An Efficacy and Safety Study of Daratumumab in Patients With Multiple Myeloma Who Have Received at Least 3 Prior Lines of Therapy (Including a Proteasome Inhibitor [PI] and Immunomodulatory Drug [IMiD]) or Are Double Refractory to a PI and an IMiD

Completed · Phase 2

Conditions studied: Multiple Myeloma

In brief

The purpose of this study is to evaluate the efficacy and safety of 2 daratumumab treatment regimens in participants with multiple myeloma who have received at least 3 prior lines of therapy (including a proteasome inhibitor \[PI\] and immunomodulatory drug \[IMiD\]) or are double refractory to a PI and an IMiD.

Key facts

Study ID

NCT01985126

Run by

Janssen Research & Development, LLC

People needed

124

Starts

2013-09-27

Expected to finish

2017-05-30

Last updated by the study team

2018-06-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Documented multiple myeloma according to protocol-defined criteria
• Evidence of disease progression on the most recent prior treatment regimen based on International Myeloma Working Group criteria
• Eastern Cooperative Oncology Group performance status score of 0, 1, or 2
• Laboratory values and electrocardiogram within protocol-defined parameters at screening

You may not qualify if…

• Received daratumumab or other anti-CD38 therapies previously
• Nonsecretory multiple myeloma
• Previously received an allogenic stem cell transplant or has received an autologous stem cell transplantation within 12 weeks
• 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
• Has plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes), or amyloidosis

Where it is running

• Study site — Duarte, California, United States
• Study site — Los Angeles, California, United States
• Study site — Atlanta, Georgia, United States
• Study site — Chicago, Illinois, United States
• Study site — Louisville, Kentucky, United States
• Study site — Detroit, Michigan, United States
• Study site — New Brunswick, New Jersey, United States
• Study site — New York, New York, United States
• Study site — Chapel Hill, North Carolina, United States
• Study site — Charlotte, North Carolina, United States
• Study site — Portland, Oregon, United States
• Study site — Philadelphia, Pennsylvania, United States
• Study site — Nashville, Tennessee, United States
• Study site — Houston, Texas, United States
• Study site — Madison, Wisconsin, United States
• Study site — Calgary, Alberta, Canada
• Study site — Edmonton, Alberta, Canada
• Study site — Vancouver, British Columbia, Canada
• Study site — Halifax, Nova Scotia, Canada
• Study site — Montreal, Quebec, Canada
• Study site — Barcelona, Spain
• Study site — Salamanca, Spain
• Study site — Valencia, Spain

Full record on ClinicalTrials.gov

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