A Study of JNJ-54767414 (HuMax CD38) (Anti-CD38 Monoclonal Antibody) in Combination With Backbone Treatments for the Treatment of Patients With Multiple Myeloma
NCT ID: NCT01998971
Last Updated: 2025-04-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
240 participants
INTERVENTIONAL
2014-02-18
2024-01-11
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Daratumumab + VD
Daratumumab will be administered with Velcade-dexamethasone (VD).
Daratumumab
Administered by either intravenous or subcutaneous infusions, in combination with the applicable backbone treatment.
Velcade
Administered subcutaneously in accordance with product labeling and local standards.
Dexamethasone
Administered intravenously or orally in accordance with product labeling and local standards.
Diphenhydramine
Administered in prophylactic doses intravenously (or equivalent) in accordance with product labeling and local standards.
Acetaminophen
Administered in prophylactic doses by mouth in accordance with product labeling and local standards.
Daratumumab + VMP
Daratumumab will be administered with Velcade-melphalan-prednisone (VMP).
Daratumumab
Administered by either intravenous or subcutaneous infusions, in combination with the applicable backbone treatment.
Velcade
Administered subcutaneously in accordance with product labeling and local standards.
Melphalan
Administered orally in accordance with product labeling and local standards.
Prednisone
Administered intravenously or orally in accordance with product labeling and local standards.
Diphenhydramine
Administered in prophylactic doses intravenously (or equivalent) in accordance with product labeling and local standards.
Acetaminophen
Administered in prophylactic doses by mouth in accordance with product labeling and local standards.
Daratumumab + VTD
Daratumumab will be administered with Velcade-thalidomide-dexamethasone (VTD).
Daratumumab
Administered by either intravenous or subcutaneous infusions, in combination with the applicable backbone treatment.
Velcade
Administered subcutaneously in accordance with product labeling and local standards.
Dexamethasone
Administered intravenously or orally in accordance with product labeling and local standards.
Thalidomide
Administered orally in accordance with product labeling and local standards.
Diphenhydramine
Administered in prophylactic doses intravenously (or equivalent) in accordance with product labeling and local standards.
Acetaminophen
Administered in prophylactic doses by mouth in accordance with product labeling and local standards.
Daratumumab + Pom-dex
Daratumumab will be administered with pomalidomide-dexamethasone (Pom-dex).
Daratumumab
Administered by either intravenous or subcutaneous infusions, in combination with the applicable backbone treatment.
Pomalidomide
Administered orally in accordance with product labeling and local standards.
Dexamethasone
Administered intravenously or orally in accordance with product labeling and local standards.
Diphenhydramine
Administered in prophylactic doses intravenously (or equivalent) in accordance with product labeling and local standards.
Acetaminophen
Administered in prophylactic doses by mouth in accordance with product labeling and local standards.
Daratumumab + CFZ-dex
Daratumumab will be administered with carfilzomib (CFZ)-dexamethasone (CFZ-dex) regimen.
Daratumumab
Administered by either intravenous or subcutaneous infusions, in combination with the applicable backbone treatment.
Dexamethasone
Administered intravenously or orally in accordance with product labeling and local standards.
Diphenhydramine
Administered in prophylactic doses intravenously (or equivalent) in accordance with product labeling and local standards.
Acetaminophen
Administered in prophylactic doses by mouth in accordance with product labeling and local standards.
Carfilzomib
Administered intravenously in accordance with product labeling and local standards.
Montelukast
Administered intravenously or orally only with the first daratumumab dose in accordance with product labeling and local standards.
Daratumumab + KRd
Daratumumab will be administered with carfilzomib- lenalidomide-dexamethasone (KRd) regimen.
Daratumumab
Administered by either intravenous or subcutaneous infusions, in combination with the applicable backbone treatment.
Dexamethasone
Administered intravenously or orally in accordance with product labeling and local standards.
Diphenhydramine
Administered in prophylactic doses intravenously (or equivalent) in accordance with product labeling and local standards.
Acetaminophen
Administered in prophylactic doses by mouth in accordance with product labeling and local standards.
Carfilzomib
Administered intravenously in accordance with product labeling and local standards.
Lenalidomide
Administered orally in accordance with product labeling and local standards.
Montelukast
Administered intravenously or orally only with the first daratumumab dose in accordance with product labeling and local standards.
Interventions
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Daratumumab
Administered by either intravenous or subcutaneous infusions, in combination with the applicable backbone treatment.
Velcade
Administered subcutaneously in accordance with product labeling and local standards.
Pomalidomide
Administered orally in accordance with product labeling and local standards.
Dexamethasone
Administered intravenously or orally in accordance with product labeling and local standards.
Melphalan
Administered orally in accordance with product labeling and local standards.
Prednisone
Administered intravenously or orally in accordance with product labeling and local standards.
Thalidomide
Administered orally in accordance with product labeling and local standards.
Diphenhydramine
Administered in prophylactic doses intravenously (or equivalent) in accordance with product labeling and local standards.
