Multiple Myeloma
Conditions
Brief summary
The purpose of this study is to evaluate the safety and effect on the body of Tabalumab (LY2127399) in combination with bortezomib and dexamethasone in Japanese participants with relapsed or refractory multiple myeloma (MM).
Detailed description
The study has 3 cohorts. Cohort 2 and cohort 2-SC will be conducted in parallel with some data presented combined. Cohort 1 - Participants will receive 100 mg Tabalumab (LY2127399) intravenously (IV), 1.3 milligram per square meter (mg/m\^2) bortezomib IV, and 20 mg dexamethasone orally. Cohort 2 - Participants will receive 300 mg Tabalumab (LY2127399) IV, 1.3 mg/m\^2 bortezomib IV, and 20 mg dexamethasone orally. Cohort 2-SC - Participants will receive 300 mg Tabalumab (LY2127399) IV, 1.3 mg/m\^2 bortezomib subcutaneously (SC), and 20 mg dexamethasone orally. Cohort 2-SC was added per protocol amendment in February 2013.
Interventions
BIOLOGICALTabalumab
Administered IV
DRUGBortezomib IV
Administered IV
DRUGBortezomib SC
Administered SC
DRUGDexamethasone
Administered orally
Sponsors
Eli Lilly and Company
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Have relapsed or refractory MM treated with at least 1 prior regimen. Prior therapy with bortezomib is allowed if there was previously at least a minimal response (MR). * Have measurable disease as defined by one or more of the following: * serum M-protein concentration ≥ 1 g/dL (10 g/L) * urine monoclonal light chain concentration ≥ 200 mg/24 hours as determined by urine protein electrophoresis * involved serum free light chain (SFLC) concentration ≥ 10 mg/dL (100 mg/L) and an abnormal SFLC ratio * Have adequate organ function including: * Absolute neutrophil count (ANC) ≥ 1000/microliter * Platelet (PLT) count ≥ 75,000/microliter * Hemoglobin (Hgb) ≥ 8.0 g/dL * Total bilirubin ≤ 1.5 x upper limit of normal (ULN) (if total is elevated check direct and, if normal, participant is eligible) * Aspartate transaminase (AST) and alanine aminotransferase (ALT) are ≤ 3 x ULN * Serum creatinine ≤ 3.0 mg/dL. * Have an Eastern Cooperative Oncology Group performance status (ECOG PS) score of ≤ 2. * Have discontinued all previous therapies for cancer, including chemotherapy, surgery, and radiotherapy for at least 2 weeks (6 weeks for mitomycin-C or nitrosoureas) before study enrollment and recovered from the acute effects of therapy. * Males and females with reproductive potential: Must agree to use medically approved contraceptive precautions during the study and for 4 months following the last dose of study drug. * Females with childbearing potential: Must have had a negative urine or serum pregnancy test \<7 days before the first dose of study drug. * Have an estimated life expectancy of ≥16 weeks, in the opinion of the investigator.
