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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.

Primary Purpose

Multiple Myeloma

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Pomalidomide
Dexamethasone
Venetoclax
Sponsored by
AbbVie
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Myeloma focused on measuring Cancer, Multiple Myeloma (MM), Relapsed or Refractory Multiple Myeloma (R/R MM), pharmacokinetics, CANOVA

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 relapsed/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 central nervous system involvement of MM.
  • Concurrent conditions as listed in the protocol.

Sites / Locations

  • University of Arizona Cancer Center - North Campus /ID# 218407
  • VA Central California Health Care System /ID# 200047
  • University of California, Los Angeles /ID# 171524
  • Rocky Mountain Regional VA Medical Center/Eastern Colorado Health Care System /ID# 222904
  • Mayo Clinic /ID# 200075
  • Cleveland Clinic Florida /ID# 208884
  • Norton Cancer Institute /ID# 200834
  • University of Maryland School of Medicine /ID# 217422
  • Boston Medical Center /ID# 223606
  • Barbara Ann Karmanos Cancer In /ID# 201377
  • Henry Ford Hospital /ID# 171531
  • Mayo Clinic - Rochester /ID# 201091
  • Columbia University Medical Center /ID# 200715
  • Fairview Hospital - Moll Pavilion /ID# 208919
  • Cleveland Clinic Main Campus /ID# 202247
  • UPMC Hillman Cancer Ctr /ID# 200063
  • MD Anderson Cancer Center at Texas Medical Center /ID# 200060
  • Huntsman Cancer Institute /ID# 218406
  • VA Puget Sound Health Care System /ID# 222708
  • Liverpool Hospital /ID# 202431
  • Sydney Adventist Hospital /ID# 222874
  • Wollongong Hospital /ID# 205545
  • Icon Cancer Care - Townsville /ID# 206565
  • Icon Cancer Centre /ID# 205663
  • The Queen Elizabeth Hospital /ID# 202432
  • Perth Blood Institute Ltd /ID# 206649
  • Tom Baker Cancer Centre /ID# 218846
  • BC Cancer - Vancouver /ID# 222804
  • QE II Health Sciences Centre /ID# 218883
  • CISSS-CA (Centre Integre de sante et de services sociaux de Chaudiere-Appalache) /ID# 218887
  • Beijing Chaoyang Hospital,Capital Medical University /ID# 216014Recruiting
  • Peking University Third Hospital /ID# 216371Recruiting
  • Peking Union Medical College Hospital /ID# 216040Recruiting
  • Sun Yat-Sen University Cancer Center /ID# 223828Recruiting
  • Guangdong Provincial People's Hospital /ID# 215860Recruiting
  • Henan Cancer Hospital /ID# 215987Recruiting
  • Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 215850Recruiting
  • Nanjing Drum Tower Hospital /ID# 223143Recruiting
  • The First Affiliated Hospital of Soochow University /ID# 216094Recruiting
  • The First Affiliated Hospital of Nanchang University /ID# 216954Recruiting
  • The First Hospital of China Medical University /ID# 215996Recruiting
  • Ruijin Hospital, Shanghai Jiaotong University School of Medicine /ID# 216643Recruiting
  • Shanghai Tongji Hospital /ID# 218865Recruiting
  • West China Hospital, Sichuan University /ID# 216647Recruiting
  • Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sc /ID# 216041Recruiting
  • Tianjin Medical University Cancer Institute & Hospital /ID# 223550Recruiting
  • The First Affiliated Hospital, Zhejiang University School of Medicine /ID# 215989Recruiting
  • The First Affiliated Hospital, Zhejiang University School of Medicine /ID# 218691Recruiting
  • The First Affiliated Hospital of Wenzhou Medical University /ID# 218953Recruiting
  • Beijing Chaoyang Hospital, Capital Medical University(West campus) /ID# 234033Recruiting
  • Shengjing Hospital of China Medical University /ID# 223435Recruiting
  • Fakultni Nemocnice Brno /ID# 204512
  • Fakultni nemocnice Hradec Kralove /ID# 221291
  • Fakultni nemocnice Olomouc /ID# 221290
  • Fakultni nemocnice Ostrava /ID# 204515
  • Vseobecna fakultni nemocnice v Praze /ID# 221166
  • Herlev Hospital /ID# 223221
  • Aalborg University Hospital /ID# 223220
  • Odense Universitets Hospital /ID# 223217
  • Sygehus Lillebalt, Vejle /ID# 223216
  • Roskilde Hospital /ID# 223366
  • HCL - Hopital Lyon Sud /ID# 200097
  • CHRU Lille - Hopital Claude Huriez /ID# 202213
  • CHU Reims - Hôpital Robert Debre /ID# 233907
  • CHRU Nancy - Hopitaux de Brabois /ID# 201076
  • CHU de Nantes, Hotel Dieu -HME /ID# 200099
  • CH Henri Duffaut /ID# 234154
  • Hopital Henri Mondor /ID# 202211
  • CHU Grenoble - Hopital Michallon /ID# 223182
  • Hopital Pitie Salpetriere /ID# 214173
  • Centre Henri Becquerel /ID# 223186
  • Robert-Bosch-Krankenhaus /ID# 223947
  • Universitaetsklinikum Tuebingen /ID# 238646
  • Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 201830
  • Universitaetsklinikum Jena /ID# 201254
  • Charite Universitaetsklinikum Berlin - Campus Benjamin Franklin /ID# 200051
  • Klinikum Chemnitz gGmbH /ID# 233797
  • Universitaetsklinikum Hamburg-Eppendorf (UKE) /ID# 215495
  • Asklepios Klinik Altona /ID# 222506
  • Universitaetsklinikum Wuerzburg /ID# 200055
  • Alexandra General Hospital /ID# 202386
  • University General Hospital of Heraklion PA.G.N.I /ID# 222879
  • General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 213982
