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

Phase 1CompletedNCT01998971

Janssen Research & Development, LLC240 enrolled

Overview

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 participants per VTD and VMP backbone treatment regimen, 6 for the VD regimen, up to 100 participants in the Pom-dex regimen, 80 for the CFZ-dex regimen \[10 participants will receive a single-dose of daratumumab and the remaining participants will receive a split-dose of daratumumab\], 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 in the Pom-dex and CFZ-dex regimens, until disease progression, unacceptable toxicity, or until the end of study. Follow-up will continue until the study ends (approximately 25 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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

240

Conditions

Multiple Myeloma

Interventions

DaratumumabDRUG

Administered by either intravenous or subcutaneous infusions, in combination with the applicable backbone treatment.

VelcadeDRUG

Administered subcutaneously in accordance with product labeling and local standards.

PomalidomideDRUG

Administered orally in accordance with product labeling and local standards.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (22)

Unnamed facility

Duarte, California, United States

Unnamed facility

Atlanta, Georgia, United States

Unnamed facility

Chicago, Illinois, United States

Outcomes

Primary Outcomes

Number of participants affected by adverse events by MedDRA system organ class (SOC) and Preferred term (PT)

Time frame: Up to 30 days after the last dose of study medication

Number of participants affected by dose-limiting toxicities

Time frame: Up to 30 days after the last dose of study medication

Secondary Outcomes

Maximum observed concentration of daratumumab

Time frame: Up to post-treatment visit Week 9

Number of participants with generation of antibodies to daratumumab

Time frame: Up to post-treatment visit Week 9

Complete response rate

Time frame: Up to 25 months after last patient receives first dose of study drug

Overall response rate

Time frame: Up to 25 months after last patient receives first dose of study drug

Duration of response

Time frame: Up to 25 months after last patient receives first dose of study drug

Data from ClinicalTrials.gov

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