Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:14 PM
Ignite Modification Date:
2025-12-24 @ 11:14 PM
NCT ID:
NCT02116569
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Study:
NCT02116569
Study Brief:
Protocol Section:
NCT02116569