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A Study Evaluating Venetoclax (ABT-199) in Multiple Myeloma Subjects Who Are Receiving Bortezomib and Dexamethasone as Standard Therapy (Bellini)

Primary Purpose

Relapsed/Refractory Multiple Myeloma

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Venetoclax
Bortezomib
Dexamethasone
Placebo for venetoclax
Sponsored by
AbbVie
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Relapsed/Refractory Multiple Myeloma focused on measuring Relapsed/refractory multiple myeloma, Relapsed multiple myeloma, Refractory multiple myeloma, Multiple myeloma

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Eastern Cooperative Oncology Group (ECOG) performance score less than or equal to 2
  • Participant has documented relapsed or progressive multiple myeloma on or after any regimen or who are refractory to the most recent line of therapy. Relapsed myeloma is defined as previously treated myeloma that progresses and requires initiation of salvage therapy, but does not meet the criteria for refractory myeloma. Refractory myeloma is defined as disease that is non responsive (failure to achieve minimal response or development of progressive disease [PD]) while on primary or salvage therapy, or progresses within 60 days of last therapy.
  • Participant must have received prior treatment with at least one, but no more than three, prior lines of therapy for multiple myeloma. A line of therapy consists of greater than or equal to 1 complete cycle of a single agent, a regimen consisting of combination of several drugs, or a planned sequential therapy of various regimens.
  • Prior treatment with bortezomib or other proteasome inhibitor is allowed, provided ALL of the following criteria are met: Disease is NOT refractory to any proteasome inhibitor, defined as no disease progression (i.e., PD, per IMWG or European Society for Blood and Marrow Transplantation [EBMT] criteria) while receiving proteasome inhibitor therapy or within 60 days after the last dose, AND best response achieved with any proteasome inhibitor therapy (alone or in combination) was at least a PR, AND participant did not discontinue any proteasome inhibitor due to intolerance or greater than or equal to Grade 3 related toxicity.
  • Participant has measurable disease at Screening, defined as at least one of the following: Serum M-protein greater than or equal to 0.5 g/dL, OR Urine M-protein greater than or equal to 200 mg in 24-hours, OR serum immunoglobulin free light chain (FLC) greater than or equal to 10 mg/dL provided serum FLC ratio is abnormal.

Exclusion Criteria:

  • Participant is refractory to any proteasome inhibitor, defined as progression on or within 60 days of the last dose of a proteasome inhibitor-containing regimen.
  • Participant has had prior treatment with proteasome inhibitor within 60 days prior to first dose of study drug.
  • Participant has any of the following conditions:

Non-secretory multiple myeloma, active plasma cell leukemia i.e., either 20% of peripheral white blood cells or greater than 2.0 X 10^9/liter (L) circulating plasma cells by standard differential, waldenstrom's macroglobulinemia, amyloidosis, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes), known Human Immunodeficiency Viral (HIV) infection, active hepatitis B or C infection based on blood screen tests, significant cardiovascular disease, including uncontrolled angina, severe or uncontrolled arrhythmia, recent myocardial infarction within 6 months of randomization, or congestive heart failure New York Heart Association (NYHA) Class greater than or equal to 3, Major surgery within 4 weeks prior to randomization, acute infections requiring parenteral therapy (antibiotic, antifungal, or antiviral) within 14 days prior to randomization, peripheral neuropathy greater than or equal to Grade 3 or greater than or equal to Grade 2 with pain within 2 weeks prior to randomization, uncontrolled diabetes or uncontrolled hypertension within 14 days prior to randomization, any other medical condition that, in the opinion of the Investigator, would adversely affect the participant's participation in the study

  • Participant has a history of other active malignancies, including myelodysplastic syndrome (MDS), within the past 3 years prior to study entry, with the following exceptions: Adequately treated in situ carcinoma of the cervix uteri or the breast, basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin, prostate cancer Gleason grade 6 or lower AND with stable Prostate Specific Antigen (PSA) levels off treatment, previous malignancy with no evidence of disease confined and surgically resected (or treated with other modalities) with curative intent and unlikely to impact survival during the duration of the study
  • If participant had prior allogeneic stem cell transplant (SCT), participant has evidence of ongoing graft-versus-host disease (GvHD).

