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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03539744




Registration number
NCT03539744
Ethics application status
Date submitted
17/05/2018
Date registered
29/05/2018

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.
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
Secondary ID [1] 0 0
2023-506112-40
Secondary ID [2] 0 0
M13-494
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Multiple Myeloma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Other cancer types

Intervention/exposure
Study type
Interventional(has expanded access)
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression-Free Survival (PFS)
Timepoint [1] 0 0
Up to approximately 43 months from first randomization
Secondary outcome [1] 0 0
Overall Response Rate (ORR)
Timepoint [1] 0 0
Up to approximately 43 months from first randomization
Secondary outcome [2] 0 0
Very Good Partial Response or Better Response Rate (VGPR)
Timepoint [2] 0 0
Up to approximately 43 months from first randomization
Secondary outcome [3] 0 0
Overall survival (OS)
Timepoint [3] 0 0
Up to approximately 51 months from first randomization
Secondary outcome [4] 0 0
Minimal Residual Disease (MRD) Negativity Rate
Timepoint [4] 0 0
Up to approximately 43 months from first randomization
Secondary outcome [5] 0 0
Time to Deterioration in Disease Symptoms
Timepoint [5] 0 0
Up to approximately 51 months from first randomization
Secondary outcome [6] 0 0
Time to Deterioration in Physical Functioning
Timepoint [6] 0 0
Up to approximately 51 months from first randomization
Secondary outcome [7] 0 0
Change from Baseline in PROMIS Fatigue Score
Timepoint [7] 0 0
Up to approximately 51 months from first randomization
Secondary outcome [8] 0 0
Change from Baseline in BPI-SF Worst Pain Score
Timepoint [8] 0 0
Up to approximately 51 months from first randomization
Secondary outcome [9] 0 0
Change from Baseline in EuroQoL 5 Dimension 5 Level (EQ-5D-5L)
Timepoint [9] 0 0
Up to approximately 51 months from first randomization
Secondary outcome [10] 0 0
Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
Timepoint [10] 0 0
Up to approximately 51 months from first randomization
Secondary outcome [11] 0 0
Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Multiple Myeloma Module 20 (EORTC QLQ-MY20)
Timepoint [11] 0 0
Up to approximately 51 months from first randomization
Secondary outcome [12] 0 0
Duration of response (DOR)
Timepoint [12] 0 0
Up to approximately 43 months from first randomization
Secondary outcome [13] 0 0
Time to Disease Progression (TTP)
Timepoint [13] 0 0
Up to approximately 43 months from first randomization
Secondary outcome [14] 0 0
Time to Response (TTR)
Timepoint [14] 0 0
Up to approximately 43 months from first randomization
Secondary outcome [15] 0 0
Cmax of Venetoclax
Timepoint [15] 0 0
Up to approximately 225 days from initial dose
Secondary outcome [16] 0 0
Trough Concentration (Ctrough) of Venetoclax
Timepoint [16] 0 0
Up to approximately 225 days from initial dose
Secondary outcome [17] 0 0
Number of Participants With Adverse Events (AEs)
Timepoint [17] 0 0
Up to approximately 51 months from first randomization

