A Study of Tabalumab (LY2127399) in Participants With Previously Treated Multiple Myeloma (MM)
NCT ID: NCT01602224
Last Updated: 2019-10-08
Study Results
Results available
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE2
Total Enrollment
220 participants
Study Classification
INTERVENTIONAL
Study Start Date
2012-07-31
Study Completion Date
2014-07-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Multiple Myeloma
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
TRIPLE
Participants
Caregivers
Investigators
Study Groups
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100 mg Tabalumab+Dexamethasone (Dex)+Bortezomib (BTZ)
Tabalumab 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.
Group Type
EXPERIMENTAL
Dexamethasone
Intervention Type
DRUG
Administered orally
Bortezomib
Intervention Type
DRUG
Administered SQ
Tabalumab
Intervention Type
BIOLOGICAL
Administered IV
300 mg Tabalumab+Dexamethasone+Bortezomib
Tabalumab 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.
Group Type
EXPERIMENTAL
Dexamethasone
Intervention Type
DRUG
Administered orally
Bortezomib
Intervention Type
DRUG
Administered SQ
Tabalumab
Intervention Type
BIOLOGICAL
Administered IV
Placebo Comparator: Placebo + Dexamethasone + Bortezomib
Placebo 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.
Group Type
PLACEBO_COMPARATOR
Placebo
Intervention Type
DRUG
Administered IV
Dexamethasone
Intervention Type
DRUG
Administered orally
Bortezomib
Intervention Type
DRUG
Administered SQ
Interventions
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Placebo
Administered IV
Intervention Type
DRUG
Dexamethasone
Administered orally
Intervention Type
DRUG
Bortezomib
Administered SQ
Intervention Type
DRUG
Tabalumab
Administered IV
Intervention Type
BIOLOGICAL
Other Intervention Names
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LY2127399
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
Exclusion Criteria
* 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
* 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
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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Tucson, Arizona, United States
Site Status
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Fullerton, California, United States
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Los Angeles, California, United States
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Santa Barbara, California, United States
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Grand Junction, Colorado, United States
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Atlanta, Georgia, United States
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Indianapolis, Indiana, United States
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Cedar Rapids, Iowa, United States
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Iowa City, Iowa, United States
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Ashland, Kentucky, United States
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Boston, Massachusetts, United States
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Omaha, Nebraska, United States
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Albuquerque, New Mexico, United States
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Salt Lake City, Utah, United States
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Campinas, , Brazil
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Porto Alegre, , Brazil
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São Paulo, , Brazil
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Calgary, Alberta, Canada
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Vancouver, British Columbia, Canada
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Lille, , France
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Nantes, , France
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Nîmes, , France
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Paris, , France
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Tours, , France
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Bamberg, , Germany
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Cologne, , Germany
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Heidelberg, , Germany
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Ampelokipoi, , Greece
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Athens, , Greece
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Bari, , Italy
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Catania, , Italy
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Florence, , Italy
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Milan, , Italy
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Rome, , Italy
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Torino, , Italy
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Mexico City, , Mexico
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Toluca, , Mexico
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Rotterdam, , Netherlands
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Krakow, , Poland
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Lublin, , Poland
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Warsaw, , Poland
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Wroclaw, , Poland
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Goyang-si, , South Korea
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Seoul, , South Korea
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Badalona, , Spain
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Barcelona, , Spain
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Madrid, , Spain
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Neihu Taipei, , Taiwan
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Taipei, , Taiwan
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Izmir, , Turkey (Türkiye)
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Melikgazi, , Turkey (Türkiye)
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Sihhiye, , Turkey (Türkiye)
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Headington, Oxford, United Kingdom
Site Status
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Sutton, Surrey, United Kingdom
Site Status
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Birmingham, , United Kingdom
Site Status
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London, , United Kingdom
Site Status
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Manchester, , United Kingdom
Site Status
Countries
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United States
Brazil
Canada
France
Germany
Greece
Italy
Mexico
Netherlands
Poland
South Korea
Spain
Taiwan
Turkey (Türkiye)
United Kingdom
Other Identifiers
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H9S-MC-JDCG
Identifier Type: OTHER
Identifier Source: secondary_id
14199
Identifier Type: -
Identifier Source: org_study_id
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PHASE2
Selinexor With Alternating Bortezomib or Lenalidomide Plus Dexamethasone in TIE Newly Diagnosed MM Patients
NCT04717700
ACTIVE_NOT_RECRUITING
PHASE2
Study of Lenalidomide/Ixazomib/Dexamethasone/Daratumumab in Transplant-Ineligible Patients With Newly Diagnosed MM
NCT04009109
ACTIVE_NOT_RECRUITING
PHASE2
Daratumumab in Combination With Bortezomib and Dexamethasone in Subjects With Relapsed or Relapsed and Refractory Multiple Myeloma and Severe Renal Impairment
NCT02977494
COMPLETED
PHASE2
S0417 Bortezomib, Thalidomide, and Dexamethasone in Treating Patients With Relapsed or Refractory Multiple Myeloma
NCT00124579
TERMINATED
PHASE2
Doxorubicin Hydrochloride Liposome, Bortezomib, and Dexamethasone in Treating Patients With Newly Diagnosed Multiple Myeloma
NCT00742404
UNKNOWN
PHASE2
A Study of Elotuzumab With Pomalidomide, Bortezomib, and Dexamethasone in Relapsed Multiple Myeloma
NCT02718833
ACTIVE_NOT_RECRUITING
PHASE2
Bortezomib, Doxorubicin Hydrochloride Liposome, and Dexamethasone Followed by Thalidomide and Dexamethasone With or Without Bortezomib in Treating Patients With Multiple Myeloma
NCT00458705
COMPLETED
PHASE2
A Study to Learn About the Study Medicine Elranatamab Alone and With Daratumumab in People With Multiple Myeloma Who Have Received Other Treatments
NCT05020236
RECRUITING
PHASE3
Bortezomib, Thalidomide, and Dexamethasone After Melphalan and Stem Cell Transplant in Treating Patients With Stage I-III Multiple Myeloma
NCT00792142
COMPLETED
PHASE2
Combination Study of Pomalidomide, Marizomib, and Low-Dose Dexamethasone in Relapsed and Refractory Multiple Myeloma
NCT02103335
COMPLETED
PHASE1
A Study to Assess Change in Disease Activity and Adverse Events (AE)s in Adult Participants With Multiple Myeloma Receiving Etentamig (ABBV-383) as an Intravenous (IV) Infusion Alone or in Combination With Oral, IV, Subcutaneous Daratumumab; Lenalidomide; Dexamethasone; Carfilzomib
NCT06892522
RECRUITING
PHASE1/PHASE2
Phase 1b/2 Study Testing Radium-223 Dichloride/Bortezomib/Dexamethasone Combination in Relapsed Multiple Myeloma
NCT02605356
WITHDRAWN
PHASE1/PHASE2
Bortezomib, Melphalan, and Total-Body Irradiation Before Stem Cell Transplant in Treating Patients With Multiple Myeloma
NCT01936090
COMPLETED
PHASE1
Lenalidomide, Dexamethasone and MEDI-551 in Untreated Multiple Myeloma
NCT01861340
COMPLETED
EARLY_PHASE1