Multiple myeloma
Conditions
Sponsors
Janssen Pharmaceutical K.K.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Subject must be at least 18 years of age - Subject must have documented multiple myeloma and have evidence of disease progression on or after the most recent prior treatment regimen as defined by IMWG criteria: Subjects who have received at least 3 prior lines of therapy including a proteasome inhibitor (greater than or equal to [>=] 2 cycles or 2 months of treatment) and an IMiD (>= 2 cycles or 2 months of treatment) in any order during the course of treatment (except for subjects who discontinued either of these treatments due to a severe allergic reaction within the first 2 cycles/months) OR Subjects whose disease is double refractory to a proteasome inhibitor (PI) and an immunomodulatory agent (IMiD). For subjects who have received more than 1 type of PI, their disease must be refractory to the most recent one. Similarly, for those who have received more than 1 type of IMiD, their disease must be refractory to the most recent one - Subject must have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2 - A woman of childbearing potential must have a negative serum or urine pregnancy test at Screening - A man who is sexually active with a woman of childbearing potential and has not had a vasectomy must agree to use a barrier method of birth control during the study, and all men must also not donate sperm during the study and for 6 months after receiving the last dose of study drug
Exclusion criteria
Exclusion criteria: - Ever enrolled in a nother daratumumab study or eligible for enrollment in another ongoing clinical study of daratumumab - Subject receives any other antimyeloma therapy while receiving daratumumab - Enrolled in another interventional clinical study with therapeutic intent - Subject has known chronic obstructive pulmonary disease (COPD) with a Forced Expiratory Volume in 1 second (FEV1) less than 50% of predicted normal - Subject has known moderate or severe persistent asthma within the past 2 years, or currently has uncontrolled asthma of any classification - Prior exposure to any antiCD38 monoclonal antibody
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety (Time Frame: Up to 1 year) | — |
Outcome results
None listed