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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 February 2017 by AbbVie
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
AbbVie
ClinicalTrials.gov Identifier:
NCT02755597
First received: April 20, 2016
Last updated: February 13, 2017
Last verified: February 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 2016
Estimated Study Completion Date: June 2020
Estimated Primary Completion Date: December 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
Site Reference ID/Investigator# 149130 Recruiting
Aurora, Colorado, United States, 80045
Principal Investigator: Site Reference ID/Investigator# 149130, MD         
United States, Illinois
Site Reference ID/Investigator# 149125 Not yet recruiting
Maywood, Illinois, United States, 60153
Principal Investigator: Site Reference ID/Investigator# 149125, MD         
Site Reference ID/Investigator# 149097 Recruiting
Park Ridge, Illinois, United States, 60068
Principal Investigator: Site Reference ID/Investigator# 149097, MD         
United States, Maryland
Site Reference ID/Investigator# 149127 Recruiting
Baltimore, Maryland, United States, 21215
Principal Investigator: Site Reference ID/Investigator# 149127, MD         
United States, New York
Northern Westchester Hospital Recruiting
Mount Kisco, New York, United States, 10549
Principal Investigator: Jonathan Goldberg, MD         
United States, North Carolina
Site Reference ID/Investigator# 149099 Recruiting
Durham, North Carolina, United States, 27710
Principal Investigator: Site Reference ID/Investigator# 149099, MD         
United States, Ohio
Site Reference ID/Investigator# 149098 Recruiting
Canton, Ohio, United States, 44718
Principal Investigator: Site Reference ID/Investigator# 149098, MD         
Australia
Site Reference ID/Investigator# 149109 Recruiting
Adelaide, Australia, 5000
Principal Investigator: Site Reference ID/Investigator# 149109, DO         
Site Reference ID/Investigator# 149112 Recruiting
Box Hill, Australia, 3128
Principal Investigator: Site Reference ID/Investigator# 149112, MD         
Site Reference ID/Investigator# 149108 Recruiting
Camperdown, Australia, 2050
Principal Investigator: Site Reference ID/Investigator# 149108, MD         
Site Reference ID/Investigator# 149106 Recruiting
Concord, Australia, 2139
Principal Investigator: Site Reference ID/Investigator# 149106, MD         
Site Reference ID/Investigator# 149105 Recruiting
Herston, Australia, 4029
Principal Investigator: Site Reference ID/Investigator# 149105, MD         
Site Reference ID/Investigator# 149111 Recruiting
Hobart, Australia, 7000
Principal Investigator: Site Reference ID/Investigator# 149111, DO         
Site Reference ID/Investigator# 149110 Recruiting
Liverpool, Sydney, Australia, 2170
Principal Investigator: Site Reference ID/Investigator# 149110, MD         
Site Reference ID/Investigator# 150085 Recruiting
Melbourne, Australia, 3004
Principal Investigator: Site Reference ID/Investigator# 150085, MD         
Site Reference ID/Investigator# 148967 Recruiting
Murdoch, Australia, 6150
Principal Investigator: Site Reference ID/Investigator# 148967, DO         
Site Reference ID/Investigator# 148966 Recruiting
Nedlands, Australia, 6009
Principal Investigator: Site Reference ID/Investigator# 148966, MD         
Site Reference ID/Investigator# 149107 Recruiting
Parkville, Australia, 3000
Principal Investigator: Site Reference ID/Investigator# 149107, MD         
Site Reference ID/Investigator# 149104 Recruiting
Woodville South, Australia, 5011
Principal Investigator: Site Reference ID/Investigator# 149104, MD         
Brazil
Site Reference ID/Investigator# 149027 Recruiting
Porto Alegre, Brazil, 90610-000