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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
22/10/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
17/08/2026
Actual
Sample size
Target
Accrual to date
Final
265
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,WA
Recruitment hospital [1] 0 0
Liverpool Hospital /ID# 202431 - Liverpool
Recruitment hospital [2] 0 0
Sydney Adventist Hospital /ID# 222874 - Wahroonga
Recruitment hospital [3] 0 0
Wollongong Hospital /ID# 205545 - Wollongong
Recruitment hospital [4] 0 0
ICON Cancer Care - Townsville /ID# 206565 - Hyde Park
Recruitment hospital [5] 0 0
Icon Cancer Centre /ID# 205663 - South Brisbane
Recruitment hospital [6] 0 0
The Queen Elizabeth Hospital /ID# 202432 - Woodville South
Recruitment hospital [7] 0 0
Perth Blood Institute Ltd /ID# 206649 - Nedlands
Recruitment postcode(s) [1] 0 0
2170 - Liverpool
Recruitment postcode(s) [2] 0 0
2076 - Wahroonga
Recruitment postcode(s) [3] 0 0
2500 - Wollongong
Recruitment postcode(s) [4] 0 0
4812 - Hyde Park
Recruitment postcode(s) [5] 0 0
4101 - South Brisbane
Recruitment postcode(s) [6] 0 0
5011 - Woodville South
Recruitment postcode(s) [7] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Kentucky
Country [6] 0 0
United States of America
State/province [6] 0 0
Maryland
Country [7] 0 0
United States of America
State/province [7] 0 0
Massachusetts
Country [8] 0 0
United States of America
State/province [8] 0 0
Michigan
Country [9] 0 0
United States of America
State/province [9] 0 0
Minnesota
Country [10] 0 0
United States of America
State/province [10] 0 0
New York
Country [11] 0 0
United States of America
State/province [11] 0 0
Ohio
Country [12] 0 0
United States of America
State/province [12] 0 0
Pennsylvania
Country [13] 0 0
United States of America
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Texas
Country [14] 0 0
United States of America
State/province [14] 0 0
Utah
Country [15] 0 0
United States of America
State/province [15] 0 0
Washington
Country [16] 0 0
Canada
State/province [16] 0 0
Alberta
Country [17] 0 0
Canada
State/province [17] 0 0
British Columbia
Country [18] 0 0
Canada
State/province [18] 0 0
Nova Scotia
Country [19] 0 0
Canada
State/province [19] 0 0
Quebec
Country [20] 0 0
China
State/province [20] 0 0
Beijing
Country [21] 0 0
China
State/province [21] 0 0
Guangdong
Country [22] 0 0
China
State/province [22] 0 0
Henan
Country [23] 0 0
China
State/province [23] 0 0
Hubei
Country [24] 0 0
China
State/province [24] 0 0
Jiangsu
Country [25] 0 0
China
State/province [25] 0 0
Jiangxi
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China
State/province [26] 0 0
Liaoning
Country [27] 0 0
China
State/province [27] 0 0
Shanghai
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China
State/province [28] 0 0
Sichuan
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China
State/province [29] 0 0
Tianjin
Country [30] 0 0
China
State/province [30] 0 0
Zhejiang
Country [31] 0 0
Czechia
State/province [31] 0 0
Brno
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Czechia
State/province [32] 0 0
Hradec Kralove
Country [33] 0 0
Czechia
State/province [33] 0 0
Olomouc
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Czechia
State/province [34] 0 0
Ostrava
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Czechia
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Praha
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Denmark
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Hovedstaden
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Denmark
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Nordjylland
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Denmark
State/province [38] 0 0
Syddanmark
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Denmark
State/province [39] 0 0
Roskilde
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France
State/province [40] 0 0
Ile-de-France
Country [41] 0 0
France
State/province [41] 0 0
Isere
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France
State/province [42] 0 0
Marne
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France
State/province [43] 0 0
Meurthe-et-Moselle
Country [44] 0 0
France
State/province [44] 0 0
Nord
Country [45] 0 0
France
State/province [45] 0 0
Paris
Country [46] 0 0
France
State/province [46] 0 0
Pays-de-la-Loire
Country [47] 0 0
France
State/province [47] 0 0
Rhone
Country [48] 0 0
France
State/province [48] 0 0
Vaucluse
Country [49] 0 0
France
State/province [49] 0 0
Rouen
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Germany
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Baden-Wuerttemberg
Country [51] 0 0
Germany
State/province [51] 0 0
Schleswig-Holstein
Country [52] 0 0
Germany
State/province [52] 0 0
Thueringen
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Germany
State/province [53] 0 0
Berlin
Country [54] 0 0
Germany
State/province [54] 0 0
Chemnitz
Country [55] 0 0
Germany
State/province [55] 0 0
Hamburg
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Germany
State/province [56] 0 0
Wuerzburg
Country [57] 0 0
Greece
State/province [57] 0 0
Attiki
Country [58] 0 0
Greece
State/province [58] 0 0
Kriti
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Greece
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Athens
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Greece
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Patras
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Greece
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Thessaloniki
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Israel
State/province [62] 0 0
H_efa
Country [63] 0 0
Israel
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HaDarom
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Israel
State/province [64] 0 0
Tel-Aviv
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Israel
State/province [65] 0 0
Yerushalayim
Country [66] 0 0
