Clinical trial NCT02519452 (phase 1, status: active, not recruiting)
Conditions: multiple myeloma
ICD codes: C90.01, C90.02, C90.00
Drugs: daratumumab subcutaneous (sc) administration, recombinant human hyaluronidase [rhuph20]) sc administration
SMILES: [H][C@@]12C[C@@H](C)[C@](O)(C(=O)CO)[C@@]1(C)C[C@H](O)[C@@]1(F)[C@@]2([H])CCC2=CC(=O)C=C[C@]12C, CCCCN1CCCCC1C(=O)NC1=C(C)C=CC=C1C
Eligibility criteria:

        Inclusion Criteria:

          -  Participants proven to have multiple myeloma (MM) diagnosis according to the
             International Myeloma Working Group (IMWG) diagnostic criteria

          -  Measurable disease as defined by any of the following: (a) immunoglobulin (Ig) G
             myeloma (serum monoclonal paraprotein [M-protein] level >=1.0 gram/deciliter [g/dL] or
             urine M-protein level greater than or equal to (>=) 200 milligram[mg]/24 hours[hrs];
             or (b) IgA, IgD, or IgE multiple myeloma (serum M-protein level >= 0.5 g/dL or urine
             M-protein level >= 200 mg/24 hrs); or (c) light chain multiple myeloma (serum
             immunoglobulin free light chain >=10 mg/dL and abnormal serum immunoglobulin kappa
             lambda free light chain ratio)

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

          -  Pretreatment clinical laboratory values must meet protocol-defined parameters during
             the Screening phase

          -  Man, who is sexually active with a woman of child-bearing potential and has not had a
             vasectomy, must agree to use a barrier method of birth control example (eg), either
             condom with spermicidal foam/gel/film/cream/suppository or partner with occlusive cap
             (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository,
             and all men must also not donate sperm during the study and for 3 months after
             receiving the final dose of study drug

          -  Relapsed or refractory disease. Relapse is defined as progression of disease after an
             initial response to previous treatment, more than 60 days after cessation of
             treatment. Refractory disease is defined as less than (<) 25 percent (%) reduction in
             M-protein or progression of disease during treatment or within 60 days after cessation
             of treatment

          -  Prior treatment with less than or equal to (>=) 2 treatment lines of anti-myeloma
             therapy. Prior lines of therapy must include a proteasome inhibitor (PI) (eg,
             bortezomib, carfilzomib) and an immunomodulatory drug (IMiD) (example, thalidomide,
             lenalidomide, pomalidomide) in any order during the course of treatment. Each prior
             line of therapy may consist of one or more agents and may include induction,
             hematopoietic stem cell transplantation, and/or maintenance therapy. Radiotherapy,
             bisphosphonates, or a single short course of steroids is not considered a prior line
             of therapy

        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 Cycle 1 Day 1

          -  Participant has previously received an allogenic stem cell transplant; or participant
             has received autologous stem cell transplantation (ASCT) within 12 weeks before Cycle
             1 Day 1

          -  Participant has a history of malignancy (other than multiple myeloma) within 5 years
             before Cycle 1 Day 1 (exceptions are squamous and basal cell carcinomas of the skin
             and carcinoma in situ of the cervix, or malignancy that in the opinion of the
             investigator, with concurrence with the sponsor's medical monitor, is considered cured
             with minimal risk of recurrence)

          -  Participant is exhibiting clinical signs of meningeal involvement of multiple myeloma