Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01602224 | A Study of Tabalumab (LY2127399) in Participants With Previously Treated Multiple Myeloma (MM) | PHASE2 | COMPLETED | 220 | — | — | Jul 1, 2012 | Jul 1, 2014 | Oct 8, 2019 | 57 | United States, Brazil +13 |
| NCT01556438 | Study of Tabalumab (LY2127399) in Japanese Participants With Relapsed or Refactory Multiple Myeloma | PHASE1 | COMPLETED | 16 | — | — | Jul 1, 2012 | Aug 1, 2015 | Mar 20, 2019 | 5 | Japan |
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.
A summary of other non-serious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section.
| Arm | Type | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 100 mg Tabalumab+Bortezomib (BTZ)IV+Dexamethasone (Dex) | EXPERIMENTAL | Cohort 1. 100 mg tabalumab (LY2127399) intravenously (IV) on day 1 of each cycle, each cyle is 21 days. 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 IV+Dex | EXPERIMENTAL | Cohort 2. 300 mg tabalumab (LY2127399) IV on day 1 of each cycle, each cycle is 21 days. 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. |
| 300 mg Tabalumab+BTZ SC+Dex | EXPERIMENTAL | Cohort 2-SC. 300 mg tabalumab (LY2127399)IV on day 1 of each cycle, each cycle is 21 days. BTZ, 1.3 mg/m\^2, subcutaneously (SC) 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. Cohort 2-SC was added per protocol amendment in February 2013. |
| Name | Type | Description |
|---|---|---|
| Placebo | DRUG | Administered IV |
| Dexamethasone | DRUG | Administered orally |
| Bortezomib | DRUG | Administered SQ |
| Tabalumab | BIOLOGICAL | Administered IV |
| Bortezomib IV | DRUG | Administered IV |
| Bortezomib SC | DRUG | Administered SC |
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 p...