Trial Outcomes & Findings for Study of Tabalumab (LY2127399) in Japanese Participants With Relapsed or Refactory Multiple Myeloma (NCT NCT01556438)

Last Updated: 2019-03-20

Results Overview

A summary of other non-serious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

16 participants

Primary outcome timeframe

Baseline through 8 months

Results posted on

2019-03-20

Participant Flow

Participant milestones

Participant milestones
Measure	100 mg Tabalumab+BTZ IV+Dex Cohort 1. 100 mg tabalumab (LY2127399)intravenously (IV) on day 1 of each cycle. Bortezomib (BTZ), 1.3 milligram per square meter (mg/m\^2), IV on days 1, 4, 8, 11 of Cycle 1-8, then on days 1, 8, 15, 22 from Cycle 9 onward. Oral dexamethasone (Dex), 20 mg/day, on day of and day after BTZ.	300 mg Tabalumab+ BTZ +Dex Cohort 2. 300 mg tabalumab (LY2127399) IV on day 1 of each cycle. BTZ, 1.3 mg/m\^2, IV on days 1, 4, 8, 11 of Cycle 1-8, then on days 1, 8, 15, 22 from Cycle 9 onward. Oral dex, 20 mg/day, on day of and day after BTZ subcutaneously or intravenously (SC, IV respectively).
Overall Study STARTED	4	12
Overall Study Received at Least 1 Dose of Study Drug	4	12
Overall Study Received BTZ IV	4	4
Overall Study Received BTZ SC	0	8
Overall Study COMPLETED	0	1
Overall Study NOT COMPLETED	4	11

Reasons for withdrawal

Reasons for withdrawal
Measure	100 mg Tabalumab+BTZ IV+Dex Cohort 1. 100 mg tabalumab (LY2127399)intravenously (IV) on day 1 of each cycle. Bortezomib (BTZ), 1.3 milligram per square meter (mg/m\^2), IV on days 1, 4, 8, 11 of Cycle 1-8, then on days 1, 8, 15, 22 from Cycle 9 onward. Oral dexamethasone (Dex), 20 mg/day, on day of and day after BTZ.	300 mg Tabalumab+ BTZ +Dex Cohort 2. 300 mg tabalumab (LY2127399) IV on day 1 of each cycle. BTZ, 1.3 mg/m\^2, IV on days 1, 4, 8, 11 of Cycle 1-8, then on days 1, 8, 15, 22 from Cycle 9 onward. Oral dex, 20 mg/day, on day of and day after BTZ subcutaneously or intravenously (SC, IV respectively).
Overall Study Adverse Event	4	2
Overall Study Sponsor Decision	0	2
Overall Study Progressive Disease	0	6
Overall Study Death	0	1

Baseline Characteristics

Study of Tabalumab (LY2127399) in Japanese Participants With Relapsed or Refactory Multiple Myeloma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	100 mg Tabalumab+BTZ IV+Dex n=4 Participants Cohort 1. 100 mg tabalumab (LY2127399) intravenously (IV) on day 1 of each cycle. Bortezomib (BTZ), 1.3 milligram per square meter (mg/m\^2), IV on days 1, 4, 8, 11 of Cycle 1-8, then on days 1, 8, 15, 22 from Cycle 9 onward. Oral dexamethasone (Dex), 20 mg/day, on day of and day after BTZ.	300 mg Tabalumab+BTZ +Dex n=12 Participants Cohort 2. 300 mg tabalumab (LY2127399) IV on day 1 of each cycle. BTZ, 1.3 mg/m\^2, IV on days 1, 4, 8, 11 of Cycle 1-8, then on days 1, 8, 15, 22 from Cycle 9 onward. Oral dex, 20 mg/day, on day of and day after BTZ subcutaneously or intravenously (SC, IV respectively).	Total n=16 Participants Total of all reporting groups
Age, Continuous	70.7 years n=5 Participants	71.3 years n=7 Participants	71.1 years n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	8 Participants n=7 Participants	10 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	4 Participants n=5 Participants	12 Participants n=7 Participants	16 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	4 Participants n=5 Participants	12 Participants n=7 Participants	16 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Japan	4 Participants n=5 Participants	12 Participants n=7 Participants	16 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline through 8 months

Population: All participants who received at least 1 dose of study drug.

A summary of other non-serious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section.

