Clinical trial NCT02116569: A Study of Daratumumab in Japanese Participants With Relapsed or Refractory Multiple Myeloma
Official title: A Phase I Study of JNJ-54761414 (Daratumumab) in Japanese Patients With Relapsed or Refractory Multiple Myeloma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Multiple Myeloma
Keywords: Multiple Myeloma
Daratumumab
JNJ-54767414
Phase 1
Relapse
Refractory
Lead sponsor: Janssen Pharmaceutical K.K.
Sponsor class: INDUSTRY
First posted: 2014-04-17
Enrollment: 9
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the tolerability and safety of Daratumumab in Japanese participants with relapsed (the return of a medical problem) or refractory (not responding to treatment) multiple myeloma (cancer of plasma cells in bone marrow, characterized by the presence of abnormal proteins in the blood).

Detailed description: This is a Phase 1, open-label (all participants and study personnel will know the identity of the study treatments) and multicenter (study conducted at multiple sites) study in Japanese participants. The study will include a Screening Phase, a Treatment Phase, and a Follow-up Phase. The Treatment Phase consists of 2 parts: intense dosing regimen and less intense dosing regimen. Follow-up phase will be until 8 weeks after last dose administration/death/lost to follow up/consent withdrawal for study participation or study end, whichever occurs first. The primary endpoints will be Dose Limiting Toxicity (DLTs) and overall Adverse Events (AEs) profiling. Participants' safety will be monitored throughout the study.

Eligibility criteria: Inclusion Criteria:

* Participants proven to have symptomatic (having symptoms) multiple myeloma according the International Myeloma Working Group (IMWG) diagnostic criteria
* Participant must have measurable disease defined by either or both the following measurements: a) Serum M-protein greater than or equal to (\>=) 1 gram per deciliter (g/dL) (\>=10 gram per liter \[g/L\]) (except for serum immunoglobulin A \[IgA\] M-protein \>= 0.5 g/dL); b) Urine M-protein \>=200 milligram per 24 hour (mg/24 h); in case immunoglobulin D \[IgD\] or immunoglobulin E \[IgE\] M-protein, quantification should be performed
* Participant must have relapsed or refractory multiple myeloma after receiving at least 2 previous therapies, and without further established treatment options
* Participant must have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2
* Participant must have life expectancy greater than (\>) 3 months

Exclusion Criteria:

* Participant has received daratumumab or other anti-cluster of differentiation 38 (anti-CD38) therapies previously
* Participant has received anti-myeloma treatment within 2 weeks before administration of the study drug
* Participant has previously received an allogenic stem cell transplant; or participant has received autologous stem cell transplantation (ASCT) within 12 weeks before administration of the study drug
* Participant has a history of malignancy (other than multiple myeloma) within 5 years before administration of the study drug
* Participant is exhibiting clinical signs of meningeal involvement of multiple myeloma

Primary outcomes:
measure: Number of Participants With Dose Limiting Toxicities (DLT)
timeFrame: Day 1 up to Day 36
measure: Number of Participants affected by Adverse Events
timeFrame: Baseline up to 4 Weeks after the last dose of study drug administration
Secondary outcomes:
measure: Percentage of Participants With Overall Response
timeFrame: Baseline until disease progression, unmanageable adverse event or death, whichever occurs first, up to 1 year
measure: Time to Response
timeFrame: Baseline until first documented response or up to 1 year
Other outcomes:
Locations:
city: Nagoya
country: Japan
city: Tokyo
country: Japan
Study officials:
affiliation: Janssen Pharmaceutical K.K.
name: Janssen Pharmaceutical K.K., Japan Clinical Trial
role: STUDY_DIRECTOR
References: