Clinical Trials /

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

NCT03539744

Description:

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.

Related Conditions:
  • Multiple Myeloma
Recruiting Status:

Recruiting

Phase:

Phase 3

Trial Eligibility

Document

Title

  • Brief Title: A Study of Venetoclax and Dexamethasone Compared With Pomalidomide and Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma
  • 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

Clinical Trial IDs

  • ORG STUDY ID: M13-494
  • SECONDARY ID: 2017-003838-88
  • NCT ID: NCT03539744

Conditions

  • Multiple Myeloma

Interventions

DrugSynonymsArms
PomalidomidePomalystArm 2 PomDex
DexamethasoneArm 1 VenDex
VenetoclaxABT-199, GDC-0199Arm 1 VenDex

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
Arm 1 VenDexExperimentalVenetoclax administered orally once daily (QD) plus dexamethasone administered orally once every week (Q1W) for each 28-day cycle.
  • Dexamethasone
  • Venetoclax
Arm 2 PomDexActive ComparatorPomalidomide 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.
  • Pomalidomide
  • Dexamethasone
  • Venetoclax

Eligibility 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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Progression-Free Survival (PFS)
Time Frame:Up to approximately 28 months from first randomization
Safety Issue:
Description: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

Measure:Very Good Partial Response or Better Response Rate (VGPR)
Time Frame:Up to approximately 28 months from first randomization
Safety Issue:
Description:VGPR or better response rate is defined as the proportion of participants with documented stringent complete response (sCR), complete response (CR), or VGPR.
Measure:Overall Response Rate (ORR)
Time Frame:Up to approximately 28 months from first randomization
Safety Issue:
Description:ORR is defined as the proportion of participants with documented best response (sCR, CR, VGPR or partial response [PR]) prior to first documented PD.
Measure:Overall survival (OS)
Time Frame:Up to approximately 37 months from first randomization
Safety Issue:
Description:OS is defined as the number of days from the date that the participant was randomized to the date of the participant's death.
Measure:Duration of response (DOR)
Time Frame:Up to approximately 28 months from first randomization
Safety Issue:
Description: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.
Measure:Time to Disease Progression (TTP)
Time Frame:Up to approximately 28 months from first randomization
Safety Issue:
Description: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.
Measure:Time to Response (TTR)
Time Frame:Up to approximately 28 months from first randomization
Safety Issue:
Description: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).
Measure:Minimal Residual Disease (MRD) Negativity Rate
Time Frame:Up to approximately 28 months from first randomization
Safety Issue:
Description: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).
Measure:Cmax of Venetoclax
Time Frame:Up to approximately 225 days from initial dose
Safety Issue:
Description:Maximum plasma concentration (Cmax) of venetoclax
Measure:Trough Concentration (Ctrough) of Venetoclax
Time Frame:Up to approximately 225 days from initial dose
Safety Issue:
Description:Observed plasma concentration at trough (Ctrough) of venetoclax.
Measure:Change from Baseline in PROMIS Fatigue Score.
Time Frame:Up to approximately 28 months from first randomization
Safety Issue:
Description:Change from baseline in the Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue Short Form 7a score.
Measure:Change from Baseline in BPI-SF Worst Pain Score
Time Frame:Up to approximately 28 months from first randomization
Safety Issue:
Description:Change from baseline in the Brief Pain Inventory - Short Form (BPI-SF) worst pain score.
Measure:Change from Baseline in EORTC QLQ-30 Physical Functioning Score
Time Frame:Up to approximately 28 months from first randomization
Safety Issue:
Description: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.
Measure:Change from Baseline in EORTC QLQ-30 Global Health Status/Quality of Life Score
Time Frame:Up to approximately 28 months from first randomization
Safety Issue:
Description:Change from baseline in EORTC QLQ-30 Global Health Status/Quality of Life Score

Details

Phase:Phase 3
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:AbbVie

Trial Keywords

  • Cancer
  • Multiple Myeloma (MM)
  • Relapsed or Refractory Multiple Myeloma (R/R MM)
  • pharmacokinetics

Last Updated

March 24, 2020