Outcome measures

Outcome measures
Measure	100 mg Tabalumab+BTZ IV+Dex n=4 Participants Cohort 1. 100 mg tabalumab (LY2127399) intravenously (IV) on day 1 of each cycle. Bortezomib (BTZ), 1.3 milligram per square meter (mg/m\^2), IV on days 1, 4, 8, 11 of Cycle 1-8, then on days 1, 8, 15, 22 from Cycle 9 onward. Oral dexamethasone (Dex), 20 mg/day, on day of and day after BTZ.	300 mg Tabalumab+BTZ +Dex n=12 Participants Cohort 2. 300 mg tabalumab (LY2127399) IV on day 1 of each cycle. BTZ, 1.3 mg/m\^2, IV on days 1, 4, 8, 11 of Cycle 1-8, then on days 1, 8, 15, 22 from Cycle 9 onward. Oral dex, 20 mg/day, on day of and day after BTZ subcutaneously or intravenously (SC, IV respectively).	300 mg Tabalumab+ SC BTZ +Dex Cohort 2. 300 mg tabalumab (LY2127399) IV on day 1 of each cycle. BTZ, 1.3 mg/m\^2, IV on days 1, 4, 8, 11 of Cycle 1-8, then on days 1, 8, 15, 22 from Cycle 9 onward. Oral dex, 20 mg/day, on day of and day after BTZ SC.
Number of Participants With One or More Drug Related Adverse Events (AEs) or Any Serious AEs	4 Participants	12 Participants	—

SECONDARY outcome

Timeframe: Cycle 1, Day 1: 6 + or - hours after bortezomib (BTZ); Cycle 7, Day 1: immediately post BTZ dose and 2 hours after tabalumab

Population: All participants who received at least 1 dose of any study drug and had evaluable PK data.

Outcome measures

Outcome measures
Measure	100 mg Tabalumab+BTZ IV+Dex n=4 Participants Cohort 1. 100 mg tabalumab (LY2127399) intravenously (IV) on day 1 of each cycle. Bortezomib (BTZ), 1.3 milligram per square meter (mg/m\^2), IV on days 1, 4, 8, 11 of Cycle 1-8, then on days 1, 8, 15, 22 from Cycle 9 onward. Oral dexamethasone (Dex), 20 mg/day, on day of and day after BTZ.	300 mg Tabalumab+BTZ +Dex n=4 Participants Cohort 2. 300 mg tabalumab (LY2127399) IV on day 1 of each cycle. BTZ, 1.3 mg/m\^2, IV on days 1, 4, 8, 11 of Cycle 1-8, then on days 1, 8, 15, 22 from Cycle 9 onward. Oral dex, 20 mg/day, on day of and day after BTZ subcutaneously or intravenously (SC, IV respectively).	300 mg Tabalumab+ SC BTZ +Dex n=8 Participants Cohort 2. 300 mg tabalumab (LY2127399) IV on day 1 of each cycle. BTZ, 1.3 mg/m\^2, IV on days 1, 4, 8, 11 of Cycle 1-8, then on days 1, 8, 15, 22 from Cycle 9 onward. Oral dex, 20 mg/day, on day of and day after BTZ SC.
Pharmacokinetics (PK): Maximum Plasma Concentration (Cmax) for Tabalumab (LY2127399) Cycle 1 Day 1	38.5 microgram per milliliter (μg/mL) Geometric Coefficient of Variation 12	154 microgram per milliliter (μg/mL) Geometric Coefficient of Variation 21	139 microgram per milliliter (μg/mL) Geometric Coefficient of Variation 14
Pharmacokinetics (PK): Maximum Plasma Concentration (Cmax) for Tabalumab (LY2127399) Cycle 7 Day 1	70.5 microgram per milliliter (μg/mL) Geometric Coefficient of Variation NA N of 1, Individual data presented, no CV value.	179 microgram per milliliter (μg/mL) Geometric Coefficient of Variation NA N of 1, Individual data presented, no CV value.	220 microgram per milliliter (μg/mL) Geometric Coefficient of Variation 25

SECONDARY outcome

Timeframe: Cycle 1, Day 1: 6 + or - hours after bortezomib (BTZ); Cycle 7, Day 1: immediately post BTZ dose and 2 hours after tabalumab

Population: All participants who received at least 1 dose of any study drug and had evaluable PK data.

