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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
Date last updated
19/07/2024

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.
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
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United States of America
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California
Country [3] 0 0
United States of America
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Colorado
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Florida
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Kentucky
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Maryland
Country [7] 0 0
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Massachusetts
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Michigan
Country [9] 0 0
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Minnesota
Country [10] 0 0
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New York
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Ohio
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Pennsylvania
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Texas
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Utah
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United States of America
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Washington
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Canada
State/province [16] 0 0
Alberta
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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
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Quebec
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China
State/province [20] 0 0
Beijing
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China
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Guangdong
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China
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Henan
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China
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Hubei
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China
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Jiangsu
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China
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Jiangxi
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China
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Liaoning
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China
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Shanghai
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China
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Sichuan
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China
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Tianjin
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China
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Zhejiang
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Czechia
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Brno
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Czechia
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Hradec Kralove
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Czechia
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Olomouc
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Ostrava
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Czechia
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Praha
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Hovedstaden
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Roskilde
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France
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Ile-de-France
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France
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Isere
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France
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Marne
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France
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Meurthe-et-Moselle
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France
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Nord
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France
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Paris
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France
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Pays-de-la-Loire
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France
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Rhone
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France
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Vaucluse
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France
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Rouen
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Germany
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Baden-Wuerttemberg
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Germany
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Schleswig-Holstein
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Germany
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Thueringen
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Germany
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Berlin
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Germany
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Chemnitz
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Germany
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Hamburg
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Germany
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Wuerzburg
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Greece
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Attiki
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Kriti
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Athens
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Patras
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Greece
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Thessaloniki
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H_efa
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Israel
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HaDarom
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Tel-Aviv
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Yerushalayim
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Israel
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Haifa
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Italy
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Ancona
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Italy
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Piemonte
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Italy
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Potenza
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Italy
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Bologna
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Italy
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Milan
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Italy
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Palermo
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Italy
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Terni
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Japan
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Aichi
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Chiba
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Fukuoka
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Gifu
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Gunma
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Hiroshima
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Hyogo
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Japan
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Ibaraki
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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
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Japan
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Tokyo
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Japan
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Yamagata
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Korea, Republic of
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Gyeonggido
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Korea, Republic of
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Seoul Teugbyeolsi
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Korea, Republic of
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Ulsan Gwang Yeogsi
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Korea, Republic of
State/province [92] 0 0
Seoul
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Russian Federation
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Moskva
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Russian Federation
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Novosibirskaya Oblast
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Russian Federation
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Stavropol Skiy Kray
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Russian Federation
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Moscow
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Russian Federation
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Saint Petersburg
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Russian Federation
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Sankt-Peterburg
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Russian Federation
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Tula
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Singapore
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Singapore
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Spain
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Illes Balears
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Spain
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Malaga
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Spain
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Ourense
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Spain
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Santa Cruz De Tenerife
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Spain
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Barcelona
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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
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Spain
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Toledo
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Spain
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Valencia
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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
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Turkey
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Izmir
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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
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London
Country [131] 0 0
United Kingdom
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Manchester
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United Kingdom
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Portsmouth
Country [133] 0 0
United Kingdom
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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
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.
Trial website
https://clinicaltrials.gov/study/NCT03539744
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT03539744