Multiple MyelomaPhase 2NCT01602224

A Study of Tabalumab (LY2127399) in Participants With Previously Treated Multiple Myeloma (MM)

A Phase 2 study testing Dexamethasone, Bortezomib and Tabalumab in people with Multiple Myeloma, run by Eli Lilly and Company at 57 sites in 15 countries.

Completed

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

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Multiple Myeloma
What is being tested?: Dexamethasone, Bortezomib and Tabalumab
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 220 participants
Where: 57 sitesin 15 countries
Study dates: Jul 2012to Jul 2014
Phase: Phase 2
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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)

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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

Trial locations and contacts

57 sites in 15 countries.

Country

City, postcode or hospital

57 sites in 15 countries

United States14 sites

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Albuquerque, New Mexico, 87109
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Ashland, Kentucky, 41101
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Atlanta, Georgia, 30322
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Boston, Massachusetts, 02115
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Cedar Rapids, Iowa, 52402
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Fullerton, California, 92835
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Grand Junction, Colorado, 81501
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Indianapolis, Indiana, 46202
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Iowa City, Iowa, 52242
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Los Angeles, California, 90095
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Omaha, Nebraska, 68114
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Salt Lake City, Utah, 84106
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Santa Barbara, California, 93105
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Tucson, Arizona, 85715

Other trials in United States

Italy6 sites

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Bari, 70124
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Catania, 95124
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Florence, 50134
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Milan, 20162
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Rome, 00161
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Torino, 10126

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France5 sites

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Lille, 59037
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Nantes, 44093
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Nîmes, 30029
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Paris, 75475
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Tours, 37044

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United Kingdom5 sites

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Birmingham, B95SS
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Headington, Oxford, OX3 7LJ
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London, W1T 4TJ
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Manchester, M20 4BX
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Sutton, Surrey, SM2 5PT

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Poland4 sites

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Krakow, 31-501
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Lublin, 20-081
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Warsaw, 02-507
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Wroclaw, 50-367

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Brazil3 sites

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Campinas, 13083970
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Porto Alegre, 90035-903
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São Paulo, 01223001

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Germany3 sites

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Bamberg, 96049
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Cologne, 50931
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Heidelberg, 69120

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Spain3 sites

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Badalona, 08916
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Barcelona, 08036
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Madrid, 28006

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Turkey (Türkiye)3 sites

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Izmir, 35100
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Melikgazi, 38039
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Sihhiye, 06100

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Canada2 sites

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Calgary, Alberta, T2N 4N2
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Vancouver, British Columbia, V5Z 1M9

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Greece2 sites

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Ampelokipoi, 11527
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Athens, 115 28

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Mexico2 sites

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Mexico City, 14000
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Toluca, 50080

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South Korea2 sites

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Goyang-si, 411-764
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Seoul, 110-744

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Taiwan2 sites

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Neihu Taipei, 114
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Taipei, 100

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Netherlands1 site

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Rotterdam, 3015 CE

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About this study

Official title: 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

Conditions: Multiple Myeloma
Being tested: Placebo, Dexamethasone, Bortezomib, Tabalumab
Medical subject headings: Multiple Myeloma

What participants receive

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

PlaceboDrug
Administered IV
DexamethasoneDrug
Administered orally
BortezomibDrug
Administered SQ
TabalumabBiological
Also called LY2127399
Administered IV

Study groups in NCT01602224
Study group	Role	What they receive
100 mg Tabalumab+Dexamethasone (Dex)+Bortezomib (BTZ)	Experimental	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. Receives: Drug: Dexamethasone; Drug: Bortezomib; Biological: Tabalumab
300 mg Tabalumab+Dexamethasone+Bortezomib	Experimental	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. Receives: Drug: Dexamethasone; Drug: Bortezomib; Biological: Tabalumab
Placebo Comparator: Placebo + Dexamethasone + Bortezomib	Placebo comparator	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. Receives: Drug: Placebo; Drug: Dexamethasone; Drug: Bortezomib