Outcome measures

Outcome measures
Measure	100 mg Tabalumab+BTZ IV+Dex n=4 Participants Cohort 1. 100 mg tabalumab (LY2127399) intravenously (IV) on day 1 of each cycle. Bortezomib (BTZ), 1.3 milligram per square meter (mg/m\^2), IV on days 1, 4, 8, 11 of Cycle 1-8, then on days 1, 8, 15, 22 from Cycle 9 onward. Oral dexamethasone (Dex), 20 mg/day, on day of and day after BTZ.	300 mg Tabalumab+BTZ +Dex n=4 Participants Cohort 2. 300 mg tabalumab (LY2127399) IV on day 1 of each cycle. BTZ, 1.3 mg/m\^2, IV on days 1, 4, 8, 11 of Cycle 1-8, then on days 1, 8, 15, 22 from Cycle 9 onward. Oral dex, 20 mg/day, on day of and day after BTZ subcutaneously or intravenously (SC, IV respectively).	300 mg Tabalumab+ SC BTZ +Dex n=8 Participants Cohort 2. 300 mg tabalumab (LY2127399) IV on day 1 of each cycle. BTZ, 1.3 mg/m\^2, IV on days 1, 4, 8, 11 of Cycle 1-8, then on days 1, 8, 15, 22 from Cycle 9 onward. Oral dex, 20 mg/day, on day of and day after BTZ SC.
Pharmacokinetics (PK): Area Under the Plasma Concentration-time Curve From Time Zero to the Last Measurable Plasma Concentration (AUC0-tlast) of Tabalumab (LY2127399) Cycle 1 Day 1	8100 hours times nanograms per milliliter Geometric Coefficient of Variation 15	34600 hours times nanograms per milliliter Geometric Coefficient of Variation 23	26900 hours times nanograms per milliliter Geometric Coefficient of Variation 48
Pharmacokinetics (PK): Area Under the Plasma Concentration-time Curve From Time Zero to the Last Measurable Plasma Concentration (AUC0-tlast) of Tabalumab (LY2127399) Cycle 7 Day 1	9400 hours times nanograms per milliliter Geometric Coefficient of Variation NA N of 1, Individual data presented, no CV value.	27300 hours times nanograms per milliliter Geometric Coefficient of Variation NA N of 1, Individual data presented, no CV value.	22900 hours times nanograms per milliliter Geometric Coefficient of Variation 71

SECONDARY outcome

Timeframe: Cycle 1, Day 1: 6 + or - hours after bortezomib (BTZ); Cycle 7, Day 1: immediately post BTZ dose and 2 hours after tabalumab

Population: All participants who received at least 1 dose of any study drug and had evaluable PK data. Participants in the 300 mg tabalumab group may have received IV and SC BTZ and may be counted in the IV and SC group for analysis.

Outcome measures

Outcome measures
Measure	100 mg Tabalumab+BTZ IV+Dex n=4 Participants Cohort 1. 100 mg tabalumab (LY2127399) intravenously (IV) on day 1 of each cycle. Bortezomib (BTZ), 1.3 milligram per square meter (mg/m\^2), IV on days 1, 4, 8, 11 of Cycle 1-8, then on days 1, 8, 15, 22 from Cycle 9 onward. Oral dexamethasone (Dex), 20 mg/day, on day of and day after BTZ.	300 mg Tabalumab+BTZ +Dex n=4 Participants Cohort 2. 300 mg tabalumab (LY2127399) IV on day 1 of each cycle. BTZ, 1.3 mg/m\^2, IV on days 1, 4, 8, 11 of Cycle 1-8, then on days 1, 8, 15, 22 from Cycle 9 onward. Oral dex, 20 mg/day, on day of and day after BTZ subcutaneously or intravenously (SC, IV respectively).	300 mg Tabalumab+ SC BTZ +Dex n=8 Participants Cohort 2. 300 mg tabalumab (LY2127399) IV on day 1 of each cycle. BTZ, 1.3 mg/m\^2, IV on days 1, 4, 8, 11 of Cycle 1-8, then on days 1, 8, 15, 22 from Cycle 9 onward. Oral dex, 20 mg/day, on day of and day after BTZ SC.
Pharmacokinetics (PK): Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC0-∞) of Tabalumab (LY2127399) Cycle 7 Day 1	NA ng*hr/mL Geometric Coefficient of Variation NA N of 1, no value obtained, no CV value.	84100 ng*hr/mL Geometric Coefficient of Variation NA N of 1, Individual data presented, no CV value.	131000 ng*hr/mL Geometric Coefficient of Variation NA CV not available from N=3 for analysis.
Pharmacokinetics (PK): Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC0-∞) of Tabalumab (LY2127399) Cycle 1 Day 1	13300 ng*hr/mL Geometric Coefficient of Variation 21	64200 ng*hr/mL Geometric Coefficient of Variation 35	50900 ng*hr/mL Geometric Coefficient of Variation 60