  • University Gen Hosp of Patra /ID# 201691
  • Theageneio Anticancer Hospital /ID# 213983
  • General Hospital of Thessaloniki George Papanikolaou /ID# 201692
  • Soroka University Medical Center /ID# 218768
  • The Chaim Sheba Medical Center /ID# 169778
  • Tel Aviv Sourasky Medical Center /ID# 169437
  • Assuta Ashdod Medical Center /ID# 222968
  • Rambam Health Care Campus /ID# 169678
  • Bnai Zion Medical Center /ID# 169466
  • The Lady Davis Carmel Medical Center /ID# 222969
  • Hadassah /ID# 169474
  • Rabin Medical Center /ID# 244611
  • Irccs-Crob /Id# 170955
  • Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona /ID# 170950
  • IRCCS Azienda Ospedaliero-Universitaria di Bologna /ID# 170952
  • Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 212498
  • A.O. Ospedali Riuniti Villa Sofia - Cervello /ID# 222988
  • Azienda Ospedaliera Santa Maria Terni /ID# 170948
  • A.O.U. Citta della Salute e della Scienza di Torino /ID# 170962
  • Nagoya City University Hospital /ID# 170880
  • The Jikei University Kashiwa Hospital /ID# 223031
  • Kyushu University Hospital /ID# 171117
  • Ogaki Municipal Hospital /ID# 171043
  • Gunma University Hospital /ID# 170966
  • Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital /ID# 171255
  • Kobe City Medical Center General Hospital /ID# 170992
  • National Hospital Organization Mito Medical Center /ID# 171187
  • Hitachi General Hospital /ID# 200843
  • Iwate Medical University Hospital /ID# 222849
  • Tohoku University Hospital /ID# 201935
  • Okayama Medical Center /ID# 200119
  • Japanese Red Cross Osaka Hospital /ID# 171493
  • Osaka University Hospital /ID# 201966
  • Tokushima University Hospital /ID# 202571
  • The Jikei University Hospital /ID# 239014
  • Japanese Red Cross Medical Center /ID# 171256
  • Yamagata University Hospital /ID# 238329
  • Yonsei University Health System Severance Hospital /ID# 202709
  • Gachon University Gil Medical Center /ID# 202827
  • Seoul National University Hospital /ID# 202711
  • Samsung Medical Center /ID# 202710
  • The Catholic University of Korea, Seoul St. Mary's Hospital /ID# 234045
  • Ulsan University Hospital /ID# 222716
  • Moscow State budget healthcare /ID# 169685
  • Research Institute of Fundamental and Clinical Immunology /ID# 223594
  • LLC Novaya Klinika /ID# 169689
  • City Clinical Hospital #52 /ID# 206289
  • Leningrad Regional Clinical Hospital /ID# 202776
  • Almazov National Medical Research Centre /ID# 169681
  • Tula Regional Clinical Hospital /ID# 223226
  • National University Hospital /ID# 203988
  • Singapore General Hospital /ID# 202131
  • Tan Tock Seng Hospital /ID# 204374
  • Hospital Universitari Son Espases /ID# 222889
  • Hospital Costa Del Sol /ID# 234083
  • Complejo Hospitalario Universitario Ourense /ID# 222876
  • Hospital Universitario Canarias /ID# 238452
  • Hospital Universitario Vall d'Hebron /ID# 218106
  • Instituto Catalan de Oncologia (ICO) Girona /ID# 171311
  • Hospital de Leon /ID# 233878
  • Hospital Universitario Fundacion Jimenez Diaz /ID# 171304
  • Hospital Universitario 12 de Octubre /ID# 171288
  • Hospital Universitario La Paz /ID# 218107
  • Hospital Universitario de Salamanca /ID# 171294
  • Hospital Universitario Virgen del Rocio /ID# 171286
  • Hospital General Universitario de Toledo Complejo Hosp. de Toledo /ID# 222887
  • Hospital Universitario y Politecnico La Fe /ID# 234019
  • Sunderby sjukhus /ID# 201314
  • Sodra Alvsborgs sjukhus /ID# 213061
  • Duplicate_Universitetssjukhuset Linköping /ID# 200789
  • Uddevalla sjukhus /ID# 201315
  • Cukurova Universitesi Tip Fakultesi /ID# 201955
  • Izmir Ekonomi Universitesi Ozel Medicalpoint Hastanesi /ID# 201954
  • Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastirma Hastanesi /ID# 201956
  • Gazi University Medical Faculty /ID# 222698
  • Ankara Univ Medical Faculty /ID# 201881
  • Istanbul University Istanbul Medical Faculty /ID# 201953
  • Bagcilar Medipol Mega Universite Hastanesi /ID# 222914
  • Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi /ID# 201952
  • Ege University Medical Faculty /ID# 222697
  • Communal Nonprofit Enterprise Cherkasy Regional Oncology Dispensary /ID# 223943
  • Communal non-profit enterprise Regional Center of Oncology /ID# 223945
  • Khmelnytskyi Regional Hospital /ID# 223942
  • National Cancer Institute /ID# 223944
  • SI Institute of Blood Pathology and Transfusion Medicine of NAMS of Ukraine /ID# 223941
  • Norfolk and Norwich University Hospitals NHS Foundation Trust /ID# 218213
  • Nottingham University Hospitals NHS Trust /ID# 223292
  • NHS Greater Glasgow and Clyde /ID# 202199
  • University Hospitals of North Midlands NHS Trust /ID# 218355
  • Cambridge University Hospitals NHS Foundation Trust /ID# 223097
  • University College London Hospitals NHS Foundation Trust /ID# 171428
  • Duplicate_Duplicate_Lewisham and Greenwich NHS Trust /ID# 171445
  • Imperial College Healthcare NHS Trust /ID# 171446
  • Manchester University NHS Foundation Trust /ID# 171440
  • Portsmouth Hospitals University NHS Trust /ID# 171444
  • Royal Berkshire NHS Foundation Trust /ID# 217835
  • Sheffield Teaching Hospitals NHS Foundation Trust /ID# 171447