What is being measured

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

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.
Measured: Baseline up to Objective Disease Progression or Death From Any Cause (assessed up to 9 months)

Secondary outcomes (13)

Overall Survival
Overall survival is the duration from enrollment to death from any cause. For participants who were alive, overall survival was censored at the last contact.
Measured: Baseline to Death From Any Cause (assessed up to 19 months)
Time to First Skeletal-Related Event (SRE)
Time to first SRE is defined as time from randomization to any one of the following related to multiple myeloma: New Pathological Fracture, Spinal Cord Compression, Surgery to the Bone, Radiation to the Bone collected until participant death, study closure or lost to follow up. Participants not known to have had an SRE at the time of the analysis were censored at the date of their last complete documented assessment for SRE.
Measured: 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
BPI is assessed by 7 questions rated "0" for "no pain" and higher numbers indicated more pain.
Measured: Baseline through End of Treatment (19 months)
Time to Progression (TTP)
Time to progression is defined as the time from the date of randomization to the date of first observed objective progression or death due to study disease. Time to progression will be censored as for PFS for those participants not known to have progressed or that died from other causes.
Measured: Baseline to Objective Disease Progression or Death (assessed up to 9 months)
Duration of Response (DoR)
DOR is measured by the International Myeloma Working Group Uniform Response Criteria: from the date of first evidence of a confirmed response to the date of objective progression or the date of death due to any cause, whichever is earlier. If a responder is not known to have died or have objective progression as of the data inclusion cutoff date, the DOR time will be censored at the last complete objective progression-free disease assessment date. Progressive disease is an increase of 25% from baseline in Serum M, Urine M, bone marrow plasma cell increase of 10 %, development of new bone lesions, development of new soft tissue plasmacytomas or bone lesions, hypercalcemia >11.5 milligrams per deciliter, decrease in hemoglobin of 2 grams per deciliter, rise in serum creatinine by 2 mg/deciliter.
Measured: Time from Response to Objective Disease Progression (assessed up to 38 months)
Time to Next Treatment (TNT)
TNT is defined as the time from the date of randomization to the date of initiation of the first poststudy treatment course of anticancer therapy or death from any cause. Time to next treatment will be censored at the date of the last visit for participant who did not initiate additional anticancer therapy.
Measured: Baseline to Initiation of New Cancer Treatment or Death From Any Cause (18 Months)
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Tabalumab
Maximum Concentration (Cmax) of Tabalumab.
Measured: Cycle (C)1 Day (D)1: Predose, 3O minutes, 2 hours Postdose; C1 D4, 8, 11: Predose, (D11 only, 30 minutes Postdose); C2 and C6-C10 D1: Predose and immediately Postdose; C2 D 4, 8, 11: Anytime
PK: Time to Maximum Plasma Concentration (Tmax) of Tabalumab
Measured: C1 D1: Predose, 3O minutes, 2 hours Postdose; C1 D4, 8, 11: Predose, (D11 only, 30 minutes Postdose); C2 and C6-C10 D1: Predose and immediately Postdose; C2 D 4, 8, 11: Anytime
PK: Area Under the Curve Over the Dosing Interval (AUC-T) for Tabalumab
Measured: C1 D1: Predose, 3O minutes, 2 hours Postdose; C1 D4, 8, 11: Predose, (D11 only, 30 minutes Postdose); C2 and C6-C10 D1: Predose and immediately Postdose; C2 D 4, 8, 11: Anytime
Number of Participants Developing Anti-tabalumab Antibodies
Measured: Baseline through Cycle 8
Participants With Best Overall Response (BOR) in Each Category
Stringent Complete Response-Complete Response and normal free light chain ration and no clonal cells in bone marrow Complete Response- no monoclonal protein (mp) in blood, no serum or urine mp, less than 5% plasma cells in bone marrow Very Good Partial Response-more than 90% decrease in mp and urine protein Partial Response- over 50% decrease in serum mp Stable Disease- less than 25 percent decrease of monoclonal protein Progressive Disease- 25% increase compared to lowest value of serum mp, urine mp, no measurable mp
Measured: Baseline to Objective Disease Progression or Initiation of New Cancer Treatment (28 Months)
Number of Participants With a Given Best Objective Myeloma Response (Quality of Response [QoR])
Response categories in order of decreasing quality are: Stringent Complete Response(sCR),Complete Response(CR), Very Good Partial Response(VGPR),Partial Response(PR),Minimal Response(MR),Stable Disease(SD), or Progressive Disease(PD), according to the International Uniform Response Criteria for Multiple Myeloma.SCR:normal free light chain ration and no clonal cells in bone marrow;CR-no monoclonal protein(mp) in blood, no serum/urine,<5% plasma cells in bone marrow; VGPR-more than 90% decrease in mp and urine protein; PR->50% decrease in serum MP;SD-<25% decrease in mp; PD-25% increase compared to lowest value of serum mp, urine mp and no measurable mp.
Measured: Baseline to Objective Disease Progression or Initiation of New Cancer Treatment (up to 28 Months)
Overall Response Rate (ORR)
Overall Response Rate (ORR) is the percentage of participants that had a response.
Measured: Baseline to Objective Disease Progression or Initiation of New Cancer Treatment (28 Months)

