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

• Status: Active, not recruiting
• Trial end date: 2022-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the safety, tolerability, and dose regimen of daratumumab when administered in combination with various treatment regimens for the treatment of multiple myeloma.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Janssen Research & Development, LLC
• Treatments: Acetaminophen; Antibodies; Antibodies, Monoclonal; BB 1101; Bortezomib; Daratumumab; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Diphenhydramine; Immunoglobulins; Lenalidomide; Melphalan; Montelukast; Pomalidomide; Prednisone; Promethazine; Thalidomide

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