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A Phase 1 Study of LY2127399 in Combination With Bortezomib and Dexamethasone in Japanese Patients With Relapsed or Refractory Multiple Myeloma


Phase 1
20 Years
N/A
Open (Enrolling)
Both
Multiple Myeloma

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Trial Information

A Phase 1 Study of LY2127399 in Combination With Bortezomib and Dexamethasone in Japanese Patients With Relapsed or Refractory Multiple Myeloma


The study has 3 cohorts. Participants will only enroll in one cohort. Cohort 2 and cohort
2-SC will be conducted in parallel.

Cohort 1 - Participants will receive 100 mg 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 LY2127399 IV, 1.3 mg/m^2 bortezomib IV, and 20
mg dexamethasone orally.

Cohort 2-SC - Participants will receive 300 mg 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.


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, 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.

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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of participants with one or more drug related adverse events (AEs) or any serious AEs

Outcome Time Frame:

Baseline up to 30 days after discontinuation of study drug (estimated to be 12 months)

Safety Issue:

Yes

Principal Investigator

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Investigator Role:

Study Director

Investigator Affiliation:

Eli Lilly and Company

Authority:

Japan: Ministry of Health, Labor and Welfare

Study ID:

14459

NCT ID:

NCT01556438

Start Date:

July 2012

Completion Date:

August 2014

Related Keywords:

  • Multiple Myeloma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

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