Timeline

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

Jul 2012Jul 2014

First posted18 May 2012 (estimated)
Study startJul 2012
Primary completionJul 2014
Study completionJul 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Multiple MyelomaStudies of the same condition, open and under way.
More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 220 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01602224
Sponsor's protocol ID: 14199
Other IDs: H9S-MC-JDCG
Status last verified: Sep 2019
First submitted: 16 May 2012
Last updated: 8 Oct 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: Yes: 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.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Active, not recruitingPhase 1/2
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All Multiple Myeloma trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT01602224
Acronym / sponsor ID: 14199
Conditions: Multiple Myeloma
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 220 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: Jul 2012
Primary completion: Jul 2014 (actual)
Study completion: Jul 2014 (actual)
First posted: 18 May 2012 (estimated)
Results: Posted 15 Aug 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 3

Arm	Type	Receives
100 mg Tabalumab+Dexamethasone (Dex)+Bortezomib (BTZ)	Experimental	Drug: Dexamethasone, Drug: Bortezomib, Biological: TabalumabTabalumab 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	Experimental	Drug: Dexamethasone, Drug: Bortezomib, Biological: TabalumabTabalumab 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 comparator	Drug: Placebo, Drug: Dexamethasone, Drug: BortezomibPlacebo 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (15 listed)

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:

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PlaceboAdministered IV	Drug	Placebo Comparator: Placebo + Dexamethasone + Bortezomib
DexamethasoneAdministered orally	Drug	100 mg Tabalumab+Dexamethasone (Dex)+Bortezomib (BTZ), 300 mg Tabalumab+Dexamethasone+Bortezomib, Placebo Comparator: Placebo + Dexamethasone + Bortezomib
BortezomibAdministered SQ	Drug	100 mg Tabalumab+Dexamethasone (Dex)+Bortezomib (BTZ), 300 mg Tabalumab+Dexamethasone+Bortezomib, Placebo Comparator: Placebo + Dexamethasone + Bortezomib
TabalumabAlso: LY2127399Administered IV	Biological	100 mg Tabalumab+Dexamethasone (Dex)+Bortezomib (BTZ), 300 mg Tabalumab+Dexamethasone+Bortezomib

Primary outcome

Progression Free Survival (PFS)
Time frame: Baseline up to Objective Disease Progression or Death From Any Cause (assessed up to 9 months)
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.

