A Study of JNJ-54767414 (HuMax CD38) (Anti-CD38 Monoclonal Antibody) in Combination With Backbone Treatments for the Treatment of Patients With Multiple Myeloma
Conditions
Multiple Myeloma
Conditions: official terms
Multiple Myeloma - Neoplasms, Plasma Cell
Conditions: Keywords
Multiple myeloma, Daratumumab, JNJ-54767414, Velcade-dexamethasone, Velcade-melphalan-prednisone, Velcade-thalidomide-dexamethasone, Pomalidomide-dexamethasone, Anti-CD38 Monoclonal Antibody, Immunomodulatory drug, IMiD
Study Type
Interventional
Study Phase
Phase 1
Study Design
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Daratumumab Type: Drug
Name: Velcade Type: Drug
Name: Pomalidomide Type: Drug
Name: Dexamethasone Type: Drug
Name: Melphalan Type: Drug
Name: Prednisone Type: Drug
Name: Thalidomide Type: Drug
Name: Diphenhydramine Type: Drug
Name: Acetaminophen Type: Drug
Overall Status
Recruiting
Summary
The purpose of this study is to evaluate the safety, tolerability, and dose regimen of daratumumab when administered in combination with various backbone treatments for the treatment of multiple myeloma.
Detailed Description
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 backbone treatments for different settings of multiple myeloma. The backbone treatments to be combined with daratumumab in this study include Velcade-dexamethasone, Velcade-melphalan-prednisone, Velcade-thalidomide-dexamethasone, and pomalidomide-dexamethasone. Approximately 130 patients (approximately 12 per Velcade-thalidomide-dexamethasone and Velcade-melphalan-prednisone backbone treatment regimen, 6 for the Velcade-dexamethasone regimen, and up to 100 subjects in the pomalidomide-dexamethasone regimen) will be enrolled in this study.The study will consist of screening, treatment, and follow-up phases. Treatment will extend to either the planned treatment duration for a maximum of 1 year (in Velcade-dexamethasone, Velcade-melphalan-prednisone, Velcade-thalidomide-dexamethasone regimens), or until disease progression. Follow-up will continue until the study ends (approximately 15 months after the last patient receives the first dose of daratumumab). Serial pharmacokinetic (study of what a drug does to the body) blood samples will be collected. Clinical efficacy outcomes and safety will be monitored throughout the study.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

- Confirmed diagnosis of symptomatic multiple myeloma and measurable secretory 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
Locations
Duarte, California, United States
Status: Recruiting
Atlanta, Georgia, United States
Status: Recruiting
Indianapolis, Indiana, United States
Status: Recruiting
Boston, Massachusetts, United States
Status: Recruiting
New York, New York, United States
Status: Recruiting
Rochester, New York, United States
Status: Recruiting
Philadelphia, Pennsylvania, United States
Status: Recruiting
Dallas, Texas, United States
Status: Recruiting
Lille Cedex, France
Status: Recruiting
Nantes, France
Status: Recruiting
Paris, France
Status: Recruiting
Pessac, France
Status: Recruiting
Toulouse, France
Status: Recruiting
Tours, France
Status: Recruiting
Badalona, Spain
Status: Recruiting
Barcelona, Spain
Status: Recruiting
Madrid, Spain
Status: Recruiting
Pamplona, Spain
Status: Recruiting
Salamanca, Spain
Status: Recruiting
Valencia, Spain
Status: Recruiting
Start Date
February 2014
Completion Date
May 2017
Sponsors
Janssen Research & Development, LLC
Source
Janssen Research & Development, LLC
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page