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm 1 VenDex

Arm 2 PomDex

Arm Description

Venetoclax administered orally once daily (QD) plus dexamethasone administered orally once every week (Q1W) for each 28-day cycle.

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.

Outcomes

Primary Outcome Measures

Progression-Free Survival (PFS)
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

Overall Response Rate (ORR)
ORR is defined as the percentage of participants with documented best response (sCR, CR, VGPR or partial response [PR]) prior to first documented PD.
Very Good Partial Response or Better Response Rate (VGPR)
VGPR or better response rate is defined as the proportion of participants with documented stringent complete response (sCR), complete response (CR), or VGPR.
Overall survival (OS)
OS is defined as the number of days from the date that the participant was randomized to the date of the participant's death.
Minimal Residual Disease (MRD) Negativity Rate
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).
Time to Deterioration in Disease Symptoms
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).
Time to Deterioration in Physical Functioning
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).
Change from Baseline in PROMIS Fatigue Score
Change from baseline in the Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue Short Form 7a score.
Change from Baseline in BPI-SF Worst Pain Score
Change from baseline in the Brief Pain Inventory - Short Form (BPI-SF) worst pain score.
Change from Baseline in EuroQoL 5 Dimension 5 Level (EQ-5D-5L)
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."
Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
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).
Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Multiple Myeloma Module 20 (EORTC QLQ-MY20)
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.
Duration of response (DOR)
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.
Time to Disease Progression (TTP)
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.
Time to Response (TTR)
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).
Cmax of Venetoclax
Maximum plasma concentration (Cmax) of venetoclax
Trough Concentration (Ctrough) of Venetoclax
Observed plasma concentration at trough (Ctrough) of venetoclax.
Number of Participants With Adverse Events (AEs)
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.

Full Information

First Posted
May 17, 2018
Last Updated
September 28, 2023
Sponsor
AbbVie
Collaborators
Roche-Genentech
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1. Study Identification

Unique Protocol Identification Number
NCT03539744
Brief 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.
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 22, 2018 (Actual)
Primary Completion Date
October 25, 2025 (Anticipated)
Study Completion Date
October 25, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AbbVie
Collaborators
Roche-Genentech

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
Keywords
Cancer, Multiple Myeloma (MM), Relapsed or Refractory Multiple Myeloma (R/R MM), pharmacokinetics, CANOVA

