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AzTrials

Relapsed/Refractory Multiple MyelomaPhase 3BelliniNCT02755597

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

A Phase 3 study testing Venetoclax, Bortezomib and Dexamethasone in people with Relapsed/Refractory Multiple Myeloma, run by AbbVie at 97 sites in 16 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 to 99 years
Conditions the study is for
Relapsed/Refractory Multiple Myeloma
What is being tested?
Venetoclax, Bortezomib and Dexamethasone
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
291 participants
Where
97 sitesin 16 countries
Study dates
11 Jul 2016to 15 Aug 2022
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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)

Trial locations and contacts

97 sites in 16 countries.

97 sites in 16 countries

Japan19 sites

  • National Cancer Center Hospital /ID# 151039

    Chuo-ku, Tokyo, 104-0045

  • Kyushu University Hospital /ID# 150896

    Fukuoka, Fukuoka, 812-8582

  • National Hospital Organization Mito Medical Center /ID# 151051

    Higashi Ibaraki-gun, Ibaraki, 311-3193

  • Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital /ID# 150242

    Hiroshima, Hiroshima, 730-8619

  • Saitama Medical Center /ID# 151044

    Kawagoe-shi, Saitama, 350-8550

  • Kobe City Medical Center General Hospital /ID# 150944

    Kobe, Hyōgo, 650-0047

  • The Cancer Institute Hospital Of JFCR /ID# 150780

    Koto-ku, Tokyo, 135-8550

  • Duplicate_Kyoto Prefectural University of Medicine /ID# 150719

    Kyoto, Kyoto, 602-8566

  • JCHO Kyoto Kuramaguchi Medical /ID# 150781

    Kyoto, Kyoto, 603-8151

  • Gunma University Hospital /ID# 150275

    Maebashi, Gunma, 371-8511

  • Nagoya City University Hospital /ID# 150943

    Nagoya, Aichi-ken, 467-8602

  • Ogaki Municipal Hospital /ID# 150783

    Ogaki-shi, Gifu, 503-8502

  • Okayama Medical Center /ID# 150717

    Okayama, Okayama-ken, 701-1192

  • Japanese Red Cross Osaka Hospital /ID# 150716

    Osaka, Osaka, 543-8555

  • Tohoku University Hospital /ID# 150945

    Sendai, Miyagi, 9808574

  • National Hospital Organization Shibukawa Medical Center /ID# 150281

    Shibukawa-shi, Gunma, 377-0280

  • Japanese Red Cross Medical Center /ID# 149902

    Shibuya-ku, Tokyo, 150-8935

  • National Hospital Organization Disaster Medical Center /ID# 150784

    Tachikawa-shi, Tokyo, 190-0014

  • Tochigi Cancer Center /ID# 150192

    Utsunomiya, Tochigi, 320-0834

Other trials in Japan

Australia11 sites

  • Box Hill Hospital /ID# 149112

    Box Hill, Victoria, 3128

  • Royal Prince Alfred Hospital /ID# 149108

    Camperdown, New South Wales, 2050

  • Concord Repatriation General Hospital /ID# 149106

    Concord, New South Wales, 2139

  • Royal Brisbane and Women's Hospital /ID# 149105

    Herston, Queensland, 4029

  • Royal Hobart Hospital /ID# 149111

    Hobart, Tasmania, 7000

  • Liverpool Hospital /ID# 149110

    Liverpool, New South Wales, 2170

  • Peter MacCallum Cancer Ctr /ID# 149107

    Melbourne, Victoria, 3000

  • Alfred Health /ID# 150085

    Melbourne, Victoria, 3004

  • Fiona Stanley Hospital /ID# 148967

    Murdoch, Western Australia, 6150

  • Perth Blood Institute Ltd /ID# 148966

    Nedlands, Western Australia, 6009

  • The Queen Elizabeth Hospital /ID# 149104

    Woodville South, South Australia, 5011

Other trials in Australia

United Kingdom10 sites

  • Blackpool Teaching Hospitals NHS Foundation Trust /ID# 149058

    Blackpool, FY3 8NR

  • East Kent Hospitals University NHS Foundation Trust /ID# 149059

    Canterbury, CT1 3NG

  • Leicester Royal Infirmary /ID# 149057

    Leicester, England, LE1 5WW

  • Barts Health NHS Trust /ID# 149050

    London, London, City of, E1 2ES

  • University College London Hospitals NHS Foundation Trust /ID# 149044

    London, NW1 2PG