Sites / Locations

  • Rocky Mountain Regional VA Medical Center/Eastern Colorado Health Care System /ID# 156524
  • Univ of Colorado Cancer Center /ID# 149130
  • Duke Cancer Center /ID# 149099
  • Gabrail Cancer Center Research /ID# 149098
  • Royal Prince Alfred Hospital /ID# 149108
  • Concord Repatriation General Hospital /ID# 149106
  • Liverpool Hospital /ID# 149110
  • Royal Brisbane and Women's Hospital /ID# 149105
  • The Queen Elizabeth Hospital /ID# 149104
  • Royal Hobart Hospital /ID# 149111
  • Box Hill Hospital /ID# 149112
  • Peter MacCallum Cancer Ctr /ID# 149107
  • Alfred Health /ID# 150085
  • Fiona Stanley Hospital /ID# 148967
  • Perth Blood Institute Ltd /ID# 148966
  • Hospital das Clinicas da Universidade Federal de Goiás /ID# 149290
  • Liga Norte Riograndense Contra o Câncer /ID# 149023
  • Hospital Sao Lucas da PUCRS /ID# 149027
  • Clinica Sao Germano /ID# 149851
  • Instituto Nacional de Câncer José Alencar Gomes da Silva (INCA) /ID# 149020
  • Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo /ID# 149025
  • Victoria Hospital /ID# 149846
  • CISSS de la Monteregie /ID# 149844
  • CHU Limoges - Dupuytren 1 /ID# 149292
  • CHU de Nantes, Hotel Dieu -HME /ID# 149294
  • Duplicate_Centre Hospitalier Lyon Sud /ID# 149300
  • CHRU de Brest - Hopital Morvan /ID# 149299
  • CHU Grenoble - Hopital Michallon /ID# 149301
  • Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 148949
  • Universitaetsklinikum Carl Gustav Carus an der TU Dresden /ID# 148948
  • Asklepios Klinik Altona /ID# 150116
  • Debreceni Egyetem Klinikai Kozpont /ID# 152517
  • Somogy Megyei Kaposi Mor Oktato Korhaz /ID# 152516
  • Semmelweis Egyetem /ID# 152519
  • Semmelweis Egyetem /ID# 152520
  • Del-pesti Centrumkorhaz Orszagos Hematologiai es Infektologiai Intezet /ID# 152518
  • University Hospital Galway /ID# 149061
  • Azienda Ospedaliero-Universitaria Policlinico Umberto I /ID# 148939
  • Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona /ID# 148942
  • IRCCS Azienda Ospedaliero-Universitaria di Bologna /ID# 148936
  • Ospedale S.Eugenio /ID# 148938
  • A.O.U. Città della Salute e della Scienza di Torino/Ospedale Molinette /ID# 148943
  • Nagoya City University Hospital /ID# 150943
  • Kyushu University Hospital /ID# 150896
  • Ogaki Municipal Hospital /ID# 150783
  • Gunma University Hospital /ID# 150275
  • National Hospital Organization Shibukawa Medical Center /ID# 150281
  • Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital /ID# 150242
  • Kobe City Medical Center General Hospital /ID# 150944
  • National Hospital Organization Mito Medical Center /ID# 151051
  • Duplicate_Kyoto Prefectural University of Medicine /ID# 150719
  • JCHO Kyoto Kuramaguchi Medical /ID# 150781
  • Tohoku University Hospital /ID# 150945
  • Okayama Medical Center /ID# 150717
  • Japanese Red Cross Osaka Hospital /ID# 150716
  • Saitama Medical Center /ID# 151044
  • Tochigi Cancer Center /ID# 150192
  • National Cancer Center Hospital /ID# 151039
  • The Cancer Institute Hospital Of JFCR /ID# 150780
  • Japanese Red Cross Medical Center /ID# 149902
  • National Hospital Organization Disaster Medical Center /ID# 150784
  • National Cancer Center /ID# 150889
  • Seoul National University Bundang Hospital /ID# 150888
  • Duplicate_Yonsei University Health System, Severance hospital. /ID# 150891
  • Chonnam National University Hospital /ID# 150894
  • Gachon University Gil Medical Center /ID# 150893
  • Seoul National University Hospital /ID# 150890
  • Samsung Medical Center /ID# 150892
  • The Catholic University of Korea, Seoul St. Mary's Hospital /ID# 150895
  • Kuzbass Regional Clinical Hospital /ID# 148955
  • State Institution of Health of the Ryazan Regional Clinical Hospital /ID# 148956
  • LLC Novaya Klinika /ID# 148974
  • Central Clinical Hospital RZHD Medicine /ID# 148954
  • Clinical Oncology Dispensary of Omsk /ID# 148953
  • Samara State Medical University /ID# 148952
  • Bashkir State Medical University /ID# 151206
  • Hospital Duran i Reynals /ID# 148989
  • Hospital Universitario de la Princesa /ID# 148980
  • Hospital Universitario 12 de Octubre /ID# 148981
  • Hospital Universitario Dr. Peset /ID# 148986
  • Changhua Christian Hospital /ID# 154447
  • China Medical University Hospital /ID# 154446
  • National Taiwan University Hospital /ID# 154444
  • Taipei Veterans General Hosp /ID# 154445
  • Communal Nonprofit Enterprise Cherkasy Regional Oncology Dispensary /ID# 152414
  • Municipal Non-Profit Enterprise City Clinical Hospital 4 of Dnipro City Council /ID# 152411
  • National Cancer Institute /ID# 152413
  • Leicester Royal Infirmary /ID# 149057
  • Barts Health NHS Trust /ID# 149050
  • Nottingham University Hospitals NHS Trust /ID# 149047
  • Blackpool Teaching Hospitals NHS Foundation Trust /ID# 149058
  • East Kent Hospitals University NHS Foundation Trust /ID# 149059
  • University College London Hospitals NHS Foundation Trust /ID# 149044
  • King's College Hospital NHS Foundation Trust /ID# 149045
  • Manchester University NHS Foundation Trust /ID# 149046
  • Barking, Havering and Redbridge University Hospitals NHS Trust /ID# 149055
  • The Royal Wolverhampton NHS Trust /ID# 149043

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Venetoclax + Bortezomib and Dexamethasone

Placebo + Bortezomib and Dexamethasone

Arm Description

Cycles 1-8: Venetoclax 800 mg orally every day (QD) on Days 1 - 21 plus bortezomib 1.3 mg/m^2 subcutaneously or IV on Days 1, 4, 8 & 11 and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 & 12; Cycles 9 and beyond: Venetoclax 800 mg orally every day (QD) on Days 1 - 35 plus bortezomib 1.3 mg/m^2 subcutaneously or IV on Days 1, 8, 15 and 22 and dexamethasone 20 mg orally on Days 1, 2, 8, 9, 15, 16, 22 and 23

Cycles 1-8: Placebo (to match venetoclax 100 mg tablet) 800 mg orally every day (QD) on Days 1 - 21 plus bortezomib 1.3 mg/m^2 subcutaneously or IV on Days 1, 4, 8 & 11 and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 & 12; Cycles 9 and beyond: Placebo (to match venetoclax 100 mg tablet) 800 mg orally every day (QD) on Days 1 - 35 plus bortezomib 1.3 mg/m^2 subcutaneously or IV on Days 1, 8, 15 and 22 and dexamethasone 20 mg orally on Days 1, 2, 8, 9, 15, 16, 22 & 23

Outcomes

Primary Outcome Measures

Progression-free Survival (PFS)
PFS is defined as the number of days from the date the participant was randomized to the date of the first documented progressive disease (PD) as determined by an Independent Review Committee (IRC) or death due to any cause, whichever occurs first. PFS was analyzed by Kaplan-Meier methodology.