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
244 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm 1 VenDex
Arm Type
Experimental
Arm Description
Venetoclax administered orally once daily (QD) plus dexamethasone administered orally once every week (Q1W) for each 28-day cycle.
Arm Title
Arm 2 PomDex
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Pomalidomide
Other Intervention Name(s)
Pomalyst
Intervention Description
capsule, oral
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Intervention Description
oral, locally available form
Intervention Type
Drug
Intervention Name(s)
Venetoclax
Other Intervention Name(s)
ABT-199, GDC-0199
Intervention Description
tablet; oral
Primary Outcome Measure Information:
Title
Progression-Free Survival (PFS)
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.
Time Frame
Up to approximately 43 months from first randomization
Secondary Outcome Measure Information:
Title
Overall Response Rate (ORR)
Description
ORR is defined as the percentage of participants with documented best response (sCR, CR, VGPR or partial response [PR]) prior to first documented PD.
Time Frame
Up to approximately 43 months from first randomization
Title
Very Good Partial Response or Better Response Rate (VGPR)
Description
VGPR or better response rate is defined as the proportion of participants with documented stringent complete response (sCR), complete response (CR), or VGPR.
Time Frame
Up to approximately 43 months from first randomization
Title
Overall survival (OS)
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.
Time Frame
Up to approximately 51 months from first randomization
Title
Minimal Residual Disease (MRD) Negativity Rate
Description
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).
Time Frame
Up to approximately 43 months from first randomization
Title
Time to Deterioration in Disease Symptoms
Description
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).
Time Frame
Up to approximately 51 months from first randomization
Title
Time to Deterioration in Physical Functioning
Description
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).
Time Frame
Up to approximately 51 months from first randomization
Title
Change from Baseline in PROMIS Fatigue Score
Description
Change from baseline in the Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue Short Form 7a score.
Time Frame
Up to approximately 51 months from first randomization
Title
Change from Baseline in BPI-SF Worst Pain Score
Description
Change from baseline in the Brief Pain Inventory - Short Form (BPI-SF) worst pain score.
Time Frame
Up to approximately 51 months from first randomization
Title
Change from Baseline in EuroQoL 5 Dimension 5 Level (EQ-5D-5L)
Description
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."
Time Frame
Up to approximately 51 months from first randomization
Title
Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
Description
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).
Time Frame
Up to approximately 51 months from first randomization
Title
Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Multiple Myeloma Module 20 (EORTC QLQ-MY20)
Description
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.
Time Frame
Up to approximately 51 months from first randomization
Title
Duration of response (DOR)
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.
Time Frame
Up to approximately 43 months from first randomization
Title
Time to Disease Progression (TTP)
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.
Time Frame
Up to approximately 43 months from first randomization
Title
Time to Response (TTR)
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).
Time Frame
Up to approximately 43 months from first randomization
Title
Cmax of Venetoclax
Description
Maximum plasma concentration (Cmax) of venetoclax
Time Frame
Up to approximately 225 days from initial dose
Title
Trough Concentration (Ctrough) of Venetoclax
Description
Observed plasma concentration at trough (Ctrough) of venetoclax.
Time Frame
Up to approximately 225 days from initial dose
Title
Number of Participants With Adverse Events (AEs)
Description
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.
Time Frame
Up to approximately 51 months from first randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
ABBVIE CALL CENTER
Phone
844-663-3742
Email
abbvieclinicaltrials@abbvie.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ABBVIE INC.
Organizational Affiliation
AbbVie
Official's Role
Study Director
Facility Information:
Facility Name
University of Arizona Cancer Center - North Campus /ID# 218407
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85719-1478
Country
United States
Individual Site Status
Completed
Facility Name
VA Central California Health Care System /ID# 200047
City
Fresno
State/Province
California
ZIP/Postal Code
93703-2223
Country
United States
Individual Site Status
Completed
Facility Name
University of California, Los Angeles /ID# 171524
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Individual Site Status
Completed
Facility Name
Rocky Mountain Regional VA Medical Center/Eastern Colorado Health Care System /ID# 222904
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Completed
Facility Name
Mayo Clinic /ID# 200075
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Individual Site Status
Completed
Facility Name
Cleveland Clinic Florida /ID# 208884
City
Weston
State/Province
Florida
ZIP/Postal Code
33331-3609
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Norton Cancer Institute /ID# 200834
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202-3700
Country
United States
Individual Site Status
Completed
Facility Name
University of Maryland School of Medicine /ID# 217422
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201-1544
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Boston Medical Center /ID# 223606
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Individual Site Status
Completed
Facility Name
Barbara Ann Karmanos Cancer In /ID# 201377
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Individual Site Status
Completed
Facility Name
Henry Ford Hospital /ID# 171531
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Individual Site Status
Completed
Facility Name
Mayo Clinic - Rochester /ID# 201091
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905-0001
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Columbia University Medical Center /ID# 200715
City
New York
State/Province
New York
ZIP/Postal Code
10032-3729
Country
United States
Individual Site Status
Completed
Facility Name
Fairview Hospital - Moll Pavilion /ID# 208919
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44111-5605
Country
United States
Individual Site Status
Completed
Facility Name
Cleveland Clinic Main Campus /ID# 202247
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
UPMC Hillman Cancer Ctr /ID# 200063
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Individual Site Status
Completed
Facility Name
