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