Secondary Outcome Measures

Very Good Partial Response (VGPR) or Better Response Rate
The percentage of participants with documented best overall response of Very Good Partial Response (VGPR) or better (VGPR, Complete response [CR], or Stringent complete response [sCR]) per 2016 standard International Myeloma Working Group (IMWG) criteria as determined by an Independent Review Committee (IRC) was computed.
Progression-Free Survival (PFS) in Participants With High B-cell Lymphoma 2 (BCL-2) Expression
PFS is defined as the number of days from the date the participant was randomized to the date of the first documented progressive disease (PD) per investigator assessment or death due to any cause, whichever occurs first. PFS was analyzed by Kaplan-Meier methodology. BCL-2 expression was determined through central laboratory testing by immunohistochemistry (IHC) and based on a pre-specified scoring algorithm. High clinical score of 2+: ≥50% of tumor cells with moderate or higher cytoplasmic staining but < 50% of tumor cells with strong staining intensity; high clinical score of 3+: ≥50% of tumor cells with strong cytoplasmic staining.
Duration of Response (DOR)
DOR is defined as the number of days from the participant's date of first documented response (partial response [PR] or better) to the date of first documented progressive disease (PD) as determined by an Independent Review Committee (IRC) or death due to multiple myeloma, whichever occurs first. DOR was analyzed by Kaplan-Meier methodology.
Mean Change From Baseline in Brief Pain Inventory - Short Form (BPI-SF) Worst Pain
The BPI-SF is a pain-specific measure developed to assess patient-reported severity (or intensity) of pain (4 items) and the impact of pain on daily functioning (7 items) in patients with cancer pain. The four pain severity items assess pain at its "worst in last 24 hours," "least in last 24 hours," "average," and "now" (current pain). For these items, participants are asked to rate their pain on an 11-point numeric rating scale with anchors of 0 (no pain) and 10 (pain as bad as you can imagine). The Worst Pain scores range from 0 to 10, with higher scores indicating severe pain. Negative changes from baseline indicate improvement.
Mean Change From Baseline in Physical Functioning Scale of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
The QLQ-C30 is a 30-item subject self-report questionnaire composed of both multi-item and single scales, including five functional scales (physical, role, emotional, social, and cognitive), three symptom scales (fatigue, nausea and vomiting, and pain), a global health status/quality of life scale, and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). For the Physical Functioning scale, participants rate five items on a four-point scale, with 1 as "not at all" and 4 as "very much." The Physical Functioning Scale scores range from 0 to 100 and were calculated per the EORTC QLQ-C30 Scoring Manual (3rd edition), version 3.0. A high scale score represents high/healthy level of functioning. Positive changes from baseline indicate improvement.
Mean Change From Baseline in Global Health Status/Quality of Life Scale of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
The QLQ-C30 is a 30-item subject self-report questionnaire composed of both multi-item and single scales, including five functional scales (physical, role, emotional, social, and cognitive), three symptom scales (fatigue, nausea and vomiting, and pain), a global health status/quality of life scale, and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). For the Global Health Status/Quality of Life scale, participants rate two items on a seven point scale, with 1 as "very poor" and 7 as "excellent." The Global Health Status/Quality of Life scale ranges from 0 to 100 and was calculated per the EORTC QLQ-C30 Scoring Manual (3rd edition), version 3.0. A high score for the global health status/QoL represents a high QoL. Positive changes from baseline indicate improvement.
Mean Change From Baseline in Patient Reported Outcomes Measurement Information System [PROMIS] Cancer Fatigue Short Form [SF] Score
PROMIS Cancer Fatigue SF is a seven item questionnaire that assesses the impact and experience of fatigue over the past 7 days. All questions employ the following five response options: 1 = Not at all, 2 = A little bit, 3 = Somewhat, 4 = Quite a bit, and 5 = Very much. The total raw score is the sum of the responses to each question and is converted to a T-score. The T-score re-scales the total raw score to a standardized score with a mean of 50 and a standard deviation of 10. The [PROMIS] Cancer Fatigue Short Form [SF] 7a T-Scores range from 29.4 to 83.2, with higher scores indicating more fatigue. Negative changes from baseline indicate improvement.
Overall Survival (OS).
OS is defined as the number of days from the date of randomization to the date of death due to any cause. All events of death were to be included, regardless of whether the event occurred while the participant was still taking study drug or after the participant discontinued study drug. If a participant is not known to have died, OS was censored at the date of last contact. The distribution of OS was estimated using Kaplan-Meier methodology.
Time to Progression (TTP)
TTP is defined as the number of days from the date of randomization to the date of first documented progressive disease (PD) as determined by an Independent Review Committee (IRC) or death due to multiple myeloma, whichever occurs first. TTP was analyzed by Kaplan-Meier methodology.
Overall Response Rate (ORR)
Overall response rate is defined as the percentage of participants with documented best overall response of Partial Response (PR) or better (PR, Very good partial response [VGPR], Complete response [CR], or Stringent complete response [sCR]) per International Myeloma Working Group (IMWG) criteria as determined by an Independent Review Committee (IRC).
Minimal Residual Disease (MRD) Negativity Rate
MRD negativity rate is defined as the percentage of participants who have negative MRD by bone marrow aspirate at any time point after randomization and before progression or starting subsequent therapy. MRD negativity was defined at 10^-5 threshold (less than one residual myeloma cell per 10^5 total nucleated cells) as measured by centralized testing of bone marrow aspirate by Next Generation Sequencing (NGS). MRD positive participants include those of which all tested samples were found to be MRD positive or indeterminate. Participants with missing or unevaluable MRD status were considered as MRD positive.

Full Information

First Posted
April 20, 2016
Last Updated
August 18, 2023
Sponsor
AbbVie
Collaborators
Genentech, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02755597
Brief Title
A Study Evaluating Venetoclax (ABT-199) in Multiple Myeloma Subjects Who Are Receiving Bortezomib and Dexamethasone as Standard Therapy
Acronym
Bellini
Official Title
A Phase 3, Multicenter, Randomized, Double Blind Study of Bortezomib and Dexamethasone in Combination With Either Venetoclax or Placebo in Subjects With Relapsed or Refractory Multiple Myeloma Who Are Sensitive or Naïve to Proteasome Inhibitors
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
July 11, 2016 (Actual)
Primary Completion Date
March 15, 2021 (Actual)
Study Completion Date
August 15, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AbbVie
Collaborators
Genentech, Inc.

