A Study of JNJ-54767414 (HuMax CD38) (Anti-CD38 Monoclonal Antibody) in Combination With Backbone Treatments for the Treatment of Patients With Multiple Myeloma

Launched by JANSSEN RESEARCH & DEVELOPMENT, LLC · Nov 25, 2013

Keywords

ClinConnect Summary

This is an open-label (identity of assigned study drug will be known) study to evaluate the safety, tolerability, and dose of daratumumab when administered in combination with various treatment regimens for different settings of multiple myeloma. The various treatment regimens to be combined with daratumumab in this study include Velcade-dexamethasone (VD), Velcade-melphalan-prednisone (VMP), Velcade-thalidomide-dexamethasone (VTD), pomalidomide-dexamethasone (Pom-dex), carfilzomib-dexamethasone (CFZ-dex) and carfilzomib-lenalidomide-dexamethasone (KRd). Approximately 250 patients (approxim...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Confirmed diagnosis of symptomatic multiple myeloma and measurable secretory disease
• • For carfilzomib-lenalidomide-dexamethasone (KRd) regimen: newly diagnosed myeloma. For carfilzomib-dexamethasone (CFZ-dex) regimen: relapsed or refractory disease
• • Eastern Cooperative Oncology Group performance status score of 0, 1, or 2
• • Pretreatment clinical laboratory values must meet protocol-defined parameters during the screening phase
• Exclusion Criteria:
• • Previously received daratumumab or other anti-CD38 therapies
• • Diagnosis of primary amyloidosis, monoclonal gammopathy of undetermined significance, smoldering multiple myeloma, Waldenström's disease, or other conditions in which IgM M-protein is present in the absence of a clonal plasma cell infiltration with lytic bone lesions
• • Peripheral neuropathy or neuropathic pain Grade 2 or higher
• • Prior or concurrent invasive malignancy (other than multiple myeloma) within 5 years of study start
• • Exhibiting clinical signs of meningeal involvement of multiple myeloma
• • Known chronic obstructive pulmonary disease, persistent asthma, or a history of asthma within 2 years
• • Seropositive for human immunodeficiency virus, hepatitis B, or hepatitis C
• • Any concurrent medical or psychiatric condition or disease that is likely to interfere with the 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
• • Plasma cell leukemia or POEMS (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes) syndrome