Overview

A Study of Daratumumab in Japanese Participants With Relapsed or Refractory Multiple Myeloma

Status:
Completed
Trial end date:
2015-09-01
Target enrollment:
0
Participant gender:
All
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).
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Janssen Pharmaceutical K.K.
Treatments:
Antibodies, Monoclonal
Daratumumab
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