Daratumumab in Combination With Lenalidomide and Dexamethasone in Relapsed and Relapsed-refractory Multiple Myeloma

The study is conducted in two parts. The dose escalation portion of the trial (Part 1)
participants are enrolled into cohorts at increasing dose levels of daratumumab in
combination with Len/Dex in 28 day treatment cycles. Part 2, the cohort expansion part of the
trial, will further explore the maximum tolerated dose (MTD) (or the maximum tested dose) of
daratumumab as determined in Part 1.

Inclusion Criteria:

- (Part 1) Have relapsed multiple myeloma after receiving a minimum of 2 and a maximum
of 4 prior lines of therapy and be eligible for treatment with lenalidomide and
dexamethasone (Len/Dex)

- (Part 2) Have received at least 1 prior line of therapy for multiple myeloma

- Be older than or be 18 years of age

- Eastern Cooperative Oncology Group (ECOG) performance status (0-2)

- Provide signed informed consent after receipt of oral and written information about
the study and before any study-related activity is performed

Exclusion Criteria:

- Have previously received an allogenic stem cell transplant

- Have received autologous stem cell transplant within 12 weeks before the first
infusion

- Have received antimyeloma treatment, radiotherapy, or any experimental drug or therapy
within 2 weeks before the first infusion

- Have discontinued lenalidomide due to any treatment-related adverse event or be
refractory to any dose of lenalidomide. Refractory to lenalidomide is defined as
either, participants whose disease progresses within 60 days of lenalidomide, or
participants whose disease is nonresponsive while on any dose of lenalidomide.
Nonresponsive disease is defined as either failure to achieve at least an minimal
response (MR) or development of progressive disease (PD) while on lenalidomide