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

This study is currently recruiting participants.
See Contacts and Locations
Verified April 2017 by AbbVie
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
AbbVie
ClinicalTrials.gov Identifier:
NCT02755597
First received: April 20, 2016
Last updated: April 17, 2017
Last verified: April 2017
  Purpose
This is a Phase 3, multicenter, randomized, double blind, placebo-controlled study evaluating the efficacy and safety of venetoclax plus bortezomib and dexamethasone in subjects 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.

Condition Intervention Phase
Relapsed/Refractory Multiple Myeloma Drug: Venetoclax Drug: Placebo Drug: Bortezomib Drug: Dexamethasone Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, Investigator, Outcomes Assessor
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by AbbVie:

Primary Outcome Measures:
  • Progression-free survival (PFS). [ Time Frame: Measured at subject's baseline (prior to subject's first dose) and at Day 1 of every Cycle thereafter for up to 3 years following the last subject first dose. ]
    Collect International Myeloma Working Group (IMWG) disease assessments at Cycle 1 Day 1 (C1D1) of each cycle or to confirm disease progression.


Secondary Outcome Measures:
  • Very Good Partial Response (VGPR) or better response rate. [ Time Frame: Measured at subject's baseline (prior to subject's first dose) and at Day 1 of every Cycle thereafter for up to 3 years following the last subject first dose. ]
    Collect International Myeloma Working Group (IMWG) disease assessments at C1D1 of each cycle or to confirm disease progression.

  • Progression-Free Survival (PFS) in subjects with high B-cell lymphoma 2 (BCL-2) expression. [ Time Frame: Measured at subject's baseline (prior to subject's first dose) and at Day 1 of every Cycle thereafter for up to 3 years following the last subject first dose. ]
    Bone marrow aspirate and bone marrow core biopsy tissue will be evaluated with the goal of defining the relationship between BCL-2 expression and disease status.

  • Duration of Response (DOR). [ Time Frame: Measured at subject's initial response and at Day 1 of every Cycle thereafter for up to 3 years following the last subject first dose. ]
    Collect International Myeloma Working Group (IMWG) disease assessments at C1D1 of each cycle or to confirm disease progression.

  • Overall survival (OS). [ Time Frame: Measured up to 6 years after the first subject is randomized. ]
    Measured from the date of the last dose and continuing either until the endpoint of death, until the subject is lost to follow-up, subject withdraws consent, or until study termination by AbbVie, whichever occurs first.

  • Time to disease progression (TTP). [ Time Frame: Measured at subject's baseline (prior to subject's first dose) and at Day 1 of every Cycle thereafter for up to 3 years following the last subject first dose. ]
    Collect International Myeloma Working Group (IMWG) disease assessments at C1D1 of each cycle or to confirm disease progression.

  • Objective Response Rate (ORR). [ Time Frame: Measured at subject's baseline (prior to subject's first dose) and at Day 1 of every Cycle thereafter for up to 3 years following the last subject first dose. ]
    Collect International Myeloma Working Group (IMWG) disease assessments at C1D1 of each cycle or to confirm disease progression.

  • Minimal Residual Disease (MRD) status. [ Time Frame: Measured from baseline up to the time of suspected CR/stringent complete response (sCR) with an expected average of 6 months. ]
    MRD status will be assessed using Next Generation Sequencing.

  • Brief Pain Inventory - Short Form [BPI-SF] - Worst Pain [ Time Frame: Starting with Cycle 1 (Cycles 1 - 8 are 21 days, Cycles 9 and beyond are 35 days), collect on Day 1 of every other cycle and the Treatment Completion Visit (TCV) while participant is on treatment (approximately 2 years). ]
  • European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core (EORTC QLQ-C30) - Physical Functioning [ Time Frame: Starting with Cycle 1 (Cycles 1 - 8 are 21 days, Cycles 9 and beyond are 35 days), collect on Day 1 of every other cycle and the Treatment Completion Visit (TCV) while participant is on treatment (approximately 2 years). ]
  • Patient Reported Outcomes Measurement Information System - (PROMIS) [ Time Frame: Starting with Cycle 1 (Cycles 1 - 8 are 21 days, Cycles 9 and beyond are 35 days), collect on Day 1 of every other cycle and the Treatment Completion Visit (TCV) while participant is on treatment (approximately 2 years). ]
  • European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core (EORTC QLQ-C30) - Global Health Status [ Time Frame: Starting with Cycle 1 (Cycles 1 - 8 are 21 days, Cycles 9 and beyond are 35 days), collect on Day 1 of every other cycle and the Treatment Completion Visit (TCV) while participant is on treatment (approximately 2 years). ]

