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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02755597
Registration number
NCT02755597
Ethics application status
Date submitted
20/04/2016
Date registered
29/04/2016
Date last updated
22/08/2023
Titles & IDs
Public title
A Study Evaluating Venetoclax (ABT-199) in Multiple Myeloma Subjects Who Are Receiving Bortezomib and Dexamethasone as Standard Therapy
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Scientific 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
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Secondary ID [1]
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2015-004411-20
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Secondary ID [2]
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M14-031
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Universal Trial Number (UTN)
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Trial acronym
Bellini
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Relapsed/Refractory Multiple Myeloma
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Condition category
Condition code
Cancer
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Other cancer types
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Intervention/exposure
Study type
Interventional(has expanded access)
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Description of intervention(s) / exposure
Treatment: Drugs - Venetoclax
Treatment: Drugs - Bortezomib
Treatment: Drugs - Dexamethasone
Treatment: Drugs - Placebo for venetoclax
Experimental: Venetoclax + Bortezomib and Dexamethasone - 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
Placebo Comparator: Placebo + Bortezomib and Dexamethasone - 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
Treatment: Drugs: Venetoclax
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.
Treatment: Drugs: Bortezomib
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.
Treatment: Drugs: Dexamethasone
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).
Treatment: Drugs: Placebo for venetoclax
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.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Progression-free Survival (PFS)
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Assessment method [1]
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PFS is defined as the 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.
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Timepoint [1]
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Median duration of follow-up was 28.6 months for the venetoclax group and 28.6 months for the placebo group
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Secondary outcome [1]
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Very Good Partial Response (VGPR) or Better Response Rate
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Assessment method [1]
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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.
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Timepoint [1]
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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
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Secondary outcome [2]
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Progression-Free Survival (PFS) in Participants With High B-cell Lymphoma 2 (BCL-2) Expression
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Assessment method [2]
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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.
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Timepoint [2]
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Median duration of follow-up was 28.6 months for the venetoclax group and 28.6 months for the placebo group
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Secondary outcome [3]
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Duration of Response (DOR)
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Assessment method [3]
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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.
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Timepoint [3]
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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
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Secondary outcome [4]
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Mean Change From Baseline in Brief Pain Inventory - Short Form (BPI-SF) Worst Pain
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Assessment method [4]
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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.
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Timepoint [4]
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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
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Secondary outcome [5]
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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)
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Assessment method [5]
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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.
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Timepoint [5]
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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
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Secondary outcome [6]
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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)
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Assessment method [6]
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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.
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Timepoint [6]
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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
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Secondary outcome [7]
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Mean Change From Baseline in Patient Reported Outcomes Measurement Information System [PROMIS] Cancer Fatigue Short Form [SF] Score
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Assessment method [7]
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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.
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Timepoint [7]
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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
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Secondary outcome [8]
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Overall Survival (OS).
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Assessment method [8]
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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.
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Timepoint [8]
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Median duration of follow-up was 45.6 months for the venetoclax group and 45.6 months for the placebo group
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Secondary outcome [9]
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Time to Progression (TTP)
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Assessment method [9]
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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.
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Timepoint [9]
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Median time on follow-up up was 28.6 months for the venetoclax group and 28.6 months for the placebo group
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Secondary outcome [10]
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Overall Response Rate (ORR)
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Assessment method [10]
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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).
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Timepoint [10]
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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
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Secondary outcome [11]
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Minimal Residual Disease (MRD) Negativity Rate
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Assessment method [11]
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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.
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Timepoint [11]
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Assessed at Screening; to confirm a stringent Complete Response (sCR) or Complete Response (CR); at 6 months and 12 months post-confirmed CR/sCR
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Eligibility
Key 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.