Principal Investigator: Site Reference ID/Investigator# 149027, MD         
Site Reference ID/Investigator# 149851 Recruiting
Sao Paulo, Brazil, 4537080
Principal Investigator: Site Reference ID/Investigator# 149851, MD         
Canada
Site Reference ID/Investigator# 149844 Recruiting
Greenfield Park, Canada, J4V2H1
Principal Investigator: Site Reference ID/Investigator# 149844, MD         
Site Reference ID/Investigator# 149846 Recruiting
London, Canada, N6A5W9
Principal Investigator: Site Reference ID/Investigator# 149846, MD         
France
Site Reference ID/Investigator# 149299 Recruiting
BREST Cedex, France, 29609
Principal Investigator: Site Reference ID/Investigator# 149299, MD         
Site Reference ID/Investigator# 149301 Recruiting
Grenoble, France, 38043
Principal Investigator: Site Reference ID/Investigator# 149301, MD         
Site Reference ID/Investigator# 149292 Recruiting
Limoges, France, 87042
Principal Investigator: Site Reference ID/Investigator# 149292, MD         
Site Reference ID/Investigator# 149294 Recruiting
Nantes, France, 44093
Principal Investigator: Site Reference ID/Investigator# 149294, MD/PhD         
Site Reference ID/Investigator# 149300 Recruiting
Pierre-Benite Cedex, France, 69495
Principal Investigator: Site Reference ID/Investigator# 149300, MD         
Site Reference ID/Investigator# 149297 Not yet recruiting
Strasbourg, France, 67000
Principal Investigator: Site Reference ID/Investigator# 149297, MD         
Site Reference ID/Investigator# 149295 Recruiting
Tours, France, 37044
Principal Investigator: Site Reference ID/Investigator# 149295, MD         
Germany
Site Reference ID/Investigator# 148949 Not yet recruiting
Berlin, Germany, 10117
Principal Investigator: Site Reference ID/Investigator# 148949, MD         
Site Reference ID/Investigator# 148948 Recruiting
Dresden, Germany, 01307
Principal Investigator: Site Reference ID/Investigator# 148948, MD         
Site Reference ID/Investigator# 150116 Recruiting
Hamburg, Germany, 22763
Principal Investigator: Site Reference ID/Investigator# 150116, MD         
Hungary
Site Reference ID/Investigator# 152519 Recruiting
Budapest, Hungary, 1083
Principal Investigator: Site Reference ID/Investigator# 152519, MD         
Site Reference ID/Investigator# 152518 Recruiting
Budapest, Hungary, 1097
Principal Investigator: Site Reference ID/Investigator# 152518, MD         
Site Reference ID/Investigator# 152520 Recruiting
Budapest, Hungary, 1125
Principal Investigator: Site Reference ID/Investigator# 152520, MD         
Site Reference ID/Investigator# 152517 Recruiting
Debrecen, Hungary, 4032
Principal Investigator: Site Reference ID/Investigator# 152517, MD         
Site Reference ID/Investigator# 152516 Recruiting
Kaposvar, Hungary, 7400
Principal Investigator: Site Reference ID/Investigator# 152516, MD         
Ireland
Site Reference ID/Investigator# 149064 Not yet recruiting
Dublin 7, Ireland
Principal Investigator: Site Reference ID/Investigator# 149064, MD         
Site Reference ID/Investigator# 155368 Not yet recruiting
Dublin 7, Ireland
Principal Investigator: Site Reference ID/Investigator# 155368, MD         
Italy
Site Reference ID/Investigator# 148942 Recruiting
Ancona, Italy, 60126
Principal Investigator: Site Reference ID/Investigator# 148942, MD         
Site Reference ID/Investigator# 148936 Recruiting
Bologna, Italy, 40138
Principal Investigator: Site Reference ID/Investigator# 148936, MD         
Site Reference ID/Investigator# 148938 Not yet recruiting
Roma, Italy, 00144
Principal Investigator: Site Reference ID/Investigator# 148938, MD         
Site Reference ID/Investigator# 148939 Recruiting
Rome, Italy, 00161
Principal Investigator: Site Reference ID/Investigator# 148939         