Estimated Enrollment: 240
Study Start Date: July 11, 2016
Estimated Study Completion Date: June 15, 2020
Estimated Primary Completion Date: December 27, 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Venetoclax + Bortezomib and Dexamethasone
Evaluate the safety and efficacy profile of venetoclax administered with standard therapy bortezomib and dexamethasone.
Drug: Venetoclax
Tablet
Other Name: ABT-199
Drug: Bortezomib
Solution for subcutaneous injection
Drug: Dexamethasone
Tablet
Placebo Comparator: Placebo + Bortezomib and Dexamethasone
Compare the placebo arm plus standard therapy bortezomib and dexamethasone to venetoclax administered with standard therapy bortezomib and dexamethasone.
Drug: Placebo
Tablet
Drug: Bortezomib
Solution for subcutaneous injection
Drug: Dexamethasone
Tablet

  Eligibility

Ages Eligible for Study:   18 Years to 99 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 or oligo-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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02755597

Contacts
Contact: AbbVie_Call Center 847-283-8955 abbvieclinicaltrials@abbvie.com

  Hide Study Locations
Locations
United States, Colorado
University of Colorado Cancer Center /ID# 149130 Recruiting
Aurora, Colorado, United States, 80045
VA Eastern Colorado Healthcare System /ID# 156524 Not yet recruiting
Denver, Colorado, United States, 80220
United States, Illinois
Loyola University Medical Center /ID# 149125 Not yet recruiting
Maywood, Illinois, United States, 60153
Oncology Specialists, S.C. /ID# 149097 Recruiting
Park Ridge, Illinois, United States, 60068
United States, Maryland
Sinai Hospital of Baltimore, Inc. /ID# 149127 Recruiting
Baltimore, Maryland, United States, 21215
United States, Minnesota
Mayo Clinic /ID# 149100 Not yet recruiting
Rochester, Minnesota, United States, 55905
United States, New York
Northern Westchester Hospital /ID# 149128 Recruiting
Mount Kisco, New York, United States, 10549
Contact: Jonathan Goldberg, MD         
United States, North Carolina
Duke Univ Medical Center /ID# 149099 Recruiting
Durham, North Carolina, United States, 27710
United States, Ohio
Gabrail Cancer Center Research /ID# 149098 Recruiting
Canton, Ohio, United States, 44718
Australia
Royal Adelaide Hospital /ID# 149109 Recruiting
Adelaide, Australia, 5000
Box Hill Hospital /ID# 149112 Recruiting
Box Hill, Australia, 3128
Royal Prince Alfred Hospital /ID# 149108 Recruiting
Camperdown, Australia, 2050
Concord Hospital /ID# 149106 Recruiting
Concord, Australia, 2139
Royal Brisbane and Women's Hospital /ID# 149105 Recruiting
Herston, Australia, 4029
Royal Hobart Hospital /ID# 149111 Recruiting
Hobart, Australia, 7000
Liverpool Hospital /ID# 149110 Recruiting
Liverpool, Sydney, Australia, 2170
The Alfred Hospital /ID# 150085 Recruiting
Melbourne, Australia, 3004
Fiona Stanley Hospital /ID# 148967 Recruiting
Murdoch, Australia, 6150
Perth Blood Institute Ltd /ID# 148966 Recruiting
Nedlands, Australia, 6009
Peter MacCallum Cancer Centre /ID# 149107 Recruiting
Parkville, Australia, 3000
The Queen Elizabeth Hospital /ID# 149104 Recruiting
Woodville South, Australia, 5011
Brazil
Hospital Das Clinicas Da UFG /ID# 149290 Recruiting
Goiania, Brazil, 74605-020
Liga Norte Rigrandese Contra o Cancer /ID# 149023 Not yet recruiting
Natal, Brazil, 59075-740
Hospital Sao Lucas da PUCRS /ID# 149027 Not yet recruiting
Porto Alegre, Brazil, 90610-000
Instituto Nacional de Cancer Jose Alencar Gomes da Silva /ID# 149020 Recruiting
Rio de Janeiro, Brazil, 20231-050
Hospital das Clinicas da Faculdade de Medicina da Universida /ID# 149025 Not yet recruiting
Sao Paulo, Brazil, 05403-010
Clinica Sao Germano /ID# 149851 Recruiting
Sao Paulo, Brazil, 4537080
Canada
Centre integre de services sociaux de la Monteregie-Centre /ID# 149844 Recruiting
