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NCT01556438 · REGISTRY CONDITION SEARCH

Study of Tabalumab (LY2127399) in Japanese Participants With Relapsed or Refactory Multiple Myeloma

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
PHASE1
Status at capture
COMPLETED
Registry last update
2019-03-20

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).

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Number of Participants With One or More Drug Related Adverse Events (AEs) or Any Serious AEs

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outcome · POSTED

Pharmacokinetics (PK): Maximum Plasma Concentration (Cmax) for Tabalumab (LY2127399)

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outcome · POSTED

Pharmacokinetics (PK): Area Under the Plasma Concentration-time Curve From Time Zero to the Last Measurable Plasma Concentration (AUC0-tlast) of Tabalumab (LY2127399)

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outcome · POSTED

Pharmacokinetics (PK): Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC0-∞) of Tabalumab (LY2127399)

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outcome · POSTED

Number of Participants With Tumor Response (Tumor Response Rate)

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outcome · POSTED

Duration of Response (DoR)

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outcome · POSTED

Time to Progression (TTP)

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outcome · POSTED

Pharmacodynamics (PD): Change From Baseline in Absolute B-cell Count

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outcome · POSTED

Pharmacodynamics (PD): Change From Baseline in B-cell Subset Fractions

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
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 \<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.
healthy Volunteers
false
minimum Age
20 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    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.
    intervention Names
    1. Biological: Tabalumab
    2. Drug: Bortezomib IV
    3. Drug: Dexamethasone
    label
    100 mg Tabalumab+Bortezomib (BTZ)IV+Dexamethasone (Dex)
    type
    EXPERIMENTAL
  2. description
    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.
    intervention Names
    1. Biological: Tabalumab
    2. Drug: Bortezomib IV
    3. Drug: Dexamethasone
    label
    300 mg Tabalumab+BTZ IV+Dex
    type
    EXPERIMENTAL
  3. description
    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.
    intervention Names
    1. Biological: Tabalumab
    2. Drug: Bortezomib SC
    3. Drug: Dexamethasone
    label
    300 mg Tabalumab+BTZ SC+Dex
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. 100 mg Tabalumab+Bortezomib (BTZ)IV+Dexamethasone (Dex)
    2. 300 mg Tabalumab+BTZ IV+Dex
    3. 300 mg Tabalumab+BTZ SC+Dex
    description
    Administered IV
    name
    Tabalumab
    other Names
    1. LY2127399
    type
    BIOLOGICAL
  2. arm Group Labels
    1. 100 mg Tabalumab+Bortezomib (BTZ)IV+Dexamethasone (Dex)
    2. 300 mg Tabalumab+BTZ IV+Dex
    description
    Administered IV
    name
    Bortezomib IV
    type
    DRUG
  3. arm Group Labels
    1. 300 mg Tabalumab+BTZ SC+Dex
    description
    Administered SC
    name
    Bortezomib SC
    type
    DRUG
  4. arm Group Labels
    1. 100 mg Tabalumab+Bortezomib (BTZ)IV+Dexamethasone (Dex)
    2. 300 mg Tabalumab+BTZ IV+Dex
    3. 300 mg Tabalumab+BTZ SC+Dex
    description
    Administered orally
    name
    Dexamethasone
    type
    DRUG
Study design
allocation
NON_RANDOMIZED
intervention Model
PARALLEL
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
16
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    A summary of other non-serious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section.
    measure
    Number of Participants With One or More Drug Related Adverse Events (AEs) or Any Serious AEs
    time Frame
    Baseline through 8 months
secondary Outcomes
  1. measure
    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
  2. measure
    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
  3. measure
    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
  4. description
    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.
    measure
    Number of Participants With Tumor Response (Tumor Response Rate)
    time Frame
    Baseline to disease progression (up to 421 days)
  5. description
    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.
    measure
    Duration of Response (DoR)
    time Frame
    Time from Response until measured Progressive Disease (up to 455 days)
  6. description
    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.
    measure
    Time to Progression (TTP)
    time Frame
    Baseline to date of Progressive Disease (up to 455 days)
  7. measure
    Pharmacodynamics (PD): Change From Baseline in Absolute B-cell Count
    time Frame
    Baseline through study completion (up to 455 days)
  8. description
    CD19+ peripheral B-cells counts are based on the percentage of total leukocyte population and absolute cell counts.
    measure
    Pharmacodynamics (PD): Change From Baseline in B-cell Subset Fractions
    time Frame
    Baseline, Cycle 1 and Cycle 7: prior to first tabalumab dose.
Full study description
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.
Source references
references
  1. citation
    Iida S, Ogiya D, Abe Y, Taniwaki M, Asou H, Maeda K, Uenaka K, Nagaoka S, Ishiki T, Conti I, Tobinai K. Dose-escalation study of tabalumab with bortezomib and dexamethasone in Japanese patients with multiple myeloma. Cancer Sci. 2016 Sep;107(9):1281-9. doi: 10.1111/cas.13000. Epub 2016 Sep 1.
    pmid
    27350068
    type
    DERIVED
Source notices and limitations
    Discovery and provenance
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    Preserved source evidence · Not medical advice