SECONDARY outcome

Timeframe: Baseline to disease progression (up to 421 days)

Population: All participants who received at least 1 dose of study drug.

Stringent Complete Response- Complete response in addition to 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.

Outcome measures

Outcome measures
Measure	100 mg Tabalumab+BTZ IV+Dex n=4 Participants Cohort 1. 100 mg tabalumab (LY2127399) intravenously (IV) on day 1 of each cycle. Bortezomib (BTZ), 1.3 milligram per square meter (mg/m\^2), IV on days 1, 4, 8, 11 of Cycle 1-8, then on days 1, 8, 15, 22 from Cycle 9 onward. Oral dexamethasone (Dex), 20 mg/day, on day of and day after BTZ.	300 mg Tabalumab+BTZ +Dex n=12 Participants Cohort 2. 300 mg tabalumab (LY2127399) IV on day 1 of each cycle. BTZ, 1.3 mg/m\^2, IV on days 1, 4, 8, 11 of Cycle 1-8, then on days 1, 8, 15, 22 from Cycle 9 onward. Oral dex, 20 mg/day, on day of and day after BTZ subcutaneously or intravenously (SC, IV respectively).	300 mg Tabalumab+ SC BTZ +Dex Cohort 2. 300 mg tabalumab (LY2127399) IV on day 1 of each cycle. BTZ, 1.3 mg/m\^2, IV on days 1, 4, 8, 11 of Cycle 1-8, then on days 1, 8, 15, 22 from Cycle 9 onward. Oral dex, 20 mg/day, on day of and day after BTZ SC.
Number of Participants With Tumor Response (Tumor Response Rate) Numbers of Responders	4 Participants	5 Participants	—
Number of Participants With Tumor Response (Tumor Response Rate) Stringent Complete Response (sCR)	0 Participants	0 Participants	—
Number of Participants With Tumor Response (Tumor Response Rate) Complete Response (CR)	0 Participants	0 Participants	—
Number of Participants With Tumor Response (Tumor Response Rate) Very Good Partial Response (VGPR)	2 Participants	1 Participants	—
Number of Participants With Tumor Response (Tumor Response Rate) Partial Response(PR)	2 Participants	4 Participants	—
Number of Participants With Tumor Response (Tumor Response Rate) Stable Disease(SD)	0 Participants	2 Participants	—
Number of Participants With Tumor Response (Tumor Response Rate) Progressive Disease	0 Participants	3 Participants	—

SECONDARY outcome

Timeframe: Time from Response until measured Progressive Disease (up to 455 days)

Population: All participants who received at least 1 dose of study drug, 4 participants were censored from Cohort 1 and 5 participants from Cohort 2. 300 mg tabalumab group administered BTZ IV or SC data were combined per protocol, BTZ was a supplemental therapy for participants.

DoR is defined as the time from the date when the measurement criteria are met for CR, CRu, or PR (whichever status is recorded first) until the date of first observation of measured progressive disease. For responding participants who die without progressive disease (including death from study disease),DoR will be censored at the date of death. For responding participants not known to have died as of the data cut-off date and who do not have progressive disease, DoR will be censored at the last objective progression-free assessment date prior to the data cut-off date.

