A Study of Subcutaneous Versus (vs.) Intravenous Administration of Daratumumab in Participants With Relapsed or Refractory Multiple Myeloma

The study population will consist of adults diagnosed with multiple myeloma who have received
at least 3 prior lines of therapy including a proteasome inhibitor (PI) and an
immunomodulatory drug (IMiD), or whose disease is refractory to both a PI and an IMiD. The
study consists of 3 phases: a screening phase (up to 28 days), a treatment phase, and a
follow-up phase. Efficacy, pharmacokinetics, immunogenicity, biomarkers and safety will be
assessed at scheduled time. Follow-up will continue until the end of study, approximately 18
months after the last participant was randomized or when the sponsor decides to stop the
study. The primary hypotheses is that the ORR and maximum Ctrough for Dara SC 1800 milligram
(mg) are not inferior to the ORR and maximum Ctrough, respectively, for Dara IV 16 mg per
kilogram (mg/kg) in participants with multiple myeloma who have received at least 3 prior
lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory drug (IMiD),
or whose disease is refractory to both a PI and an IMiD.

Inclusion Criteria:

- Evidence of a response (Partial response [PR] or better based on investigator's
determination of response by international myeloma working group [IMWG] criteria) to
at least 1 prior treatment regimen

- Received at least 3 prior lines of therapy including a proteasome inhibitor (PI)
(greater than or equal to [>=] 2 cycles or 2 months of treatment) and an
immunomodulatory drug (IMiD) (>=2 cycles or 2 months of treatment) in any order during
the course of treatment (except for participants who discontinued either of these
treatments due to a severe allergic reaction within the first 2 cycles/months). A
single line of therapy may consist of 1 or more agents, and may include induction,
hematopoietic stem cell transplantation, and maintenance therapy. Radiotherapy,
bisphosphonate, or a single short course of corticosteroids (no more than the
equivalent of dexamethasone 40 milligram/day [mg/day] for 4 days) would not be
considered prior lines of therapy

- Documented multiple myeloma as defined by the criteria below:

1. Multiple myeloma diagnosis according to the IMWG diagnostic criteria

2. Measurable disease at Screening as defined by any of the following:

1. Serum M-protein level >=1.0 gram per deciliter (g/dL) or urine M-protein
level >=200 mg/24 hours; or

2. Light chain multiple myeloma without measurable disease in the serum or the
urine: Serum immunoglobulin free light chain (FLC) >=10 mg/dL and abnormal
serum immunoglobulin kappa lambda FLC ratio

- Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2

- Meet the clinical laboratory criteria as specified in the protocol

- Women of childbearing potential must have a negative urine or serum pregnancy test at
screening within 14 days prior to randomization

Exclusion Criteria:

- Received daratumumab or other anti-CD38 therapies previously

- Received anti-myeloma treatment within 2 weeks or 5 pharmacokinetic half-lives of the
treatment, whichever is longer, before the date of randomization. The only exception
is emergency use of a short course of corticosteroids (equivalent of dexamethasone 40
mg/day for a maximum of 4 days before treatment

- Received autologous stem cell transplant within 12 weeks before the date of
randomization, or the participant has previously received allogeneic stem cell
transplant (regardless of timing)

- Plans to undergo a stem cell transplant prior to progression of disease on this study
(these participants should not be enrolled to reduce disease burden prior to
transplant)

- History of malignancy (other than multiple myeloma) unless all treatment of that
malignancy was completed at least 2 years before consent and the patient has no
evidence of disease. Further exceptions are squamous and basal cell carcinomas of the
skin and carcinoma in situ of the cervix, or breast, or other non-invasive lesion,
that in the opinion of the investigator, with concurrence with the sponsor's medical
monitor, is considered cured with minimal risk of recurrence within 3 years