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
This was a Phase 3, multicenter, randomized, double blind, placebo-controlled study evaluating the efficacy and safety of venetoclax plus bortezomib and dexamethasone in participants with relapsed or refractory multiple myeloma who are considered sensitive or naïve to proteasome inhibitors and received 1 to 3 prior lines of therapy for multiple myeloma.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Relapsed/Refractory Multiple Myeloma
Keywords
Relapsed/refractory multiple myeloma, Relapsed multiple myeloma, Refractory multiple myeloma, Multiple myeloma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
291 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Venetoclax + Bortezomib and Dexamethasone
Arm Type
Experimental
Arm Description
Cycles 1-8: Venetoclax 800 mg orally every day (QD) on Days 1 - 21 plus bortezomib 1.3 mg/m^2 subcutaneously or IV on Days 1, 4, 8 & 11 and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 & 12; Cycles 9 and beyond: Venetoclax 800 mg orally every day (QD) on Days 1 - 35 plus bortezomib 1.3 mg/m^2 subcutaneously or IV on Days 1, 8, 15 and 22 and dexamethasone 20 mg orally on Days 1, 2, 8, 9, 15, 16, 22 and 23
Arm Title
Placebo + Bortezomib and Dexamethasone
Arm Type
Placebo Comparator
Arm Description
Cycles 1-8: Placebo (to match venetoclax 100 mg tablet) 800 mg orally every day (QD) on Days 1 - 21 plus bortezomib 1.3 mg/m^2 subcutaneously or IV on Days 1, 4, 8 & 11 and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 & 12; Cycles 9 and beyond: Placebo (to match venetoclax 100 mg tablet) 800 mg orally every day (QD) on Days 1 - 35 plus bortezomib 1.3 mg/m^2 subcutaneously or IV on Days 1, 8, 15 and 22 and dexamethasone 20 mg orally on Days 1, 2, 8, 9, 15, 16, 22 & 23
Intervention Type
Drug
Intervention Name(s)
Venetoclax
Other Intervention Name(s)
VENCLEXTA, VENCLYXTO
Intervention Description
Participants self-administered venetoclax tablets by mouth QD in combination with bortezomib. Venetoclax was to be given before other agents administered on the same day, if applicable. Each venetoclax dose was to be taken all at one time with approximately 240 mL of water within 30 minutes after completion of breakfast or the subject's first meal of the day. Tablets were to be swallowed whole and must not have been broken, chewed, or crushed. On days that pre-dose PK sampling was required, dosing occurred at the clinic to facilitate PK sampling.
Intervention Type
Drug
Intervention Name(s)
Bortezomib
Other Intervention Name(s)
Velcade
Intervention Description
Bortezomib (subcutaneous injection [preferred] or IV) was given following administration of venetoclax or placebo in Cycles 1 -8 on Days 1, 4, 8 and 11, and for Cycles 9 and beyond, on Days 1, 8, 15 and 22 and was to be administered per the prescribing information. The route of administration was to stay the same during the study.
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Intervention Description
Dexamethasone was to be given orally, administered per the prescribing information, the day of bortezomib dosing and the following day, given the protocol-defined dosing window (bortezomib dosing window is ± 1 day) is maintained. If bortezomib was interrupted or a dose is skipped, dexamethasone was to be administered as scheduled per protocol (unless dexamethasone was interrupted due to toxicity).
Intervention Type
Drug
Intervention Name(s)
Placebo for venetoclax
Intervention Description
Participants self-administered placebo tablets by mouth QD in combination with bortezomib. Placebo was to be given before other agents administered on the same day, if applicable. Each placebo dose was to be taken all at one time with approximately 240 mL of water within 30 minutes after completion of breakfast or the subject's first meal of the day. Tablets were to be swallowed whole and must not have been broken, chewed, or crushed. On days that pre-dose PK sampling was required, dosing occurred at the clinic to facilitate PK sampling.
Primary Outcome Measure Information:
Title
Progression-free Survival (PFS)
Description
PFS is defined as the number of days from the date the participant was randomized to the date of the first documented progressive disease (PD) as determined by an Independent Review Committee (IRC) or death due to any cause, whichever occurs first. PFS was analyzed by Kaplan-Meier methodology.
Time Frame
Median duration of follow-up was 28.6 months for the venetoclax group and 28.6 months for the placebo group
Secondary Outcome Measure Information:
Title
Very Good Partial Response (VGPR) or Better Response Rate
Description
The percentage of participants with documented best overall response of Very Good Partial Response (VGPR) or better (VGPR, Complete response [CR], or Stringent complete response [sCR]) per 2016 standard International Myeloma Working Group (IMWG) criteria as determined by an Independent Review Committee (IRC) was computed.
Time Frame
Response was assessed at Cycle 1, Day 1, and on Day 1 of every cycle thereafter; median time on follow-up was 28.6 months for the venetoclax group and 28.6 months for the placebo group
Title
Progression-Free Survival (PFS) in Participants With High B-cell Lymphoma 2 (BCL-2) Expression
Description
PFS is defined as the number of days from the date the participant was randomized to the date of the first documented progressive disease (PD) per investigator assessment or death due to any cause, whichever occurs first. PFS was analyzed by Kaplan-Meier methodology. BCL-2 expression was determined through central laboratory testing by immunohistochemistry (IHC) and based on a pre-specified scoring algorithm. High clinical score of 2+: ≥50% of tumor cells with moderate or higher cytoplasmic staining but < 50% of tumor cells with strong staining intensity; high clinical score of 3+: ≥50% of tumor cells with strong cytoplasmic staining.
Time Frame
Median duration of follow-up was 28.6 months for the venetoclax group and 28.6 months for the placebo group
Title
Duration of Response (DOR)
Description
DOR is defined as the number of days from the participant's date of first documented response (partial response [PR] or better) to the date of first documented progressive disease (PD) as determined by an Independent Review Committee (IRC) or death due to multiple myeloma, whichever occurs first. DOR was analyzed by Kaplan-Meier methodology.
Time Frame
Response was assessed at Cycle 1, Day 1, and on Day 1 of every cycle thereafter; median time on follow-up was 28.6 months for the venetoclax group and 28.6 months for the placebo group
Title
Mean Change From Baseline in Brief Pain Inventory - Short Form (BPI-SF) Worst Pain