MD Anderson Cancer Center at Texas Medical Center /ID# 200060
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-4000
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Huntsman Cancer Institute /ID# 218406
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112-5500
Country
United States
Individual Site Status
Completed
Facility Name
VA Puget Sound Health Care System /ID# 222708
City
Seattle
State/Province
Washington
ZIP/Postal Code
98108-1597
Country
United States
Individual Site Status
Completed
Facility Name
Liverpool Hospital /ID# 202431
City
Liverpool
State/Province
New South Wales
ZIP/Postal Code
2170
Country
Australia
Individual Site Status
Active, not recruiting
Facility Name
Sydney Adventist Hospital /ID# 222874
City
Wahroonga
State/Province
New South Wales
ZIP/Postal Code
2076
Country
Australia
Individual Site Status
Active, not recruiting
Facility Name
Wollongong Hospital /ID# 205545
City
Wollongong
State/Province
New South Wales
ZIP/Postal Code
2500
Country
Australia
Individual Site Status
Active, not recruiting
Facility Name
Icon Cancer Care - Townsville /ID# 206565
City
Hyde Park
State/Province
Queensland
ZIP/Postal Code
4812
Country
Australia
Individual Site Status
Completed
Facility Name
Icon Cancer Centre /ID# 205663
City
South Brisbane
State/Province
Queensland
ZIP/Postal Code
4101
Country
Australia
Individual Site Status
Active, not recruiting
Facility Name
The Queen Elizabeth Hospital /ID# 202432
City
Woodville South
State/Province
South Australia
ZIP/Postal Code
5011
Country
Australia
Individual Site Status
Active, not recruiting
Facility Name
Perth Blood Institute Ltd /ID# 206649
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Individual Site Status
Active, not recruiting
Facility Name
Tom Baker Cancer Centre /ID# 218846
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N2
Country
Canada
Individual Site Status
Active, not recruiting
Facility Name
BC Cancer - Vancouver /ID# 222804
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1L3
Country
Canada
Individual Site Status
Completed
Facility Name
QE II Health Sciences Centre /ID# 218883
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 1V7
Country
Canada
Individual Site Status
Active, not recruiting
Facility Name
CISSS-CA (Centre Integre de sante et de services sociaux de Chaudiere-Appalache) /ID# 218887
City
Levis
State/Province
Quebec
ZIP/Postal Code
G6V 3Z1
Country
Canada
Individual Site Status
Completed
Facility Name
Beijing Chaoyang Hospital,Capital Medical University /ID# 216014
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100020
Country
China
Individual Site Status
Recruiting
Facility Name
Peking University Third Hospital /ID# 216371
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100191
Country
China
Individual Site Status
Recruiting
Facility Name
Peking Union Medical College Hospital /ID# 216040
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China
Individual Site Status
Recruiting
Facility Name
Sun Yat-Sen University Cancer Center /ID# 223828
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
Individual Site Status
Recruiting
Facility Name
Guangdong Provincial People's Hospital /ID# 215860
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China
Individual Site Status
Recruiting
Facility Name
Henan Cancer Hospital /ID# 215987
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450008
Country
China
Individual Site Status
Recruiting
Facility Name
Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 215850
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430022
Country
China
Individual Site Status
Recruiting
Facility Name
Nanjing Drum Tower Hospital /ID# 223143
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210008
Country
China
Individual Site Status
Recruiting
Facility Name
The First Affiliated Hospital of Soochow University /ID# 216094
City
Suzhou
State/Province
Jiangsu
ZIP/Postal Code
215006
Country
China
Individual Site Status
Recruiting
Facility Name
The First Affiliated Hospital of Nanchang University /ID# 216954
City
Nanchang
State/Province
Jiangxi
ZIP/Postal Code
330006
Country
China
Individual Site Status
Recruiting
Facility Name
The First Hospital of China Medical University /ID# 215996
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110001
Country
China
Individual Site Status
Recruiting
Facility Name
Ruijin Hospital, Shanghai Jiaotong University School of Medicine /ID# 216643
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200065
Country
China
Individual Site Status
Recruiting
Facility Name
Shanghai Tongji Hospital /ID# 218865
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200065
Country
China
Individual Site Status
Recruiting
Facility Name
West China Hospital, Sichuan University /ID# 216647
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Individual Site Status
Recruiting
Facility Name
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sc /ID# 216041
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300020
Country
China
Individual Site Status
Recruiting
Facility Name
Tianjin Medical University Cancer Institute & Hospital /ID# 223550
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300060
Country
China
Individual Site Status
Recruiting
Facility Name
The First Affiliated Hospital, Zhejiang University School of Medicine /ID# 215989
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310003
Country
China
Individual Site Status
Recruiting
Facility Name
The First Affiliated Hospital, Zhejiang University School of Medicine /ID# 218691
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310003
Country
China
Individual Site Status
Recruiting
Facility Name
The First Affiliated Hospital of Wenzhou Medical University /ID# 218953
City
Wenzhou
State/Province
Zhejiang
ZIP/Postal Code
325000
Country
China
Individual Site Status
Recruiting
Facility Name
Beijing Chaoyang Hospital, Capital Medical University(West campus) /ID# 234033
City
Beijing
ZIP/Postal Code
100043
Country
China
Individual Site Status
Recruiting
Facility Name
Shengjing Hospital of China Medical University /ID# 223435
City
Shenyang
ZIP/Postal Code
110022
Country
China
Individual Site Status
Recruiting
Facility Name
Fakultni Nemocnice Brno /ID# 204512
City
Brno
ZIP/Postal Code
625 00
Country
Czechia
Individual Site Status
Active, not recruiting
Facility Name
Fakultni nemocnice Hradec Kralove /ID# 221291
City
Hradec Kralove
ZIP/Postal Code
500 05
Country
Czechia
Individual Site Status
Active, not recruiting
Facility Name
Fakultni nemocnice Olomouc /ID# 221290
City
Olomouc
ZIP/Postal Code
779 00
Country
Czechia
Individual Site Status
Active, not recruiting
Facility Name
Fakultni nemocnice Ostrava /ID# 204515
City
Ostrava
ZIP/Postal Code
708 52
Country
Czechia
Individual Site Status
Active, not recruiting
Facility Name
Vseobecna fakultni nemocnice v Praze /ID# 221166
City
Praha
ZIP/Postal Code
128 08
Country
Czechia
Individual Site Status
Active, not recruiting
Facility Name
Herlev Hospital /ID# 223221
City
Herlev
State/Province
Hovedstaden
ZIP/Postal Code
2730
Country
Denmark
Individual Site Status
Completed
Facility Name
