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

  • Interventional
  • Recruiting
  • NCT01998971
Eligibility Details Visit Clinicaltrials.gov

An Open-Label, Multicenter, Phase 1b Study of JNJ-54767414 (HuMax CD38) (Anti-CD38 Monoclonal Antibody) in Combination With Backbone Regimens for the Treatment of Subjects With Multiple Myeloma

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.

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 (approximately 12 subjects per VTD and VMP backbone treatment regimen, 6 for the VD regimen, up to 100 subjects in the Pom-dex regimen, 80 for the CFZ-dex regimen [10 subjects will receive a single-dose of daratumumab and the remaining subjects will receive a split-dose of daratumumab], and up to 40 for the KRd 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 and KRd regimens), or until disease progression (in the Pom-dex and CFZ-dex regimen). 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.

Gender
All

Age Group
18 Years and up

Accepting Healthy Volunteers?
No

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

At a Glance

National Government IDNCT01998971

IRB#IRB15-0995

Lead SponsorJanssen Research & Development, LLC

Lead PhysicianAndrzej Jakubowiak

Collaborator(s)N/A

EligibilityAll
18 Years and up
Recruiting