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

• Status: Completed
• Trial end date: 2017-05-30
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Janssen Research & Development, LLC
• Treatments: Acetaminophen; Antibodies, Monoclonal; Daratumumab; Diphenhydramine; Methylprednisolone; Methylprednisolone acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate; Promethazine; Proteasome Inhibitors

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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