Outcome measures

Outcome measures
Measure	100 mg Tabalumab+BTZ IV+Dex n=4 Participants Cohort 1. 100 mg tabalumab (LY2127399) intravenously (IV) on day 1 of each cycle. Bortezomib (BTZ), 1.3 milligram per square meter (mg/m\^2), IV on days 1, 4, 8, 11 of Cycle 1-8, then on days 1, 8, 15, 22 from Cycle 9 onward. Oral dexamethasone (Dex), 20 mg/day, on day of and day after BTZ.	300 mg Tabalumab+BTZ +Dex n=5 Participants Cohort 2. 300 mg tabalumab (LY2127399) IV on day 1 of each cycle. BTZ, 1.3 mg/m\^2, IV on days 1, 4, 8, 11 of Cycle 1-8, then on days 1, 8, 15, 22 from Cycle 9 onward. Oral dex, 20 mg/day, on day of and day after BTZ subcutaneously or intravenously (SC, IV respectively).	300 mg Tabalumab+ SC BTZ +Dex Cohort 2. 300 mg tabalumab (LY2127399) IV on day 1 of each cycle. BTZ, 1.3 mg/m\^2, IV on days 1, 4, 8, 11 of Cycle 1-8, then on days 1, 8, 15, 22 from Cycle 9 onward. Oral dex, 20 mg/day, on day of and day after BTZ SC.
Duration of Response (DoR)	NA months Data is not available to be presented because endpoint was not reached.	NA months Data is not available to be presented because endpoint was not reached.	—

SECONDARY outcome

Timeframe: Baseline to date of Progressive Disease (up to 455 days)

Population: All participants who received at least 1 dose of study drug and didn't have AEs . 300 mg tabalumab group administered BTZ IV or SC data were combined per protocol, BTZ was a supplemental therapy for participants. Participants that were censored prior to PD and not included in analysis:100 mg tabalumab n=4, 300 mg tabalumab n=8.

TTP is defined as the time from the date of study enrollment to the date of objectively determined progressive disease. TTP will be censored at the date of the last objective progression free disease assessment.

Outcome measures

Outcome measures
Measure	100 mg Tabalumab+BTZ IV+Dex n=4 Participants Cohort 1. 100 mg tabalumab (LY2127399) intravenously (IV) on day 1 of each cycle. Bortezomib (BTZ), 1.3 milligram per square meter (mg/m\^2), IV on days 1, 4, 8, 11 of Cycle 1-8, then on days 1, 8, 15, 22 from Cycle 9 onward. Oral dexamethasone (Dex), 20 mg/day, on day of and day after BTZ.	300 mg Tabalumab+BTZ +Dex n=12 Participants Cohort 2. 300 mg tabalumab (LY2127399) IV on day 1 of each cycle. BTZ, 1.3 mg/m\^2, IV on days 1, 4, 8, 11 of Cycle 1-8, then on days 1, 8, 15, 22 from Cycle 9 onward. Oral dex, 20 mg/day, on day of and day after BTZ subcutaneously or intravenously (SC, IV respectively).	300 mg Tabalumab+ SC BTZ +Dex Cohort 2. 300 mg tabalumab (LY2127399) IV on day 1 of each cycle. BTZ, 1.3 mg/m\^2, IV on days 1, 4, 8, 11 of Cycle 1-8, then on days 1, 8, 15, 22 from Cycle 9 onward. Oral dex, 20 mg/day, on day of and day after BTZ SC.
Time to Progression (TTP)	NA months No data collected due to censoring prior to PD.	NA months Interval 0.49 to 8.0 Due to censoring prior to PD, median not collected as per Statistical Analysis Plan.	—

SECONDARY outcome

Timeframe: Baseline through study completion (up to 455 days)

Population: Zero participants analyzed as no post baseline data collected.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, Cycle 1 and Cycle 7: prior to first tabalumab dose.

Population: All participants who received at least 1 dose of study drug and had evaluable PD. 300 mg tabalumab IV and SC dose were analyzed together.

CD19+ peripheral B-cells counts are based on the percentage of total leukocyte population and absolute cell counts.

