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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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01998971 |
Recruitment Status :
Active, not recruiting
First Posted : December 3, 2013
Last Update Posted : November 8, 2019
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Condition or disease | Intervention/treatment | Phase |
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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 |
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 |
Actual Primary Completion Date : | January 31, 2019 |
Estimated Study Completion Date : | December 31, 2020 |

Arm | Intervention/treatment |
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Experimental: Daratumumab + VD
Daratumumab will be administered with Velcade-dexamethasone (VD).
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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).
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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).
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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).
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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.
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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.
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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. |
- 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 ]
- 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 15 months after last patient receives first dose of study drug ]
- Overall response rate [ Time Frame: Up to 15 months after last patient receives first dose of study drug ]
- Duration of response [ Time Frame: Up to 15 months after last patient receives first dose of study drug ]

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 |
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

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
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 |
Study Director: | Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC |
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: | November 8, 2019 |
Last Verified: | November 2019 |
Studies a U.S. FDA-regulated Device Product: | No |
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 |
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 Acetaminophen |
Diphenhydramine Thalidomide Dexamethasone Dexamethasone acetate Prednisone Lenalidomide Melphalan Bortezomib Daratumumab Pomalidomide Montelukast BB 1101 Antibodies Immunoglobulins Antibodies, Monoclonal |