Aalborg University Hospital /ID# 223220
City
Aalborg
State/Province
Nordjylland
ZIP/Postal Code
9000
Country
Denmark
Individual Site Status
Active, not recruiting
Facility Name
Odense Universitets Hospital /ID# 223217
City
Odense C
State/Province
Syddanmark
ZIP/Postal Code
5000
Country
Denmark
Individual Site Status
Active, not recruiting
Facility Name
Sygehus Lillebalt, Vejle /ID# 223216
City
Vejle
State/Province
Syddanmark
ZIP/Postal Code
7100
Country
Denmark
Individual Site Status
Active, not recruiting
Facility Name
Roskilde Hospital /ID# 223366
City
Roskilde
ZIP/Postal Code
4000
Country
Denmark
Individual Site Status
Active, not recruiting
Facility Name
HCL - Hopital Lyon Sud /ID# 200097
City
Pierre Benite CEDEX
State/Province
Auvergne-Rhone-Alpes
ZIP/Postal Code
69495
Country
France
Individual Site Status
Active, not recruiting
Facility Name
CHRU Lille - Hopital Claude Huriez /ID# 202213
City
Lille
State/Province
Hauts-de-France
ZIP/Postal Code
59037
Country
France
Individual Site Status
Active, not recruiting
Facility Name
CHU Reims - Hôpital Robert Debre /ID# 233907
City
Reims CEDEX
State/Province
Marne
ZIP/Postal Code
51092
Country
France
Individual Site Status
Completed
Facility Name
CHRU Nancy - Hopitaux de Brabois /ID# 201076
City
Vandoeuvre-les-Nancy
State/Province
Meurthe-et-Moselle
ZIP/Postal Code
54500
Country
France
Individual Site Status
Active, not recruiting
Facility Name
CHU de Nantes, Hotel Dieu -HME /ID# 200099
City
Nantes
State/Province
Pays-de-la-Loire
ZIP/Postal Code
44000
Country
France
Individual Site Status
Active, not recruiting
Facility Name
CH Henri Duffaut /ID# 234154
City
Avignon CEDEX 9
State/Province
Vaucluse
ZIP/Postal Code
84902
Country
France
Individual Site Status
Completed
Facility Name
Hopital Henri Mondor /ID# 202211
City
Creteil
ZIP/Postal Code
94000
Country
France
Individual Site Status
Active, not recruiting
Facility Name
CHU Grenoble - Hopital Michallon /ID# 223182
City
La Tronche
ZIP/Postal Code
38700
Country
France
Individual Site Status
Completed
Facility Name
Hopital Pitie Salpetriere /ID# 214173
City
Paris
ZIP/Postal Code
75013
Country
France
Individual Site Status
Active, not recruiting
Facility Name
Centre Henri Becquerel /ID# 223186
City
Rouen
ZIP/Postal Code
76038
Country
France
Individual Site Status
Completed
Facility Name
Robert-Bosch-Krankenhaus /ID# 223947
City
Stuttgart
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
70736
Country
Germany
Individual Site Status
Completed
Facility Name
Universitaetsklinikum Tuebingen /ID# 238646
City
Tubingen
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
72076
Country
Germany
Individual Site Status
Active, not recruiting
Facility Name
Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 201830
City
Kiel
State/Province
Schleswig-Holstein
ZIP/Postal Code
24105
Country
Germany
Individual Site Status
Completed
Facility Name
Universitaetsklinikum Jena /ID# 201254
City
Jena
State/Province
Thueringen
ZIP/Postal Code
07747
Country
Germany
Individual Site Status
Active, not recruiting
Facility Name
Charite Universitaetsklinikum Berlin - Campus Benjamin Franklin /ID# 200051
City
Berlin
ZIP/Postal Code
12203
Country
Germany
Individual Site Status
Active, not recruiting
Facility Name
Klinikum Chemnitz gGmbH /ID# 233797
City
Chemnitz
ZIP/Postal Code
09116
Country
Germany
Individual Site Status
Completed
Facility Name
Universitaetsklinikum Hamburg-Eppendorf (UKE) /ID# 215495
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Individual Site Status
Active, not recruiting
Facility Name
Asklepios Klinik Altona /ID# 222506
City
Hamburg
ZIP/Postal Code
22763
Country
Germany
Individual Site Status
Active, not recruiting
Facility Name
Universitaetsklinikum Wuerzburg /ID# 200055
City
Wuerzburg
ZIP/Postal Code
97080
Country
Germany
Individual Site Status
Active, not recruiting
Facility Name
Alexandra General Hospital /ID# 202386
City
Athens
State/Province
Attiki
ZIP/Postal Code
11528
Country
Greece
Individual Site Status
Active, not recruiting
Facility Name
University General Hospital of Heraklion PA.G.N.I /ID# 222879
City
Heraklion
State/Province
Kriti
ZIP/Postal Code
71500
Country
Greece
Individual Site Status
Completed
Facility Name
General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 213982
City
Athens
ZIP/Postal Code
10676
Country
Greece
Individual Site Status
Active, not recruiting
Facility Name
University Gen Hosp of Patra /ID# 201691
City
Patras
ZIP/Postal Code
26504
Country
Greece
Individual Site Status
Completed
Facility Name
Theageneio Anticancer Hospital /ID# 213983
City
Thessaloniki
ZIP/Postal Code
54639
Country
Greece
Individual Site Status
Active, not recruiting
Facility Name
General Hospital of Thessaloniki George Papanikolaou /ID# 201692
City
Thessaloniki
ZIP/Postal Code
57010
Country
Greece
Individual Site Status
Completed
Facility Name
Soroka University Medical Center /ID# 218768
City
Be'er Sheva
State/Province
HaDarom
ZIP/Postal Code
8443901
Country
Israel
Individual Site Status
Active, not recruiting
Facility Name
The Chaim Sheba Medical Center /ID# 169778
City
Ramat Gan
State/Province
Tel-Aviv
ZIP/Postal Code
5265601
Country
Israel
Individual Site Status
Active, not recruiting
Facility Name
Tel Aviv Sourasky Medical Center /ID# 169437
City
Tel Aviv-Yafo
State/Province
Tel-Aviv
ZIP/Postal Code
6423906
Country
Israel
Individual Site Status
Active, not recruiting
Facility Name
Assuta Ashdod Medical Center /ID# 222968
City
Ashdod
ZIP/Postal Code
7747629
Country
Israel
Individual Site Status
Completed
Facility Name
Rambam Health Care Campus /ID# 169678
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
Individual Site Status
Active, not recruiting
Facility Name
Bnai Zion Medical Center /ID# 169466
City
Haifa
ZIP/Postal Code
3339419
Country
Israel
Individual Site Status
Active, not recruiting
Facility Name
The Lady Davis Carmel Medical Center /ID# 222969
City
Haifa
ZIP/Postal Code
34362
Country
Israel
Individual Site Status
Completed
Facility Name
Hadassah /ID# 169474
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
Individual Site Status
Active, not recruiting
Facility Name
Rabin Medical Center /ID# 244611
City
Petakh Tikva
ZIP/Postal Code
4941492
Country
Israel
Individual Site Status
Completed
Facility Name
Irccs-Crob /Id# 170955
City
Rionero in Vulture
State/Province
Potenza
ZIP/Postal Code
85028
Country
Italy
Individual Site Status
Active, not recruiting
Facility Name
Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona /ID# 170950
City
Ancona
ZIP/Postal Code
60126
Country
Italy
Individual Site Status
Active, not recruiting
Facility Name
IRCCS Azienda Ospedaliero-Universitaria di Bologna /ID# 170952
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Individual Site Status
Completed
Facility Name
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 212498
City
Milan
ZIP/Postal Code
20122
Country
Italy
Individual Site Status
Active, not recruiting
Facility Name
A.O. Ospedali Riuniti Villa Sofia - Cervello /ID# 222988
City
Palermo
ZIP/Postal Code
90146
Country
Italy
Individual Site Status