Outcome measures

Outcome measures
Measure	100 mg Tabalumab+BTZ IV+Dex n=4 Participants Cohort 1. 100 mg tabalumab (LY2127399) intravenously (IV) on day 1 of each cycle. Bortezomib (BTZ), 1.3 milligram per square meter (mg/m\^2), IV on days 1, 4, 8, 11 of Cycle 1-8, then on days 1, 8, 15, 22 from Cycle 9 onward. Oral dexamethasone (Dex), 20 mg/day, on day of and day after BTZ.	300 mg Tabalumab+BTZ +Dex n=12 Participants Cohort 2. 300 mg tabalumab (LY2127399) IV on day 1 of each cycle. BTZ, 1.3 mg/m\^2, IV on days 1, 4, 8, 11 of Cycle 1-8, then on days 1, 8, 15, 22 from Cycle 9 onward. Oral dex, 20 mg/day, on day of and day after BTZ subcutaneously or intravenously (SC, IV respectively).	300 mg Tabalumab+ SC BTZ +Dex Cohort 2. 300 mg tabalumab (LY2127399) IV on day 1 of each cycle. BTZ, 1.3 mg/m\^2, IV on days 1, 4, 8, 11 of Cycle 1-8, then on days 1, 8, 15, 22 from Cycle 9 onward. Oral dex, 20 mg/day, on day of and day after BTZ SC.
Pharmacodynamics (PD): Change From Baseline in B-cell Subset Fractions Baseline	9.3 percentage of b-cell change Standard Deviation 8.1	12.5 percentage of b-cell change Standard Deviation 10.7	—
Pharmacodynamics (PD): Change From Baseline in B-cell Subset Fractions Cycle 1, Day 1	1.1 percentage of b-cell change Standard Deviation 1.6	0.3 percentage of b-cell change Standard Deviation 6.7	—
Pharmacodynamics (PD): Change From Baseline in B-cell Subset Fractions Cycle 7, Day 1	NA percentage of b-cell change Standard Deviation NA N of 1, pd data not collected from participant	-14.4 percentage of b-cell change Standard Deviation 7.5	—

Adverse Events

100 mg Tabalumab+BTZ IV+Dex

Serious events: 2 serious events

Other events: 4 other events

Deaths: 0 deaths

300 mg Tabalumab+BTZ +Dex

Serious events: 8 serious events

Other events: 12 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Chief Medical Officer