Site Reference ID/Investigator# 148943 Not yet recruiting
Turin, Italy, 10129
Principal Investigator: Site Reference ID/Investigator# 148943, MD         
Japan
Site Reference ID/Investigator# 150896 Recruiting
Fukuoka, Japan
Principal Investigator: Site Reference ID/Investigator# 150896, MD         
Site Reference ID/Investigator# 150943 Recruiting
Nagoya-shi, Japan
Principal Investigator: Site Reference ID/Investigator# 150943, MD         
Site Reference ID/Investigator# 150717 Recruiting
Okayama-shi, Japan
Principal Investigator: Site Reference ID/Investigator# 150717, MD         
Site Reference ID/Investigator# 151044 Recruiting
Saitama, Japan
Principal Investigator: Site Reference ID/Investigator# 151044, MD         
Site Reference ID/Investigator# 150784 Recruiting
Tachikawa-shi, Japan
Principal Investigator: Site Reference ID/Investigator# 150784, MD         
Site Reference ID/Investigator# 149902 Recruiting
Tokyo, Japan
Principal Investigator: Site Reference ID/Investigator# 149902, MD         
Site Reference ID/Investigator# 150780 Recruiting
Tokyo, Japan
Principal Investigator: Site Reference ID/Investigator# 150780, MD         
Site Reference ID/Investigator# 151039 Recruiting
Tokyo, Japan
Principal Investigator: Site Reference ID/Investigator# 151039, MD         
Korea, Republic of
Site Reference ID/Investigator# 150889 Recruiting
Gyeonggi-do, Korea, Republic of, 10408
Principal Investigator: Site Reference ID/Investigator# 150889, MD         
Site Reference ID/Investigator# 150893 Recruiting
Incheon, Korea, Republic of, 21565
Principal Investigator: Site Reference ID/Investigator# 150893, MD         
Site Reference ID/Investigator# 150894 Recruiting
Jeollanam-do, Korea, Republic of, 58128
Principal Investigator: Site Reference ID/Investigator# 150894, MD         
Site Reference ID/Investigator# 150895 Recruiting
Seocho-gu, Seoul, Korea, Republic of, 06591
Principal Investigator: Site Reference ID/Investigator# 150895, MD         
Site Reference ID/Investigator# 150888 Recruiting
Seongnam-si, Korea, Republic of, 13620
Principal Investigator: Site Reference ID/Investigator# 150888, MD         
Site Reference ID/Investigator# 150890 Recruiting
Seoul, Korea, Republic of, 03080
Principal Investigator: Site Reference ID/Investigator# 150890, MD         
Site Reference ID/Investigator# 150891 Recruiting
Seoul, Korea, Republic of, 03722
Principal Investigator: Site Reference ID/Investigator# 150891, MD         
Site Reference ID/Investigator# 150892 Recruiting
Seoul, Korea, Republic of, 06351
Principal Investigator: Site Reference ID/Investigator# 150892, MD         
Russian Federation
Site Reference ID/Investigator# 148955 Recruiting
Kemerovo, Russian Federation, 650066
Principal Investigator: Site Reference ID/Investigator# 148955, MD         
Site Reference ID/Investigator# 148954 Not yet recruiting
Moscow, Russian Federation, 129128
Principal Investigator: Site Reference ID/Investigator# 148954, MD         
Site Reference ID/Investigator# 148953 Recruiting
Omsk, Russian Federation, 644013
Principal Investigator: Site Reference ID/Investigator# 148953, MD         
Site Reference ID/Investigator# 148974 Recruiting
Pjatigorsk, Russian Federation, 357519
Principal Investigator: Site Reference ID/Investigator# 148974, MD         
Site Reference ID/Investigator# 148956 Recruiting
Ryazan, Russian Federation, 390039
Principal Investigator: Site Reference ID/Investigator# 148956, MD         
Site Reference ID/Investigator# 148952 Recruiting
Samara, Russian Federation, 443099
Principal Investigator: Site Reference ID/Investigator# 148952, MD         
Site Reference ID/Investigator# 151206 Recruiting
Ufa, Russian Federation, 450083