Active, not recruiting
Facility Name
Azienda Ospedaliera Santa Maria Terni /ID# 170948
City
Terni
ZIP/Postal Code
05100
Country
Italy
Individual Site Status
Active, not recruiting
Facility Name
A.O.U. Citta della Salute e della Scienza di Torino /ID# 170962
City
Turin
ZIP/Postal Code
10126
Country
Italy
Individual Site Status
Active, not recruiting
Facility Name
Nagoya City University Hospital /ID# 170880
City
Nagoya shi
State/Province
Aichi
ZIP/Postal Code
467-8602
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
The Jikei University Kashiwa Hospital /ID# 223031
City
Kashiwa-shi
State/Province
Chiba
ZIP/Postal Code
277-8567
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
Kyushu University Hospital /ID# 171117
City
Fukuoka-shi
State/Province
Fukuoka
ZIP/Postal Code
812-8582
Country
Japan
Individual Site Status
Completed
Facility Name
Ogaki Municipal Hospital /ID# 171043
City
Ogaki-shi
State/Province
Gifu
ZIP/Postal Code
503-8502
Country
Japan
Individual Site Status
Completed
Facility Name
Gunma University Hospital /ID# 170966
City
Maebashi-shi
State/Province
Gunma
ZIP/Postal Code
371-8511
Country
Japan
Individual Site Status
Completed
Facility Name
Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital /ID# 171255
City
Hiroshima-shi
State/Province
Hiroshima
ZIP/Postal Code
730-8619
Country
Japan
Individual Site Status
Completed
Facility Name
Kobe City Medical Center General Hospital /ID# 170992
City
Kobe-shi
State/Province
Hyogo
ZIP/Postal Code
650-0047
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
National Hospital Organization Mito Medical Center /ID# 171187
City
Higashi Ibaraki-gun
State/Province
Ibaraki
ZIP/Postal Code
311-3193
Country
Japan
Individual Site Status
Completed
Facility Name
Hitachi General Hospital /ID# 200843
City
Hitachi-shi
State/Province
Ibaraki
ZIP/Postal Code
317-0077
Country
Japan
Individual Site Status
Completed
Facility Name
Iwate Medical University Hospital /ID# 222849
City
Shiwa-gun
State/Province
Iwate
ZIP/Postal Code
028-3695
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
Tohoku University Hospital /ID# 201935
City
Sendai-shi
State/Province
Miyagi
ZIP/Postal Code
9808574
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
Okayama Medical Center /ID# 200119
City
Okayama-shi
State/Province
Okayama
ZIP/Postal Code
701-1192
Country
Japan
Individual Site Status
Completed
Facility Name
Japanese Red Cross Osaka Hospital /ID# 171493
City
Osaka-shi
State/Province
Osaka
ZIP/Postal Code
543-8555
Country
Japan
Individual Site Status
Completed
Facility Name
Osaka University Hospital /ID# 201966
City
Suita-shi
State/Province
Osaka
ZIP/Postal Code
565-0871
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
Tokushima University Hospital /ID# 202571
City
Tokushima-shi
State/Province
Tokushima
ZIP/Postal Code
770-8503
Country
Japan
Individual Site Status
Completed
Facility Name
The Jikei University Hospital /ID# 239014
City
Minato-ku
State/Province
Tokyo
ZIP/Postal Code
105-8471
Country
Japan
Individual Site Status
Completed
Facility Name
Japanese Red Cross Medical Center /ID# 171256
City
Shibuya-ku
State/Province
Tokyo
ZIP/Postal Code
150-8935
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
Yamagata University Hospital /ID# 238329
City
Yamagata-shi
State/Province
Yamagata
ZIP/Postal Code
990-9585
Country
Japan
Individual Site Status
Completed
Facility Name
Yonsei University Health System Severance Hospital /ID# 202709
City
Seoul
State/Province
Seoul Teugbyeolsi
ZIP/Postal Code
03722
Country
Korea, Republic of
Individual Site Status
Active, not recruiting
Facility Name
Gachon University Gil Medical Center /ID# 202827
City
Incheon
ZIP/Postal Code
21565
Country
Korea, Republic of
Individual Site Status
Completed
Facility Name
Seoul National University Hospital /ID# 202711
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Individual Site Status
Active, not recruiting
Facility Name
Samsung Medical Center /ID# 202710
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Individual Site Status
Completed
Facility Name
The Catholic University of Korea, Seoul St. Mary's Hospital /ID# 234045
City
Seoul
ZIP/Postal Code
06591
Country
Korea, Republic of
Individual Site Status
Active, not recruiting
Facility Name
Ulsan University Hospital /ID# 222716
City
Ulsan
ZIP/Postal Code
44033
Country
Korea, Republic of
Individual Site Status
Active, not recruiting
Facility Name
Moscow State budget healthcare /ID# 169685
City
Moscow
State/Province
Moskva
ZIP/Postal Code
125284
Country
Russian Federation
Individual Site Status
Active, not recruiting
Facility Name
Research Institute of Fundamental and Clinical Immunology /ID# 223594
City
Novosibirsk
State/Province
Novosibirskaya Oblast
ZIP/Postal Code
630099
Country
Russian Federation
Individual Site Status
Completed
Facility Name
LLC Novaya Klinika /ID# 169689
City
Pyatigorsk
State/Province
Stavropol Skiy Kray
ZIP/Postal Code
357500
Country
Russian Federation
Individual Site Status
Active, not recruiting
Facility Name
City Clinical Hospital #52 /ID# 206289
City
Moscow
ZIP/Postal Code
123182
Country
Russian Federation
Individual Site Status
Active, not recruiting
Facility Name
Leningrad Regional Clinical Hospital /ID# 202776
City
Saint Petersburg
ZIP/Postal Code
194291
Country
Russian Federation
Individual Site Status
Active, not recruiting
Facility Name
Almazov National Medical Research Centre /ID# 169681
City
Sankt-Peterburg
ZIP/Postal Code
197341
Country
Russian Federation
Individual Site Status
Active, not recruiting
Facility Name
Tula Regional Clinical Hospital /ID# 223226
City
Tula
ZIP/Postal Code
300053
Country
Russian Federation
Individual Site Status
Completed
Facility Name
National University Hospital /ID# 203988
City
Singapore
ZIP/Postal Code
119228
Country
Singapore
Individual Site Status
Active, not recruiting
Facility Name
Singapore General Hospital /ID# 202131
City
Singapore
ZIP/Postal Code
169608
Country
Singapore
Individual Site Status
Active, not recruiting
Facility Name
Tan Tock Seng Hospital /ID# 204374
City
Singapore
ZIP/Postal Code
308433
Country
Singapore
Individual Site Status
Completed
Facility Name
Hospital Universitari Son Espases /ID# 222889
City
Palma de Mallorca
State/Province
Illes Balears
ZIP/Postal Code
07120
Country
Spain
Individual Site Status
Completed
Facility Name
Hospital Costa Del Sol /ID# 234083
City
Marbella
State/Province
Malaga
ZIP/Postal Code
29603
Country
Spain
Individual Site Status
Active, not recruiting
Facility Name
Complejo Hospitalario Universitario Ourense /ID# 222876
City
Orense
State/Province
Ourense
ZIP/Postal Code
32005
Country
Spain
Individual Site Status
Active, not recruiting
Facility Name
Hospital Universitario Canarias /ID# 238452
City
San Cristóbal de La Laguna
State/Province
Santa Cruz De Tenerife
ZIP/Postal Code
38320
Country
Spain
Individual Site Status
Completed
Facility Name
Hospital Universitario Vall d'Hebron /ID# 218106
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Individual Site Status
Completed
Facility Name
Instituto Catalan de Oncologia (ICO) Girona /ID# 171311
