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NCT Number: NCT03539744

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.

A study designed tocompare progression-free survival (PFS) in participants with t(11;14)-positive MM treated with venetoclax in combination with dexamethasone versus pomalidomide in combination with dexamethasone.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Liverpool Hospital /ID# 202431, Liverpool, New South Wales, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Documented diagnosis of multiple myeloma (MM) based on standard International Myeloma Working Group (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 relapsed/refractory to lenalidomide, as defined per protocol.
  • Has received at least 2 consecutive cycles of a proteasome inhibitor (PI).
  • Has t(11;14)-positive status determined by an analytically validated fluorescent in situ hybridization (FISH) assay per centralized laboratory testing.
  • 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 central nervous system involvement of MM.
  • Concurrent conditions as listed in the protocol.

Treatment and study plan

Pomalidomide

Drug

capsule, oral

Other names: Pomalyst

Dexamethasone

Drug

oral, locally available form

Venetoclax

Drug

tablet; oral

Other names: ABT-199, GDC-0199

Primary outcomes

  1. Progression-Free Survival (PFS)

    Time frame: Up to approximately 43 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 outcomes

  1. Overall Response Rate (ORR)

    Time frame: Up to approximately 43 months from first randomization

    ORR is defined as the percentage of participants with documented best response (sCR, CR, VGPR or partial response [PR]) prior to first documented PD.

  2. Very Good Partial Response or Better Response Rate (VGPR)

    Time frame: Up to approximately 43 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.

  3. Overall survival (OS)

    Time frame: Up to approximately 51 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. Minimal Residual Disease (MRD) Negativity Rate

    Time frame: Up to approximately 43 months from first randomization

    MRD defined as the percentage 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).

  5. Time to Deterioration in Disease Symptoms

    Time frame: Up to approximately 51 months from first randomization

    Time to deterioration in disease symptoms is measured by the disease symptom domain of the European Organization for Research and Treatment of Cancer Quality of Life Multiple Myeloma Module 20 (EORTC QLQ-MY20).

  6. Time to Deterioration in Physical Functioning

    Time frame: Up to approximately 51 months from first randomization

    Time to deterioration in physical functioning is measured by the physical functioning domain of European Organization for Research and Treatment of Cancer Quality of Life Core 30 Question Questionnaire (EORTC-QLQ-C30).

  7. Change from Baseline in PROMIS Fatigue Score

    Time frame: Up to approximately 51 months from first randomization

    Change from baseline in the Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue Short Form 7a score.

  8. Change from Baseline in BPI-SF Worst Pain Score

    Time frame: Up to approximately 51 months from first randomization

    Change from baseline in the Brief Pain Inventory - Short Form (BPI-SF) worst pain score.

  9. Change from Baseline in EuroQoL 5 Dimension 5 Level (EQ-5D-5L)

    Time frame: Up to approximately 51 months from first randomization

    EQ-5D-5L consists of 2 components: the EQ-5D descriptive system and the EQ visual analog scale (VAS). The EQ-5D descriptive system comprises 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The EQ VAS records the participant's self-rated health on a vertical VAS where the endpoints are labelled "The best health you can imagine" and "The worst health you can imagine."

  10. Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)

    Time frame: Up to approximately 51 months from first randomization

    EORTC QLQ-C30 is a 30-item subject self-report questionnaire composed of both multi-item and single scales, including 5 functional scales (physical, role, emotional, social, and cognitive), 3 symptom scales (fatigue, nausea and vomiting, and pain), a global health status/quality of life scale, and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties).

  11. Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Multiple Myeloma Module 20 (EORTC QLQ-MY20)

    Time frame: Up to approximately 51 months from first randomization

    EORTC QLQ-MY20 includes scales for disease symptoms, side effects of treatment, future perspective, and body image. Values for each scale range from 0 to 100.

  12. Duration of response (DOR)

    Time frame: Up to approximately 43 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.

  13. Time to Disease Progression (TTP)

    Time frame: Up to approximately 43 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.

  14. Time to Response (TTR)

    Time frame: Up to approximately 43 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).

  15. Cmax of Venetoclax

    Time frame: Up to approximately 225 days from initial dose

    Maximum plasma concentration (Cmax) of venetoclax

  16. Trough Concentration (Ctrough) of Venetoclax

    Time frame: Up to approximately 225 days from initial dose

    Observed plasma concentration at trough (Ctrough) of venetoclax.

  17. Number of Participants With Adverse Events (AEs)

    Time frame: Up to approximately 51 months from first randomization

    An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study.

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Collaborators

  • Roche-Genentech

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2026
Study completion
2027
First posted
May 29, 2018
Registry last updated
Jun 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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