Description
The BPI-SF is a pain-specific measure developed to assess patient-reported severity (or intensity) of pain (4 items) and the impact of pain on daily functioning (7 items) in patients with cancer pain. The four pain severity items assess pain at its "worst in last 24 hours," "least in last 24 hours," "average," and "now" (current pain). For these items, participants are asked to rate their pain on an 11-point numeric rating scale with anchors of 0 (no pain) and 10 (pain as bad as you can imagine). The Worst Pain scores range from 0 to 10, with higher scores indicating severe pain. Negative changes from baseline indicate improvement.
Time Frame
Baseline; Cycle 3 (Cycles 1 - 8 are 21 days, Cycles 9 and beyond are 35 days) through Cycle 47, collected on Day 1 of every other cycle and at the Treatment Completion Visit (TCV) while participant is on treatment
Title
Mean Change From Baseline in Physical Functioning Scale of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
Description
The QLQ-C30 is a 30-item subject self-report questionnaire composed of both multi-item and single scales, including five functional scales (physical, role, emotional, social, and cognitive), three symptom scales (fatigue, nausea and vomiting, and pain), a global health status/quality of life scale, and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). For the Physical Functioning scale, participants rate five items on a four-point scale, with 1 as "not at all" and 4 as "very much." The Physical Functioning Scale scores range from 0 to 100 and were calculated per the EORTC QLQ-C30 Scoring Manual (3rd edition), version 3.0. A high scale score represents high/healthy level of functioning. Positive changes from baseline indicate improvement.
Time Frame
Baseline; Cycle 3 (Cycles 1 - 8 are 21 days, Cycles 9 and beyond are 35 days) through Cycle 47, collected on Day 1 of every other cycle and at the Treatment Completion Visit (TCV) while participant is on treatment
Title
Mean Change From Baseline in Global Health Status/Quality of Life Scale of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
Description
The QLQ-C30 is a 30-item subject self-report questionnaire composed of both multi-item and single scales, including five functional scales (physical, role, emotional, social, and cognitive), three symptom scales (fatigue, nausea and vomiting, and pain), a global health status/quality of life scale, and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). For the Global Health Status/Quality of Life scale, participants rate two items on a seven point scale, with 1 as "very poor" and 7 as "excellent." The Global Health Status/Quality of Life scale ranges from 0 to 100 and was calculated per the EORTC QLQ-C30 Scoring Manual (3rd edition), version 3.0. A high score for the global health status/QoL represents a high QoL. Positive changes from baseline indicate improvement.
Time Frame
Baseline; Cycle 3 (Cycles 1 - 8 are 21 days, Cycles 9 and beyond are 35 days) through Cycle 47, collected on Day 1 of every other cycle and at the Treatment Completion Visit (TCV) while participant is on treatment
Title
Mean Change From Baseline in Patient Reported Outcomes Measurement Information System [PROMIS] Cancer Fatigue Short Form [SF] Score
Description
PROMIS Cancer Fatigue SF is a seven item questionnaire that assesses the impact and experience of fatigue over the past 7 days. All questions employ the following five response options: 1 = Not at all, 2 = A little bit, 3 = Somewhat, 4 = Quite a bit, and 5 = Very much. The total raw score is the sum of the responses to each question and is converted to a T-score. The T-score re-scales the total raw score to a standardized score with a mean of 50 and a standard deviation of 10. The [PROMIS] Cancer Fatigue Short Form [SF] 7a T-Scores range from 29.4 to 83.2, with higher scores indicating more fatigue. Negative changes from baseline indicate improvement.
Time Frame
Baseline; Cycle 3 (Cycles 1 - 8 are 21 days, Cycles 9 and beyond are 35 days) through Cycle 47, collected on Day 1 of every other cycle and at the Treatment Completion Visit (TCV) while participant is on treatment
Title
Overall Survival (OS).
Description
OS is defined as the number of days from the date of randomization to the date of death due to any cause. All events of death were to be included, regardless of whether the event occurred while the participant was still taking study drug or after the participant discontinued study drug. If a participant is not known to have died, OS was censored at the date of last contact. The distribution of OS was estimated using Kaplan-Meier methodology.
Time Frame
Median duration of follow-up was 45.6 months for the venetoclax group and 45.6 months for the placebo group
Title
Time to Progression (TTP)
Description
TTP is defined as the number of days from the date of randomization to the date of first documented progressive disease (PD) as determined by an Independent Review Committee (IRC) or death due to multiple myeloma, whichever occurs first. TTP was analyzed by Kaplan-Meier methodology.
Time Frame
Median time on follow-up up was 28.6 months for the venetoclax group and 28.6 months for the placebo group
Title
Overall Response Rate (ORR)
Description
Overall response rate is defined as the percentage of participants with documented best overall response of Partial Response (PR) or better (PR, Very good partial response [VGPR], Complete response [CR], or Stringent complete response [sCR]) per International Myeloma Working Group (IMWG) criteria as determined by an Independent Review Committee (IRC).
Time Frame
Response was assessed at Cycle 1, Day 1, and on Day 1 of every cycle thereafter; median time on follow-up was 28.6 months for the venetoclax group and 28.6 months for the placebo group
Title
Minimal Residual Disease (MRD) Negativity Rate
Description
MRD negativity rate is defined as the percentage of participants who have negative MRD by bone marrow aspirate at any time point after randomization and before progression or starting subsequent therapy. MRD negativity was defined at 10^-5 threshold (less than one residual myeloma cell per 10^5 total nucleated cells) as measured by centralized testing of bone marrow aspirate by Next Generation Sequencing (NGS). MRD positive participants include those of which all tested samples were found to be MRD positive or indeterminate. Participants with missing or unevaluable MRD status were considered as MRD positive.
Time Frame
Assessed at Screening; to confirm a stringent Complete Response (sCR) or Complete Response (CR); at 6 months and 12 months post-confirmed CR/sCR

