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

April 24, 2025 updated by: Janssen Research & Development, LLC

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
240

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Lille Cedex, France
      • Nantes, France
      • Paris, France
      • Pessac, France
      • Toulouse cedex 9, France
      • Tours, France
  • Spain
      • Badalona, Spain
      • Barcelona, Spain
      • Madrid, Spain
      • Pamplona, Spain
      • Salamanca, Spain
      • Valencia, Spain
  • United States
    • California
      • Duarte, California, United States
    • Georgia
      • Atlanta, Georgia, United States
    • Illinois
      • Chicago, Illinois, United States
    • Indiana
      • Indianapolis, Indiana, United States
    • Massachusetts
      • Boston, Massachusetts, United States
    • New York
      • New York, New York, United States
      • Rochester, New York, United States
    • North Carolina
      • Charlotte, North Carolina, United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States
    • Texas
      • Dallas, Texas, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Daratumumab + VD
Daratumumab will be administered with Velcade-dexamethasone (VD).
Drug: Daratumumab
Administered by either intravenous or subcutaneous infusions, in combination with the applicable backbone treatment.
Drug: Velcade
Administered subcutaneously in accordance with product labeling and local standards.
Drug: Dexamethasone
Administered intravenously or orally in accordance with product labeling and local standards.
Drug: Diphenhydramine
Administered in prophylactic doses intravenously (or equivalent) in accordance with product labeling and local standards.
Drug: Acetaminophen
Administered in prophylactic doses by mouth in accordance with product labeling and local standards.
Experimental: Daratumumab + VMP
Daratumumab will be administered with Velcade-melphalan-prednisone (VMP).
Drug: Daratumumab
Administered by either intravenous or subcutaneous infusions, in combination with the applicable backbone treatment.
Drug: Velcade
Administered subcutaneously in accordance with product labeling and local standards.
Drug: Diphenhydramine
Administered in prophylactic doses intravenously (or equivalent) in accordance with product labeling and local standards.
Drug: Acetaminophen
Administered in prophylactic doses by mouth in accordance with product labeling and local standards.
Drug: Melphalan
Administered orally in accordance with product labeling and local standards.
Drug: Prednisone
Administered intravenously or orally in accordance with product labeling and local standards.
Experimental: Daratumumab + VTD
Daratumumab will be administered with Velcade-thalidomide-dexamethasone (VTD).
Drug: Daratumumab
Administered by either intravenous or subcutaneous infusions, in combination with the applicable backbone treatment.
Drug: Velcade
Administered subcutaneously in accordance with product labeling and local standards.
Drug: Dexamethasone
Administered intravenously or orally in accordance with product labeling and local standards.
Drug: Diphenhydramine
Administered in prophylactic doses intravenously (or equivalent) in accordance with product labeling and local standards.
Drug: Acetaminophen
Administered in prophylactic doses by mouth in accordance with product labeling and local standards.
Drug: Thalidomide
Administered orally in accordance with product labeling and local standards.
Experimental: Daratumumab + Pom-dex
Daratumumab will be administered with pomalidomide-dexamethasone (Pom-dex).
Drug: Daratumumab
Administered by either intravenous or subcutaneous infusions, in combination with the applicable backbone treatment.
Drug: Dexamethasone
Administered intravenously or orally in accordance with product labeling and local standards.
Drug: Diphenhydramine
Administered in prophylactic doses intravenously (or equivalent) in accordance with product labeling and local standards.
Drug: Acetaminophen
Administered in prophylactic doses by mouth in accordance with product labeling and local standards.
Drug: Pomalidomide
Administered orally in accordance with product labeling and local standards.
Experimental: Daratumumab + CFZ-dex
Daratumumab will be administered with carfilzomib (CFZ)-dexamethasone (CFZ-dex) regimen.
Drug: Daratumumab
Administered by either intravenous or subcutaneous infusions, in combination with the applicable backbone treatment.
Drug: Dexamethasone
Administered intravenously or orally in accordance with product labeling and local standards.
Drug: Diphenhydramine
Administered in prophylactic doses intravenously (or equivalent) in accordance with product labeling and local standards.
Drug: Acetaminophen
Administered in prophylactic doses by mouth in accordance with product labeling and local standards.
Drug: Carfilzomib
Administered intravenously in accordance with product labeling and local standards.
Drug: Montelukast
Administered intravenously or orally only with the first daratumumab dose in accordance with product labeling and local standards.
Experimental: Daratumumab + KRd
Daratumumab will be administered with carfilzomib- lenalidomide-dexamethasone (KRd) regimen.
Drug: Daratumumab
Administered by either intravenous or subcutaneous infusions, in combination with the applicable backbone treatment.
Drug: Dexamethasone
Administered intravenously or orally in accordance with product labeling and local standards.
Drug: Diphenhydramine
Administered in prophylactic doses intravenously (or equivalent) in accordance with product labeling and local standards.
Drug: Acetaminophen
Administered in prophylactic doses by mouth in accordance with product labeling and local standards.
Drug: Carfilzomib
Administered intravenously in accordance with product labeling and local standards.
Drug: Montelukast
Administered intravenously or orally only with the first daratumumab dose in accordance with product labeling and local standards.
Drug: Lenalidomide
Administered orally in accordance with product labeling and local standards.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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
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
Up to 30 days after the last dose of study medication

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Maximum observed concentration of daratumumab
Time Frame: Up to post-treatment visit Week 9
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
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
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
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
Up to 25 months after last patient receives first dose of study drug

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Janssen Research & Development, LLC

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 18, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 31, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 11, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 25, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 25, 2013

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 3, 2013

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 24, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CR103015
  • 54767414MMY1001 (Other Identifier: Janssen Research & Development, LLC)
  • 2013-003491-12 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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