Greenfield Park, Canada, J4V2H1
London Health Science Center /ID# 149846 Recruiting
London, Canada, N6A5W9
France
CHRU de Brest - Hopital Morvan /ID# 149299 Recruiting
BREST Cedex, France, 29609
CHU de Grenoble - Hopital Albert Michallon /ID# 149301 Recruiting
Grenoble, France, 38043
CHU Dupuytren /ID# 149292 Recruiting
Limoges, France, 87042
CHU de Nantes - Hopital Hotel Dieu /ID# 149294 Recruiting
Nantes, France, 44093
Centre Hospitalier Lyon Sud /ID# 149300 Recruiting
Pierre-Benite Cedex, France, 69495
clinique Sainte Anne /ID# 149297 Recruiting
Strasbourg, France, 67000
CHU de Tours, Hopital Bretonneau /ID# 149295 Recruiting
Tours, France, 37044
Germany
Charite Universitatesmedizin Berlin, CCM /ID# 148949 Not yet recruiting
Berlin, Germany, 10117
Universitaetklinikum Dresden /ID# 148948 Recruiting
Dresden, Germany, 01307
Asklepios Klinik Altona /ID# 150116 Recruiting
Hamburg, Germany, 22763
Hungary
Semmelweis Egyetem /ID# 152519 Recruiting
Budapest, Hungary, 1083
Szent Laszlo-Szent Istvan Korhaz /ID# 152518 Recruiting
Budapest, Hungary, 1097
Semmelweis Egyetem /ID# 152520 Recruiting
Budapest, Hungary, 1125
Debreceni Egyetem /ID# 152517 Recruiting
Debrecen, Hungary, 4032
Kaposi Mor Oktato Korhaz /ID# 152516 Recruiting
Kaposvar, Hungary, 7400
Ireland
Mater Misericordiae University Hospital /ID# 149064 Not yet recruiting
Dublin 7, Ireland
Mater Private Hospital /ID# 155368 Not yet recruiting
Dublin 7, Ireland
Galway University Hospital /ID# 149061 Recruiting
Galway, Ireland
Italy
Azienda Ospedaliero Universitaria Ospedali Riuniti /ID# 148942 Recruiting
Ancona, Italy, 60126
Policlinico Universitario S. Orsola Malpighi /ID# 148936 Recruiting
Bologna, Italy, 40138
Ospedale S.Eugenio /ID# 148938 Recruiting
Rome, Italy, 00144
Universita La Sapienza Azienda Policlinico Umberto I /ID# 148939 Recruiting
Rome, Italy, 00161
AOU"Citta della Salute e della Scienza"-Presidio Molinette /ID# 148943 Not yet recruiting
Turin, Italy, 10129
Japan
Kyushu University Hospital /ID# 150896 Recruiting
Fukuoka, Japan
National Hospital Organization Shibukawa Medical Center /ID# 150281 Recruiting
Gunma, Japan
National Hospital Organization Mito Medical Center /ID# 151051 Recruiting
Higashiibaraki-gun, Japan
Nagoya City University Hospital /ID# 150943 Recruiting
Nagoya-shi, Japan
Ogaki Municipal Hospital /ID# 150783 Recruiting
Ogaki-shi, Japan
Okayama Medical Center /ID# 150717 Recruiting
Okayama-shi, Japan
Saitama Medical Center /ID# 151044 Recruiting
Saitama, Japan
National Hospital Organization Disaster Medical Center /ID# 150784 Recruiting
Tachikawa-shi, Japan
Japanese Red Cross Medical Center /ID# 149902 Recruiting
Tokyo, Japan
National Cancer Center Hospital /ID# 151039 Recruiting
Tokyo, Japan
The Cancer Institute Hospital of JFCR /ID# 150780 Recruiting
Tokyo, Japan
Korea, Republic of
National Cancer Center /ID# 150889 Recruiting
Gyeonggi-do, Korea, Republic of, 10408
Gachon University Gil Medical Center /ID# 150893 Recruiting
Incheon, Korea, Republic of, 21565
Chonnam National University Hwasun Hospital /ID# 150894 Recruiting
Jeollanam-do, Korea, Republic of, 58128
The Catholic University of Korea, Seoul St. Mary's Hospital /ID# 150895 Recruiting
Seocho-gu, Seoul, Korea, Republic of, 06591
Seoul National University Bundang Hospital /ID# 150888 Recruiting
Seongnam-si, Korea, Republic of, 13620
Seoul National University Hospital /ID# 150890 Recruiting
Seoul, Korea, Republic of, 03080
Severance Hospital /ID# 150891 Recruiting
Seoul, Korea, Republic of, 03722
Samsung Medical Center /ID# 150892 Recruiting
Seoul, Korea, Republic of, 06351
Russian Federation
Kemerovo Regional Clinical Hospital /ID# 148955 Recruiting
Kemerovo, Russian Federation, 650066
Central Clinical Hospital 2 of JSC Russian Railways /ID# 148954 Recruiting