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Eastern Cooperative Oncology Group (ECOG) performance score ≤ 2 Participant has documented relapsed or progressive multiple myeloma on or after any regimen or who are refractory to the most recent line of therapy. Relapsed myeloma is defined as previously treated myeloma that progresses and requires initiation of salvage therapy, but does not meet the criteria for refractory myeloma. Refractory myeloma is defined as disease that is nonresponsive (failure to achieve minimal response or development of progressive disease [PD]) while on primary or salvage therapy, or progresses within 60 days of last therapy. Participant must have received prior treatment with at least one, but no more than three, prior lines of therapy for multiple myeloma. A line of therapy consists of ≥ 1 complete cycle of a single agent, a regimen consisting of combination of several drugs, or a planned sequential therapy of various regimens. Prior treatment with bortezomib or other proteasome inhibitor is allowed, provided ALL of the following criteria are met: Disease is NOT refractory to any proteasome inhibitor, defined as no disease progression (i.e., PD, per International Myeloma Working Group [IMWG] or European Society for Blood and Marrow Transplantation [EBMT] criteria) while receiving proteasome inhibitor therapy or within 60 days after the last dose, AND best response achieved with any proteasome inhibitor therapy (alone or in combination) was at least a Partial Response (PR), AND participant did not discontinue any proteasome inhibitor due to intolerance or ≥ Grade 3 related toxicity. Participant has measurable disease at Screening, defined as at least one of the following: Serum M-protein ≥ 0.5 g/dL, OR Urine M-protein ≥ 200 mg in 24-hours, OR serum immunoglobulin free light chain (FLC) ≥ 10 mg/dL provided serum FLC ratio is abnormal. Exclusion Criteria: Participant is refractory to any proteasome inhibitor, defined as progression on or within 60 days of the last dose of a proteasome inhibitor-containing regimen. Participant has had prior treatment with proteasome inhibitor within 60 days prior to first dose of study drug. Participant has any of the following conditions: Non-secretory multiple myeloma, active plasma cell leukemia i.e., either 20% of peripheral white blood cells or greater than 2.0 X 10^9/liter (L) circulating plasma cells by standard differential, Waldenstrom's macroglobulinemia, amyloidosis, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes), known Human Immunodeficiency Viral (HIV) infection, active hepatitis B or C infection based on blood screen tests, significant cardiovascular disease, including uncontrolled angina, severe or uncontrolled arrhythmia, recent myocardial infarction within 6 months of randomization, or congestive heart failure New York Heart Association (NYHA) Class ≥ 3, major surgery within 4 weeks prior to randomization, acute infections requiring parenteral therapy (antibiotic, antifungal, or antiviral) within 14 days prior to randomization, peripheral neuropathy ≥ Grade 3 or ≥ Grade 2 with pain within 2 weeks prior to randomization, uncontrolled diabetes or uncontrolled hypertension within 14 days prior to randomization, any other medical condition that, in the opinion of the Investigator, would adversely affect the participant's participation in the study Participant has a history of other active malignancies, including myelodysplastic syndrome (MDS), within the past 3 years prior to study entry, with the following exceptions: Adequately treated in situ carcinoma of the cervix uteri or the breast, basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin, prostate cancer Gleason grade 6 or lower AND with stable Prostate Specific Antigen (PSA) levels off treatment, previous malignancy with no evidence of disease confined and surgically resected (or treated with other modalities) with curative intent and unlikely to impact survival during the duration of the study If participant had prior allogeneic stem cell transplant (SCT), participant has evidence of ongoing graft-versus-host disease (GvHD)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ABBVIE INC.
Organizational Affiliation
AbbVie
Official's Role
Study Director
Facility Information:
Facility Name
Rocky Mountain Regional VA Medical Center/Eastern Colorado Health Care System /ID# 156524
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Univ of Colorado Cancer Center /ID# 149130
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Duke Cancer Center /ID# 149099
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710-3000
Country
United States
Facility Name
Gabrail Cancer Center Research /ID# 149098
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
Facility Name
Royal Prince Alfred Hospital /ID# 149108
City
Camperdown
State/Province
New South Wales
ZIP/Postal Code
2050
Country
Australia
Facility Name
Concord Repatriation General Hospital /ID# 149106
City
Concord
State/Province
New South Wales
ZIP/Postal Code
2139
Country
Australia
Facility Name
Liverpool Hospital /ID# 149110
City
Liverpool
State/Province
New South Wales
ZIP/Postal Code
2170
Country
Australia
Facility Name
Royal Brisbane and Women's Hospital /ID# 149105
City
Herston
State/Province
Queensland
ZIP/Postal Code
4029
Country
Australia
Facility Name
The Queen Elizabeth Hospital /ID# 149104
City
Woodville South
State/Province
South Australia
ZIP/Postal Code
5011
Country
Australia
Facility Name
Royal Hobart Hospital /ID# 149111
City
Hobart
State/Province
Tasmania
ZIP/Postal Code
7000
Country
Australia
Facility Name
Box Hill Hospital /ID# 149112
City
Box Hill
State/Province
Victoria
ZIP/Postal Code
3128
Country
Australia
Facility Name
Peter MacCallum Cancer Ctr /ID# 149107
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3000
Country
Australia
Facility Name
Alfred Health /ID# 150085
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
Facility Name
