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

Launched by JANSSEN PHARMACEUTICAL K.K. · Apr 15, 2014

Keywords

ClinConnect Summary

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 Limitin...

Gender

ALL

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