  • King's College Hospital NHS Foundation Trust /ID# 149045

    London, SE5 9RS

  • Manchester University NHS Foundation Trust /ID# 149046

    Manchester, M13 9WL

  • Nottingham University Hospitals NHS Trust /ID# 149047

    Nottingham, Nottinghamshire, NG5 1PB

  • Barking, Havering and Redbridge University Hospitals NHS Trust /ID# 149055

    Romford, RM7 0AG

  • The Royal Wolverhampton NHS Trust /ID# 149043

    Wolverhampton, WV10 0QP

Other trials in United Kingdom

South Korea8 sites

  • National Cancer Center /ID# 150889

    Goyang, Gyeonggido, 10408

  • Chonnam National University Hospital /ID# 150894

    Gwangju, 61469

  • Gachon University Gil Medical Center /ID# 150893

    Incheon, 21565

  • Seoul National University Bundang Hospital /ID# 150888

    Seongnam, Gyeonggido, 13620

  • Duplicate_Yonsei University Health System, Severance hospital. /ID# 150891

    Seoul, Seoul Teugbyeolsi, 03722

  • Seoul National University Hospital /ID# 150890

    Seoul, 03080

  • Samsung Medical Center /ID# 150892

    Seoul, 06351

  • The Catholic University of Korea, Seoul St. Mary's Hospital /ID# 150895

    Seoul, 06591

Other trials in South Korea

Russia7 sites

  • Kuzbass Regional Clinical Hospital /ID# 148955

    Kemerovo, Kemerovo Oblast, 650099

  • Central Clinical Hospital RZHD Medicine /ID# 148954

    Moscow, 129128

  • Clinical Oncology Dispensary of Omsk /ID# 148953

    Omsk, 644013

  • LLC Novaya Klinika /ID# 148974

    Pyatigorsk, Stavropol Kray, 357500

  • State Institution of Health of the Ryazan Regional Clinical Hospital /ID# 148956

    Ryazan, Ryazan Oblast, 390039

  • Samara State Medical University /ID# 148952

    Samara, 443099

  • Bashkir State Medical University /ID# 151206

    Ufa, 450008

Other trials in Russia

Brazil6 sites

  • Hospital das Clinicas da Universidade Federal de Goiás /ID# 149290

    Goiânia, Goiás, 74605-020

  • Liga Norte Riograndense Contra o Câncer /ID# 149023

    Natal, Rio Grande do Norte, 59075-740

  • Hospital Sao Lucas da PUCRS /ID# 149027

    Porto Alegre, Rio Grande do Sul, 90610-000

  • Instituto Nacional de Câncer José Alencar Gomes da Silva (INCA) /ID# 149020

    Rio de Janeiro, 20231-050

  • Clinica Sao Germano /ID# 149851

    São Paulo, São Paulo, 04537-080

  • Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo /ID# 149025

    São Paulo, 05403-000

Other trials in Brazil

France5 sites

  • CHRU de Brest - Hopital Morvan /ID# 149299

    Brest, 29200

  • CHU Grenoble - Hopital Michallon /ID# 149301

    La Tronche, 38700

  • CHU Limoges - Dupuytren 1 /ID# 149292

    Limoges, Franche-Comte, 87042

  • CHU de Nantes, Hotel Dieu -HME /ID# 149294

    Nantes, Pays de la Loire Region, 44000

  • Duplicate_Centre Hospitalier Lyon Sud /ID# 149300

    Pierre-Bénite, Rhone, 69495

Other trials in France

Hungary5 sites

  • Semmelweis Egyetem /ID# 152519

    Budapest, 1085

  • Semmelweis Egyetem /ID# 152520

    Budapest, 1085

  • Del-pesti Centrumkorhaz Orszagos Hematologiai es Infektologiai Intezet /ID# 152518

    Budapest, 1097

  • Debreceni Egyetem Klinikai Kozpont /ID# 152517

    Debrecen, Hajdú-Bihar, 4032

  • Somogy Megyei Kaposi Mor Oktato Korhaz /ID# 152516

    Kaposvár, Somogy County, 7400

Other trials in Hungary

Italy5 sites

  • Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona /ID# 148942

    Ancona, 60126

  • IRCCS Azienda Ospedaliero-Universitaria di Bologna /ID# 148936

    Bologna, 40138

  • Azienda Ospedaliero-Universitaria Policlinico Umberto I /ID# 148939

    Rome, Lazio, 00161

  • Ospedale S.Eugenio /ID# 148938

    Rome, 00144

  • A.O.U. Città della Salute e della Scienza di Torino/Ospedale Molinette /ID# 148943

    Turin, 10126

Other trials in Italy

United States4 sites

  • Rocky Mountain Regional VA Medical Center/Eastern Colorado Health Care System /ID# 156524