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Minimum age
18
Years
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Maximum age
99
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- 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)
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
11/07/2016
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
15/08/2022
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Sample size
Target
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Accrual to date
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Final
291
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,TAS,VIC,WA
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Recruitment hospital [1]
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Royal Prince Alfred Hospital /ID# 149108 - Camperdown
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Recruitment hospital [2]
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Concord Repatriation General Hospital /ID# 149106 - Concord
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Liverpool Hospital /ID# 149110 - Liverpool
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Royal Brisbane and Women's Hospital /ID# 149105 - Herston
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The Queen Elizabeth Hospital /ID# 149104 - Woodville South
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Royal Hobart Hospital /ID# 149111 - Hobart
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Recruitment hospital [7]
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Box Hill Hospital /ID# 149112 - Box Hill
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Recruitment hospital [8]
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Peter MacCallum Cancer Ctr /ID# 149107 - Melbourne
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Recruitment hospital [9]
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Alfred Health /ID# 150085 - Melbourne
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Recruitment hospital [10]
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Fiona Stanley Hospital /ID# 148967 - Murdoch
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Recruitment hospital [11]
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Perth Blood Institute Ltd /ID# 148966 - Nedlands
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Recruitment postcode(s) [1]
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2050 - Camperdown
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Recruitment postcode(s) [2]
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2139 - Concord
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Recruitment postcode(s) [3]
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2170 - Liverpool
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Recruitment postcode(s) [4]
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4029 - Herston
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Recruitment postcode(s) [5]
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5011 - Woodville South
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Recruitment postcode(s) [6]
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7000 - Hobart
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Recruitment postcode(s) [7]
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3128 - Box Hill
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Recruitment postcode(s) [8]
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3000 - Melbourne
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Recruitment postcode(s) [9]
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3004 - Melbourne
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Recruitment postcode(s) [10]
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6150 - Murdoch
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Recruitment postcode(s) [11]
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6009 - Nedlands
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Recruitment outside Australia
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United States of America
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Colorado
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North Carolina
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Ohio
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Brazil
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Goias
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Brazil
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Rio Grande Do Norte
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Rio Grande Do Sul
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Brazil
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Sao Paulo
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Brazil
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Rio de Janeiro
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Ontario
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France
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France
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France
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France
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La Tronche
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Germany
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Berlin
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Germany
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Dresden
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Hajdu-Bihar
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Somogy
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Lazio
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Italy
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Rome
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Italy
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Turin
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Aichi
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Fukuoka
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Gifu
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Gunma
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Hiroshima
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Hyogo
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Ibaraki
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Kyoto
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Miyagi
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Okayama
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Osaka
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Saitama
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Tochigi
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Tokyo
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Korea, Republic of
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Gyeonggido
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Korea, Republic of
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Seoul Teugbyeolsi
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Korea, Republic of
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Gwangju
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Korea, Republic of
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Incheon
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Korea, Republic of
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Seoul
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Russian Federation
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Kemerovskaya Oblast
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Russian Federation
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Ryazanskaya Oblast
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Russian Federation
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Stavropol Skiy Kray
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Russian Federation
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Moscow
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Russian Federation
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Omsk
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Russian Federation
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Samara
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Russian Federation
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Ufa
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Spain
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Barcelona
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Spain
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Madrid
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Spain
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Valencia
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Taiwan
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Changhua City, Changhua County
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Taiwan
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Taichung City
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Taiwan
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Taipei City
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Ukraine
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Cherkasy
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Ukraine
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Dnipro
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Ukraine
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Kyiv
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United Kingdom
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England
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United Kingdom
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London, City Of
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United Kingdom
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Nottinghamshire
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United Kingdom
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Blackpool
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United Kingdom
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Canterbury
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United Kingdom
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London
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United Kingdom
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Manchester
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United Kingdom
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Romford
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United Kingdom
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Wolverhampton
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
AbbVie
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Commercial sector/Industry
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Genentech, Inc.
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02755597
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Public notes
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Contacts
Principal investigator
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ABBVIE INC.
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AbbVie
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Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02755597
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