Phase 1
Completed N=16
Study of Tabalumab (LY2127399) in Japanese Participants With Relapsed or Refactory Multiple Myeloma
Source: ClinicalTrials.gov NCT01556438 ↗Enrolled (actual)
16
Serious AEs
62.5%
Results posted
Mar 2019
Primary outcomePrimary: Number of Participants With One or More Drug Related Adverse Events (AEs) or Any Serious AEs — 4; 12 Participants
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With One or More Drug Related Adverse Events (AEs) or Any Serious AEs |
4; 12 | — |
| SECONDARY Pharmacokinetics (PK): Maximum Plasma Concentration (Cmax) for Tabalumab (LY2127399) |
38.5; 154; 139; 70.5; 179; 220 | — |
| SECONDARY Pharmacokinetics (PK): Area Under the Plasma Concentration-time Curve From Time Zero to the Last Measurable Plasma Concentration (AUC0-tlast) of Tabalumab (LY2127399) |
8100; 34600; 26900; 9400; 27300; 22900 | — |
| SECONDARY Pharmacokinetics (PK): Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC0-∞) of Tabalumab (LY2127399) |
13300; 64200; 50900; NA; 84100; 131000 | — |
| SECONDARY Number of Participants With Tumor Response (Tumor Response Rate) |
4; 5; 0; 0; 0; 0 | — |
| SECONDARY Duration of Response (DoR) |
NA; NA | — |
| SECONDARY Time to Progression (TTP) |
NA; NA | — |
| SECONDARY Pharmacodynamics (PD): Change From Baseline in Absolute B-cell Count |
— | — |
| SECONDARY Pharmacodynamics (PD): Change From Baseline in B-cell Subset Fractions |
9.3; 12.5; 1.1; 0.3; NA; -14.4 | — |
Eligibility Criteria
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 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.
Data sourced from ClinicalTrials.gov (NCT01556438). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.