A Study of Tabalumab (LY2127399) in Participants With Previously Treated Multiple Myeloma (MM)
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 2 Study of Tabalumab in Combination With Bortezomib and Dexamethasone in Patients With Previously Treated Multiple Myeloma
2 other identifiers
interventional
220
15 countries
57
Brief Summary
The purpose of this study is to evaluate an investigational drug called tabalumab in participants with Multiple Myeloma (MM) who have tried at least one other therapy in the past. Tabalumab will be given in combination with standard doses of two other drugs that are often used to treat MM. Study doctors will collect information about the effectiveness and side effects of this therapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 multiple-myeloma
Started Jul 2012
Shorter than P25 for phase_2 multiple-myeloma
57 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 16, 2012
CompletedFirst Posted
Study publicly available on registry
May 18, 2012
CompletedStudy Start
First participant enrolled
July 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2014
CompletedResults Posted
Study results publicly available
August 15, 2018
CompletedOctober 8, 2019
September 1, 2019
2 years
May 16, 2012
March 24, 2018
September 25, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Progression Free Survival (PFS)
PFS is defined as the time from date of first dose to the first observation of disease progression or death due to any cause. If a participant does not have a complete baseline disease assessment, then the PFS time is censored at the enrollment date, regardless of whether or not objectively determined disease progression (Increase of \> 25% from lowest response in serum M component, urine M component, bone marrow plasma cell percentage, development of bone lesions) or death has been observed for the participant. If a participant is not known to have died or have objective progression as of the data inclusion cutoff date for the analysis, the PFS time is censored at the last complete objective progression-free disease assessment date.
Baseline up to Objective Disease Progression or Death From Any Cause (assessed up to 9 months)
Secondary Outcomes (13)
Overall Survival
Baseline to Death From Any Cause (assessed up to 19 months)
Time to First Skeletal-Related Event (SRE)
Baseline to Date of First Skeletal Related Event (assessed up to 19 months)
Number of Participants With >30% Reduction in Brief Pain Inventory (BPI) - Worst Pain Score
Baseline through End of Treatment (19 months)
Time to Progression (TTP)
Baseline to Objective Disease Progression or Death (assessed up to 9 months)
Duration of Response (DoR)
Time from Response to Objective Disease Progression (assessed up to 38 months)
- +8 more secondary outcomes
Study Arms (3)
100 mg Tabalumab+Dexamethasone (Dex)+Bortezomib (BTZ)
EXPERIMENTALTabalumab 100 milligram (mg) administered once intravenously (IV) over 30 minutes on Day 1 every 21 days for 8 cycles. Dexamethasone 20 mg administered once orally on Days 1, 2, 4, 5, 8, 9, 11 and 12 every 21 days for 8 cycles. Bortezomib 1.3 milligram per square meter (mg/m\^2) administered once subcutaneously (SQ) on Days 1, 4, 8 and 11 every 21 days for a minimum 8 cycles. All treatment may continue past 8 cycles.
300 mg Tabalumab+Dexamethasone+Bortezomib
EXPERIMENTALTabalumab 300 mg administered once IV over 30 minutes on Day 1 every 21 days for 8 cycles. Dexamethasone 20 mg administered orally on Days 1, 2, 4, 5, 8, 9, 11 and 12 every 21 days for a minimum 8 cycles. Bortezomib 1.3 mg/m\^2 administered once SQ on Days 1, 4, 8 and 11 every 21 days for 8 cycles. All treatment may continue past 8 cycles.
Placebo Comparator: Placebo + Dexamethasone + Bortezomib
PLACEBO COMPARATORPlacebo administered once IV on Day 1 every 21 days for 8 cycles. Dexamethasone 20 mg administered once orally on Days 1, 2, 4, 5, 8, 9, 11 and 12 every 21 days for a minimum 8 cycles. Bortezomib 1.3 mg/m\^2 administered once SQ on Days 1, 4, 8 and 11 every 21 days for 8 cycles. All treatment may continue past 8 cycles.