    Aurora, Colorado, 80045

  • Univ of Colorado Cancer Center /ID# 149130

    Aurora, Colorado, 80045

  • Gabrail Cancer Center Research /ID# 149098

    Canton, Ohio, 44718

  • Duke Cancer Center /ID# 149099

    Durham, North Carolina, 27710-3000

Other trials in United States

Spain4 sites

  • Hospital Duran i Reynals /ID# 148989

    L'Hospitalet de Llobregat, Barcelona, 08907

  • Hospital Universitario de la Princesa /ID# 148980

    Madrid, 28006

  • Hospital Universitario 12 de Octubre /ID# 148981

    Madrid, 28041

  • Hospital Universitario Dr. Peset /ID# 148986

    Valencia, 46017

Other trials in Spain

Taiwan4 sites

  • Changhua Christian Hospital /ID# 154447

    Changhua City, Changhua County, 50006

  • China Medical University Hospital /ID# 154446

    Taichung, 40447

  • National Taiwan University Hospital /ID# 154444

    Taipei, 100

  • Taipei Veterans General Hosp /ID# 154445

    Taipei, 11217

Other trials in Taiwan

Germany3 sites

  • Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 148949

    Berlin, 10117

  • Universitaetsklinikum Carl Gustav Carus an der TU Dresden /ID# 148948

    Dresden, 01307

  • Asklepios Klinik Altona /ID# 150116

    Hamburg, 22763

Other trials in Germany

Ukraine3 sites

  • Communal Nonprofit Enterprise Cherkasy Regional Oncology Dispensary /ID# 152414

    Cherkasy, 18009

  • Municipal Non-Profit Enterprise City Clinical Hospital 4 of Dnipro City Council /ID# 152411

    Dnipro, 49102

  • National Cancer Institute /ID# 152413

    Kyiv, 03022

Other trials in Ukraine

Canada2 sites

  • CISSS de la Monteregie /ID# 149844

    Greenfield Park, Quebec, J4V 2H1

  • Victoria Hospital /ID# 149846

    London, Ontario, N6A 4L6

Other trials in Canada

Ireland1 site

  • University Hospital Galway /ID# 149061

    Galway, H91 YR71

Other trials in Ireland

About this study

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

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.

Being tested
Venetoclax, Bortezomib, Dexamethasone, Placebo for venetoclax
Keywords
Relapsed/refractory multiple myeloma, Relapsed multiple myeloma, Refractory multiple myeloma, Multiple myeloma
Medical subject headings
Multiple Myeloma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VenetoclaxDrug

    Also called VENCLEXTA, VENCLYXTO

    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.

  • BortezomibDrug

    Also called Velcade

    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.

  • DexamethasoneDrug

    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).

  • Placebo for venetoclaxDrug

    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.

Study groups in NCT02755597
Study groupRoleWhat they receive
Venetoclax + Bortezomib and DexamethasoneExperimentalCycles 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
Receives: Drug: Venetoclax; Drug: Bortezomib; Drug: Dexamethasone
Placebo + Bortezomib and DexamethasonePlacebo comparatorCycles 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
Receives: Drug: Bortezomib; Drug: Dexamethasone; Drug: Placebo for venetoclax

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Median duration of follow-up was 28.6 months for the venetoclax group and 28.6 months for the placebo group

Secondary outcomes (11)

  1. 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.

    Measured: 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

  2. 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.

    Measured: Median duration of follow-up was 28.6 months for the venetoclax group and 28.6 months for the placebo group

  3. 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.

    Measured: 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

  4. 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.

    Measured: 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

  5. 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.

    Measured: 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

  6. 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.

    Measured: 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

  7. 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.

    Measured: 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

  8. 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.

    Measured: Median duration of follow-up was 45.6 months for the venetoclax group and 45.6 months for the placebo group

  9. 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.

    Measured: Median time on follow-up up was 28.6 months for the venetoclax group and 28.6 months for the placebo group

  10. 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).

    Measured: 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

  11. 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.

    Measured: Assessed at Screening; to confirm a stringent Complete Response (sCR) or Complete Response (CR); at 6 months and 12 months post-confirmed CR/sCR

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Apr 2016 (estimated)
  2. Study start11 Jul 2016
  3. Primary completion15 Mar 2021
  4. Study completion15 Aug 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
291 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02755597
Sponsor's protocol ID
M14-031
Other IDs
2015-004411-20, 2015
Acronym
Bellini
Status last verified
Aug 2023
First submitted
20 Apr 2016
Last updated
22 Aug 2023
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.
Expanded access
Available

Publications

  • Kumar SK, Harrison SJ, Cavo M, de la Rubia J, Popat R, Gasparetto C, Hungria V, Salwender H, Suzuki K, Kim I, Onishi M, Ku G, Pothacamury R, Jalaluddin M, Zeng J, Ross JA, Dobkowska E, Moreau P. Venetoclax or placebo in combination with bortezomib and dexamethasone in relapsed or refractory multiple myeloma (BELLINI): final overall survival results from a randomised, phase 3 study. Lancet Haematol. 2025 Aug;12(8):e574-e587. doi: 10.1016/S2352-3026(25)00139-5. Epub 2025 Jun 27.

    PubMed 40587991

  • 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.

    PubMed 33129376

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Venetoclax, Bortezomib and Dexamethasone in people with Relapsed/Refractory Multiple Myeloma, run by AbbVie at 97 sites in 16 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 97 sites in Japan, Australia, United Kingdom, South Korea, Russia and 11 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Aug 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free Survival (PFS) (time frame: Median duration of follow-up was 28.6 months for the venetoclax group and 28.6 months for the placebo group). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02755597, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2023.

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