Israel
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Haifa
Country [67] 0 0
Italy
State/province [67] 0 0
Ancona
Country [68] 0 0
Italy
State/province [68] 0 0
Piemonte
Country [69] 0 0
Italy
State/province [69] 0 0
Potenza
Country [70] 0 0
Italy
State/province [70] 0 0
Bologna
Country [71] 0 0
Italy
State/province [71] 0 0
Milan
Country [72] 0 0
Italy
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Palermo
Country [73] 0 0
Italy
State/province [73] 0 0
Terni
Country [74] 0 0
Japan
State/province [74] 0 0
Aichi
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Japan
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Chiba
Country [76] 0 0
Japan
State/province [76] 0 0
Fukuoka
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Gifu
Country [78] 0 0
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Gunma
Country [79] 0 0
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Hiroshima
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Japan
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Hyogo
Country [81] 0 0
Japan
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Ibaraki
Country [82] 0 0
Japan
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Iwate
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Japan
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Miyagi
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Japan
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Okayama
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Japan
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Osaka
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Japan
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Tokushima
Country [87] 0 0
Japan
State/province [87] 0 0
Tokyo
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Japan
State/province [88] 0 0
Yamagata
Country [89] 0 0
Korea, Republic of
State/province [89] 0 0
Gyeonggido
Country [90] 0 0
Korea, Republic of
State/province [90] 0 0
Seoul Teugbyeolsi
Country [91] 0 0
Korea, Republic of
State/province [91] 0 0
Ulsan Gwang Yeogsi
Country [92] 0 0
Korea, Republic of
State/province [92] 0 0
Seoul
Country [93] 0 0
Russian Federation
State/province [93] 0 0
Moskva
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Russian Federation
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Novosibirskaya Oblast
Country [95] 0 0
Russian Federation
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Stavropol Skiy Kray
Country [96] 0 0
Russian Federation
State/province [96] 0 0
Moscow
Country [97] 0 0
Russian Federation
State/province [97] 0 0
Saint Petersburg
Country [98] 0 0
Russian Federation
State/province [98] 0 0
Sankt-Peterburg
Country [99] 0 0
Russian Federation
State/province [99] 0 0
Tula
Country [100] 0 0
Singapore
State/province [100] 0 0
Singapore
Country [101] 0 0
Spain
State/province [101] 0 0
Illes Balears
Country [102] 0 0
Spain
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Malaga
Country [103] 0 0
Spain
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Ourense
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Spain
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Santa Cruz De Tenerife
Country [105] 0 0
Spain
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Barcelona
Country [106] 0 0
Spain
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Girona
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Spain
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Leon
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Spain
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Madrid
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Spain
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Salamanca
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Spain
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Sevilla
Country [111] 0 0
Spain
State/province [111] 0 0
Toledo
Country [112] 0 0
Spain
State/province [112] 0 0
Valencia
Country [113] 0 0
Sweden
State/province [113] 0 0
Norrbottens Lan
Country [114] 0 0
Sweden
State/province [114] 0 0
Vastra Gotalands Lan
Country [115] 0 0
Turkey
State/province [115] 0 0
Adana
Country [116] 0 0
Turkey
State/province [116] 0 0
Izmir
Country [117] 0 0
Turkey
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Ankara
Country [118] 0 0
Turkey
State/province [118] 0 0
Istanbul
Country [119] 0 0
Ukraine
State/province [119] 0 0
Cherkasy
Country [120] 0 0
Ukraine
State/province [120] 0 0
Kharkiv
Country [121] 0 0
Ukraine
State/province [121] 0 0
Khmelnytskyi
Country [122] 0 0
Ukraine
State/province [122] 0 0
Kyiv
Country [123] 0 0
Ukraine
State/province [123] 0 0
Lviv
Country [124] 0 0
United Kingdom
State/province [124] 0 0
Cambridgeshire
Country [125] 0 0
United Kingdom
State/province [125] 0 0
London, City Of
Country [126] 0 0
United Kingdom
State/province [126] 0 0
Norfolk
Country [127] 0 0
United Kingdom
State/province [127] 0 0
Nottinghamshire
Country [128] 0 0
United Kingdom
State/province [128] 0 0
Scotland
Country [129] 0 0
United Kingdom
State/province [129] 0 0
Staffordshire
Country [130] 0 0
United Kingdom
State/province [130] 0 0
London
Country [131] 0 0
United Kingdom
State/province [131] 0 0
Manchester
Country [132] 0 0
United Kingdom
State/province [132] 0 0
Portsmouth
Country [133] 0 0
United Kingdom
State/province [133] 0 0
Reading
Country [134] 0 0
United Kingdom
State/province [134] 0 0
Sheffield

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AbbVie
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Roche-Genentech
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
ABBVIE INC.
Address 0 0
AbbVie
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
When will data be available (start and end dates)?
For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
Available to whom?
To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://vivli.org/ourmember/abbvie/


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT03539744