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

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ClinicalTrials.gov Identifier: NCT01998971
Recruitment Status : Active, not recruiting
First Posted : December 3, 2013
Last Update Posted : September 14, 2018
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Multiple Myeloma Drug: Daratumumab Drug: Velcade Drug: Pomalidomide Drug: Dexamethasone Drug: Melphalan Drug: Prednisone Drug: Thalidomide Drug: Diphenhydramine Drug: Acetaminophen Drug: Carfilzomib Drug: Lenalidomide Drug: Montelukast Phase 1

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 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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 240 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : February 18, 2014
Estimated Primary Completion Date : June 14, 2019
Estimated Study Completion Date : June 12, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma
Drug Information available for: Daratumumab

Arms and Interventions
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Arm Intervention/treatment
Experimental: Daratumumab + VD
Daratumumab will be administered with Velcade-dexamethasone (VD).
 Drug: Daratumumab
Administered by intravenous infusion 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 intravenous infusion in combination with the applicable backbone treatment.

Drug: Velcade
Administered subcutaneously 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.

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 + VTD
Daratumumab will be administered with Velcade-thalidomide-dexamethasone (VTD).
 Drug: Daratumumab
Administered by intravenous infusion 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: Thalidomide
Administered 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 + Pom-dex
Daratumumab will be administered with pomalidomide-dexamethasone (Pom-dex).
 Drug: Daratumumab
Administered by intravenous infusion in combination with the applicable backbone treatment.

Drug: Pomalidomide
Administered orally 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 + CFZ-dex
Daratumumab will be administered with carfilzomib (CFZ)-dexamethasone (CFZ-dex) regimen.
 Drug: Daratumumab
Administered by intravenous infusion 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 intravenous infusion 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: Lenalidomide
Administered orally 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.


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]
  2. Number of participants affected by dose-limiting toxicities [ Time Frame: Up to 30 days after the last dose of study medication ]

Secondary Outcome Measures :
  1. Maximum observed concentration of daratumumab [ Time Frame: Up to post-treatment visit Week 9 ]
  2. Number of participants with generation of antibodies to daratumumab [ Time Frame: Up to post-treatment visit Week 9 ]
  3. Complete response rate [ Time Frame: Up to 15 months after last patient receives first dose of study drug ]
  4. Overall response rate [ Time Frame: Up to 15 months after last patient receives first dose of study drug ]
  5. Duration of response [ Time Frame: Up to 15 months after last patient receives first dose of study drug ]

Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01998971


Locations
United States, California
Duarte, California, United States
United States, Georgia
Atlanta, Georgia, United States
United States, Illinois
Chicago, Illinois, United States
United States, Indiana
Indianapolis, Indiana, United States
United States, Massachusetts
Boston, Massachusetts, United States
United States, New York
New York, New York, United States
Rochester, New York, United States
United States, North Carolina
Charlotte, North Carolina, United States
United States, Pennsylvania
Philadelphia, Pennsylvania, United States
United States, Texas
Dallas, Texas, United States
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
Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT01998971     History of Changes
Other Study ID Numbers: CR103015
54767414MMY1001 ( Other Identifier: Janssen Research & Development, LLC )
2013-003491-12 ( EudraCT Number )
First Posted: December 3, 2013    Key Record Dates
Last Update Posted: September 14, 2018
Last Verified: September 2018

Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Janssen Research & Development, LLC:
Multiple myeloma
Daratumumab
JNJ-54767414
Velcade-dexamethasone
Velcade-melphalan-prednisone
Velcade-thalidomide-dexamethasone
 Pomalidomide-dexamethasone
Carfilzomib-dexamethasone
Carfilzomib-lenalidomide-dexamethasone
Anti-CD38 Monoclonal Antibody
Immunomodulatory drug
IMiD

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Dexamethasone acetate
 Dexamethasone
Prednisone
Diphenhydramine
Lenalidomide
Pomalidomide
Daratumumab
Melphalan
Thalidomide
Bortezomib
Montelukast
Acetaminophen
BB 1101
Antibodies
Immunoglobulins
Antibodies, Monoclonal