Acetaminophen
Administered in prophylactic doses by mouth in accordance with product labeling and local standards.
Carfilzomib
Administered intravenously in accordance with product labeling and local standards.
Lenalidomide
Administered orally in accordance with product labeling and local standards.
Montelukast
Administered intravenously or orally only with the first daratumumab dose in accordance with product labeling and local standards.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Janssen Research & Development, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Janssen Research & Development, LLC Clinical Trial
Role: STUDY_DIRECTOR
Janssen Research & Development, LLC
Locations
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Duarte, California, United States
Atlanta, Georgia, United States
Chicago, Illinois, United States
Indianapolis, Indiana, United States
Boston, Massachusetts, United States
New York, New York, United States
Rochester, New York, United States
Charlotte, North Carolina, United States
Philadelphia, Pennsylvania, United States
Dallas, Texas, United States
Lille, , France
Nantes, , France
Paris, , France
Pessac, , France
Toulouse, , France
Tours, , France
Badalona, , Spain
Barcelona, , Spain
Madrid, , Spain
Pamplona, , Spain
Salamanca, , Spain
Valencia, , Spain
Countries
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References
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Xu XS, Moreau P, Usmani SZ, Lonial S, Jakubowiak A, Oriol A, Krishnan A, Blade J, Luo M, Sun YN, Zhou H, Nnane I, Deraedt W, Qi M, Ukropec J, Clemens PL. Split First Dose Administration of Intravenous Daratumumab for the Treatment of Multiple Myeloma (MM): Clinical and Population Pharmacokinetic Analyses. Adv Ther. 2020 Apr;37(4):1464-1478. doi: 10.1007/s12325-020-01247-8. Epub 2020 Feb 20.
Chari A, Martinez-Lopez J, Mateos MV, Blade J, Benboubker L, Oriol A, Arnulf B, Rodriguez-Otero P, Pineiro L, Jakubowiak A, de Boer C, Wang J, Clemens PL, Ukropec J, Schecter J, Lonial S, Moreau P. Daratumumab plus carfilzomib and dexamethasone in patients with relapsed or refractory multiple myeloma. Blood. 2019 Aug 1;134(5):421-431. doi: 10.1182/blood.2019000722. Epub 2019 May 21.
Chari A, Suvannasankha A, Fay JW, Arnulf B, Kaufman JL, Ifthikharuddin JJ, Weiss BM, Krishnan A, Lentzsch S, Comenzo R, Wang J, Nottage K, Chiu C, Khokhar NZ, Ahmadi T, Lonial S. Daratumumab plus pomalidomide and dexamethasone in relapsed and/or refractory multiple myeloma. Blood. 2017 Aug 24;130(8):974-981. doi: 10.1182/blood-2017-05-785246. Epub 2017 Jun 21.
Moreau P, Chari A, Oriol A, Martinez-Lopez J, Haenel M, Touzeau C, Ailawadhi S, Besemer B, de la Rubia Comos J, Encinas C, Mateos MV, Salwender H, Rodriguez-Otero P, Hulin C, Karlin L, Sureda Balari A, Bargay J, Benboubker L, Rosinol L, Tarantolo S, Terebelo H, Yang S, Wang J, Nnane I, Qi M, Kosh M, Delioukina M, Goldschmidt H. Daratumumab, carfilzomib, and dexamethasone in relapsed or refractory myeloma: final analysis of PLEIADES and EQUULEUS. Blood Cancer J. 2023 Mar 7;13(1):33. doi: 10.1038/s41408-023-00805-x. No abstract available.
He J, Berringer H, Heeg B, Ruan H, Kampfenkel T, Dwarakanathan HR, Johnston S, Mendes J, Lam A, Bathija S, Mackay EK. Indirect Treatment Comparison of Daratumumab, Pomalidomide, and Dexamethasone Versus Standard of Care in Patients with Difficult-to-Treat Relapsed/Refractory Multiple Myeloma. Adv Ther. 2022 Sep;39(9):4230-4249. doi: 10.1007/s12325-022-02226-x. Epub 2022 Jul 22.
Leleu X, Beksac M, Chou T, Dimopoulos M, Yoon SS, Prince HM, Pour L, Shelekhova T, Chari A, Khurana M, Zhang J, Obreja M, Qi M, Oriol A, Siegel D. Efficacy and safety of weekly carfilzomib (70 mg/m2), dexamethasone, and daratumumab (KdD70) is comparable to twice-weekly KdD56 while being a more convenient dosing option: a cross-study comparison of the CANDOR and EQUULEUS studies. Leuk Lymphoma. 2021 Feb;62(2):358-367. doi: 10.1080/10428194.2020.1832672. Epub 2020 Oct 28.
Other Identifiers
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54767414MMY1001
Identifier Type: OTHER
Identifier Source: secondary_id
2013-003491-12
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CR103015
Identifier Type: -
Identifier Source: org_study_id
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