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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT03539744
Registration number
NCT03539744
Ethics application status
Date submitted
17/05/2018
Date registered
29/05/2018
Date last updated
24/05/2024
Titles & IDs
Public title
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.
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Scientific 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
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Secondary ID [1]
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2017-003838-88
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Secondary ID [2]
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M13-494
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Multiple Myeloma
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Condition category
Condition code
Cancer
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Other cancer types
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Intervention/exposure
Study type
Interventional(has expanded access)
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Description of intervention(s) / exposure
Treatment: Drugs - Pomalidomide
Treatment: Drugs - Dexamethasone
Treatment: Drugs - Venetoclax
Experimental: Arm 1 VenDex - Venetoclax administered orally once daily (QD) plus dexamethasone administered orally once every week (Q1W) for each 28-day cycle.
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.
Treatment: Drugs: Pomalidomide
capsule, oral
Treatment: Drugs: Dexamethasone
oral, locally available form
Treatment: Drugs: Venetoclax
tablet; oral
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Progression-Free Survival (PFS)
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Assessment method [1]
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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.
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Timepoint [1]
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Up to approximately 43 months from first randomization
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Secondary outcome [1]
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Overall Response Rate (ORR)
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Assessment method [1]
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ORR is defined as the percentage of participants with documented best response (sCR, CR, VGPR or partial response [PR]) prior to first documented PD.
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Timepoint [1]
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Up to approximately 43 months from first randomization
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Secondary outcome [2]
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Very Good Partial Response or Better Response Rate (VGPR)
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Assessment method [2]
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VGPR or better response rate is defined as the proportion of participants with documented stringent complete response (sCR), complete response (CR), or VGPR.
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Timepoint [2]
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Up to approximately 43 months from first randomization
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Secondary outcome [3]
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Overall survival (OS)
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Assessment method [3]
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OS is defined as the number of days from the date that the participant was randomized to the date of the participant's death.
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Timepoint [3]
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Up to approximately 51 months from first randomization
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Secondary outcome [4]
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Minimal Residual Disease (MRD) Negativity Rate
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Assessment method [4]
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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).
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Timepoint [4]
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Up to approximately 43 months from first randomization
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Secondary outcome [5]
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Time to Deterioration in Disease Symptoms
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Assessment method [5]
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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).
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Timepoint [5]
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Up to approximately 51 months from first randomization
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Secondary outcome [6]
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Time to Deterioration in Physical Functioning
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Assessment method [6]
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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).
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Timepoint [6]
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Up to approximately 51 months from first randomization
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Secondary outcome [7]
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Change from Baseline in PROMIS Fatigue Score
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Assessment method [7]
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Change from baseline in the Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue Short Form 7a score.
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Timepoint [7]
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Up to approximately 51 months from first randomization
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Secondary outcome [8]
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Change from Baseline in BPI-SF Worst Pain Score
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Assessment method [8]
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Change from baseline in the Brief Pain Inventory - Short Form (BPI-SF) worst pain score.
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Timepoint [8]
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Up to approximately 51 months from first randomization
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Secondary outcome [9]
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Change from Baseline in EuroQoL 5 Dimension 5 Level (EQ-5D-5L)
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Assessment method [9]
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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."
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Timepoint [9]
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Up to approximately 51 months from first randomization
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Secondary outcome [10]
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Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
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Assessment method [10]
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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).
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Timepoint [10]
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Up to approximately 51 months from first randomization
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Secondary outcome [11]
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Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Multiple Myeloma Module 20 (EORTC QLQ-MY20)
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Assessment method [11]
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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.
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Timepoint [11]
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Up to approximately 51 months from first randomization
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Secondary outcome [12]
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Duration of response (DOR)
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Assessment method [12]
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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.
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Timepoint [12]
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Up to approximately 43 months from first randomization
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Secondary outcome [13]
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Time to Disease Progression (TTP)
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Assessment method [13]
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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.
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Timepoint [13]
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Up to approximately 43 months from first randomization
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Secondary outcome [14]
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Time to Response (TTR)
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Assessment method [14]
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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).
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Timepoint [14]
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Up to approximately 43 months from first randomization
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Secondary outcome [15]
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Cmax of Venetoclax
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Assessment method [15]
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Maximum plasma concentration (Cmax) of venetoclax
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Timepoint [15]
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Up to approximately 225 days from initial dose
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Secondary outcome [16]
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Trough Concentration (Ctrough) of Venetoclax
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Assessment method [16]
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Observed plasma concentration at trough (Ctrough) of venetoclax.
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Timepoint [16]
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Up to approximately 225 days from initial dose
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Secondary outcome [17]
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Number of Participants With Adverse Events (AEs)
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Assessment method [17]
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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.
