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Multiple MyelomaPhase 1NCT01556438

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

A Phase 1 study testing Tabalumab, Bortezomib IV and Bortezomib SC in people with Multiple Myeloma, run by Eli Lilly and Company at 5 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Multiple Myeloma
What is being tested?
Tabalumab, Bortezomib IV and Bortezomib SC
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
5 sitesJapan
Study dates
Jul 2012to Aug 2015
Phase
Phase 1
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
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  • 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.

Who cannot join

  • 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:
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  • positive for hepatitis B surface antigen (HBsAg+). OR
  • positive for anti-hepatitis B core antibody and positive for hepatitis B deoxyribonucleic acid (HBV DNA).
  • OR
  • 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.

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

Japan5 sites

  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

    Aichi, 467-0001

  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

    Fukuoka, 811-1395

  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

    Kanagawa, 259-1193

  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

    Kyoto, 602-0841

  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

    Tokyo, 104-0045

Other trials in Japan

About this study

Official title: A Phase 1 Study of Tabalumab (LY2127399) in Combination With Bortezomib and Dexamethasone in Japanese Patients With Relapsed or Refractory Multiple Myeloma

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).

Read the 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.

Being tested
Tabalumab, Bortezomib IV, Bortezomib SC, Dexamethasone
Medical subject headings
Multiple Myeloma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TabalumabBiological

    Also called LY2127399

    Administered IV

  • Bortezomib IVDrug

    Administered IV

  • Bortezomib SCDrug

    Administered SC

  • DexamethasoneDrug

    Administered orally

Study groups in NCT01556438
Study groupRoleWhat they receive
100 mg Tabalumab+Bortezomib (BTZ)IV+Dexamethasone (Dex)ExperimentalCohort 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.
Receives: Biological: Tabalumab; Drug: Bortezomib IV; Drug: Dexamethasone
300 mg Tabalumab+BTZ IV+DexExperimentalCohort 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.
Receives: Biological: Tabalumab; Drug: Bortezomib IV; Drug: Dexamethasone
300 mg Tabalumab+BTZ SC+DexExperimentalCohort 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.
Receives: Biological: Tabalumab; Drug: Bortezomib SC; Drug: Dexamethasone

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    A summary of other non-serious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section.

    Measured: Baseline through 8 months

Secondary outcomes (8)

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

    Measured: Cycle 1, Day 1: 6 + or - hours after bortezomib (BTZ); Cycle 7, Day 1: immediately post BTZ dose and 2 hours after tabalumab

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

    Measured: Cycle 1, Day 1: 6 + or - hours after bortezomib (BTZ); Cycle 7, Day 1: immediately post BTZ dose and 2 hours after tabalumab

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

    Measured: Cycle 1, Day 1: 6 + or - hours after bortezomib (BTZ); Cycle 7, Day 1: immediately post BTZ dose and 2 hours after tabalumab

  4. Number of Participants With Tumor Response (Tumor Response Rate)

    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.

    Measured: Baseline to disease progression (up to 421 days)

  5. Duration of Response (DoR)

    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.

    Measured: Time from Response until measured Progressive Disease (up to 455 days)

  6. Time to Progression (TTP)

    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.

    Measured: Baseline to date of Progressive Disease (up to 455 days)

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

    Measured: Baseline through study completion (up to 455 days)

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

    CD19+ peripheral B-cells counts are based on the percentage of total leukocyte population and absolute cell counts.

    Measured: Baseline, Cycle 1 and Cycle 7: prior to first tabalumab dose.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Mar 2012 (estimated)
  2. Study startJul 2012
  3. Primary completionFeb 2015
  4. Study completionAug 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01556438
Sponsor's protocol ID
14459
Other IDs
H9S-JE-JDCI
Status last verified
Nov 2018
First submitted
15 Mar 2012
Last updated
20 Mar 2019
Data monitoring committee
No

Publications

  • 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.

    PubMed 27350068

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Tabalumab, Bortezomib IV and Bortezomib SC in people with Multiple Myeloma, run by Eli Lilly and Company at 5 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Mar 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With One or More Drug Related Adverse Events (AEs) or Any Serious AEs (time frame: Baseline through 8 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01556438, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2019.

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