Principal Investigator: Site Reference ID/Investigator# 151206, MD         
Spain
Site Reference ID/Investigator# 148983 Not yet recruiting
Barcelona, Spain, 08036
Principal Investigator: Site Reference ID/Investigator# 148983, MD         
Site Reference ID/Investigator# 148989 Not yet recruiting
Barcelona, Spain, 08908
Principal Investigator: Site Reference ID/Investigator# 148989, MD         
Site Reference ID/Investigator# 148980 Not yet recruiting
Madrid, Spain, 28006
Principal Investigator: Site Reference ID/Investigator# 148980, MD         
Site Reference ID/Investigator# 148981 Not yet recruiting
Madrid, Spain, 28041
Principal Investigator: Site Reference ID/Investigator# 148981, MD         
Site Reference ID/Investigator# 148987 Recruiting
Santiago De Compostela, Spain, 15706
Principal Investigator: Site Reference ID/Investigator# 148987, MD         
Site Reference ID/Investigator# 148988 Recruiting
Sevilla, Spain, 41013
Principal Investigator: Site Reference ID/Investigator# 148988, MD         
Site Reference ID/Investigator# 148986 Not yet recruiting
Valencia, Spain, 46017
Principal Investigator: Site Reference ID/Investigator# 148986, MD         
Taiwan
Site Reference ID/Investigator# 154446 Not yet recruiting
Taichung, Taiwan, 40447
Principal Investigator: Site Reference ID/Investigator# 154446, MD         
Site Reference ID/Investigator# 154444 Recruiting
Taipei City, Taiwan, 10002
Principal Investigator: Site Reference ID/Investigator# 154444, MD         
Site Reference ID/Investigator# 154445 Recruiting
Taipei City, Taiwan, 11217
Principal Investigator: Site Reference ID/Investigator# 154445, MD         
United Kingdom
Site Reference ID/Investigator# 149058 Recruiting
Blackpool, lancashire, United Kingdom, FY3 8NR
Principal Investigator: Site Reference ID/Investigator# 149058, MD         
Site Reference ID/Investigator# 149059 Recruiting
Canterbury, United Kingdom, CT1 3NG
Principal Investigator: Site Reference ID/Investigator# 149059, MD         
Site Reference ID/Investigator# 149055 Recruiting
Essex, United Kingdom, RM7 OAG
Principal Investigator: Site Reference ID/Investigator# 149055, MD         
Site Reference ID/Investigator# 149057 Recruiting
Leicester, United Kingdom, LE1 5WW
Principal Investigator: Site Reference ID/Investigator# 149057, MD         
Site Reference ID/Investigator# 149050 Not yet recruiting
London, United Kingdom, EC1A 7BE
Principal Investigator: Site Reference ID/Investigator# 149050, MD         
Site Reference ID/Investigator# 149044 Recruiting
London, United Kingdom, NW1 2PG
Principal Investigator: Site Reference ID/Investigator# 149044, MD         
Site Reference ID/Investigator# 149045 Recruiting
London, United Kingdom, SE5 9RS
Principal Investigator: Site Reference ID/Investigator# 149045, MD         
Site Reference ID/Investigator# 149046 Recruiting
Manchester, United Kingdom, M13 9WL
Principal Investigator: Site Reference ID/Investigator# 149046, MD         
Site Reference ID/Investigator# 149051 Recruiting
Manchester, United Kingdom, M20 4BX
Principal Investigator: Site Reference ID/Investigator# 149051, MD         
Site Reference ID/Investigator# 149047 Recruiting
Nottingham, United Kingdom, NG5 1PB
Principal Investigator: Site Reference ID/Investigator# 149047, MD         
Site Reference ID/Investigator# 149043 Recruiting
Wolverhampton, West Midlands, United Kingdom, WV10 0QP
Principal Investigator: Site Reference ID/Investigator# 149043, MD         
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: February 13, 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
Dexamethasone 21-phosphate
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

ClinicalTrials.gov processed this record on March 22, 2017