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NCT01998971 · CITED IN SOURCE DOCUMENTS

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

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

Phase
PHASE1
Status at capture
COMPLETED
Registry last update
2025-04-25

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

No posted result sections were captured. Registered plans do not establish that a treatment works.

Who could take part
eligibility 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
healthy Volunteers
false
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Daratumumab will be administered with Velcade-dexamethasone (VD).
    intervention Names
    1. Drug: Daratumumab
    2. Drug: Velcade
    3. Drug: Dexamethasone
    4. Drug: Diphenhydramine
    5. Drug: Acetaminophen
    label
    Daratumumab + VD
    type
    EXPERIMENTAL
  2. description
    Daratumumab will be administered with Velcade-melphalan-prednisone (VMP).
    intervention Names
    1. Drug: Daratumumab
    2. Drug: Velcade
    3. Drug: Melphalan
    4. Drug: Prednisone
    5. Drug: Diphenhydramine
    6. Drug: Acetaminophen
    label
    Daratumumab + VMP
    type
    EXPERIMENTAL
  3. description
    Daratumumab will be administered with Velcade-thalidomide-dexamethasone (VTD).
    intervention Names
    1. Drug: Daratumumab
    2. Drug: Velcade
    3. Drug: Dexamethasone
    4. Drug: Thalidomide
    5. Drug: Diphenhydramine
    6. Drug: Acetaminophen
    label
    Daratumumab + VTD
    type
    EXPERIMENTAL
  4. description
    Daratumumab will be administered with pomalidomide-dexamethasone (Pom-dex).
    intervention Names
    1. Drug: Daratumumab
    2. Drug: Pomalidomide
    3. Drug: Dexamethasone
    4. Drug: Diphenhydramine
    5. Drug: Acetaminophen
    label
    Daratumumab + Pom-dex
    type
    EXPERIMENTAL
  5. description
    Daratumumab will be administered with carfilzomib (CFZ)-dexamethasone (CFZ-dex) regimen.
    intervention Names
    1. Drug: Daratumumab
    2. Drug: Dexamethasone
    3. Drug: Diphenhydramine
    4. Drug: Acetaminophen
    5. Drug: Carfilzomib
    6. Drug: Montelukast
    label
    Daratumumab + CFZ-dex
    type
    EXPERIMENTAL
  6. description
    Daratumumab will be administered with carfilzomib- lenalidomide-dexamethasone (KRd) regimen.
    intervention Names
    1. Drug: Daratumumab
    2. Drug: Dexamethasone
    3. Drug: Diphenhydramine
    4. Drug: Acetaminophen
    5. Drug: Carfilzomib
    6. Drug: Lenalidomide
    7. Drug: Montelukast
    label
    Daratumumab + KRd
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Daratumumab + CFZ-dex
    2. Daratumumab + KRd
    3. Daratumumab + Pom-dex
    4. Daratumumab + VD
    5. Daratumumab + VMP
    6. Daratumumab + VTD
    description
    Administered by either intravenous or subcutaneous infusions, in combination with the applicable backbone treatment.
    name
    Daratumumab
    type
    DRUG
  2. arm Group Labels
    1. Daratumumab + VD
    2. Daratumumab + VMP
    3. Daratumumab + VTD
    description
    Administered subcutaneously in accordance with product labeling and local standards.
    name
    Velcade
    type
    DRUG
  3. arm Group Labels
    1. Daratumumab + Pom-dex
    description
    Administered orally in accordance with product labeling and local standards.
    name
    Pomalidomide
    type
    DRUG
  4. arm Group Labels
    1. Daratumumab + CFZ-dex
    2. Daratumumab + KRd
    3. Daratumumab + Pom-dex
    4. Daratumumab + VD
    5. Daratumumab + VTD
    description
    Administered intravenously or orally in accordance with product labeling and local standards.
    name
    Dexamethasone
    type
    DRUG
  5. arm Group Labels
    1. Daratumumab + VMP
    description
    Administered orally in accordance with product labeling and local standards.
    name
    Melphalan
    type
    DRUG
  6. arm Group Labels
    1. Daratumumab + VMP
    description
    Administered intravenously or orally in accordance with product labeling and local standards.
    name
    Prednisone
    type
    DRUG
  7. arm Group Labels
    1. Daratumumab + VTD
    description
    Administered orally in accordance with product labeling and local standards.
    name
    Thalidomide
    type
    DRUG
  8. arm Group Labels
    1. Daratumumab + CFZ-dex
    2. Daratumumab + KRd
    3. Daratumumab + Pom-dex
    4. Daratumumab + VD
    5. Daratumumab + VMP
    6. Daratumumab + VTD
    description
    Administered in prophylactic doses intravenously (or equivalent) in accordance with product labeling and local standards.
    name
    Diphenhydramine
    type
    DRUG
  9. arm Group Labels
    1. Daratumumab + CFZ-dex
    2. Daratumumab + KRd
    3. Daratumumab + Pom-dex
    4. Daratumumab + VD
    5. Daratumumab + VMP
    6. Daratumumab + VTD
    description
    Administered in prophylactic doses by mouth in accordance with product labeling and local standards.
    name
    Acetaminophen
    type
    DRUG
  10. arm Group Labels
    1. Daratumumab + CFZ-dex
    2. Daratumumab + KRd
    description
    Administered intravenously in accordance with product labeling and local standards.
    name
    Carfilzomib
    type
    DRUG
  11. arm Group Labels
    1. Daratumumab + KRd