Interventions
Administered orally
Administered SQ
Administered IV
Eligibility Criteria
You may qualify if:
- Have symptomatic and/or progressive MM that was previously treated with at least 1 and no more than 3 prior lines of therapy
- Have measurable disease
- Have given written informed consent prior to any study-specific procedures
- Have adequate organ function
- Treatment with prior autologous transplant is permitted
You may not qualify if:
- Are enrolled in or discontinued from a clinical trial of any drug or device within 21 days prior to the first dose of assigned study treatment
- Have had less than a minimal response or have had progressive disease within 60 days of most recent therapy with a proteasome inhibitor
- Plan to proceed to autologous transplant for consolidation after participation in this trial
- Have an active infection or ongoing treatment for systemic infection ("ongoing treatment" does not include prophylactic anti-infectives),, chest x-ray suggestive of tuberculosis, or history/risk of chronic/latent infection that may reactivate in the presence of study therapy
- Have any of the following:
- positive test results for human immunodeficiency virus (HIV)
- positive test for hepatitis B, defined as positive for hepatitis B surface antigen (HBsAg+), OR positive for anti-hepatitis B core antibody AND positive for hepatitis B deoxyribonucleic acid (HBV DNA), OR positive for anti-hepatitis B surface antibody (HBsAb+) AND positive for hepatitis B deoxyribonucleic acid (HBV DNA)
- positive test results for hepatitis C virus (HCV), defined as positive for hepatitis C antibody (HepCAb) AND confirmed positive via the hepatitis C recombinant immunoblot assay
- Have had significant allergy to human/humanized monoclonal antibodies that, in the opinion of the investigator, poses an unacceptable risk to the participants
- Have known hypersensitivity or contraindication to any of the study therapies or excipients
- Prior allogeneic hematopoietic stem cell transplant
- Prior therapy with experimental agents targeting B-cell activating factor (BAFF), including LY2127399
- Have corrected QT (QTc) interval \>500 millisecond (msec) on baseline 12-lead electrocardiogram (ECG)
- Have Waldenstrom's macroglobulinemia
- History of malignancy with adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, in situ breast cancer, in situ prostate cancer, are eligible regardless of the time of diagnosis/treatment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (57)
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Tucson, Arizona, 85715, United States
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Fullerton, California, 92835, United States
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Los Angeles, California, 90095, United States
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Santa Barbara, California, 93105, United States
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Grand Junction, Colorado, 81501, United States
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Atlanta, Georgia, 30322, United States
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Indianapolis, Indiana, 46202, United States
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Cedar Rapids, Iowa, 52402, United States
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Iowa City, Iowa, 52242, United States
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Ashland, Kentucky, 41101, United States
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Boston, Massachusetts, 02115, United States
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Omaha, Nebraska, 68114, United States
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Albuquerque, New Mexico, 87109, United States
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Salt Lake City, Utah, 84106, United States
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Campinas, 13083970, Brazil
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Porto Alegre, 90035-903, Brazil
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São Paulo, 01223001, Brazil
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Calgary, Alberta, T2N 4N2, Canada
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Vancouver, British Columbia, V5Z 1M9, Canada
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Lille, 59037, France
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Nantes, 44093, France
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Nîmes, 30029, France
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Paris, 75475, France
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Tours, 37044, France
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Bamberg, 96049, Germany
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Cologne, 50931, Germany
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Heidelberg, 69120, Germany
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Ampelokipoi, 11527, Greece
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Athens, 115 28, Greece
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Bari, 70124, Italy
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Catania, 95124, Italy
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Florence, 50134, Italy
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Milan, 20162, Italy
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Rome, 00161, Italy
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Torino, 10126, Italy
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Mexico City, 14000, Mexico
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Toluca, 50080, Mexico
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Rotterdam, 3015 CE, Netherlands
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Krakow, 31-501, Poland
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Lublin, 20-081, Poland
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Warsaw, 02-507, Poland
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Wroclaw, 50-367, Poland
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Goyang-si, 411-764, South Korea
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Seoul, 110-744, South Korea
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Badalona, 08916, Spain
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Barcelona, 08036, Spain
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Madrid, 28006, Spain
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Neihu Taipei, 114, Taiwan
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Taipei, 100, Taiwan
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Izmir, 35100, Turkey (Türkiye)
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Melikgazi, 38039, Turkey (Türkiye)
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Sihhiye, 06100, Turkey (Türkiye)
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Headington, Oxford, OX3 7LJ, United Kingdom
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Sutton, Surrey, SM2 5PT, United Kingdom
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Birmingham, B95SS, United Kingdom
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London, W1T 4TJ, United Kingdom
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Manchester, M20 4BX, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Chief Medical Officer
- Organization
- Eli Lilly and Company
Study Officials
- STUDY DIRECTOR
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Eli Lilly and Company
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 16, 2012
First Posted
May 18, 2012
Study Start
July 1, 2012
Primary Completion
July 1, 2014
Study Completion
July 1, 2014
Last Updated
October 8, 2019
Results First Posted
August 15, 2018
Record last verified: 2019-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
- Access Criteria
- A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Lilly provides access to the individual patient data from studies on approved medicines and indications as defined by the sponsor specific information on ClinicalStudyDataRequest.com. This access is provided in a timely fashion after the primary publication is accepted. Researchers need to have an approved research proposal submitted through ClinicalStudyDataRequest.com. Access to the data will be provided in a secure data sharing environment after signing a data sharing agreement.