A Phase 1 Study of LY2127399 in Combination With Bortezomib and Dexamethasone in Japanese Patients With Relapsed or Refractory Multiple Myeloma
- 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, patient 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.
- 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).
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
- 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.