Moscow, Russian Federation, 129128
BHI of Omsk Region /ID# 148953 Recruiting
Omsk, Russian Federation, 644013
LLC Novaya Klinika /ID# 148974 Recruiting
Pjatigorsk, Russian Federation, 357519
Ryazan Regional Clinical Hospital /ID# 148956 Recruiting
Ryazan, Russian Federation, 390039
Samara State Medical University /ID# 148952 Recruiting
Samara, Russian Federation, 443099
Medical Clinica of Bashkir State Medical University /ID# 151206 Recruiting
Ufa, Russian Federation, 450083
Spain
Hospital Clinic de Barcelona /ID# 148983 Recruiting
Barcelona, Spain, 08036
Instituto Catalan de Oncologia, L'Hospitalet de Llobregat /ID# 148989 Recruiting
Barcelona, Spain, 08908
Hospital Universitario de la Princesa /ID# 148980 Not yet recruiting
Madrid, Spain, 28006
Hospital Universitario 12 de Octubre /ID# 148981 Not yet recruiting
Madrid, Spain, 28041
Clinica Universitaria de Navarra /ID# 148984 Recruiting
Pamplona, Spain, 31008
Hospital Universitario de Salamanca /ID# 148982 Recruiting
Salamanca, Spain, 37007
CHU Santiago de Compostela /ID# 148987 Recruiting
Santiago De Compostela, Spain, 15706
Hospital Universitario Virgen del Rocio /ID# 148988 Recruiting
Sevilla, Spain, 41013
Hospital Doctor Peset de Valencia /ID# 148986 Recruiting
Valencia, Spain, 46017
Taiwan
Changhua Christian Hospital /ID# 154447 Recruiting
Changhua, Taiwan, 50006
China Medical University Hospital /ID# 154446 Recruiting
Taichung, Taiwan, 40447
National Taiwan University Hospital /ID# 154444 Recruiting
Taipei City, Taiwan, 10002
Taipei Veterans General Hospital /ID# 154445 Recruiting
Taipei City, Taiwan, 11217
Ukraine
Cherkassy Regional Oncology Ctr Cherkassy Regional Counsel /ID# 152414 Recruiting
Cherkasy, Ukraine, 18009
Dnipropetrovsk City Multifield Clinical Hospital #4 /ID# 152411 Not yet recruiting
Dnipro, Ukraine, 49102
National Cancer Institute /ID# 152413 Recruiting
Kiev, Ukraine, 03022
Public Institution Kyiv Regional Oncology Center /ID# 152412 Not yet recruiting
Kyiv, Ukraine, 02000
United Kingdom
Blackpool Victoria Hosp. Teaching Hosp NHS Foundation Trust /ID# 149058 Recruiting
Blackpool, lancashire, United Kingdom, FY3 8NR
East Kent Hospitals University foundation NHS Trust /ID# 149059 Recruiting
Canterbury, United Kingdom, CT1 3NG
Queens Hospital /ID# 149055 Recruiting
Essex, United Kingdom, RM7 OAG
Leicester Royal Infirmary, Univ Hosp of Leicester NHS /ID# 149057 Recruiting
Leicester, United Kingdom, LE1 5WW
St Bartholomew's Hospital /ID# 149050 Recruiting
London, United Kingdom, EC1A 7BE
University College London Hospitals NHS Foundation Trust /ID# 149044 Recruiting
London, United Kingdom, NW1 2PG
King's College Hospital /ID# 149045 Recruiting
London, United Kingdom, SE5 9RS
Manchester Royal Infirmary /ID# 149046 Recruiting
Manchester, United Kingdom, M13 9WL
The Christie NHS Foundation Trust /ID# 149051 Recruiting
Manchester, United Kingdom, M20 4BX
Nottingham University Hospitals NHS Trust /ID# 149047 Recruiting
Nottingham, United Kingdom, NG5 1PB
The Royal Wolverhampton NHS Trust /ID# 149043 Recruiting
Wolverhampton, West Midlands, United Kingdom, WV10 0QP
Sponsors and Collaborators
AbbVie
Genentech, Inc.
Investigators
Study Director: Paulo Maciag, MD AbbVie
  More Information

Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT02755597     History of Changes
Other Study ID Numbers: M14-031
2015-004411-20 ( EudraCT Number )
Study First Received: April 20, 2016
Last Updated: April 17, 2017

Keywords provided by AbbVie:
relapsed/refractory multiple myeloma
refractory multiple myeloma
multiple myeloma
relapsed multiple myeloma

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Dexamethasone acetate
Dexamethasone
Bortezomib
BB 1101
Proteasome Inhibitors
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents

ClinicalTrials.gov processed this record on July 21, 2017