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Timepoint [17]
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Up to approximately 51 months from first randomization
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Eligibility
Key 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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
22/10/2018
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
17/08/2026
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Actual
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Sample size
Target
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Accrual to date
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Final
265
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,WA
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Recruitment hospital [1]
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Liverpool Hospital /ID# 202431 - Liverpool
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Recruitment hospital [2]
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Sydney Adventist Hospital /ID# 222874 - Wahroonga
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Recruitment hospital [3]
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Wollongong Hospital /ID# 205545 - Wollongong
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Recruitment hospital [4]
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ICON Cancer Care - Townsville /ID# 206565 - Hyde Park
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Recruitment hospital [5]
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Icon Cancer Centre /ID# 205663 - South Brisbane
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Recruitment hospital [6]
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The Queen Elizabeth Hospital /ID# 202432 - Woodville South
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Recruitment hospital [7]
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Perth Blood Institute Ltd /ID# 206649 - Nedlands
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Recruitment postcode(s) [1]
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2170 - Liverpool
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Recruitment postcode(s) [2]
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2076 - Wahroonga
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Recruitment postcode(s) [3]
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2500 - Wollongong
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Recruitment postcode(s) [4]
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4812 - Hyde Park
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Recruitment postcode(s) [5]
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4101 - South Brisbane
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Recruitment postcode(s) [6]
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5011 - Woodville South
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Recruitment postcode(s) [7]
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6009 - Nedlands
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Recruitment outside Australia
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Ulsan Gwang Yeogsi
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Country [91]
0
0
Korea, Republic of
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State/province [91]
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0
Seoul
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Country [92]
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0
Russian Federation
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State/province [92]
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0
Moskva
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Country [93]
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0
Russian Federation
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State/province [93]
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0
Novosibirskaya Oblast
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Country [94]
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Russian Federation
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State/province [94]
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0
Stavropol Skiy Kray
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Country [95]
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0
Russian Federation
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State/province [95]
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0
Moscow
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Country [96]
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0
Russian Federation
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State/province [96]
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Saint Petersburg
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Country [97]
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Russian Federation
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Sankt-Peterburg
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Country [98]
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Russian Federation
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Tula
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Country [99]
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Singapore
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Singapore
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Country [100]
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0
Spain
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Illes Balears
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Country [101]
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0
Spain
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State/province [101]
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Malaga
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Country [102]
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0
Spain
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State/province [102]
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Ourense
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Country [103]
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Spain
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State/province [103]
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Santa Cruz De Tenerife
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Country [104]
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0
Spain
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State/province [104]
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Barcelona
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Country [105]
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Spain
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State/province [105]
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Girona
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Country [106]
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Spain
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State/province [106]
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Leon
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Country [107]
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0
Spain
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State/province [107]
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Madrid
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Country [108]
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Spain
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State/province [108]
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Salamanca
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Country [109]
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Spain
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State/province [109]
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Sevilla
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Country [110]
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Spain
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State/province [110]
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Toledo
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Country [111]
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Spain
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State/province [111]
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Valencia
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Country [112]
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Sweden
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State/province [112]
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Norrbottens Lan
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Country [113]
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Sweden
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State/province [113]
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Vastra Gotalands Lan
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Country [114]
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Turkey
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State/province [114]
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Adana
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Country [115]
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Turkey
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State/province [115]
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Izmir
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Country [116]
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0
Turkey
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State/province [116]
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Ankara
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Country [117]
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Turkey
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State/province [117]
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Istanbul
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Country [118]
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Ukraine
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State/province [118]
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Cherkasy
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Country [119]
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Ukraine
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State/province [119]
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Kharkiv
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Country [120]
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Ukraine
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State/province [120]
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Khmelnytskyi
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Country [121]
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Ukraine
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State/province [121]
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Kyiv
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Country [122]
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Ukraine
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State/province [122]
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Lviv
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Country [123]
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United Kingdom
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State/province [123]
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Cambridgeshire
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Country [124]
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United Kingdom
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State/province [124]
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London, City Of
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Country [125]
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United Kingdom
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State/province [125]
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Norfolk
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Country [126]
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United Kingdom
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State/province [126]
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Nottinghamshire
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Country [127]
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United Kingdom
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State/province [127]
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Scotland
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Country [128]
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United Kingdom
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State/province [128]
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Staffordshire
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Country [129]
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United Kingdom
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State/province [129]
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London
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Country [130]
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United Kingdom
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Manchester
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Country [131]
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United Kingdom
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State/province [131]
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Portsmouth
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Country [132]
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United Kingdom
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State/province [132]
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Reading
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Country [133]
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United Kingdom
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State/province [133]
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Sheffield
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
AbbVie
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Address
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Other collaborator category [1]
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0
Commercial sector/Industry
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Name [1]
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Roche-Genentech
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Ethics approval
Ethics application status
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Summary
Brief summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03539744
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Public notes
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Contacts
Principal investigator
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ABBVIE INC.
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AbbVie
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03539744
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