myeloma.

The study will consist of 2 distinct parts:

  • Part 1 includes participants with t(11;14) positive relapsed/refractory (R/R) multiple myeloma who will receive venetoclax in combination with daratumumab and dexamethasone (VenDd);

  • Part 2 includes participants with R/R multiple myeloma who will receive venetoclax in combination with daratumumab, bortezomib, and dexamethasone (VenDVd).

Each Part will be initiated with a dose-escalation phase. During the open-label, escalation phases, increasing doses of venetoclax with fixed doses of daratumumab and dexamethasone (Part 1a) or daratumumab, bortezomib, and dexamethasone (Part 2a) will be administered. The dose-escalation phases will be followed by either a randomized, and blinded (Part 1b) expansion phase or single-arm and open-label (Part 2b) expansion phase.

SparkCures ID 923
Trial Phase Phase 2
Enrollment 90 Patients
Treatments
Tags
Trial Sponsors
  • AbbVie
NCT Identifier

NCT03314181

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:

  • Eastern Cooperative Oncology Group (ECOG) performance status <= 2.
  • Participant has relapsed or refractory multiple myeloma with documented evidence of progression that occurred during or after the participant's last treatment regimen based on investigator's determination of International Myeloma Working Group (IMWG) criteria.
  • Measurable disease confirmed by central lab at Screening, defined by at least 1 of the following:
    • Serum M-protein >= 1.0 g/dL (>= 10 g/L), OR
    • Urine M-protein >= 200 mg/24 hours, OR
    • Serum free light chain (FLC) >= 10 mg/dL, provided serum FLC ratio is abnormal in participants who do not have measurable disease by Serum Protein Electrophoresis (SPEP) or Urine Protein Electrophoresis (UPEP) criteria.
  • Participant has received previous multiple myeloma treatment as defined in the protocol for Part 1 and Part 2 of this study.
  • Bone marrow aspirate samples have been collected.
  • To qualify for Part 1, the participant must be t(11;14) positive as determined by an analytically validated Fluorescent In Situ Hybridization (FISH) assay per central laboratory testing.
  • Participants must have adequate hematologic, renal and hepatic function.

Exclusion Criteria:

  • Previous treatment with venetoclax or other B-Cell Lymphoma 2 (BCL-2) inhibitor OR previous treatment with daratumumab or other anti-CD38 therapy.
  • For participants in Part 2:
    • Participant is refractory to any proteasome inhibitor, defined as progression on or within 60 days of the last dose of a proteasome inhibitor-containing regimen.
    • Participant has had prior treatment with proteasome inhibitor within 60 days prior to first dose of study drug.
  • Treatment with anti-myeloma chemotherapy, radiotherapy, biological, immunotherapy or an investigational therapy, including targeted small molecule agents within 2 weeks or 5 half-lives (whichever is longer and/or applicable) before first dose.
  • Treatment with anti-myeloma monoclonal antibodies within 6 weeks prior first dose.
  • Recent corticosteroid therapy at a cumulative dose equivalent to >= 140 mg of prednisone or a single dose equivalent to >= 40 mg/day of dexamethasone within 2 weeks prior the first dose of study drug.
  • Known meningeal involvement of multiple myeloma.
  • Significant history of medical conditions as listed in the protocol.

US Trial Locations

Not Currently Accepting Patients

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

Verified Winship Cancer Institute of Emory University -

SparkCures Verified Accurate, up-to-date information. Learn more


University of Colorado Cancer Center - Anschutz Cancer Pavilion

Aurora, CO

Carolinas Medical Center

Charlotte, NC

Seattle Cancer Care Alliance

Seattle, WA

Colorado
University of Colorado Cancer Center - Anschutz Cancer Pavilion

Aurora, CO

Florida
Georgia
Verified Winship Cancer Institute of Emory University -

SparkCures Verified Accurate, up-to-date information. Learn more

Illinois
Massachusetts
New York
North Carolina
Carolinas Medical Center

Charlotte, NC

Oregon
Washington
Seattle Cancer Care Alliance

Seattle, WA

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

There are no resources, links or videos to display for this clinical trial.