Eli Lilly and Company

Phone: 800-545-5979

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60

Measure	100 mg Tabalumab+BTZ IV+Dex n=4 participants at risk Cohort 1. 100 mg tabalumab (LY2127399) intravenously (IV) on day 1 of each cycle. Bortezomib (BTZ), 1.3 milligram per square meter (mg/m\^2), IV on days 1, 4, 8, 11 of Cycle 1-8, then on days 1, 8, 15, 22 from Cycle 9 onward. Oral dexamethasone (Dex), 20 mg/day, on day of and day after BTZ.	300 mg Tabalumab+BTZ +Dex n=12 participants at risk Cohort 2. 300 mg tabalumab (LY2127399) IV on day 1 of each cycle. BTZ, 1.3 mg/m\^2, IV on days 1, 4, 8, 11 of Cycle 1-8, then on days 1, 8, 15, 22 from Cycle 9 onward. Oral dex, 20 mg/day, on day of and day after BTZ subcutaneously or intravenously (SC, IV respectively).
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/4 300 mg tabalumab (LY2127399) group administered BTZ IV or SC data were combined per protocol, BTZ was a supplemental therapy for participants.	8.3% 1/12 • Number of events 1 300 mg tabalumab (LY2127399) group administered BTZ IV or SC data were combined per protocol, BTZ was a supplemental therapy for participants.
Gastrointestinal disorders Ileus	25.0% 1/4 • Number of events 1 300 mg tabalumab (LY2127399) group administered BTZ IV or SC data were combined per protocol, BTZ was a supplemental therapy for participants.	0.00% 0/12 300 mg tabalumab (LY2127399) group administered BTZ IV or SC data were combined per protocol, BTZ was a supplemental therapy for participants.
Infections and infestations Bronchopulmonary aspergillosis	0.00% 0/4 300 mg tabalumab (LY2127399) group administered BTZ IV or SC data were combined per protocol, BTZ was a supplemental therapy for participants.	8.3% 1/12 • Number of events 1 300 mg tabalumab (LY2127399) group administered BTZ IV or SC data were combined per protocol, BTZ was a supplemental therapy for participants.
Infections and infestations Gastroenteritis	0.00% 0/4 300 mg tabalumab (LY2127399) group administered BTZ IV or SC data were combined per protocol, BTZ was a supplemental therapy for participants.	8.3% 1/12 • Number of events 1 300 mg tabalumab (LY2127399) group administered BTZ IV or SC data were combined per protocol, BTZ was a supplemental therapy for participants.
Infections and infestations Infection	0.00% 0/4 300 mg tabalumab (LY2127399) group administered BTZ IV or SC data were combined per protocol, BTZ was a supplemental therapy for participants.	8.3% 1/12 • Number of events 1 300 mg tabalumab (LY2127399) group administered BTZ IV or SC data were combined per protocol, BTZ was a supplemental therapy for participants.
Injury, poisoning and procedural complications Fall	25.0% 1/4 • Number of events 1 300 mg tabalumab (LY2127399) group administered BTZ IV or SC data were combined per protocol, BTZ was a supplemental therapy for participants.	0.00% 0/12 300 mg tabalumab (LY2127399) group administered BTZ IV or SC data were combined per protocol, BTZ was a supplemental therapy for participants.
Injury, poisoning and procedural complications Femoral neck fracture	25.0% 1/4 • Number of events 1 300 mg tabalumab (LY2127399) group administered BTZ IV or SC data were combined per protocol, BTZ was a supplemental therapy for participants.	0.00% 0/12 300 mg tabalumab (LY2127399) group administered BTZ IV or SC data were combined per protocol, BTZ was a supplemental therapy for participants.
Injury, poisoning and procedural complications Subdural haematoma	0.00% 0/4 300 mg tabalumab (LY2127399) group administered BTZ IV or SC data were combined per protocol, BTZ was a supplemental therapy for participants.	8.3% 1/12 • Number of events 1 300 mg tabalumab (LY2127399) group administered BTZ IV or SC data were combined per protocol, BTZ was a supplemental therapy for participants.
Metabolism and nutrition disorders Tumour lysis syndrome	0.00% 0/4 300 mg tabalumab (LY2127399) group administered BTZ IV or SC data were combined per protocol, BTZ was a supplemental therapy for participants.	8.3% 1/12 • Number of events 1 300 mg tabalumab (LY2127399) group administered BTZ IV or SC data were combined per protocol, BTZ was a supplemental therapy for participants.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/4 300 mg tabalumab (LY2127399) group administered BTZ IV or SC data were combined per protocol, BTZ was a supplemental therapy for participants.	8.3% 1/12 • Number of events 1 300 mg tabalumab (LY2127399) group administered BTZ IV or SC data were combined per protocol, BTZ was a supplemental therapy for participants.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer	0.00% 0/4 300 mg tabalumab (LY2127399) group administered BTZ IV or SC data were combined per protocol, BTZ was a supplemental therapy for participants.	8.3% 1/12 • Number of events 1 300 mg tabalumab (LY2127399) group administered BTZ IV or SC data were combined per protocol, BTZ was a supplemental therapy for participants.
Nervous system disorders Nerve compression	0.00% 0/4 300 mg tabalumab (LY2127399) group administered BTZ IV or SC data were combined per protocol, BTZ was a supplemental therapy for participants.	8.3% 1/12 • Number of events 1 300 mg tabalumab (LY2127399) group administered BTZ IV or SC data were combined per protocol, BTZ was a supplemental therapy for participants.
Nervous system disorders Peripheral sensory neuropathy	0.00% 0/4 300 mg tabalumab (LY2127399) group administered BTZ IV or SC data were combined per protocol, BTZ was a supplemental therapy for participants.	8.3% 1/12 • Number of events 1 300 mg tabalumab (LY2127399) group administered BTZ IV or SC data were combined per protocol, BTZ was a supplemental therapy for participants.
Nervous system disorders Subarachnoid haemorrhage	0.00% 0/4 300 mg tabalumab (LY2127399) group administered BTZ IV or SC data were combined per protocol, BTZ was a supplemental therapy for participants.	8.3% 1/12 • Number of events 1 300 mg tabalumab (LY2127399) group administered BTZ IV or SC data were combined per protocol, BTZ was a supplemental therapy for participants.
Nervous system disorders Syncope	0.00% 0/4 300 mg tabalumab (LY2127399) group administered BTZ IV or SC data were combined per protocol, BTZ was a supplemental therapy for participants.	8.3% 1/12 • Number of events 1 300 mg tabalumab (LY2127399) group administered BTZ IV or SC data were combined per protocol, BTZ was a supplemental therapy for participants.
Vascular disorders Embolism	0.00% 0/4 300 mg tabalumab (LY2127399) group administered BTZ IV or SC data were combined per protocol, BTZ was a supplemental therapy for participants.	8.3% 1/12 • Number of events 1 300 mg tabalumab (LY2127399) group administered BTZ IV or SC data were combined per protocol, BTZ was a supplemental therapy for participants.