Exclusion criteria
* Have received treatment within 30 days of the initial dose of study drug with an experimental agent for non-cancer indications that has not received regulatory approval for any indication. * Have one or more serious preexisting medical conditions that, in the opinion of the investigator, would preclude participation in this study. * Have an uncontrolled infection. * Females who are pregnant or breastfeeding. * Have known positive test results for human immunodeficiency virus (HIV), hepatitis B\*, or hepatitis C antibodies (HCAb). \* Have evidence of or test positive for hepatitis B. A positive test for hepatitis B is defined as: 1. positive for hepatitis B surface antigen (HBsAg+). OR 2. positive for anti-hepatitis B core antibody and positive for hepatitis B deoxyribonucleic acid (HBV DNA). OR 3. positive for anti-hepatitis B surface antibody (HBsAb+) and positive for hepatitis B deoxyribonucleic acid (HBV DNA). * Have ≥ Grade 2 peripheral neuropathy or any grade with pain as assessed using the Common Terminology Criteria for Adverse Events, version 4.03 (CTCAE v 4.03). * Have previously received an allogenic hematopoietic stem cell transplant. * Have previously received treatment with an experimental agent that targets B-cell activating factor (BAFF). * Have a corrected QT (QTc) interval \>470 msec on their baseline electrocardiogram (ECG). * Have interstitial pneumonitis (interstitial pneumonia) or pulmonary fibrosis manifested as opacity on chest X-ray or computed tomography (CT) scan. * Have had another active malignancy within the past 5 years.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With One or More Drug Related Adverse Events (AEs) or Any Serious AEs | Baseline through 8 months | A summary of other non-serious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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: 6 + or - hours after bortezomib (BTZ); Cycle 7, Day 1: immediately post BTZ dose and 2 hours after tabalumab | — |
| Pharmacokinetics (PK): Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC0-∞) of Tabalumab (LY2127399) | Cycle 1, Day 1: 6 + or - hours after bortezomib (BTZ); Cycle 7, Day 1: immediately post BTZ dose and 2 hours after tabalumab | — |
| Number of Participants With Tumor Response (Tumor Response Rate) | Baseline to disease progression (up to 421 days) | 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. |
| Pharmacokinetics (PK): Maximum Plasma Concentration (Cmax) for Tabalumab (LY2127399) | Cycle 1, Day 1: 6 + or - hours after bortezomib (BTZ); Cycle 7, Day 1: immediately post BTZ dose and 2 hours after tabalumab | — |
| Time to Progression (TTP) | Baseline to date of Progressive Disease (up to 455 days) | 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. |
| Pharmacodynamics (PD): Change From Baseline in Absolute B-cell Count | Baseline through study completion (up to 455 days) | — |
| Pharmacodynamics (PD): Change From Baseline in B-cell Subset Fractions | Baseline, Cycle 1 and Cycle 7: prior to first tabalumab dose. | CD19+ peripheral B-cells counts are based on the percentage of total leukocyte population and absolute cell counts. |
| Duration of Response (DoR) | Time from Response until measured Progressive Disease (up to 455 days) | 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. |
Countries
Japan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 4 |
| 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). | 12 |
| Total | 16 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 4 | 2 |
| Overall Study | Death | 0 | 1 |
| Overall Study | Progressive Disease | 0 | 6 |
| Overall Study | Sponsor Decision | 0 | 2 |
Baseline characteristics
| Characteristic | 100 mg Tabalumab+BTZ IV+Dex | Total | 300 mg Tabalumab+BTZ +Dex |
|---|---|---|---|
| Age, Continuous | 70.7 years | 71.1 years | 71.3 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 4 Participants | 16 Participants | 12 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 4 Participants | 16 Participants | 12 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Japan | 4 Participants | 16 Participants | 12 Participants |
| Sex: Female, Male Female | 2 Participants | 10 Participants | 8 Participants |
| Sex: Female, Male Male | 2 Participants | 6 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 4 / 4 | 12 / 12 |
| serious Total, serious adverse events | 2 / 4 | 8 / 12 |
Outcome results
Primary
Number of Participants With One or More Drug Related Adverse Events (AEs) or Any Serious AEs
A summary of other non-serious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section.
Time frame: Baseline through 8 months
Population: All participants who received at least 1 dose of study drug.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 100 mg Tabalumab+BTZ IV+Dex | Number of Participants With One or More Drug Related Adverse Events (AEs) or Any Serious AEs | 4 Participants |
| 300 mg Tabalumab+BTZ +Dex | Number of Participants With One or More Drug Related Adverse Events (AEs) or Any Serious AEs | 12 Participants |
Secondary
Duration of Response (DoR)
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.
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 100 mg Tabalumab+BTZ IV+Dex | Duration of Response (DoR) | NA months |
| 300 mg Tabalumab+BTZ +Dex | Duration of Response (DoR) | NA months |
Secondary
Number of Participants With Tumor Response (Tumor Response Rate)
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.
