Daratumumab Study in Advanced Multiple Myeloma

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 110

Inclusion Criteria

Principal Inclusion Criteria in Lay Language (for a complete list of
inclusion criteria refer to the protocol):

- Documented multiple myeloma according to protocol-defined criteria
- Evidence of disease progression based on International Myeloma Working Group criteria
- Evidence of response to at least 1 prior treatment regimen and received an alkylating agent either alone or in combination with other myeloma treatments - Received at least 3 prior lines of therapy including a proteasome inhibitor (PI) and an
immunomodulatory drug (IMiD) in any order during the course of treatment or patients whose disease is double refractory to a PI and an IMiD - Eastern Cooperative Oncology Group performance status score of 0, 1, or 2 - Agrees to protocol-defined use of effective contraception
- A woman of childbearing potential must have a negative serum or urine pregnancy test at screening
- Laboratory values and electrocardiogram within protocol-defined parameters at screening
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 83
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 27

Exclusion Criteria

Principal Exclusion Criteria in Lay Language (for a complete list of
exclusion criteria refer to the protocol):

- Received daratumumab or other anti-CD38 therapies previously - Received anti-myeloma treatment within 2 weeks before Cycle 1, Day 1
- Nonsecretory multiple myeloma - Previously received an allogenic stem cell transplant or has received an autologous stem cell transplantation within 12 weeks before Cycle 1, Day 1
- Received a cumulative dose of corticosteroids more than the equivalent of >=140 mg of prednisone within the 2?week period before Cycle 1, Day 1
- 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)
- Exhibiting clinical signs of meningeal involvement of multiple myeloma
- Known chronic obstructive pulmonary disease, persistent asthma, or a history of asthma within 5 years - Seropositive for human immunodeficiency virus, hepatitis B or antibodies to hepatitis B surface and core antigens, or hepatitis C
- Any concurrent medical condition or disease that is likely to interfere with study procedures or results, or that in the opinion of the investigator would constitute a hazard for participating in this study
- Clinically significant cardiac disease, including myocardial infarction within 1 year before Cycle 1, Day 1, unstable or uncontrolled disease/condition related to or affecting cardiac function, cardiac arrhythmia, or clinically significant
electrocardiogram abnormalities - Known allergies, hypersensitivity, or intolerance to monoclonal antibodies
or human proteins or their excipients, or known sensitivity to mammalian-derived products
- Has plasma cell leukemia, Waldenstrom?s macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly,
endocrinopathy, monoclonal protein, and skin changes), or amyloidosis
- Woman who is pregnant or breast-feeding or planning to become pregnant while enrolled in this study or within 6 months after the last dose of study drug
- Received an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 4 weeks before Cycle 1, Day 1 (except for investigational
anti-myeloma agents, which cannot be taken within 2 weeks prior to Cycle 1, Day 1, as described in the protocol)
- Had major surgery within 2 weeks before Cycle 1, Day 1, or will not have fully recovered from surgery, or has surgery planned during the time the patient is expected to participate in the study or within 2 weeks after the last dose of study drug administration (Note: patients with planned surgical procedures to
be conducted under local anesthesia may participate)

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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