Fiona Stanley Hospital /ID# 148967
City
Murdoch
State/Province
Western Australia
ZIP/Postal Code
6150
Country
Australia
Facility Name
Perth Blood Institute Ltd /ID# 148966
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Facility Name
Hospital das Clinicas da Universidade Federal de Goiás /ID# 149290
City
Goiania
State/Province
Goias
ZIP/Postal Code
74605-020
Country
Brazil
Facility Name
Liga Norte Riograndense Contra o Câncer /ID# 149023
City
Natal
State/Province
Rio Grande Do Norte
ZIP/Postal Code
59075-740
Country
Brazil
Facility Name
Hospital Sao Lucas da PUCRS /ID# 149027
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90610-000
Country
Brazil
Facility Name
Clinica Sao Germano /ID# 149851
City
São Paulo
State/Province
Sao Paulo
ZIP/Postal Code
04537-080
Country
Brazil
Facility Name
Instituto Nacional de Câncer José Alencar Gomes da Silva (INCA) /ID# 149020
City
Rio de Janeiro
ZIP/Postal Code
20231-050
Country
Brazil
Facility Name
Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo /ID# 149025
City
Sao Paulo
ZIP/Postal Code
05403-000
Country
Brazil
Facility Name
Victoria Hospital /ID# 149846
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4L6
Country
Canada
Facility Name
CISSS de la Monteregie /ID# 149844
City
Greenfield Park
State/Province
Quebec
ZIP/Postal Code
J4V 2H1
Country
Canada
Facility Name
CHU Limoges - Dupuytren 1 /ID# 149292
City
Limoges CEDEX 1
State/Province
Franche-Comte
ZIP/Postal Code
87042
Country
France
Facility Name
CHU de Nantes, Hotel Dieu -HME /ID# 149294
City
Nantes
State/Province
Pays-de-la-Loire
ZIP/Postal Code
44000
Country
France
Facility Name
Duplicate_Centre Hospitalier Lyon Sud /ID# 149300
City
Pierre Benite CEDEX
State/Province
Rhone
ZIP/Postal Code
69495
Country
France
Facility Name
CHRU de Brest - Hopital Morvan /ID# 149299
City
Brest
ZIP/Postal Code
29200
Country
France
Facility Name
CHU Grenoble - Hopital Michallon /ID# 149301
City
La Tronche
ZIP/Postal Code
38700
Country
France
Facility Name
Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 148949
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Universitaetsklinikum Carl Gustav Carus an der TU Dresden /ID# 148948
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Asklepios Klinik Altona /ID# 150116
City
Hamburg
ZIP/Postal Code
22763
Country
Germany
Facility Name
Debreceni Egyetem Klinikai Kozpont /ID# 152517
City
Debrecen
State/Province
Hajdu-Bihar
ZIP/Postal Code
4032
Country
Hungary
Facility Name
Somogy Megyei Kaposi Mor Oktato Korhaz /ID# 152516
City
Kaposvár
State/Province
Somogy
ZIP/Postal Code
7400
Country
Hungary
Facility Name
Semmelweis Egyetem /ID# 152519
City
Budapest
ZIP/Postal Code
1085
Country
Hungary
Facility Name
Semmelweis Egyetem /ID# 152520
City
Budapest
ZIP/Postal Code
1085
Country
Hungary
Facility Name
Del-pesti Centrumkorhaz Orszagos Hematologiai es Infektologiai Intezet /ID# 152518
City
Budapest
ZIP/Postal Code
1097
Country
Hungary
Facility Name
University Hospital Galway /ID# 149061
City
Galway
ZIP/Postal Code
H91 YR71
Country
Ireland
Facility Name
Azienda Ospedaliero-Universitaria Policlinico Umberto I /ID# 148939
City
Rome
State/Province
Lazio
ZIP/Postal Code
00161
Country
Italy
Facility Name
Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona /ID# 148942
City
Ancona
ZIP/Postal Code
60126
Country
Italy
Facility Name
IRCCS Azienda Ospedaliero-Universitaria di Bologna /ID# 148936
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
Ospedale S.Eugenio /ID# 148938
City
Rome
ZIP/Postal Code
00144
Country
Italy
Facility Name
A.O.U. Città della Salute e della Scienza di Torino/Ospedale Molinette /ID# 148943
City
Turin
ZIP/Postal Code
10126
Country
Italy
Facility Name
Nagoya City University Hospital /ID# 150943
City
Nagoya shi
State/Province
Aichi
ZIP/Postal Code
467-8602
Country
Japan
Facility Name
Kyushu University Hospital /ID# 150896
City
Fukuoka-shi
State/Province
Fukuoka
ZIP/Postal Code
812-8582
Country
Japan
Facility Name
Ogaki Municipal Hospital /ID# 150783
City
Ogaki-shi
State/Province
Gifu
ZIP/Postal Code
503-8502
Country
Japan
Facility Name
Gunma University Hospital /ID# 150275
City
Maebashi-shi
State/Province
Gunma
ZIP/Postal Code
371-8511
Country
Japan
Facility Name
National Hospital Organization Shibukawa Medical Center /ID# 150281
City
Shibukawa-shi
State/Province
Gunma
ZIP/Postal Code
377-0280
Country
Japan
Facility Name
Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital /ID# 150242
City
Hiroshima-shi
State/Province
Hiroshima
ZIP/Postal Code
730-8619
Country
Japan
Facility Name
Kobe City Medical Center General Hospital /ID# 150944
City
Kobe-shi
State/Province
Hyogo
ZIP/Postal Code
650-0047
Country
Japan
Facility Name
National Hospital Organization Mito Medical Center /ID# 151051
City
Higashi Ibaraki-gun
State/Province
Ibaraki
ZIP/Postal Code
311-3193
Country
Japan
Facility Name
Duplicate_Kyoto Prefectural University of Medicine /ID# 150719
City
Kyoto-shi
State/Province
Kyoto
ZIP/Postal Code
602-8566
Country
Japan
Facility Name
JCHO Kyoto Kuramaguchi Medical /ID# 150781
City
Kyoto-shi
State/Province
Kyoto
ZIP/Postal Code
603-8151
Country
Japan
Facility Name
Tohoku University Hospital /ID# 150945
City
Sendai-shi
State/Province
Miyagi
ZIP/Postal Code
9808574
Country
Japan
Facility Name
Okayama Medical Center /ID# 150717
City
Okayama-shi
State/Province
Okayama
ZIP/Postal Code
701-1192
Country
Japan
Facility Name
Japanese Red Cross Osaka Hospital /ID# 150716
City
Osaka-shi
State/Province
Osaka
ZIP/Postal Code
543-8555
Country
Japan
Facility Name
Saitama Medical Center /ID# 151044
City
Kawagoe-shi
State/Province
Saitama
ZIP/Postal Code
350-8550
Country
Japan
Facility Name
Tochigi Cancer Center /ID# 150192
City
Utsunomiya-shi
State/Province
Tochigi
ZIP/Postal Code
320-0834
Country
Japan
Facility Name
National Cancer Center Hospital /ID# 151039
City
Chuo-ku
State/Province
Tokyo
ZIP/Postal Code
104-0045
Country
Japan
Facility Name
The Cancer Institute Hospital Of JFCR /ID# 150780
City
Koto-ku
State/Province