Time frame: Baseline to disease progression (up to 421 days)
Population: All participants who received at least 1 dose of study drug.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 100 mg Tabalumab+BTZ IV+Dex | Number of Participants With Tumor Response (Tumor Response Rate) | Complete Response (CR) | 0 Participants |
| 100 mg Tabalumab+BTZ IV+Dex | Number of Participants With Tumor Response (Tumor Response Rate) | Partial Response(PR) | 2 Participants |
| 100 mg Tabalumab+BTZ IV+Dex | Number of Participants With Tumor Response (Tumor Response Rate) | Stringent Complete Response (sCR) | 0 Participants |
| 100 mg Tabalumab+BTZ IV+Dex | Number of Participants With Tumor Response (Tumor Response Rate) | Stable Disease(SD) | 0 Participants |
| 100 mg Tabalumab+BTZ IV+Dex | Number of Participants With Tumor Response (Tumor Response Rate) | Very Good Partial Response (VGPR) | 2 Participants |
| 100 mg Tabalumab+BTZ IV+Dex | Number of Participants With Tumor Response (Tumor Response Rate) | Progressive Disease | 0 Participants |
| 100 mg Tabalumab+BTZ IV+Dex | Number of Participants With Tumor Response (Tumor Response Rate) | Numbers of Responders | 4 Participants |
| 300 mg Tabalumab+BTZ +Dex | Number of Participants With Tumor Response (Tumor Response Rate) | Progressive Disease | 3 Participants |
| 300 mg Tabalumab+BTZ +Dex | Number of Participants With Tumor Response (Tumor Response Rate) | Numbers of Responders | 5 Participants |
| 300 mg Tabalumab+BTZ +Dex | Number of Participants With Tumor Response (Tumor Response Rate) | Stringent Complete Response (sCR) | 0 Participants |
| 300 mg Tabalumab+BTZ +Dex | Number of Participants With Tumor Response (Tumor Response Rate) | Complete Response (CR) | 0 Participants |
| 300 mg Tabalumab+BTZ +Dex | Number of Participants With Tumor Response (Tumor Response Rate) | Very Good Partial Response (VGPR) | 1 Participants |
| 300 mg Tabalumab+BTZ +Dex | Number of Participants With Tumor Response (Tumor Response Rate) | Partial Response(PR) | 4 Participants |
| 300 mg Tabalumab+BTZ +Dex | Number of Participants With Tumor Response (Tumor Response Rate) | Stable Disease(SD) | 2 Participants |
Secondary
Pharmacodynamics (PD): Change From Baseline in Absolute B-cell Count
Time frame: Baseline through study completion (up to 455 days)
Population: Zero participants analyzed as no post baseline data collected.
Secondary
Pharmacodynamics (PD): Change From Baseline in B-cell Subset Fractions
CD19+ peripheral B-cells counts are based on the percentage of total leukocyte population and absolute cell counts.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 100 mg Tabalumab+BTZ IV+Dex | Pharmacodynamics (PD): Change From Baseline in B-cell Subset Fractions | Baseline | 9.3 percentage of b-cell change | Standard Deviation 8.1 |
| 100 mg Tabalumab+BTZ IV+Dex | 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 |
| 100 mg Tabalumab+BTZ IV+Dex | Pharmacodynamics (PD): Change From Baseline in B-cell Subset Fractions | Cycle 7, Day 1 | NA percentage of b-cell change | — |
| 300 mg Tabalumab+BTZ +Dex | Pharmacodynamics (PD): Change From Baseline in B-cell Subset Fractions | Baseline | 12.5 percentage of b-cell change | Standard Deviation 10.7 |
| 300 mg Tabalumab+BTZ +Dex | Pharmacodynamics (PD): Change From Baseline in B-cell Subset Fractions | Cycle 1, Day 1 | 0.3 percentage of b-cell change | Standard Deviation 6.7 |
| 300 mg Tabalumab+BTZ +Dex | Pharmacodynamics (PD): Change From Baseline in B-cell Subset Fractions | Cycle 7, Day 1 | -14.4 percentage of b-cell change | Standard Deviation 7.5 |
Secondary
Pharmacokinetics (PK): Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC0-∞) of Tabalumab (LY2127399)