13 secondary outcomes

Overall Survival
Time frame: Baseline to Death From Any Cause (assessed up to 19 months)
Time to First Skeletal-Related Event (SRE)
Time frame: 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
Time frame: Baseline through End of Treatment (19 months)
Time to Progression (TTP)
Time frame: Baseline to Objective Disease Progression or Death (assessed up to 9 months)
Duration of Response (DoR)
Time frame: Time from Response to Objective Disease Progression (assessed up to 38 months)
Time to Next Treatment (TNT)
Time frame: Baseline to Initiation of New Cancer Treatment or Death From Any Cause (18 Months)
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Tabalumab
Time frame: Cycle (C)1 Day (D)1: Predose, 3O minutes, 2 hours Postdose; C1 D4, 8, 11: Predose, (D11 only, 30 minutes Postdose); C2 and C6-C10 D1: Predose and immediately Postdose; C2 D 4, 8, 11: Anytime
PK: Time to Maximum Plasma Concentration (Tmax) of Tabalumab
Time frame: C1 D1: Predose, 3O minutes, 2 hours Postdose; C1 D4, 8, 11: Predose, (D11 only, 30 minutes Postdose); C2 and C6-C10 D1: Predose and immediately Postdose; C2 D 4, 8, 11: Anytime
PK: Area Under the Curve Over the Dosing Interval (AUC-T) for Tabalumab
Time frame: C1 D1: Predose, 3O minutes, 2 hours Postdose; C1 D4, 8, 11: Predose, (D11 only, 30 minutes Postdose); C2 and C6-C10 D1: Predose and immediately Postdose; C2 D 4, 8, 11: Anytime
Number of Participants Developing Anti-tabalumab Antibodies
Time frame: Baseline through Cycle 8
Participants With Best Overall Response (BOR) in Each Category
Time frame: Baseline to Objective Disease Progression or Initiation of New Cancer Treatment (28 Months)
Number of Participants With a Given Best Objective Myeloma Response (Quality of Response [QoR])
Time frame: Baseline to Objective Disease Progression or Initiation of New Cancer Treatment (up to 28 Months)
Overall Response Rate (ORR)
Time frame: Baseline to Objective Disease Progression or Initiation of New Cancer Treatment (28 Months)

Results and safety

Results posted to the registry on 15 Aug 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
100 mg Tabalumab+Dexamethasone+Bortezomib	74	66
300 mg Tabalumab+Dexamethasone+Bortezomib	74	66
Placebo Comparator: Placebo + Dexamethasone + Bortezomib	72	66

Primary outcome: Progression Free Survival (PFS)

Time frame: Baseline up to Objective Disease Progression or Death From Any Cause (assessed up to 9 months). Median (95% Confidence Interval). Unit: months

Measure	100 mg Tabalumab+Dexamethasone+Bortezomib n = 74	300 mg Tabalumab+Dexamethasone+Bortezomib n = 74	Placebo Comparator: Placebo + Dexamethasone + Bortezomib n = 72
Value	6.6 (5.6 to 8.5)	7.5 (5.8 to 9.3)	7.6 (6.5 to 9.3)

Population analysed: All randomized participants.

13 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
100 mg Tabalumab+Dexamethasone+Bortezomib	33 of 73 (45.2%)	71 of 73 (97.3%)	Not reported
300 mg Tabalumab+Dexamethasone+Bortezomib	35 of 74 (47.3%)	70 of 74 (94.6%)	Not reported
Placebo Comparator: Placebo + Dexamethasone + Bortezomib	26 of 72 (36.1%)	69 of 72 (95.8%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. 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.

Related trials for Multiple Myeloma

Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
RecruitingPhase 2
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

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) study director

Eli Lilly and Company

57 sites in 15 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Dexamethasone, Bortezomib and Tabalumab in people with Multiple Myeloma, run by Eli Lilly and Company at 57 sites in 15 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 15 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 8 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 57 sites in United States, Italy, France, United Kingdom, Poland and 10 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 15 Aug 2018). 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: Baseline up to Objective Disease Progression or Death From Any Cause (assessed up to 9 months)). 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 NCT01602224.

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 8 Oct 2019.