Tokyo
ZIP/Postal Code
135-8550
Country
Japan
Facility Name
Japanese Red Cross Medical Center /ID# 149902
City
Shibuya-ku
State/Province
Tokyo
ZIP/Postal Code
150-8935
Country
Japan
Facility Name
National Hospital Organization Disaster Medical Center /ID# 150784
City
Tachikawa-shi
State/Province
Tokyo
ZIP/Postal Code
190-0014
Country
Japan
Facility Name
National Cancer Center /ID# 150889
City
Goyang
State/Province
Gyeonggido
ZIP/Postal Code
10408
Country
Korea, Republic of
Facility Name
Seoul National University Bundang Hospital /ID# 150888
City
Seongnam
State/Province
Gyeonggido
ZIP/Postal Code
13620
Country
Korea, Republic of
Facility Name
Duplicate_Yonsei University Health System, Severance hospital. /ID# 150891
City
Seoul
State/Province
Seoul Teugbyeolsi
ZIP/Postal Code
03722
Country
Korea, Republic of
Facility Name
Chonnam National University Hospital /ID# 150894
City
Gwangju
ZIP/Postal Code
61469
Country
Korea, Republic of
Facility Name
Gachon University Gil Medical Center /ID# 150893
City
Incheon
ZIP/Postal Code
21565
Country
Korea, Republic of
Facility Name
Seoul National University Hospital /ID# 150890
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Samsung Medical Center /ID# 150892
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
The Catholic University of Korea, Seoul St. Mary's Hospital /ID# 150895
City
Seoul
ZIP/Postal Code
06591
Country
Korea, Republic of
Facility Name
Kuzbass Regional Clinical Hospital /ID# 148955
City
Kemerovo
State/Province
Kemerovskaya Oblast
ZIP/Postal Code
650099
Country
Russian Federation
Facility Name
State Institution of Health of the Ryazan Regional Clinical Hospital /ID# 148956
City
Ryazan
State/Province
Ryazanskaya Oblast
ZIP/Postal Code
390039
Country
Russian Federation
Facility Name
LLC Novaya Klinika /ID# 148974
City
Pyatigorsk
State/Province
Stavropol Skiy Kray
ZIP/Postal Code
357500
Country
Russian Federation
Facility Name
Central Clinical Hospital RZHD Medicine /ID# 148954
City
Moscow
ZIP/Postal Code
129128
Country
Russian Federation
Facility Name
Clinical Oncology Dispensary of Omsk /ID# 148953
City
Omsk
ZIP/Postal Code
644013
Country
Russian Federation
Facility Name
Samara State Medical University /ID# 148952
City
Samara
ZIP/Postal Code
443099
Country
Russian Federation
Facility Name
Bashkir State Medical University /ID# 151206
City
Ufa
ZIP/Postal Code
450008
Country
Russian Federation
Facility Name
Hospital Duran i Reynals /ID# 148989
City
Hospitalet de Llobregat
State/Province
Barcelona
ZIP/Postal Code
08907
Country
Spain
Facility Name
Hospital Universitario de la Princesa /ID# 148980
City
Madrid
ZIP/Postal Code
28006
Country
Spain
Facility Name
Hospital Universitario 12 de Octubre /ID# 148981
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Hospital Universitario Dr. Peset /ID# 148986
City
Valencia
ZIP/Postal Code
46017
Country
Spain
Facility Name
Changhua Christian Hospital /ID# 154447
City
Changhua City, Changhua County
ZIP/Postal Code
50006
Country
Taiwan
Facility Name
China Medical University Hospital /ID# 154446
City
Taichung City
ZIP/Postal Code
40447
Country
Taiwan
Facility Name
National Taiwan University Hospital /ID# 154444
City
Taipei City
ZIP/Postal Code
100
Country
Taiwan
Facility Name
Taipei Veterans General Hosp /ID# 154445
City
Taipei City
ZIP/Postal Code
11217
Country
Taiwan
Facility Name
Communal Nonprofit Enterprise Cherkasy Regional Oncology Dispensary /ID# 152414
City
Cherkasy
ZIP/Postal Code
18009
Country
Ukraine
Facility Name
Municipal Non-Profit Enterprise City Clinical Hospital 4 of Dnipro City Council /ID# 152411
City
Dnipro
ZIP/Postal Code
49102
Country
Ukraine
Facility Name
National Cancer Institute /ID# 152413
City
Kyiv
ZIP/Postal Code
03022
Country
Ukraine
Facility Name
Leicester Royal Infirmary /ID# 149057
City
Leicester
State/Province
England
ZIP/Postal Code
LE1 5WW
Country
United Kingdom
Facility Name
Barts Health NHS Trust /ID# 149050
City
London
State/Province
London, City Of
ZIP/Postal Code
E1 2ES
Country
United Kingdom
Facility Name
Nottingham University Hospitals NHS Trust /ID# 149047
City
Nottingham
State/Province
Nottinghamshire
ZIP/Postal Code
NG5 1PB
Country
United Kingdom
Facility Name
Blackpool Teaching Hospitals NHS Foundation Trust /ID# 149058
City
Blackpool
ZIP/Postal Code
FY3 8NR
Country
United Kingdom
Facility Name
East Kent Hospitals University NHS Foundation Trust /ID# 149059
City
Canterbury
ZIP/Postal Code
CT1 3NG
Country
United Kingdom
Facility Name
University College London Hospitals NHS Foundation Trust /ID# 149044
City
London
ZIP/Postal Code
NW1 2PG
Country
United Kingdom
Facility Name
King's College Hospital NHS Foundation Trust /ID# 149045
City
London
ZIP/Postal Code
SE5 9RS
Country
United Kingdom
Facility Name
Manchester University NHS Foundation Trust /ID# 149046
City
Manchester
ZIP/Postal Code
M13 9WL
Country
United Kingdom
Facility Name
Barking, Havering and Redbridge University Hospitals NHS Trust /ID# 149055
City
Romford
ZIP/Postal Code
RM7 0AG
Country
United Kingdom
Facility Name
The Royal Wolverhampton NHS Trust /ID# 149043
City
Wolverhampton
ZIP/Postal Code
WV10 0QP
Country
United Kingdom

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/
Citations:
PubMed Identifier
33129376
Citation
Kumar SK, Harrison SJ, Cavo M, de la Rubia J, Popat R, Gasparetto C, Hungria V, Salwender H, Suzuki K, Kim I, Punnoose EA, Hong WJ, Freise KJ, Yang X, Sood A, Jalaluddin M, Ross JA, Ward JE, Maciag PC, Moreau P. Venetoclax or placebo in combination with bortezomib and dexamethasone in patients with relapsed or refractory multiple myeloma (BELLINI): a randomised, double-blind, multicentre, phase 3 trial. Lancet Oncol. 2020 Dec;21(12):1630-1642. doi: 10.1016/S1470-2045(20)30525-8. Epub 2020 Oct 29.
Results Reference
derived

Learn more about this trial

A Study Evaluating Venetoclax (ABT-199) in Multiple Myeloma Subjects Who Are Receiving Bortezomib and Dexamethasone as Standard Therapy

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