Time frame: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| 100 mg Tabalumab+BTZ IV+Dex | 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 |
| 100 mg Tabalumab+BTZ IV+Dex | 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 | — |
| 300 mg Tabalumab+BTZ +Dex | Pharmacokinetics (PK): Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC0-∞) of Tabalumab (LY2127399) | Cycle 1 Day 1 | 64200 ng*hr/mL | Geometric Coefficient of Variation 35 |
| 300 mg Tabalumab+BTZ +Dex | Pharmacokinetics (PK): Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC0-∞) of Tabalumab (LY2127399) | Cycle 7 Day 1 | 84100 ng*hr/mL | — |
| 300 mg Tabalumab+ SC BTZ +Dex | Pharmacokinetics (PK): Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC0-∞) of Tabalumab (LY2127399) | Cycle 7 Day 1 | 131000 ng*hr/mL | — |
| 300 mg Tabalumab+ SC BTZ +Dex | Pharmacokinetics (PK): Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC0-∞) of Tabalumab (LY2127399) | Cycle 1 Day 1 | 50900 ng*hr/mL | Geometric Coefficient of Variation 60 |
Secondary
Pharmacokinetics (PK): Area Under the Plasma Concentration-time Curve From Time Zero to the Last Measurable Plasma Concentration (AUC0-tlast) of Tabalumab (LY2127399)
Time frame: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| 100 mg Tabalumab+BTZ IV+Dex | 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 |
| 100 mg Tabalumab+BTZ IV+Dex | 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 | — |
| 300 mg Tabalumab+BTZ +Dex | 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 | 34600 hours times nanograms per milliliter | Geometric Coefficient of Variation 23 |
| 300 mg Tabalumab+BTZ +Dex | 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 | 27300 hours times nanograms per milliliter | — |
| 300 mg Tabalumab+ SC BTZ +Dex | 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 | 26900 hours times nanograms per milliliter | Geometric Coefficient of Variation 48 |
| 300 mg Tabalumab+ SC BTZ +Dex | 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 | 22900 hours times nanograms per milliliter | Geometric Coefficient of Variation 71 |
Secondary
Pharmacokinetics (PK): Maximum Plasma Concentration (Cmax) for Tabalumab (LY2127399)
Time frame: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| 100 mg Tabalumab+BTZ IV+Dex | 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 |
| 100 mg Tabalumab+BTZ IV+Dex | Pharmacokinetics (PK): Maximum Plasma Concentration (Cmax) for Tabalumab (LY2127399) | Cycle 7 Day 1 | 70.5 microgram per milliliter (μg/mL) | — |
| 300 mg Tabalumab+BTZ +Dex | Pharmacokinetics (PK): Maximum Plasma Concentration (Cmax) for Tabalumab (LY2127399) | Cycle 1 Day 1 | 154 microgram per milliliter (μg/mL) | Geometric Coefficient of Variation 21 |
| 300 mg Tabalumab+BTZ +Dex | Pharmacokinetics (PK): Maximum Plasma Concentration (Cmax) for Tabalumab (LY2127399) | Cycle 7 Day 1 | 179 microgram per milliliter (μg/mL) | — |
| 300 mg Tabalumab+ SC BTZ +Dex | Pharmacokinetics (PK): Maximum Plasma Concentration (Cmax) for Tabalumab (LY2127399) | Cycle 1 Day 1 | 139 microgram per milliliter (μg/mL) | Geometric Coefficient of Variation 14 |
| 300 mg Tabalumab+ SC BTZ +Dex | Pharmacokinetics (PK): Maximum Plasma Concentration (Cmax) for Tabalumab (LY2127399) | Cycle 7 Day 1 | 220 microgram per milliliter (μg/mL) | Geometric Coefficient of Variation 25 |
Secondary
Time to Progression (TTP)
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.
Time frame: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| 100 mg Tabalumab+BTZ IV+Dex | Time to Progression (TTP) | NA months |
| 300 mg Tabalumab+BTZ +Dex | Time to Progression (TTP) | NA months |