City
Girona
ZIP/Postal Code
17007
Country
Spain
Individual Site Status
Active, not recruiting
Facility Name
Hospital de Leon /ID# 233878
City
Leon
ZIP/Postal Code
24071
Country
Spain
Individual Site Status
Completed
Facility Name
Hospital Universitario Fundacion Jimenez Diaz /ID# 171304
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Individual Site Status
Active, not recruiting
Facility Name
Hospital Universitario 12 de Octubre /ID# 171288
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Individual Site Status
Active, not recruiting
Facility Name
Hospital Universitario La Paz /ID# 218107
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Individual Site Status
Completed
Facility Name
Hospital Universitario de Salamanca /ID# 171294
City
Salamanca
ZIP/Postal Code
37711
Country
Spain
Individual Site Status
Active, not recruiting
Facility Name
Hospital Universitario Virgen del Rocio /ID# 171286
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Individual Site Status
Active, not recruiting
Facility Name
Hospital General Universitario de Toledo Complejo Hosp. de Toledo /ID# 222887
City
Toledo
ZIP/Postal Code
45007
Country
Spain
Individual Site Status
Active, not recruiting
Facility Name
Hospital Universitario y Politecnico La Fe /ID# 234019
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Individual Site Status
Completed
Facility Name
Sunderby sjukhus /ID# 201314
City
Lulea
State/Province
Norrbottens Lan
ZIP/Postal Code
971 80
Country
Sweden
Individual Site Status
Completed
Facility Name
Sodra Alvsborgs sjukhus /ID# 213061
City
Boras
State/Province
Vastra Gotalands Lan
ZIP/Postal Code
501 82
Country
Sweden
Individual Site Status
Completed
Facility Name
Duplicate_Universitetssjukhuset Linköping /ID# 200789
City
Linkoping
State/Province
Vastra Gotalands Lan
ZIP/Postal Code
581 85
Country
Sweden
Individual Site Status
Completed
Facility Name
Uddevalla sjukhus /ID# 201315
City
Uddevalla
State/Province
Vastra Gotalands Lan
ZIP/Postal Code
451 80
Country
Sweden
Individual Site Status
Completed
Facility Name
Cukurova Universitesi Tip Fakultesi /ID# 201955
City
Saricam Adana
State/Province
Adana
ZIP/Postal Code
01330
Country
Turkey
Individual Site Status
Completed
Facility Name
Izmir Ekonomi Universitesi Ozel Medicalpoint Hastanesi /ID# 201954
City
Karsiyaka
State/Province
Izmir
ZIP/Postal Code
35575
Country
Turkey
Individual Site Status
Completed
Facility Name
Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastirma Hastanesi /ID# 201956
City
Ankara
ZIP/Postal Code
06200
Country
Turkey
Individual Site Status
Active, not recruiting
Facility Name
Gazi University Medical Faculty /ID# 222698
City
Ankara
ZIP/Postal Code
06560
Country
Turkey
Individual Site Status
Active, not recruiting
Facility Name
Ankara Univ Medical Faculty /ID# 201881
City
Ankara
ZIP/Postal Code
06590
Country
Turkey
Individual Site Status
Active, not recruiting
Facility Name
Istanbul University Istanbul Medical Faculty /ID# 201953
City
Istanbul
ZIP/Postal Code
34093
Country
Turkey
Individual Site Status
Active, not recruiting
Facility Name
Bagcilar Medipol Mega Universite Hastanesi /ID# 222914
City
Istanbul
ZIP/Postal Code
34214
Country
Turkey
Individual Site Status
Active, not recruiting
Facility Name
Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi /ID# 201952
City
Istanbul
ZIP/Postal Code
34899
Country
Turkey
Individual Site Status
Completed
Facility Name
Ege University Medical Faculty /ID# 222697
City
Izmir
ZIP/Postal Code
35040
Country
Turkey
Individual Site Status
Active, not recruiting
Facility Name
Communal Nonprofit Enterprise Cherkasy Regional Oncology Dispensary /ID# 223943
City
Cherkasy
ZIP/Postal Code
18009
Country
Ukraine
Individual Site Status
Completed
Facility Name
Communal non-profit enterprise Regional Center of Oncology /ID# 223945
City
Kharkiv
ZIP/Postal Code
61070
Country
Ukraine
Individual Site Status
Active, not recruiting
Facility Name
Khmelnytskyi Regional Hospital /ID# 223942
City
Khmelnytskyi
ZIP/Postal Code
29000
Country
Ukraine
Individual Site Status
Completed
Facility Name
National Cancer Institute /ID# 223944
City
Kyiv
ZIP/Postal Code
03022
Country
Ukraine
Individual Site Status
Completed
Facility Name
SI Institute of Blood Pathology and Transfusion Medicine of NAMS of Ukraine /ID# 223941
City
Lviv
ZIP/Postal Code
79044
Country
Ukraine
Individual Site Status
Completed
Facility Name
Norfolk and Norwich University Hospitals NHS Foundation Trust /ID# 218213
City
Norwich
State/Province
Norfolk
ZIP/Postal Code
NR4 7UY
Country
United Kingdom
Individual Site Status
Active, not recruiting
Facility Name
Nottingham University Hospitals NHS Trust /ID# 223292
City
Nottingham
State/Province
Nottinghamshire
ZIP/Postal Code
NG5 1PB
Country
United Kingdom
Individual Site Status
Completed
Facility Name
NHS Greater Glasgow and Clyde /ID# 202199
City
Glasgow
State/Province
Scotland
ZIP/Postal Code
G12 0XH
Country
United Kingdom
Individual Site Status
Completed
Facility Name
University Hospitals of North Midlands NHS Trust /ID# 218355
City
Stoke-on-Trent
State/Province
Staffordshire
ZIP/Postal Code
ST4 6QG
Country
United Kingdom
Individual Site Status
Completed
Facility Name
Cambridge University Hospitals NHS Foundation Trust /ID# 223097
City
Cambridge
ZIP/Postal Code
CB2 0QQ
Country
United Kingdom
Individual Site Status
Active, not recruiting
Facility Name
University College London Hospitals NHS Foundation Trust /ID# 171428
City
London
ZIP/Postal Code
NW1 2PG
Country
United Kingdom
Individual Site Status
Active, not recruiting
Facility Name
Duplicate_Duplicate_Lewisham and Greenwich NHS Trust /ID# 171445
City
London
ZIP/Postal Code
SE13 6LH
Country
United Kingdom
Individual Site Status
Completed
Facility Name
Imperial College Healthcare NHS Trust /ID# 171446
City
London
ZIP/Postal Code
W2 1NY
Country
United Kingdom
Individual Site Status
Active, not recruiting
Facility Name
Manchester University NHS Foundation Trust /ID# 171440
City
Manchester
ZIP/Postal Code
M13 9WL
Country
United Kingdom
Individual Site Status
Active, not recruiting
Facility Name
Portsmouth Hospitals University NHS Trust /ID# 171444
City
Portsmouth
ZIP/Postal Code
PO6 3LY
Country
United Kingdom
Individual Site Status
Active, not recruiting
Facility Name
Royal Berkshire NHS Foundation Trust /ID# 217835
City
Reading
ZIP/Postal Code
RG1 5AN
Country
United Kingdom
Individual Site Status
Active, not recruiting
Facility Name
Sheffield Teaching Hospitals NHS Foundation Trust /ID# 171447
City
Sheffield
ZIP/Postal Code
S5 7AT
Country
United Kingdom
Individual Site Status
Completed

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
IPD Sharing Time Frame
For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
IPD Sharing Access Criteria
Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
IPD Sharing URL
https://vivli.org/ourmember/abbvie/
Links:
URL
https://www.abbvieclinicaltrials.com/study/?
Description
Related info

Learn more about this trial

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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