    description
    Administered orally in accordance with product labeling and local standards.
    name
    Lenalidomide
    type
    DRUG
  12. arm Group Labels
    1. Daratumumab + CFZ-dex
    2. Daratumumab + KRd
    description
    Administered intravenously or orally only with the first daratumumab dose in accordance with product labeling and local standards.
    name
    Montelukast
    type
    DRUG
Study design
allocation
NON_RANDOMIZED
intervention Model
PARALLEL
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
240
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. measure
    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. measure
    Number of participants affected by dose-limiting toxicities
    time Frame
    Up to 30 days after the last dose of study medication
secondary Outcomes
  1. measure
    Maximum observed concentration of daratumumab
    time Frame
    Up to post-treatment visit Week 9
  2. measure
    Number of participants with generation of antibodies to daratumumab
    time Frame
    Up to post-treatment visit Week 9
  3. measure
    Complete response rate
    time Frame
    Up to 25 months after last patient receives first dose of study drug
  4. measure
    Overall response rate
    time Frame
    Up to 25 months after last patient receives first dose of study drug
  5. measure
    Duration of response
    time Frame
    Up to 25 months after last patient receives first dose of study drug
Full study description
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.
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.
Source references
references
  1. citation
    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.
    pmid
    36882409
    type
    DERIVED
  2. citation
    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.
    pmid
    35876974
    type
    DERIVED
  3. citation
    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.
    pmid
    33112184
    type
    DERIVED
  4. citation
    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.
    pmid
    32078124
    type
    DERIVED
  5. citation
    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.
    pmid
    31113777
    type
    DERIVED
  6. citation
    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.
    pmid
    28637662
    type
    DERIVED
Source notices and limitations
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        months (95% CI: 13.9, not estimable) in the Kd group. Figure 10 Combination Treatment with Once-Weekly (20/70 mg/m 2 ) Carfilzomib and Dexamethasone EQUULEUS (NCT01998971) was an open-label, multi-cohort trial which evaluated the combination of DARZALEX with one-weekly carfilzomib and dexamethasone in patients with relapsed or r
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        nse (CR) 12 (14%) Very good partial response (VGPR) 28 (33%) Partial response (PR) 11 (13%) Combination Treatment with Pomalidomide and Dexamethasone EQUULEUS (NCT01998971) was an open-label trial in which 103 patients with multiple myeloma who had received a prior PI and an immunomodulatory agent, received 16 mg/kg DARZALEX in c
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        MWG-URC and MRD[-] status as assessed by the next-generation sequencing assay (ClonoSEQ) at any timepoint during the trial 43 (14%) 5 (3.2%) Figure 6 EQUULEUS (NCT01998971) EQUULEUS was an open-label, multi-cohort trial which evaluated the combination of Kyprolis with intravenous daratumumab and dexamethasone in patients with rel
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      source url
      https://api.fda.gov/drug/label.json?search=%28indications_and_usage%3Acancer+OR+indications_and_usage%3Acarcinoma+OR+indications_and_usage%3Acarcinomas+OR+indications_and_usage%3Alymphoma+OR+indications_and_usage%3Alymphomas+OR+indications_and_usage%3Aleukemia+OR+indications_and_usage%3Aleukaemia+OR+indications_and_usage%3Asarcoma+OR+indications_and_usage%3Asarcomas+OR+indications_and_usage%3Amelanoma+OR+indications_and_usage%3Amyeloma+OR+indications_and_usage%3Atumor+OR+indications_and_usage%3Atumors+OR+indications_and_usage%3Atumour+OR+indications_and_usage%3Atumours+OR+indications_and_usage%3Aneoplasm+OR+indications_and_usage%3Aneoplasms+OR+indications_and_usage%3Amalignant+OR+indications_and_usage%3Amalignancy+OR+indications_and_usage%3Amyelodysplastic+OR+indications_and_usage%3Amyelofibrosis+OR+indications_and_usage%3Amastocytosis+OR+indications_and_usage%3Aglioma+OR+indications_and_usage%3Aglioblastoma+OR+indications_and_usage%3Aneuroblastoma+OR+indications_and_usage%3Aretinoblastoma+OR+indications_and_usage%3Apheochromocytoma+OR+indications_and_usage%3Aparaganglioma+OR+indications_and_usage%3Amyeloproliferative+OR+indications_and_usage%3Awaldenstrom+OR+indications_and_usage%3Apolycythemia+OR+indications_and_usage%3Athrombocythemia+OR+indications_and_usage%3Adesmoid+OR+indications_and_usage%3Aneurofibromatosis+OR+indications_and_usage%3Ahistiocytosis%29+AND+%28openfda.application_number%3ANDA%2A+OR+openfda.application_number%3ABLA%2A%29&limit=100&skip=400&sort=id%3Aasc
      spl effective time
      20250618
      spl set id
      ea66eb30-e665-4693-99a1-a9d3b4bbe2d6

    Preserved source evidence · Not medical advice