Early Access Treatment With Daratumumab for (Relapsed or Refractory) Multiple Myeloma

This is a multicenter, open-label, early access treatment protocol of single-agent
daratumumab in subjects with multiple myeloma who have received at least 3 prior lines of
therapy including a PI and an IMiD or whose disease is double refractory to both a PI and an
IMiD, who reside in areas where daratumumab is not commercially available or available
through another protocol, who have not been enrolled in another daratumumab study, and who
are not eligible for or who do not have access to enrollment in another ongoing clinical
study of daratumumab. The study will have three phases: Screening phase (30 days prior to
first dose of study drug), treatment phase (until documented progression, unacceptable
toxicity, or study end), End of Treatment (30 days after last dose of study drug).
Participants will receive daratumumab (16 milligram per kilogram [mg/kg]) as intravenous
infusion. Participants will primarily be assessed for overall response rate. Safety will be
monitored throughout the study.

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:

- Ever enrolled in another daratumumab study or eligible for enrollment in another
ongoing clinical study of daratumumab

- Subject receives any other anti-myeloma 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 anti-CD38 monoclonal antibody